User login
Novel agent shows promise against cat allergy
One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.
The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.
The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.
Dr. de Blay admitted he is “quite excited” about the results.
“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.
Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV1) of at least 20% from baseline.
The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.
Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.
“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.
To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV1 at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.
They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.
Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).
The FEV1 area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.
In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).
“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.
Regeneron plans to start a phase 3 trial soon, he reported.
Promising results
“The study is well designed and shows a reduction in drop of FEV1 in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.
“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.
“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.
“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.
Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.
The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.
The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.
Dr. de Blay admitted he is “quite excited” about the results.
“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.
Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV1) of at least 20% from baseline.
The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.
Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.
“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.
To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV1 at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.
They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.
Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).
The FEV1 area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.
In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).
“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.
Regeneron plans to start a phase 3 trial soon, he reported.
Promising results
“The study is well designed and shows a reduction in drop of FEV1 in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.
“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.
“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.
“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.
Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.
The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.
The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.
Dr. de Blay admitted he is “quite excited” about the results.
“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.
Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV1) of at least 20% from baseline.
The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.
Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.
“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.
To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV1 at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.
They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.
Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).
The FEV1 area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.
In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).
“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.
Regeneron plans to start a phase 3 trial soon, he reported.
Promising results
“The study is well designed and shows a reduction in drop of FEV1 in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.
“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.
“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.
“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.
Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AAAAI
Peanut sublingual immunotherapy feasible and effective in toddlers
Sublingual immunotherapy for the treatment of peanut allergy is safe and effective, even in children as young as age 1 year.
In a double-blind, placebo-controlled, food challenge (DBPCFC) of some 36 peanut-allergic children (mean age 2.2 years, range 1-4 years), those who were randomly assigned to receive peanut sublingual immunotherapy (PNSLIT) showed significant desensitization compared with those who received placebo.
In addition, there was a “strong potential” for sustained unresponsiveness at 3 months for the toddlers who received the active treatment.
The findings were presented in a late breaking oral abstract session at the 2021 American Academy of Allergy, Asthma & Immunology virtual annual meeting (Abstract L2).
“A year ago, the Food and Drug Administration approved the oral agent Palforzia (peanut allergen powder) for the treatment of peanut allergy in children 4 and older, and it is a great option, but I think what we have learned over time is that this approach is not for everybody,” Edwin H. Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, said in an interview.
Palforzia is a powder that is mixed in food like yogurt or pudding which the child then eats daily, according to a rigorous schedule. But Palforzia treatment presents some difficulties.
“Palforzia requires getting the powder dose, mixing it with food, like pudding or apple sauce, then eating it, which can take up to 30 minutes depending on age and kids’ cooperation. It tastes and smells like peanut which can cause aversion. Kids have to refrain from exercise or strenuous activity for at least 30 minutes before and after dosing and have to be observed for up to 2 hours post dose for symptoms,” Dr. Kim said.
“It’s a great drug, but the treatment could be overly difficult for certain families to be able to do, and in some cases the side effects may be more than certain patients are able or willing to handle, so there is a real urgent need for alternative approaches,” Dr. Kim said. “SLIT is several drops under the tongue, held for 2 minutes, swallowed and done.”
In the current placebo-controlled study, he and his group tested the feasibility, efficacy, and safety of the sublingual approach to peanut allergy in children age 4 years and younger.
Both groups were similar with regard to gender, race, ethnicity, atopic history, peanut skin prick test, and qualifying DBPCFC, and all children were previously allergic with positive blood and skin tests, with a positive reaction during baseline food challenge, thus proving the allergy and establishing the baseline threshold.
“We have learned from some studies, for instance the DEVIL and LEAP studies, that strongly suggest that the immune systems in younger patients may be more amenable to change, and there may be some justification for early intervention,” he said.
“Based on both of those ideas, we wanted to take our sublingual approach, which we have shown to have a pretty good efficacy in older children, and bring it down to this younger group and see if it still could have the same efficacy and also maintain what seems to be a very good safety signal.”
The researchers randomly assigned the children to receive PNSLIT at a daily maintenance dose of 4 mg peanut protein (n = 19) or to receive placebo (n = 17) for 36 months.
“There was a 5- to 6-month buildup period where the SLIT dose was increased every 1-2 weeks up to the target dose of 4 mg, and then the final dose of 4 mg was continued through to the end of the study,” Dr. Kim noted.
Over a total of 20,593 potential dosing days, the children took 91.2% of SLIT doses and 93.5% of placebo doses.
At the end of the 3-year study period, the children were challenged by DBPCFC with up to 4,333 mg of peanut protein.
Sustained unresponsiveness was assessed by an identical DBPCFC after discontinuation of the immunotherapy for 3 months.
Cumulative tolerated dose increased from a median of 143 mg to 4,443 mg in the PNSLIT group, compared with a median of 43 mg to 143 mg in the placebo group (P < .0001).
Fourteen of the children receiving PNSLIT, and none of the children receiving placebo, passed the desensitization food challenge. Twelve of the children receiving PNSLIT and two of the children receiving placebo passed the sustained unresponsiveness challenge.
Children who underwent the immunotherapy saw a decrease in their peanut skin prick test from 10 mm to 3.25 mm, compared to an increase from 11.5 mm to 12 mm with placebo (P < .0001).
The most common side effect reported was itching or irritation in the mouth. Most side effects resolved on their own, although some patients used an antihistamine. Getting children as young as 1 to hold the dose under their tongue was a challenge in some instances, but it eventually worked out, Dr. Kim said.
“It took a lot of work from the parents as well as from our research coordinators in trying to train these young kids to, first of all, allow us to put the peanut medication in the mouth and then to try as best as possible to keep it in their mouth for up to 2 minutes, but the families involved in our study were very dedicated and so we were able to get through that,” he said.
Study merits larger numbers
“Among the 36 who completed the 3 years of therapy, the authors report significant rates of desensitization among treated children compared with those receiving placebo. Furthermore, this effect was persistent for at least 3 months after stopping therapy in a subgroup of the children,” said Leonard B. Bacharier, MD, director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville, Tenn.
“Overall, these findings suggest the promise of peanut SLIT, which should be studied in larger numbers of preschool children,” Dr. Bacharier, who was not part of the study, said in an interview.
Jonathan A. Bernstein, MD, professor of medicine, University of Cincinnati, agreed.
“It’s a well-designed study, it’s small, but it’s promising,” Dr. Bernstein, who was not involved with the study, said in an interview.
“They did show that most of the patients who got the sublingual therapy were able to get to the target dose and develop tolerance, so I think it’s promising. We know that this stuff works. This is just more data from a well-controlled study in a younger population,” he said.
“We do OIT [oral immunotherapy] and sublingual but we don’t do it in such young children in our practice. The youngest is 3 years old, because they have to understand what is going on and cooperate. If they don’t cooperate it’s not possible.”
Dr. Kim reported financial relationships with DBV Technologies, Kenota Health, Ukko, Aimmune Therapeutics, ALK, AllerGenis, Belhaven Pharma, Duke Clinical Research Institute, Nutricia, NIH/NIAID, NIH/NCCIH, NIH/Immune Tolerance Network, FARE, and the Wallace Foundation. Dr. Bacharier and Dr. Bernstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sublingual immunotherapy for the treatment of peanut allergy is safe and effective, even in children as young as age 1 year.
In a double-blind, placebo-controlled, food challenge (DBPCFC) of some 36 peanut-allergic children (mean age 2.2 years, range 1-4 years), those who were randomly assigned to receive peanut sublingual immunotherapy (PNSLIT) showed significant desensitization compared with those who received placebo.
In addition, there was a “strong potential” for sustained unresponsiveness at 3 months for the toddlers who received the active treatment.
The findings were presented in a late breaking oral abstract session at the 2021 American Academy of Allergy, Asthma & Immunology virtual annual meeting (Abstract L2).
“A year ago, the Food and Drug Administration approved the oral agent Palforzia (peanut allergen powder) for the treatment of peanut allergy in children 4 and older, and it is a great option, but I think what we have learned over time is that this approach is not for everybody,” Edwin H. Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, said in an interview.
Palforzia is a powder that is mixed in food like yogurt or pudding which the child then eats daily, according to a rigorous schedule. But Palforzia treatment presents some difficulties.
“Palforzia requires getting the powder dose, mixing it with food, like pudding or apple sauce, then eating it, which can take up to 30 minutes depending on age and kids’ cooperation. It tastes and smells like peanut which can cause aversion. Kids have to refrain from exercise or strenuous activity for at least 30 minutes before and after dosing and have to be observed for up to 2 hours post dose for symptoms,” Dr. Kim said.
“It’s a great drug, but the treatment could be overly difficult for certain families to be able to do, and in some cases the side effects may be more than certain patients are able or willing to handle, so there is a real urgent need for alternative approaches,” Dr. Kim said. “SLIT is several drops under the tongue, held for 2 minutes, swallowed and done.”
In the current placebo-controlled study, he and his group tested the feasibility, efficacy, and safety of the sublingual approach to peanut allergy in children age 4 years and younger.
Both groups were similar with regard to gender, race, ethnicity, atopic history, peanut skin prick test, and qualifying DBPCFC, and all children were previously allergic with positive blood and skin tests, with a positive reaction during baseline food challenge, thus proving the allergy and establishing the baseline threshold.
“We have learned from some studies, for instance the DEVIL and LEAP studies, that strongly suggest that the immune systems in younger patients may be more amenable to change, and there may be some justification for early intervention,” he said.
“Based on both of those ideas, we wanted to take our sublingual approach, which we have shown to have a pretty good efficacy in older children, and bring it down to this younger group and see if it still could have the same efficacy and also maintain what seems to be a very good safety signal.”
The researchers randomly assigned the children to receive PNSLIT at a daily maintenance dose of 4 mg peanut protein (n = 19) or to receive placebo (n = 17) for 36 months.
“There was a 5- to 6-month buildup period where the SLIT dose was increased every 1-2 weeks up to the target dose of 4 mg, and then the final dose of 4 mg was continued through to the end of the study,” Dr. Kim noted.
Over a total of 20,593 potential dosing days, the children took 91.2% of SLIT doses and 93.5% of placebo doses.
At the end of the 3-year study period, the children were challenged by DBPCFC with up to 4,333 mg of peanut protein.
Sustained unresponsiveness was assessed by an identical DBPCFC after discontinuation of the immunotherapy for 3 months.
Cumulative tolerated dose increased from a median of 143 mg to 4,443 mg in the PNSLIT group, compared with a median of 43 mg to 143 mg in the placebo group (P < .0001).
Fourteen of the children receiving PNSLIT, and none of the children receiving placebo, passed the desensitization food challenge. Twelve of the children receiving PNSLIT and two of the children receiving placebo passed the sustained unresponsiveness challenge.
Children who underwent the immunotherapy saw a decrease in their peanut skin prick test from 10 mm to 3.25 mm, compared to an increase from 11.5 mm to 12 mm with placebo (P < .0001).
The most common side effect reported was itching or irritation in the mouth. Most side effects resolved on their own, although some patients used an antihistamine. Getting children as young as 1 to hold the dose under their tongue was a challenge in some instances, but it eventually worked out, Dr. Kim said.
“It took a lot of work from the parents as well as from our research coordinators in trying to train these young kids to, first of all, allow us to put the peanut medication in the mouth and then to try as best as possible to keep it in their mouth for up to 2 minutes, but the families involved in our study were very dedicated and so we were able to get through that,” he said.
Study merits larger numbers
“Among the 36 who completed the 3 years of therapy, the authors report significant rates of desensitization among treated children compared with those receiving placebo. Furthermore, this effect was persistent for at least 3 months after stopping therapy in a subgroup of the children,” said Leonard B. Bacharier, MD, director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville, Tenn.
“Overall, these findings suggest the promise of peanut SLIT, which should be studied in larger numbers of preschool children,” Dr. Bacharier, who was not part of the study, said in an interview.
Jonathan A. Bernstein, MD, professor of medicine, University of Cincinnati, agreed.
“It’s a well-designed study, it’s small, but it’s promising,” Dr. Bernstein, who was not involved with the study, said in an interview.
“They did show that most of the patients who got the sublingual therapy were able to get to the target dose and develop tolerance, so I think it’s promising. We know that this stuff works. This is just more data from a well-controlled study in a younger population,” he said.
“We do OIT [oral immunotherapy] and sublingual but we don’t do it in such young children in our practice. The youngest is 3 years old, because they have to understand what is going on and cooperate. If they don’t cooperate it’s not possible.”
Dr. Kim reported financial relationships with DBV Technologies, Kenota Health, Ukko, Aimmune Therapeutics, ALK, AllerGenis, Belhaven Pharma, Duke Clinical Research Institute, Nutricia, NIH/NIAID, NIH/NCCIH, NIH/Immune Tolerance Network, FARE, and the Wallace Foundation. Dr. Bacharier and Dr. Bernstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Sublingual immunotherapy for the treatment of peanut allergy is safe and effective, even in children as young as age 1 year.
In a double-blind, placebo-controlled, food challenge (DBPCFC) of some 36 peanut-allergic children (mean age 2.2 years, range 1-4 years), those who were randomly assigned to receive peanut sublingual immunotherapy (PNSLIT) showed significant desensitization compared with those who received placebo.
In addition, there was a “strong potential” for sustained unresponsiveness at 3 months for the toddlers who received the active treatment.
The findings were presented in a late breaking oral abstract session at the 2021 American Academy of Allergy, Asthma & Immunology virtual annual meeting (Abstract L2).
“A year ago, the Food and Drug Administration approved the oral agent Palforzia (peanut allergen powder) for the treatment of peanut allergy in children 4 and older, and it is a great option, but I think what we have learned over time is that this approach is not for everybody,” Edwin H. Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, said in an interview.
Palforzia is a powder that is mixed in food like yogurt or pudding which the child then eats daily, according to a rigorous schedule. But Palforzia treatment presents some difficulties.
“Palforzia requires getting the powder dose, mixing it with food, like pudding or apple sauce, then eating it, which can take up to 30 minutes depending on age and kids’ cooperation. It tastes and smells like peanut which can cause aversion. Kids have to refrain from exercise or strenuous activity for at least 30 minutes before and after dosing and have to be observed for up to 2 hours post dose for symptoms,” Dr. Kim said.
“It’s a great drug, but the treatment could be overly difficult for certain families to be able to do, and in some cases the side effects may be more than certain patients are able or willing to handle, so there is a real urgent need for alternative approaches,” Dr. Kim said. “SLIT is several drops under the tongue, held for 2 minutes, swallowed and done.”
In the current placebo-controlled study, he and his group tested the feasibility, efficacy, and safety of the sublingual approach to peanut allergy in children age 4 years and younger.
Both groups were similar with regard to gender, race, ethnicity, atopic history, peanut skin prick test, and qualifying DBPCFC, and all children were previously allergic with positive blood and skin tests, with a positive reaction during baseline food challenge, thus proving the allergy and establishing the baseline threshold.
“We have learned from some studies, for instance the DEVIL and LEAP studies, that strongly suggest that the immune systems in younger patients may be more amenable to change, and there may be some justification for early intervention,” he said.
“Based on both of those ideas, we wanted to take our sublingual approach, which we have shown to have a pretty good efficacy in older children, and bring it down to this younger group and see if it still could have the same efficacy and also maintain what seems to be a very good safety signal.”
The researchers randomly assigned the children to receive PNSLIT at a daily maintenance dose of 4 mg peanut protein (n = 19) or to receive placebo (n = 17) for 36 months.
“There was a 5- to 6-month buildup period where the SLIT dose was increased every 1-2 weeks up to the target dose of 4 mg, and then the final dose of 4 mg was continued through to the end of the study,” Dr. Kim noted.
Over a total of 20,593 potential dosing days, the children took 91.2% of SLIT doses and 93.5% of placebo doses.
At the end of the 3-year study period, the children were challenged by DBPCFC with up to 4,333 mg of peanut protein.
Sustained unresponsiveness was assessed by an identical DBPCFC after discontinuation of the immunotherapy for 3 months.
Cumulative tolerated dose increased from a median of 143 mg to 4,443 mg in the PNSLIT group, compared with a median of 43 mg to 143 mg in the placebo group (P < .0001).
Fourteen of the children receiving PNSLIT, and none of the children receiving placebo, passed the desensitization food challenge. Twelve of the children receiving PNSLIT and two of the children receiving placebo passed the sustained unresponsiveness challenge.
Children who underwent the immunotherapy saw a decrease in their peanut skin prick test from 10 mm to 3.25 mm, compared to an increase from 11.5 mm to 12 mm with placebo (P < .0001).
The most common side effect reported was itching or irritation in the mouth. Most side effects resolved on their own, although some patients used an antihistamine. Getting children as young as 1 to hold the dose under their tongue was a challenge in some instances, but it eventually worked out, Dr. Kim said.
“It took a lot of work from the parents as well as from our research coordinators in trying to train these young kids to, first of all, allow us to put the peanut medication in the mouth and then to try as best as possible to keep it in their mouth for up to 2 minutes, but the families involved in our study were very dedicated and so we were able to get through that,” he said.
Study merits larger numbers
“Among the 36 who completed the 3 years of therapy, the authors report significant rates of desensitization among treated children compared with those receiving placebo. Furthermore, this effect was persistent for at least 3 months after stopping therapy in a subgroup of the children,” said Leonard B. Bacharier, MD, director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt, Nashville, Tenn.
“Overall, these findings suggest the promise of peanut SLIT, which should be studied in larger numbers of preschool children,” Dr. Bacharier, who was not part of the study, said in an interview.
Jonathan A. Bernstein, MD, professor of medicine, University of Cincinnati, agreed.
“It’s a well-designed study, it’s small, but it’s promising,” Dr. Bernstein, who was not involved with the study, said in an interview.
“They did show that most of the patients who got the sublingual therapy were able to get to the target dose and develop tolerance, so I think it’s promising. We know that this stuff works. This is just more data from a well-controlled study in a younger population,” he said.
“We do OIT [oral immunotherapy] and sublingual but we don’t do it in such young children in our practice. The youngest is 3 years old, because they have to understand what is going on and cooperate. If they don’t cooperate it’s not possible.”
Dr. Kim reported financial relationships with DBV Technologies, Kenota Health, Ukko, Aimmune Therapeutics, ALK, AllerGenis, Belhaven Pharma, Duke Clinical Research Institute, Nutricia, NIH/NIAID, NIH/NCCIH, NIH/Immune Tolerance Network, FARE, and the Wallace Foundation. Dr. Bacharier and Dr. Bernstein have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AAAAI
Masks don’t affect oxygen saturation in people with asthma
Wearing a mask to protect against transmission of COVID-19 does not decrease oxygen saturation, according to a new study.
Oxygen saturation did not decline in more than 200 mask-wearing individuals attending an asthma and allergy clinic, regardless of the type of mask they were wearing and how long they had been wearing the mask.
The study was presented in a late breaking poster session by Marisa Hodges, MD, University of Michigan, Ann Arbor, at the virtual annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“In patients with or without asthma, wearing a mask does not decrease your oxygen level,” coauthor Alan P. Baptist, MD, MPH, director of the University of Michigan Comprehensive Asthma Program, said in an interview.
“Some of my asthma patients had called me requesting an exemption from wearing a mask because they feared that their oxygen intake may be affected, and that got me thinking,” said Malika Gupta, MD, assistant professor, division of allergy and immunology, University of Michigan, Ann Arbor, and the study’s lead investigator.
“We say masks are safe, but I couldn’t find any data to support that statement, and we wanted to provide them with evidence, so they could feel comfortable about wearing their masks,” Dr. Gupta added.
The study collected 223 surveys from adult and pediatric patients presenting to the University of Michigan Medicine Allergy Clinic between Sept. 10 and Oct. 23, 2020.
The patients were asked whether they had a diagnosis of asthma, their degree of perceived control if they did have asthma, the type of mask they were wearing, and how long they had been wearing it.
Investigators obtained resting pulse oximetry readings to measure oxygen saturation (SpO2) from all study participants.
Forty percent of the participants were male, 46% reported having asthma, and 27% were age 19 years or younger.
Overall, the mean SpO2 was 98% (range, 93%-100%) in both asthma and nonasthma groups.
The study also looked at SpO2 with 3 different types of masks: fabric, surgical, and N95.
The mean SpO2 for a fabric mask was 98% (119 patients), for a surgical mask it was also 98% (83 patients), and for the N95 mask it was 99% (3 patients).
Similar results were found with duration of mask use, with the mean SpO2 98% in those wearing a mask for 1 hour or less and 99% in those wearing a mask for 1 hour or longer.
People with asthma who reported they were well controlled showed similar mean SpO2 levels (98%) compared with those who reported they were not well controlled (96.5%)
“No effect on oxygen saturation was noted in any patients, whether they had asthma or not, whether it was well controlled or not, and this was also true regardless of what masks they wore and how long they wore the masks for. So our data reinforce that wearing a mask, whether it be a surgical mask, cloth mask, or N95, is completely safe,” Dr. Baptist said.
“We know wearing a mask is an essential step we can all take to reduce the spread of COVID-19, and we hope these data will give peace of mind to individuals who fear that wearing a mask will adversely affect their oxygen levels,” Dr. Gupta added.
Leonard B. Bacharier, MD, professor of pediatrics and director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn., agreed with the investigators’ conclusions.
“The authors found no differences in oxygen saturations between asthmatic and nonasthmatic patients, nor was there a difference based upon mask use or type,” Dr. Bacharier, who was not part of the study, said in an interview.
“These findings provide reassurance that patients, including those with stable asthma, do not experience impaired oxygenation while wearing a mask.”
Dr. Hodges, Dr. Baptist, and Dr. Bacharier have disclosed no relevant financial relationships.
This article was updated 3/11/21.
A version of this article first appeared on Medscape.com.
Wearing a mask to protect against transmission of COVID-19 does not decrease oxygen saturation, according to a new study.
Oxygen saturation did not decline in more than 200 mask-wearing individuals attending an asthma and allergy clinic, regardless of the type of mask they were wearing and how long they had been wearing the mask.
The study was presented in a late breaking poster session by Marisa Hodges, MD, University of Michigan, Ann Arbor, at the virtual annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“In patients with or without asthma, wearing a mask does not decrease your oxygen level,” coauthor Alan P. Baptist, MD, MPH, director of the University of Michigan Comprehensive Asthma Program, said in an interview.
“Some of my asthma patients had called me requesting an exemption from wearing a mask because they feared that their oxygen intake may be affected, and that got me thinking,” said Malika Gupta, MD, assistant professor, division of allergy and immunology, University of Michigan, Ann Arbor, and the study’s lead investigator.
“We say masks are safe, but I couldn’t find any data to support that statement, and we wanted to provide them with evidence, so they could feel comfortable about wearing their masks,” Dr. Gupta added.
The study collected 223 surveys from adult and pediatric patients presenting to the University of Michigan Medicine Allergy Clinic between Sept. 10 and Oct. 23, 2020.
The patients were asked whether they had a diagnosis of asthma, their degree of perceived control if they did have asthma, the type of mask they were wearing, and how long they had been wearing it.
Investigators obtained resting pulse oximetry readings to measure oxygen saturation (SpO2) from all study participants.
Forty percent of the participants were male, 46% reported having asthma, and 27% were age 19 years or younger.
Overall, the mean SpO2 was 98% (range, 93%-100%) in both asthma and nonasthma groups.
The study also looked at SpO2 with 3 different types of masks: fabric, surgical, and N95.
The mean SpO2 for a fabric mask was 98% (119 patients), for a surgical mask it was also 98% (83 patients), and for the N95 mask it was 99% (3 patients).
Similar results were found with duration of mask use, with the mean SpO2 98% in those wearing a mask for 1 hour or less and 99% in those wearing a mask for 1 hour or longer.
People with asthma who reported they were well controlled showed similar mean SpO2 levels (98%) compared with those who reported they were not well controlled (96.5%)
“No effect on oxygen saturation was noted in any patients, whether they had asthma or not, whether it was well controlled or not, and this was also true regardless of what masks they wore and how long they wore the masks for. So our data reinforce that wearing a mask, whether it be a surgical mask, cloth mask, or N95, is completely safe,” Dr. Baptist said.
“We know wearing a mask is an essential step we can all take to reduce the spread of COVID-19, and we hope these data will give peace of mind to individuals who fear that wearing a mask will adversely affect their oxygen levels,” Dr. Gupta added.
Leonard B. Bacharier, MD, professor of pediatrics and director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn., agreed with the investigators’ conclusions.
“The authors found no differences in oxygen saturations between asthmatic and nonasthmatic patients, nor was there a difference based upon mask use or type,” Dr. Bacharier, who was not part of the study, said in an interview.
“These findings provide reassurance that patients, including those with stable asthma, do not experience impaired oxygenation while wearing a mask.”
Dr. Hodges, Dr. Baptist, and Dr. Bacharier have disclosed no relevant financial relationships.
This article was updated 3/11/21.
A version of this article first appeared on Medscape.com.
Wearing a mask to protect against transmission of COVID-19 does not decrease oxygen saturation, according to a new study.
Oxygen saturation did not decline in more than 200 mask-wearing individuals attending an asthma and allergy clinic, regardless of the type of mask they were wearing and how long they had been wearing the mask.
The study was presented in a late breaking poster session by Marisa Hodges, MD, University of Michigan, Ann Arbor, at the virtual annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“In patients with or without asthma, wearing a mask does not decrease your oxygen level,” coauthor Alan P. Baptist, MD, MPH, director of the University of Michigan Comprehensive Asthma Program, said in an interview.
“Some of my asthma patients had called me requesting an exemption from wearing a mask because they feared that their oxygen intake may be affected, and that got me thinking,” said Malika Gupta, MD, assistant professor, division of allergy and immunology, University of Michigan, Ann Arbor, and the study’s lead investigator.
“We say masks are safe, but I couldn’t find any data to support that statement, and we wanted to provide them with evidence, so they could feel comfortable about wearing their masks,” Dr. Gupta added.
The study collected 223 surveys from adult and pediatric patients presenting to the University of Michigan Medicine Allergy Clinic between Sept. 10 and Oct. 23, 2020.
The patients were asked whether they had a diagnosis of asthma, their degree of perceived control if they did have asthma, the type of mask they were wearing, and how long they had been wearing it.
Investigators obtained resting pulse oximetry readings to measure oxygen saturation (SpO2) from all study participants.
Forty percent of the participants were male, 46% reported having asthma, and 27% were age 19 years or younger.
Overall, the mean SpO2 was 98% (range, 93%-100%) in both asthma and nonasthma groups.
The study also looked at SpO2 with 3 different types of masks: fabric, surgical, and N95.
The mean SpO2 for a fabric mask was 98% (119 patients), for a surgical mask it was also 98% (83 patients), and for the N95 mask it was 99% (3 patients).
Similar results were found with duration of mask use, with the mean SpO2 98% in those wearing a mask for 1 hour or less and 99% in those wearing a mask for 1 hour or longer.
People with asthma who reported they were well controlled showed similar mean SpO2 levels (98%) compared with those who reported they were not well controlled (96.5%)
“No effect on oxygen saturation was noted in any patients, whether they had asthma or not, whether it was well controlled or not, and this was also true regardless of what masks they wore and how long they wore the masks for. So our data reinforce that wearing a mask, whether it be a surgical mask, cloth mask, or N95, is completely safe,” Dr. Baptist said.
“We know wearing a mask is an essential step we can all take to reduce the spread of COVID-19, and we hope these data will give peace of mind to individuals who fear that wearing a mask will adversely affect their oxygen levels,” Dr. Gupta added.
Leonard B. Bacharier, MD, professor of pediatrics and director of the Center for Pediatric Asthma, Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn., agreed with the investigators’ conclusions.
“The authors found no differences in oxygen saturations between asthmatic and nonasthmatic patients, nor was there a difference based upon mask use or type,” Dr. Bacharier, who was not part of the study, said in an interview.
“These findings provide reassurance that patients, including those with stable asthma, do not experience impaired oxygenation while wearing a mask.”
Dr. Hodges, Dr. Baptist, and Dr. Bacharier have disclosed no relevant financial relationships.
This article was updated 3/11/21.
A version of this article first appeared on Medscape.com.
FROM AAAAI
Left-handed cardiology trainees face unique challenges
Left-handed cardiology trainees face unique challenges when it comes to learning how to perform common procedures, according to a new report.
About 10% of the world’s population is left-handed, and rates of left-handedness among medical students and practicing physicians is believed to be similar.
“Extrapolating this to 3,017 active general cardiovascular fellowship positions and 339 interventional cardiology fellowship positions for the year 2018-2019, it is estimated there are more than 300 LH [left-handed] trainees in U.S. cardiovascular fellowship programs at any given time. Despite this, any standard clinical setting is designed to be convenient for RH [right-handed] providers, thereby creating a variable amount of impediment for LH trainees,” wrote Prashant Patel, MD, and Mandira Patel, DO, from University of California, Riverside.
“With about 10% prevalence, left-handedness is far more common, including among cardiology trainees, than most people realize. Most of the procedural set-up is designed for the right-hand majority, and it may cause a variable amount of impediment for the left-handed trainees. It is very important for the academic cardiology community to recognize this,” Dr. Prashant Patel said in an interview.
The findings were published in the Jan.5 issue of the Journal of the American College of Cardiology.
Dr. Prashant Patel, who is left-handed, said he was prompted to look into the issue because of his own experience.
“In my first procedural rotation several years ago, I noticed that I was positioning myself somewhat differently than my attendings due to my preference for using my left hand for fine motor control,” he said. “I started looking up existing literature to see what other left-handed cardiologists have done in the past, but realized that nothing along this line was published.
“I started discussions with my colleagues and superiors and found that our small cardiology fellowship program contains about 20%-40% of left-handed trainees at any given time, and we felt it was important to elaborate on this,” he added.
Practice makes perfect, and repeated practice eventually leads to automation of motor procedures, but the learning curve may be more protracted for left-handed trainees. “Acquisition of procedural skills is a function of time and repetition. Eventually, most practicing left-handed cardiologists see that as a nonissue and do not even realize they may have gone through a differential learning curve based on their hand dominance,” Dr. Prashant Patel noted.
“South-paw” cardiology trainees face their first challenge in the examination room.
Physicians typically examine patients from the right-hand side of the bed. The majority of clinic offices are set up for the right-handed provider, with the examining table placed with the head of the bed distal from the door and the left side of the bed aligned in close proximity to the wall, leaving examination on the right side of the patient as the only option. In the hospital setting, monitors and intravenous poles are usually placed on the patient’s left-hand side of the bed.
“This practice, more than anything else, is born out of tradition. The same clinical examination can potentially be performed with the same accuracy and efficacy from the left-hand side,” said Dr. Prashant Patel.
In the echocardiography lab, some facilities perform transthoracic echocardiography from the right side of the patient, thereby requiring the operator to get the right scanning hand over and across the patient.
“This is ergonomically disadvantageous, as one has to sit on the table, reach over the patient, and twist the torso. Scanning from the left side of the patient is ergonomically superior in preventing back injuries and may be advantageous for the left-handed person as the probe is held in the dominant hand,” noted Dr. Prashant Patel.
In the cath lab, the difficulty for left-handed cardiologists starts with establishing arterial or venous access.
“The two most frequently used arterial-access sites are right radial and right femoral. Both of them pose unique challenges in terms of positioning for most left-handed trainees in the early part of their training. The right arm is kept adducted and externally rotated in a standard setup, which is difficult to access for a left-handed operator, and would require the operator to use their nondominant right hand awkwardly to gain access,” he said.
A solution could be to reposition the patient’s arm using a radial board into abduction of the arm at about 45 degrees, with external rotation.
“This creates room for the left-handed operator to stand caudal to the patient’s arm and approach the radial access site conveniently using their dominant hand,” Dr. Prashant Patel suggested.
For the femoral approach, the left-handed operator could stand left of the patient and either get left femoral access or reach out across to the right groin of the patient and obtain access in this manner, or alternatively, the operator could resort to using their right hand to gain right femoral access.
“The large size of the femoral vessels allows even the strongly left-handed operators to get accustomed to using their nondominant hand with practice. This may be preferable to switching to the left side,” he said.
There are also some advantages to being left-handed, Dr. Prashant Patel said.
This is true “especially in the cath lab, for example, establishing antegrade right femoral access for peripheral interventions,” he noted. “Having a left-handed operator can also come in handy when two operators need to simultaneously and quickly work on both groins, as is often the case in complex coronary or structural interventions. Left-handed operators are also at ease obtaining left radial access, which has been shown to have certain advantages over right radial access.”
“We hope to raise awareness among the academic cardiology community about left-handedness,” Dr. Prashant Patel added. “We hope that acknowledgment, support, and minor modifications in work flow will allow a lot of young trainees in the early part of their career to stay on course and realize their full potential in this procedural specialty.”
An insightful paper
“This paper by Dr. Prashant Patel and Dr. Mandira Patel is most insightful about the unique challenges and occasional opportunities for the left-handed cardiologist,” wrote Simon Kendall, MBBS, president of the Society for Cardiothoracic Surgery Great Britain and Ireland, London, in an accompanying response.
“As a left-handed cardiac surgeon, I am embarrassed not to have considered such significant issues for my cardiology colleagues: the edict of examining a patient from the right side, performing echocardiography with the right hand, and the complex arena of catheter laboratory that is designed around the right-handed majority. Before reading this paper, I had not appreciated that for my whole career I have had to use my less-favored right hand when inserting a balloon pump,” Dr. Kendall wrote.
“Dr. Patel and Dr. Patel have written very sensible conclusions, such as that left-handedness should be acknowledged and adapted for and the training environment has to help access the specific tips and tricks from others, as shared in cardiac surgery, for instance. They rightly describe this as not a binary phenomenon and that there is a spectrum of laterality, so that some left-handers will adapt with ease and others will need more time and patience to learn the necessary skills,” he wrote. “We are fortunate to live in an era of increasing awareness and tolerance. Left-handedness is one small example of such progress.”
A version of this article first appeared on Medscape.com.
Left-handed cardiology trainees face unique challenges when it comes to learning how to perform common procedures, according to a new report.
About 10% of the world’s population is left-handed, and rates of left-handedness among medical students and practicing physicians is believed to be similar.
“Extrapolating this to 3,017 active general cardiovascular fellowship positions and 339 interventional cardiology fellowship positions for the year 2018-2019, it is estimated there are more than 300 LH [left-handed] trainees in U.S. cardiovascular fellowship programs at any given time. Despite this, any standard clinical setting is designed to be convenient for RH [right-handed] providers, thereby creating a variable amount of impediment for LH trainees,” wrote Prashant Patel, MD, and Mandira Patel, DO, from University of California, Riverside.
“With about 10% prevalence, left-handedness is far more common, including among cardiology trainees, than most people realize. Most of the procedural set-up is designed for the right-hand majority, and it may cause a variable amount of impediment for the left-handed trainees. It is very important for the academic cardiology community to recognize this,” Dr. Prashant Patel said in an interview.
The findings were published in the Jan.5 issue of the Journal of the American College of Cardiology.
Dr. Prashant Patel, who is left-handed, said he was prompted to look into the issue because of his own experience.
“In my first procedural rotation several years ago, I noticed that I was positioning myself somewhat differently than my attendings due to my preference for using my left hand for fine motor control,” he said. “I started looking up existing literature to see what other left-handed cardiologists have done in the past, but realized that nothing along this line was published.
“I started discussions with my colleagues and superiors and found that our small cardiology fellowship program contains about 20%-40% of left-handed trainees at any given time, and we felt it was important to elaborate on this,” he added.
Practice makes perfect, and repeated practice eventually leads to automation of motor procedures, but the learning curve may be more protracted for left-handed trainees. “Acquisition of procedural skills is a function of time and repetition. Eventually, most practicing left-handed cardiologists see that as a nonissue and do not even realize they may have gone through a differential learning curve based on their hand dominance,” Dr. Prashant Patel noted.
“South-paw” cardiology trainees face their first challenge in the examination room.
Physicians typically examine patients from the right-hand side of the bed. The majority of clinic offices are set up for the right-handed provider, with the examining table placed with the head of the bed distal from the door and the left side of the bed aligned in close proximity to the wall, leaving examination on the right side of the patient as the only option. In the hospital setting, monitors and intravenous poles are usually placed on the patient’s left-hand side of the bed.
“This practice, more than anything else, is born out of tradition. The same clinical examination can potentially be performed with the same accuracy and efficacy from the left-hand side,” said Dr. Prashant Patel.
In the echocardiography lab, some facilities perform transthoracic echocardiography from the right side of the patient, thereby requiring the operator to get the right scanning hand over and across the patient.
“This is ergonomically disadvantageous, as one has to sit on the table, reach over the patient, and twist the torso. Scanning from the left side of the patient is ergonomically superior in preventing back injuries and may be advantageous for the left-handed person as the probe is held in the dominant hand,” noted Dr. Prashant Patel.
In the cath lab, the difficulty for left-handed cardiologists starts with establishing arterial or venous access.
“The two most frequently used arterial-access sites are right radial and right femoral. Both of them pose unique challenges in terms of positioning for most left-handed trainees in the early part of their training. The right arm is kept adducted and externally rotated in a standard setup, which is difficult to access for a left-handed operator, and would require the operator to use their nondominant right hand awkwardly to gain access,” he said.
A solution could be to reposition the patient’s arm using a radial board into abduction of the arm at about 45 degrees, with external rotation.
“This creates room for the left-handed operator to stand caudal to the patient’s arm and approach the radial access site conveniently using their dominant hand,” Dr. Prashant Patel suggested.
For the femoral approach, the left-handed operator could stand left of the patient and either get left femoral access or reach out across to the right groin of the patient and obtain access in this manner, or alternatively, the operator could resort to using their right hand to gain right femoral access.
“The large size of the femoral vessels allows even the strongly left-handed operators to get accustomed to using their nondominant hand with practice. This may be preferable to switching to the left side,” he said.
There are also some advantages to being left-handed, Dr. Prashant Patel said.
This is true “especially in the cath lab, for example, establishing antegrade right femoral access for peripheral interventions,” he noted. “Having a left-handed operator can also come in handy when two operators need to simultaneously and quickly work on both groins, as is often the case in complex coronary or structural interventions. Left-handed operators are also at ease obtaining left radial access, which has been shown to have certain advantages over right radial access.”
“We hope to raise awareness among the academic cardiology community about left-handedness,” Dr. Prashant Patel added. “We hope that acknowledgment, support, and minor modifications in work flow will allow a lot of young trainees in the early part of their career to stay on course and realize their full potential in this procedural specialty.”
An insightful paper
“This paper by Dr. Prashant Patel and Dr. Mandira Patel is most insightful about the unique challenges and occasional opportunities for the left-handed cardiologist,” wrote Simon Kendall, MBBS, president of the Society for Cardiothoracic Surgery Great Britain and Ireland, London, in an accompanying response.
“As a left-handed cardiac surgeon, I am embarrassed not to have considered such significant issues for my cardiology colleagues: the edict of examining a patient from the right side, performing echocardiography with the right hand, and the complex arena of catheter laboratory that is designed around the right-handed majority. Before reading this paper, I had not appreciated that for my whole career I have had to use my less-favored right hand when inserting a balloon pump,” Dr. Kendall wrote.
“Dr. Patel and Dr. Patel have written very sensible conclusions, such as that left-handedness should be acknowledged and adapted for and the training environment has to help access the specific tips and tricks from others, as shared in cardiac surgery, for instance. They rightly describe this as not a binary phenomenon and that there is a spectrum of laterality, so that some left-handers will adapt with ease and others will need more time and patience to learn the necessary skills,” he wrote. “We are fortunate to live in an era of increasing awareness and tolerance. Left-handedness is one small example of such progress.”
A version of this article first appeared on Medscape.com.
Left-handed cardiology trainees face unique challenges when it comes to learning how to perform common procedures, according to a new report.
About 10% of the world’s population is left-handed, and rates of left-handedness among medical students and practicing physicians is believed to be similar.
“Extrapolating this to 3,017 active general cardiovascular fellowship positions and 339 interventional cardiology fellowship positions for the year 2018-2019, it is estimated there are more than 300 LH [left-handed] trainees in U.S. cardiovascular fellowship programs at any given time. Despite this, any standard clinical setting is designed to be convenient for RH [right-handed] providers, thereby creating a variable amount of impediment for LH trainees,” wrote Prashant Patel, MD, and Mandira Patel, DO, from University of California, Riverside.
“With about 10% prevalence, left-handedness is far more common, including among cardiology trainees, than most people realize. Most of the procedural set-up is designed for the right-hand majority, and it may cause a variable amount of impediment for the left-handed trainees. It is very important for the academic cardiology community to recognize this,” Dr. Prashant Patel said in an interview.
The findings were published in the Jan.5 issue of the Journal of the American College of Cardiology.
Dr. Prashant Patel, who is left-handed, said he was prompted to look into the issue because of his own experience.
“In my first procedural rotation several years ago, I noticed that I was positioning myself somewhat differently than my attendings due to my preference for using my left hand for fine motor control,” he said. “I started looking up existing literature to see what other left-handed cardiologists have done in the past, but realized that nothing along this line was published.
“I started discussions with my colleagues and superiors and found that our small cardiology fellowship program contains about 20%-40% of left-handed trainees at any given time, and we felt it was important to elaborate on this,” he added.
Practice makes perfect, and repeated practice eventually leads to automation of motor procedures, but the learning curve may be more protracted for left-handed trainees. “Acquisition of procedural skills is a function of time and repetition. Eventually, most practicing left-handed cardiologists see that as a nonissue and do not even realize they may have gone through a differential learning curve based on their hand dominance,” Dr. Prashant Patel noted.
“South-paw” cardiology trainees face their first challenge in the examination room.
Physicians typically examine patients from the right-hand side of the bed. The majority of clinic offices are set up for the right-handed provider, with the examining table placed with the head of the bed distal from the door and the left side of the bed aligned in close proximity to the wall, leaving examination on the right side of the patient as the only option. In the hospital setting, monitors and intravenous poles are usually placed on the patient’s left-hand side of the bed.
“This practice, more than anything else, is born out of tradition. The same clinical examination can potentially be performed with the same accuracy and efficacy from the left-hand side,” said Dr. Prashant Patel.
In the echocardiography lab, some facilities perform transthoracic echocardiography from the right side of the patient, thereby requiring the operator to get the right scanning hand over and across the patient.
“This is ergonomically disadvantageous, as one has to sit on the table, reach over the patient, and twist the torso. Scanning from the left side of the patient is ergonomically superior in preventing back injuries and may be advantageous for the left-handed person as the probe is held in the dominant hand,” noted Dr. Prashant Patel.
In the cath lab, the difficulty for left-handed cardiologists starts with establishing arterial or venous access.
“The two most frequently used arterial-access sites are right radial and right femoral. Both of them pose unique challenges in terms of positioning for most left-handed trainees in the early part of their training. The right arm is kept adducted and externally rotated in a standard setup, which is difficult to access for a left-handed operator, and would require the operator to use their nondominant right hand awkwardly to gain access,” he said.
A solution could be to reposition the patient’s arm using a radial board into abduction of the arm at about 45 degrees, with external rotation.
“This creates room for the left-handed operator to stand caudal to the patient’s arm and approach the radial access site conveniently using their dominant hand,” Dr. Prashant Patel suggested.
For the femoral approach, the left-handed operator could stand left of the patient and either get left femoral access or reach out across to the right groin of the patient and obtain access in this manner, or alternatively, the operator could resort to using their right hand to gain right femoral access.
“The large size of the femoral vessels allows even the strongly left-handed operators to get accustomed to using their nondominant hand with practice. This may be preferable to switching to the left side,” he said.
There are also some advantages to being left-handed, Dr. Prashant Patel said.
This is true “especially in the cath lab, for example, establishing antegrade right femoral access for peripheral interventions,” he noted. “Having a left-handed operator can also come in handy when two operators need to simultaneously and quickly work on both groins, as is often the case in complex coronary or structural interventions. Left-handed operators are also at ease obtaining left radial access, which has been shown to have certain advantages over right radial access.”
“We hope to raise awareness among the academic cardiology community about left-handedness,” Dr. Prashant Patel added. “We hope that acknowledgment, support, and minor modifications in work flow will allow a lot of young trainees in the early part of their career to stay on course and realize their full potential in this procedural specialty.”
An insightful paper
“This paper by Dr. Prashant Patel and Dr. Mandira Patel is most insightful about the unique challenges and occasional opportunities for the left-handed cardiologist,” wrote Simon Kendall, MBBS, president of the Society for Cardiothoracic Surgery Great Britain and Ireland, London, in an accompanying response.
“As a left-handed cardiac surgeon, I am embarrassed not to have considered such significant issues for my cardiology colleagues: the edict of examining a patient from the right side, performing echocardiography with the right hand, and the complex arena of catheter laboratory that is designed around the right-handed majority. Before reading this paper, I had not appreciated that for my whole career I have had to use my less-favored right hand when inserting a balloon pump,” Dr. Kendall wrote.
“Dr. Patel and Dr. Patel have written very sensible conclusions, such as that left-handedness should be acknowledged and adapted for and the training environment has to help access the specific tips and tricks from others, as shared in cardiac surgery, for instance. They rightly describe this as not a binary phenomenon and that there is a spectrum of laterality, so that some left-handers will adapt with ease and others will need more time and patience to learn the necessary skills,” he wrote. “We are fortunate to live in an era of increasing awareness and tolerance. Left-handedness is one small example of such progress.”
A version of this article first appeared on Medscape.com.
Ultraprocessed food again linked to increased CVD, death
Yet another study has linked the consumption of ultraprocessed, or “junk,” foods to bad health outcomes.
In a longitudinal analysis of more than 22,000 men and women from southern Italy, those who consumed the most ultraprocessed food (UPF) had the highest risk for cardiovascular disease (CVD) and all-cause mortality, likely mediated through a diet high in sugar, researchers said.
High consumption of UPF in this Mediterranean cohort was associated with a 58% increased risk for CVD mortality and 52% higher risk of dying from ischemic heart disease (IHD) and cerebrovascular causes, independently of known risk factors for CVD, even among individuals who otherwise adhered to the Mediterranean diet.
The findings “should serve as an incentive for limiting consumption of UPF and encouraging natural or minimally processed foods, as several national nutritional policies recommend,” Marialaura Bonaccio, PhD, department of epidemiology and prevention, IRCCS Neuromed, Pozzilli, Italy, and colleagues wrote. The results were published online Dec. 18 in the American Journal of Clinical Nutrition.
Earlier this year, as reported by this news organization, researchers found mounting evidence that the obesity epidemic and the increase in incidence of related chronic conditions corresponded with an increase in the intake of UPF.
A study that was conducted in a European cohort found that adults whose diet included more UPF and beverages, such as ice cream, soda, and hamburgers, were more likely to develop CVD or die sooner than others who had a more wholesome diet.
As reported previously by this news organization, among adults in France who had a 10% higher intake of UPF and beverages, the rate of CVD, coronary heart disease, and cerebrovascular disease was 11% to 13% higher over a period of about 5 years.
Similarly, university graduates in Spain who consumed more than four servings of UPF and beverages a day were 62% more likely to die of any cause over about a decade than those who consumed less than two servings per day.
Where’s the food?
There is very little actual food in UPF. “The NOVA classification provides 4 main classes of food and beverages, the last of which is represented by the ultraprocessed food group. This comprises products (e.g., snacks, drinks, and ready meals, ‘created mostly or entirely from substances extracted from foods or derived from food constituents with little, if any intact food, which often contain flavors, colors, and other additives that imitate or intensify the sensory qualities of foods or culinary preparations made from foods,’ ” Dr. Bonaccio and colleagues wrote.
Such foods are very convenient, tasty, inexpensive, and have a long shelf life. They are highly competitive with foods that are naturally ready to consume and freshly prepared dishes and meals, the authors add.
The researchers conducted a longitudinal analysis on 22,475 men and women (mean age, 55 years; range, 43-67 years) who were recruited from the Moli-sani Study, a population-based cohort of men and women aged 35 years and older in the Molise region of southern Italy, between 2005 and 2010. Participants were followed for 8.2 years.
Food intake was assessed with the Food Frequency Questionnaire; UPF was defined using the NOVA classification according to degree of processing.
UPF intakes were categorized as quartiles of the ratio of UPF to total food consumed.
Overall, study participants reported a median of 10% (interquartile range, 6.6%-14.6%) of dietary intake as UPF and a total of 181.5 g/d of UPF intake.
The foods that contributed most to total UPF consumed were processed meat, which accounted for 19.8% of UPF intake; pizza (16.8%); and cakes and pies (13.4%).
High consumers of UPF, defined as those for whom UPF constituted more than 14.6% of their total diet, were more likely to be women, to be younger, and to have a higher educational level. They also reported fewer risk factors and fewer baseline chronic diseases and health conditions than persons who consumed UPF less frequently.
In addition, high consumption of UPF was associated with lower adherence to the Mediterranean diet; higher intake of fat, sugar, dietary cholesterol, and sodium; and lower intake of fiber.
During a median follow-up of 8.2 years, 1,216 all-cause deaths occurred. Of these, 439 were attributed to CVD, 255 to IHD/cerebrovascular disease, 477 to cancer, and 300 to other causes.
The more UPF, the higher the risk for CVD, death
The researchers found a direct linear dose-response relation between a 5% increase in the proportion of UPF in the diet and risk for all-cause and CVD mortality.
Individuals who reported the highest intake of UPF (fourth quartile, 14.6% of total food) as opposed to the lowest (first quartile, UPF <6.6%) experienced increased risks for CVD mortality (hazard ratio, 1.58; 95% CI, 1.23-2.03), death from IHD/cerebrovascular disease (HR, 1.52, 95% CI, 1.10-2.09), and all-cause mortality (HR, 1.26; 95% CI, 1.09-1.46).
High sugar content accounted for 36.3% of the relation of UPF with IHD/cerebrovascular mortality. Other nutritional factors, such as saturated fats, were unlikely to play a role, the researchers wrote.
Biomarkers of renal function accounted for 20.1% of the association of UPF with all-cause mortality and 12.0% for that of UPF with CVD mortality.
Subgroup analyses indicated that the magnitude of the association between UPF and all-cause mortality risk was greater among high-risk individuals, such as those with a history of CVD or diabetes. UPF was also likely to be more strongly associated with CVD mortality among those high-risk groups.
The interesting finding that the association between UPF and CVD mortality was greater among individuals with good adherence to the Mediterranean diet, which is known to have health benefits, could be explained by the fact that people who may benefit from a Mediterranean diet are more susceptible to losing health advantages when they also include “detrimental dietary behavior,” whereas those who consume a poor-quality diet are less likely to be harmed by an additional unhealthy behavior such as eating UPF regularly, wrote Dr. Bonaccio and colleagues.
“This is an interesting study confirming that consumption of highly processed foods such as pizza, processed meats, and soda are associated with greater risks of cardiovascular disease,” Walter Willett, MD, professor of epidemiology and nutrition, Harvard School of Public Health, Boston, said in an interview.
“These higher risks appear to be mediated in part by high intakes of saturated fat and sugar, but lower intakes of health-promoting aspects of diet also likely contribute to the findings,” Dr. Willett said.
“Some processing of food can be useful for preservation and control of infectious agents, but in general, a diet emphasizing minimally processed fruits and vegetables, whole grains, nuts, legumes, and plant sources of fat will be best for long-term well-being,” he said.
The study was supported in part by the Italian Ministry of Health and the HYPERCAN Study Italian Association for Cancer Research. Dr. Bonaccio and Dr. Willett reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Yet another study has linked the consumption of ultraprocessed, or “junk,” foods to bad health outcomes.
In a longitudinal analysis of more than 22,000 men and women from southern Italy, those who consumed the most ultraprocessed food (UPF) had the highest risk for cardiovascular disease (CVD) and all-cause mortality, likely mediated through a diet high in sugar, researchers said.
High consumption of UPF in this Mediterranean cohort was associated with a 58% increased risk for CVD mortality and 52% higher risk of dying from ischemic heart disease (IHD) and cerebrovascular causes, independently of known risk factors for CVD, even among individuals who otherwise adhered to the Mediterranean diet.
The findings “should serve as an incentive for limiting consumption of UPF and encouraging natural or minimally processed foods, as several national nutritional policies recommend,” Marialaura Bonaccio, PhD, department of epidemiology and prevention, IRCCS Neuromed, Pozzilli, Italy, and colleagues wrote. The results were published online Dec. 18 in the American Journal of Clinical Nutrition.
Earlier this year, as reported by this news organization, researchers found mounting evidence that the obesity epidemic and the increase in incidence of related chronic conditions corresponded with an increase in the intake of UPF.
A study that was conducted in a European cohort found that adults whose diet included more UPF and beverages, such as ice cream, soda, and hamburgers, were more likely to develop CVD or die sooner than others who had a more wholesome diet.
As reported previously by this news organization, among adults in France who had a 10% higher intake of UPF and beverages, the rate of CVD, coronary heart disease, and cerebrovascular disease was 11% to 13% higher over a period of about 5 years.
Similarly, university graduates in Spain who consumed more than four servings of UPF and beverages a day were 62% more likely to die of any cause over about a decade than those who consumed less than two servings per day.
Where’s the food?
There is very little actual food in UPF. “The NOVA classification provides 4 main classes of food and beverages, the last of which is represented by the ultraprocessed food group. This comprises products (e.g., snacks, drinks, and ready meals, ‘created mostly or entirely from substances extracted from foods or derived from food constituents with little, if any intact food, which often contain flavors, colors, and other additives that imitate or intensify the sensory qualities of foods or culinary preparations made from foods,’ ” Dr. Bonaccio and colleagues wrote.
Such foods are very convenient, tasty, inexpensive, and have a long shelf life. They are highly competitive with foods that are naturally ready to consume and freshly prepared dishes and meals, the authors add.
The researchers conducted a longitudinal analysis on 22,475 men and women (mean age, 55 years; range, 43-67 years) who were recruited from the Moli-sani Study, a population-based cohort of men and women aged 35 years and older in the Molise region of southern Italy, between 2005 and 2010. Participants were followed for 8.2 years.
Food intake was assessed with the Food Frequency Questionnaire; UPF was defined using the NOVA classification according to degree of processing.
UPF intakes were categorized as quartiles of the ratio of UPF to total food consumed.
Overall, study participants reported a median of 10% (interquartile range, 6.6%-14.6%) of dietary intake as UPF and a total of 181.5 g/d of UPF intake.
The foods that contributed most to total UPF consumed were processed meat, which accounted for 19.8% of UPF intake; pizza (16.8%); and cakes and pies (13.4%).
High consumers of UPF, defined as those for whom UPF constituted more than 14.6% of their total diet, were more likely to be women, to be younger, and to have a higher educational level. They also reported fewer risk factors and fewer baseline chronic diseases and health conditions than persons who consumed UPF less frequently.
In addition, high consumption of UPF was associated with lower adherence to the Mediterranean diet; higher intake of fat, sugar, dietary cholesterol, and sodium; and lower intake of fiber.
During a median follow-up of 8.2 years, 1,216 all-cause deaths occurred. Of these, 439 were attributed to CVD, 255 to IHD/cerebrovascular disease, 477 to cancer, and 300 to other causes.
The more UPF, the higher the risk for CVD, death
The researchers found a direct linear dose-response relation between a 5% increase in the proportion of UPF in the diet and risk for all-cause and CVD mortality.
Individuals who reported the highest intake of UPF (fourth quartile, 14.6% of total food) as opposed to the lowest (first quartile, UPF <6.6%) experienced increased risks for CVD mortality (hazard ratio, 1.58; 95% CI, 1.23-2.03), death from IHD/cerebrovascular disease (HR, 1.52, 95% CI, 1.10-2.09), and all-cause mortality (HR, 1.26; 95% CI, 1.09-1.46).
High sugar content accounted for 36.3% of the relation of UPF with IHD/cerebrovascular mortality. Other nutritional factors, such as saturated fats, were unlikely to play a role, the researchers wrote.
Biomarkers of renal function accounted for 20.1% of the association of UPF with all-cause mortality and 12.0% for that of UPF with CVD mortality.
Subgroup analyses indicated that the magnitude of the association between UPF and all-cause mortality risk was greater among high-risk individuals, such as those with a history of CVD or diabetes. UPF was also likely to be more strongly associated with CVD mortality among those high-risk groups.
The interesting finding that the association between UPF and CVD mortality was greater among individuals with good adherence to the Mediterranean diet, which is known to have health benefits, could be explained by the fact that people who may benefit from a Mediterranean diet are more susceptible to losing health advantages when they also include “detrimental dietary behavior,” whereas those who consume a poor-quality diet are less likely to be harmed by an additional unhealthy behavior such as eating UPF regularly, wrote Dr. Bonaccio and colleagues.
“This is an interesting study confirming that consumption of highly processed foods such as pizza, processed meats, and soda are associated with greater risks of cardiovascular disease,” Walter Willett, MD, professor of epidemiology and nutrition, Harvard School of Public Health, Boston, said in an interview.
“These higher risks appear to be mediated in part by high intakes of saturated fat and sugar, but lower intakes of health-promoting aspects of diet also likely contribute to the findings,” Dr. Willett said.
“Some processing of food can be useful for preservation and control of infectious agents, but in general, a diet emphasizing minimally processed fruits and vegetables, whole grains, nuts, legumes, and plant sources of fat will be best for long-term well-being,” he said.
The study was supported in part by the Italian Ministry of Health and the HYPERCAN Study Italian Association for Cancer Research. Dr. Bonaccio and Dr. Willett reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Yet another study has linked the consumption of ultraprocessed, or “junk,” foods to bad health outcomes.
In a longitudinal analysis of more than 22,000 men and women from southern Italy, those who consumed the most ultraprocessed food (UPF) had the highest risk for cardiovascular disease (CVD) and all-cause mortality, likely mediated through a diet high in sugar, researchers said.
High consumption of UPF in this Mediterranean cohort was associated with a 58% increased risk for CVD mortality and 52% higher risk of dying from ischemic heart disease (IHD) and cerebrovascular causes, independently of known risk factors for CVD, even among individuals who otherwise adhered to the Mediterranean diet.
The findings “should serve as an incentive for limiting consumption of UPF and encouraging natural or minimally processed foods, as several national nutritional policies recommend,” Marialaura Bonaccio, PhD, department of epidemiology and prevention, IRCCS Neuromed, Pozzilli, Italy, and colleagues wrote. The results were published online Dec. 18 in the American Journal of Clinical Nutrition.
Earlier this year, as reported by this news organization, researchers found mounting evidence that the obesity epidemic and the increase in incidence of related chronic conditions corresponded with an increase in the intake of UPF.
A study that was conducted in a European cohort found that adults whose diet included more UPF and beverages, such as ice cream, soda, and hamburgers, were more likely to develop CVD or die sooner than others who had a more wholesome diet.
As reported previously by this news organization, among adults in France who had a 10% higher intake of UPF and beverages, the rate of CVD, coronary heart disease, and cerebrovascular disease was 11% to 13% higher over a period of about 5 years.
Similarly, university graduates in Spain who consumed more than four servings of UPF and beverages a day were 62% more likely to die of any cause over about a decade than those who consumed less than two servings per day.
Where’s the food?
There is very little actual food in UPF. “The NOVA classification provides 4 main classes of food and beverages, the last of which is represented by the ultraprocessed food group. This comprises products (e.g., snacks, drinks, and ready meals, ‘created mostly or entirely from substances extracted from foods or derived from food constituents with little, if any intact food, which often contain flavors, colors, and other additives that imitate or intensify the sensory qualities of foods or culinary preparations made from foods,’ ” Dr. Bonaccio and colleagues wrote.
Such foods are very convenient, tasty, inexpensive, and have a long shelf life. They are highly competitive with foods that are naturally ready to consume and freshly prepared dishes and meals, the authors add.
The researchers conducted a longitudinal analysis on 22,475 men and women (mean age, 55 years; range, 43-67 years) who were recruited from the Moli-sani Study, a population-based cohort of men and women aged 35 years and older in the Molise region of southern Italy, between 2005 and 2010. Participants were followed for 8.2 years.
Food intake was assessed with the Food Frequency Questionnaire; UPF was defined using the NOVA classification according to degree of processing.
UPF intakes were categorized as quartiles of the ratio of UPF to total food consumed.
Overall, study participants reported a median of 10% (interquartile range, 6.6%-14.6%) of dietary intake as UPF and a total of 181.5 g/d of UPF intake.
The foods that contributed most to total UPF consumed were processed meat, which accounted for 19.8% of UPF intake; pizza (16.8%); and cakes and pies (13.4%).
High consumers of UPF, defined as those for whom UPF constituted more than 14.6% of their total diet, were more likely to be women, to be younger, and to have a higher educational level. They also reported fewer risk factors and fewer baseline chronic diseases and health conditions than persons who consumed UPF less frequently.
In addition, high consumption of UPF was associated with lower adherence to the Mediterranean diet; higher intake of fat, sugar, dietary cholesterol, and sodium; and lower intake of fiber.
During a median follow-up of 8.2 years, 1,216 all-cause deaths occurred. Of these, 439 were attributed to CVD, 255 to IHD/cerebrovascular disease, 477 to cancer, and 300 to other causes.
The more UPF, the higher the risk for CVD, death
The researchers found a direct linear dose-response relation between a 5% increase in the proportion of UPF in the diet and risk for all-cause and CVD mortality.
Individuals who reported the highest intake of UPF (fourth quartile, 14.6% of total food) as opposed to the lowest (first quartile, UPF <6.6%) experienced increased risks for CVD mortality (hazard ratio, 1.58; 95% CI, 1.23-2.03), death from IHD/cerebrovascular disease (HR, 1.52, 95% CI, 1.10-2.09), and all-cause mortality (HR, 1.26; 95% CI, 1.09-1.46).
High sugar content accounted for 36.3% of the relation of UPF with IHD/cerebrovascular mortality. Other nutritional factors, such as saturated fats, were unlikely to play a role, the researchers wrote.
Biomarkers of renal function accounted for 20.1% of the association of UPF with all-cause mortality and 12.0% for that of UPF with CVD mortality.
Subgroup analyses indicated that the magnitude of the association between UPF and all-cause mortality risk was greater among high-risk individuals, such as those with a history of CVD or diabetes. UPF was also likely to be more strongly associated with CVD mortality among those high-risk groups.
The interesting finding that the association between UPF and CVD mortality was greater among individuals with good adherence to the Mediterranean diet, which is known to have health benefits, could be explained by the fact that people who may benefit from a Mediterranean diet are more susceptible to losing health advantages when they also include “detrimental dietary behavior,” whereas those who consume a poor-quality diet are less likely to be harmed by an additional unhealthy behavior such as eating UPF regularly, wrote Dr. Bonaccio and colleagues.
“This is an interesting study confirming that consumption of highly processed foods such as pizza, processed meats, and soda are associated with greater risks of cardiovascular disease,” Walter Willett, MD, professor of epidemiology and nutrition, Harvard School of Public Health, Boston, said in an interview.
“These higher risks appear to be mediated in part by high intakes of saturated fat and sugar, but lower intakes of health-promoting aspects of diet also likely contribute to the findings,” Dr. Willett said.
“Some processing of food can be useful for preservation and control of infectious agents, but in general, a diet emphasizing minimally processed fruits and vegetables, whole grains, nuts, legumes, and plant sources of fat will be best for long-term well-being,” he said.
The study was supported in part by the Italian Ministry of Health and the HYPERCAN Study Italian Association for Cancer Research. Dr. Bonaccio and Dr. Willett reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
ACC/AHA valvular heart disease update backs less-invasive approach
The latest iteration of the American College of Cardiology/American Heart Association (ACC/AHA) Guideline for the Management of Patients With Valvular Heart Disease emphasizes a less invasive approach to the management of patients with valvular heart disease (VHD).
The 2020 ACC/AHA guideline now recommends transcatheter aortic valve implantation over surgical implantation for older individuals, a transcatheter edge-to-edge repair of the mitral valve for patients who are at high risk for surgery, and referral of patients with complicated conditions to designated centers.
The guideline was published online Dec. 17 in Circulation and was simultaneously published in the Journal of the American College of Cardiology. It replaces the 2014 guideline and the 2017 focused update of the guideline, both published in Circulation.
“A huge amount has changed,” Catherine M. Otto, MD, J. Ward Kennedy-Hamilton Endowed Chair in Cardiology and professor of medicine, University of Washington, Seattle, said in an interview.
Dr. Otto cochaired the 2020 Guideline Writing Committee with Rick A. Nishimura, MD, professor of medicine, Mayo Clinic, Rochester, Minn.
Expanded use of transcatheter procedures
“One major change is that the transcatheter valve, rather than the surgical valve, is now recommended for a large number of patients, primarily based upon the likelihood that the durability of the transcatheter valve is appropriate for the patient’s life expectancy. So, in most older adults, the transcatheter valve, rather than a surgical valve, would be the treatment for severe aortic stenosis,” she said.
“That’s a huge change,” she added. “Previously, patients had to have surgery to place a prosthetic valve, but now, many patients, particularly older adults, can have a nonsurgical approach when they are only in the hospital overnight, or sometimes even just for the day, to get their valve replaced.”
The 2020 guideline also recommends the transcatheter approach over the surgical approach for mitral valve repair or replacement for individuals who are not candidates for surgery.
“We continue to recommend surgical valve repair for the mitral valve, because we know that there are excellent long-term outcomes with surgical repair,” Dr. Otto said. “But, for people who are at high risk or prohibitive risk for surgery, we now have the option of again using a transcatheter approach or a transcatheter edge-to-edge repair of the valve. It’s a simpler procedure, doesn’t require a big incision, [and] doesn’t require a long hospital stay. Those two procedures are really changing patient management,” she said.
A tiered approach to VHD care
A third key change is a recommendation that the U.S. health care system move to a tiered approach, whereby patients with more complex conditions undergo their procedure at comprehensive, high-volume centers, and patients with simpler conditions undergo treatment at primary heart valve centers.
“More complex patients often require multidisciplinary care in order to be managed appropriately. It makes more sense to send them to a center that has the expertise and the teams in place already,” Dr. Otto said.
“Patients needing more straightforward, common procedures could be seen at a primary valve center. Those needing a more complicated procedure would go to the centers with higher volumes. So an important part of what this guideline is trying to do is to get doctors to refer their patients to the appropriate center,” she said.
Eagerly anticipated
The 2020 AHA/ACC guideline has been “eagerly anticipated,” Anthony A. Bavry, MD, MPH, UT Southwestern Medical Center, Dallas, Texas, and George J. Arnaoutakis, MD, University of Florida Health, Gainesville, wrote in a perspective article published with the guideline in Circulation.
Dr. Bavry and Dr. Arnaoutakis endorse the guideline recommendation that the U.S. health care system move to a tiered approach.
“To balance excellent outcomes and not compromise access to care, the 2020 Guideline recommends that our health care system move to a tiered approach in the treatment of valve disease, where we recognize level 1 and level 2 Centers,” they wrote.
“The level 1 Comprehensive Heart Valve Center is an important and new introduction to the Guideline,” they noted. “The level 1 Center is defined by the depth and breadth of the procedures offered. While excellent outcomes are possible at lower volume centers, literature supports that higher center and operator volumes of valve procedures are associated with excellent results and low mortality.”
The authors pointed out that level 2 primary valve centers offer many of the same valve procedures as the level 1 centers but are limited by the scope of procedures they can offer.
“For example, specialized procedures such as alternative access TAVR, valve-in-valve TAVR, transcatheter edge-to-edge mitral valve repair, paravalvular leak closure, and percutaneous mitral balloon commissurotomy are recommended to be performed at a level 1 Center,” they wrote.
Transcatheter valve therapies remain “an exciting and dynamic field which offers patients a less invasive treatment option,” Dr. Bavry and Dr. Arnaoutakis concluded. They also cautioned that the pros and cons of the newer, less invasive therapies need to be weighed against the benefits of surgical procedures that have been studied and refined for more than 50 years.
Patients with VHD have many choices and will require help making informed decisions about such things as a mechanical valve vs. a bioprosthetic valve or undergoing a traditional surgical procedure vs. a catheter-based approach. “Other patients, at the extremes of age or risk status, will lean more clearly to one direction or another,” Dr. Bavry and Dr. Arnaoutakis add.
“Overall, the 2020 Guideline is a comprehensive document that should provide a useful framework for the Heart Valve Team,” they concluded.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The latest iteration of the American College of Cardiology/American Heart Association (ACC/AHA) Guideline for the Management of Patients With Valvular Heart Disease emphasizes a less invasive approach to the management of patients with valvular heart disease (VHD).
The 2020 ACC/AHA guideline now recommends transcatheter aortic valve implantation over surgical implantation for older individuals, a transcatheter edge-to-edge repair of the mitral valve for patients who are at high risk for surgery, and referral of patients with complicated conditions to designated centers.
The guideline was published online Dec. 17 in Circulation and was simultaneously published in the Journal of the American College of Cardiology. It replaces the 2014 guideline and the 2017 focused update of the guideline, both published in Circulation.
“A huge amount has changed,” Catherine M. Otto, MD, J. Ward Kennedy-Hamilton Endowed Chair in Cardiology and professor of medicine, University of Washington, Seattle, said in an interview.
Dr. Otto cochaired the 2020 Guideline Writing Committee with Rick A. Nishimura, MD, professor of medicine, Mayo Clinic, Rochester, Minn.
Expanded use of transcatheter procedures
“One major change is that the transcatheter valve, rather than the surgical valve, is now recommended for a large number of patients, primarily based upon the likelihood that the durability of the transcatheter valve is appropriate for the patient’s life expectancy. So, in most older adults, the transcatheter valve, rather than a surgical valve, would be the treatment for severe aortic stenosis,” she said.
“That’s a huge change,” she added. “Previously, patients had to have surgery to place a prosthetic valve, but now, many patients, particularly older adults, can have a nonsurgical approach when they are only in the hospital overnight, or sometimes even just for the day, to get their valve replaced.”
The 2020 guideline also recommends the transcatheter approach over the surgical approach for mitral valve repair or replacement for individuals who are not candidates for surgery.
“We continue to recommend surgical valve repair for the mitral valve, because we know that there are excellent long-term outcomes with surgical repair,” Dr. Otto said. “But, for people who are at high risk or prohibitive risk for surgery, we now have the option of again using a transcatheter approach or a transcatheter edge-to-edge repair of the valve. It’s a simpler procedure, doesn’t require a big incision, [and] doesn’t require a long hospital stay. Those two procedures are really changing patient management,” she said.
A tiered approach to VHD care
A third key change is a recommendation that the U.S. health care system move to a tiered approach, whereby patients with more complex conditions undergo their procedure at comprehensive, high-volume centers, and patients with simpler conditions undergo treatment at primary heart valve centers.
“More complex patients often require multidisciplinary care in order to be managed appropriately. It makes more sense to send them to a center that has the expertise and the teams in place already,” Dr. Otto said.
“Patients needing more straightforward, common procedures could be seen at a primary valve center. Those needing a more complicated procedure would go to the centers with higher volumes. So an important part of what this guideline is trying to do is to get doctors to refer their patients to the appropriate center,” she said.
Eagerly anticipated
The 2020 AHA/ACC guideline has been “eagerly anticipated,” Anthony A. Bavry, MD, MPH, UT Southwestern Medical Center, Dallas, Texas, and George J. Arnaoutakis, MD, University of Florida Health, Gainesville, wrote in a perspective article published with the guideline in Circulation.
Dr. Bavry and Dr. Arnaoutakis endorse the guideline recommendation that the U.S. health care system move to a tiered approach.
“To balance excellent outcomes and not compromise access to care, the 2020 Guideline recommends that our health care system move to a tiered approach in the treatment of valve disease, where we recognize level 1 and level 2 Centers,” they wrote.
“The level 1 Comprehensive Heart Valve Center is an important and new introduction to the Guideline,” they noted. “The level 1 Center is defined by the depth and breadth of the procedures offered. While excellent outcomes are possible at lower volume centers, literature supports that higher center and operator volumes of valve procedures are associated with excellent results and low mortality.”
The authors pointed out that level 2 primary valve centers offer many of the same valve procedures as the level 1 centers but are limited by the scope of procedures they can offer.
“For example, specialized procedures such as alternative access TAVR, valve-in-valve TAVR, transcatheter edge-to-edge mitral valve repair, paravalvular leak closure, and percutaneous mitral balloon commissurotomy are recommended to be performed at a level 1 Center,” they wrote.
Transcatheter valve therapies remain “an exciting and dynamic field which offers patients a less invasive treatment option,” Dr. Bavry and Dr. Arnaoutakis concluded. They also cautioned that the pros and cons of the newer, less invasive therapies need to be weighed against the benefits of surgical procedures that have been studied and refined for more than 50 years.
Patients with VHD have many choices and will require help making informed decisions about such things as a mechanical valve vs. a bioprosthetic valve or undergoing a traditional surgical procedure vs. a catheter-based approach. “Other patients, at the extremes of age or risk status, will lean more clearly to one direction or another,” Dr. Bavry and Dr. Arnaoutakis add.
“Overall, the 2020 Guideline is a comprehensive document that should provide a useful framework for the Heart Valve Team,” they concluded.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The latest iteration of the American College of Cardiology/American Heart Association (ACC/AHA) Guideline for the Management of Patients With Valvular Heart Disease emphasizes a less invasive approach to the management of patients with valvular heart disease (VHD).
The 2020 ACC/AHA guideline now recommends transcatheter aortic valve implantation over surgical implantation for older individuals, a transcatheter edge-to-edge repair of the mitral valve for patients who are at high risk for surgery, and referral of patients with complicated conditions to designated centers.
The guideline was published online Dec. 17 in Circulation and was simultaneously published in the Journal of the American College of Cardiology. It replaces the 2014 guideline and the 2017 focused update of the guideline, both published in Circulation.
“A huge amount has changed,” Catherine M. Otto, MD, J. Ward Kennedy-Hamilton Endowed Chair in Cardiology and professor of medicine, University of Washington, Seattle, said in an interview.
Dr. Otto cochaired the 2020 Guideline Writing Committee with Rick A. Nishimura, MD, professor of medicine, Mayo Clinic, Rochester, Minn.
Expanded use of transcatheter procedures
“One major change is that the transcatheter valve, rather than the surgical valve, is now recommended for a large number of patients, primarily based upon the likelihood that the durability of the transcatheter valve is appropriate for the patient’s life expectancy. So, in most older adults, the transcatheter valve, rather than a surgical valve, would be the treatment for severe aortic stenosis,” she said.
“That’s a huge change,” she added. “Previously, patients had to have surgery to place a prosthetic valve, but now, many patients, particularly older adults, can have a nonsurgical approach when they are only in the hospital overnight, or sometimes even just for the day, to get their valve replaced.”
The 2020 guideline also recommends the transcatheter approach over the surgical approach for mitral valve repair or replacement for individuals who are not candidates for surgery.
“We continue to recommend surgical valve repair for the mitral valve, because we know that there are excellent long-term outcomes with surgical repair,” Dr. Otto said. “But, for people who are at high risk or prohibitive risk for surgery, we now have the option of again using a transcatheter approach or a transcatheter edge-to-edge repair of the valve. It’s a simpler procedure, doesn’t require a big incision, [and] doesn’t require a long hospital stay. Those two procedures are really changing patient management,” she said.
A tiered approach to VHD care
A third key change is a recommendation that the U.S. health care system move to a tiered approach, whereby patients with more complex conditions undergo their procedure at comprehensive, high-volume centers, and patients with simpler conditions undergo treatment at primary heart valve centers.
“More complex patients often require multidisciplinary care in order to be managed appropriately. It makes more sense to send them to a center that has the expertise and the teams in place already,” Dr. Otto said.
“Patients needing more straightforward, common procedures could be seen at a primary valve center. Those needing a more complicated procedure would go to the centers with higher volumes. So an important part of what this guideline is trying to do is to get doctors to refer their patients to the appropriate center,” she said.
Eagerly anticipated
The 2020 AHA/ACC guideline has been “eagerly anticipated,” Anthony A. Bavry, MD, MPH, UT Southwestern Medical Center, Dallas, Texas, and George J. Arnaoutakis, MD, University of Florida Health, Gainesville, wrote in a perspective article published with the guideline in Circulation.
Dr. Bavry and Dr. Arnaoutakis endorse the guideline recommendation that the U.S. health care system move to a tiered approach.
“To balance excellent outcomes and not compromise access to care, the 2020 Guideline recommends that our health care system move to a tiered approach in the treatment of valve disease, where we recognize level 1 and level 2 Centers,” they wrote.
“The level 1 Comprehensive Heart Valve Center is an important and new introduction to the Guideline,” they noted. “The level 1 Center is defined by the depth and breadth of the procedures offered. While excellent outcomes are possible at lower volume centers, literature supports that higher center and operator volumes of valve procedures are associated with excellent results and low mortality.”
The authors pointed out that level 2 primary valve centers offer many of the same valve procedures as the level 1 centers but are limited by the scope of procedures they can offer.
“For example, specialized procedures such as alternative access TAVR, valve-in-valve TAVR, transcatheter edge-to-edge mitral valve repair, paravalvular leak closure, and percutaneous mitral balloon commissurotomy are recommended to be performed at a level 1 Center,” they wrote.
Transcatheter valve therapies remain “an exciting and dynamic field which offers patients a less invasive treatment option,” Dr. Bavry and Dr. Arnaoutakis concluded. They also cautioned that the pros and cons of the newer, less invasive therapies need to be weighed against the benefits of surgical procedures that have been studied and refined for more than 50 years.
Patients with VHD have many choices and will require help making informed decisions about such things as a mechanical valve vs. a bioprosthetic valve or undergoing a traditional surgical procedure vs. a catheter-based approach. “Other patients, at the extremes of age or risk status, will lean more clearly to one direction or another,” Dr. Bavry and Dr. Arnaoutakis add.
“Overall, the 2020 Guideline is a comprehensive document that should provide a useful framework for the Heart Valve Team,” they concluded.
The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Intense intervention may boost addiction program retention
An intense and assertive “won’t take no for an answer” approach is effective for engaging in treatment young adults with substance abuse who have been in and out of various recovery programs for years, new research suggests.
The Youth Opioid Recovery Support (YORS) program is a team effort that includes home delivery of the prescribed medication, family engagement, assertive outreach, and contingency management.
In a new study of 42 patients in recovery for substance use disorder (SUD), those who were treated with extended-release naltrexone or extended-release buprenorphine plus YORS received more outpatient doses of their medication, and rates of opioid relapse at 12 and 24 weeks were lower compared with their peers who received only treatment as usual.
“ coinvestigator Marc Fishman, MD, director of the Maryland Treatment Centers, Johns Hopkins University, Baltimore, said in an interview.
The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
Treatment barriers
Young adults with SUD are difficult to reach, which leads to decreased addiction program retention, decreased medication adherence, early drop out, waxing and waning motivation, and worse outcomes, compared with older adults with SUD, Dr. Fishman said.
In July, positive results from a pilot trial conducted by the investigators of YORS were published online in Addiction.
In that study, 41 young adults aged 18-26 years who intended to undergo treatment for SUD with extended-release naltrexone were randomly assigned to also undergo YORS or treatment as usual, which consisted of a standard referral to outpatient care following an inpatient stay.
The primary outcomes were number of medication doses received over 24 weeks and relapse to opioid use, which was defined as 10 or more days of use within 28 days at 24 weeks.
Participants in the YORS group received more doses of extended-release naltrexone (mean, 4.28; standard deviation, 2.3) than participants in the treatment-as-usual group (mean, 0.70; SD, 1.2; P < .01).
In the YORS group, rates of relapse at both 12 and 24 weeks were lower, and there were fewer overall days of opioid use.
For the current study, the investigators wanted to test whether there was a possible effect when patients were given a choice of medication. In the earlier trial, patients did not have a choice – they had to take extended-release naltrexone. In this study, they could opt for it or extended-release buprenorphine.
The researchers recruited 22 young adults (aged 18-26 years) from their inpatient clinic to participate. Half the patients chose to take extended-release naltrexone, and the other half chose extended-release buprenorphine.
The groups were then compared to a historical group of 20 patients who received treatment as usual and served as the control group.
Positive outcomes
As in the first study, outcomes in the new study were better with YORS.
All participants who underwent YORS received more outpatient medication doses at 12 weeks and 24 weeks than those who received treatment as usual (1.91 vs. 0.40 and 3.76 vs. 0.70, respectively; P < .001).
For the YORS group, rates of opioid relapse were lower at 12 weeks (27.3% vs. 75.0%) and at 24 weeks (52.9% vs. 95.0%; P < .01.)
All components of YORS work together to improve retention, Dr. Fishman noted. Patients do much better if a relative such as a mother, father, or grandmother is closely involved, he added.
Also important is drug delivery.
“In some ways, this is similar to the assertive community treatment, or ACT, for schizophrenia. Like substance use disorder, schizophrenia requires long-acting injectable antipsychotics. When that is delivered to the patient through an organized delivery service like YORS, it improves outcomes,” said Dr. Fishman.
SUD is a chronic, relapsing illness in which an individual’s judgment is impaired, he added.
“ACT has become a relatively standard feature of treatment in most communities in this country and internationally and is sustainable under public sector funding, so it’s not an impossible leap to say it could be done. But it will not be cheap,” Dr. Fishman said.
Removing barriers
In a comment, Serra Akyar, MD, a psychiatry resident at Northwell Health’s Staten Island University Hospital, New York, said that the YORS program may appear to be labor intensive.
“However, the combination of medication-assisted treatment and support are essential to the treatment of opioid use disorder, especially for young adults. Developing effective interventions for young adults is particularly important, given the plasticity of their brains,” said Dr. Akyar, who was not involved with the research.
Inability to access medication and a lack of a supportive environment, both in everyday life and in regards to therapy, are barriers to successful treatment, she noted.
“The YORS intervention aims to remove these barriers to further enhance engagement to care through a combination of medication delivery and family engagement and assertive outreach via text messaging, a modality presumed to be well received by youth,” Dr. Akyar said.
Despite having a limited sample size, the study shows how a comprehensive intervention can have a large impact on the maintenance of medication adherence and reduction of relapse in young adults, she added.
“Its early success is encouraging and warrants further study on a larger scale to determine long-term effectiveness, overall costs and feasibility, generalizability, and whether certain independent factors exist that may predict medication adherence and reduction of relapse,” she said.
Wraparound support
The study is also a significant reminder that the opioid crisis has affected the young adult population, who are very vulnerable to OUD, said Jose Vito, MD, child, adolescent, and addiction psychiatrist at New York University.
“The study made me realize the importance of the four components of YORS, which were the outreach, family involvement, home delivery, and monetary incentives,” Dr. Vito said in an interview.
All of these components, in addition to extended-release naltrexone or extended-release buprenorphine, “have contributed to lower rates of opioid relapse, and the relapses are much later in the course of treatment if they do occur,” he said.
Overall, the findings demonstrate the importance of not giving up on these youths, he noted.
“Programs like YORS that provide wraparound support can help alleviate the opioid health care crisis by keeping these young adults in treatment,” Dr. Vito concluded.
The study was funded by the University of Maryland Center for Addiction Research, Education, and Service. Dr. Fishman has a financial relationship with Alkermes.
A version of this article first appeared on Medscape.com.
An intense and assertive “won’t take no for an answer” approach is effective for engaging in treatment young adults with substance abuse who have been in and out of various recovery programs for years, new research suggests.
The Youth Opioid Recovery Support (YORS) program is a team effort that includes home delivery of the prescribed medication, family engagement, assertive outreach, and contingency management.
In a new study of 42 patients in recovery for substance use disorder (SUD), those who were treated with extended-release naltrexone or extended-release buprenorphine plus YORS received more outpatient doses of their medication, and rates of opioid relapse at 12 and 24 weeks were lower compared with their peers who received only treatment as usual.
“ coinvestigator Marc Fishman, MD, director of the Maryland Treatment Centers, Johns Hopkins University, Baltimore, said in an interview.
The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
Treatment barriers
Young adults with SUD are difficult to reach, which leads to decreased addiction program retention, decreased medication adherence, early drop out, waxing and waning motivation, and worse outcomes, compared with older adults with SUD, Dr. Fishman said.
In July, positive results from a pilot trial conducted by the investigators of YORS were published online in Addiction.
In that study, 41 young adults aged 18-26 years who intended to undergo treatment for SUD with extended-release naltrexone were randomly assigned to also undergo YORS or treatment as usual, which consisted of a standard referral to outpatient care following an inpatient stay.
The primary outcomes were number of medication doses received over 24 weeks and relapse to opioid use, which was defined as 10 or more days of use within 28 days at 24 weeks.
Participants in the YORS group received more doses of extended-release naltrexone (mean, 4.28; standard deviation, 2.3) than participants in the treatment-as-usual group (mean, 0.70; SD, 1.2; P < .01).
In the YORS group, rates of relapse at both 12 and 24 weeks were lower, and there were fewer overall days of opioid use.
For the current study, the investigators wanted to test whether there was a possible effect when patients were given a choice of medication. In the earlier trial, patients did not have a choice – they had to take extended-release naltrexone. In this study, they could opt for it or extended-release buprenorphine.
The researchers recruited 22 young adults (aged 18-26 years) from their inpatient clinic to participate. Half the patients chose to take extended-release naltrexone, and the other half chose extended-release buprenorphine.
The groups were then compared to a historical group of 20 patients who received treatment as usual and served as the control group.
Positive outcomes
As in the first study, outcomes in the new study were better with YORS.
All participants who underwent YORS received more outpatient medication doses at 12 weeks and 24 weeks than those who received treatment as usual (1.91 vs. 0.40 and 3.76 vs. 0.70, respectively; P < .001).
For the YORS group, rates of opioid relapse were lower at 12 weeks (27.3% vs. 75.0%) and at 24 weeks (52.9% vs. 95.0%; P < .01.)
All components of YORS work together to improve retention, Dr. Fishman noted. Patients do much better if a relative such as a mother, father, or grandmother is closely involved, he added.
Also important is drug delivery.
“In some ways, this is similar to the assertive community treatment, or ACT, for schizophrenia. Like substance use disorder, schizophrenia requires long-acting injectable antipsychotics. When that is delivered to the patient through an organized delivery service like YORS, it improves outcomes,” said Dr. Fishman.
SUD is a chronic, relapsing illness in which an individual’s judgment is impaired, he added.
“ACT has become a relatively standard feature of treatment in most communities in this country and internationally and is sustainable under public sector funding, so it’s not an impossible leap to say it could be done. But it will not be cheap,” Dr. Fishman said.
Removing barriers
In a comment, Serra Akyar, MD, a psychiatry resident at Northwell Health’s Staten Island University Hospital, New York, said that the YORS program may appear to be labor intensive.
“However, the combination of medication-assisted treatment and support are essential to the treatment of opioid use disorder, especially for young adults. Developing effective interventions for young adults is particularly important, given the plasticity of their brains,” said Dr. Akyar, who was not involved with the research.
Inability to access medication and a lack of a supportive environment, both in everyday life and in regards to therapy, are barriers to successful treatment, she noted.
“The YORS intervention aims to remove these barriers to further enhance engagement to care through a combination of medication delivery and family engagement and assertive outreach via text messaging, a modality presumed to be well received by youth,” Dr. Akyar said.
Despite having a limited sample size, the study shows how a comprehensive intervention can have a large impact on the maintenance of medication adherence and reduction of relapse in young adults, she added.
“Its early success is encouraging and warrants further study on a larger scale to determine long-term effectiveness, overall costs and feasibility, generalizability, and whether certain independent factors exist that may predict medication adherence and reduction of relapse,” she said.
Wraparound support
The study is also a significant reminder that the opioid crisis has affected the young adult population, who are very vulnerable to OUD, said Jose Vito, MD, child, adolescent, and addiction psychiatrist at New York University.
“The study made me realize the importance of the four components of YORS, which were the outreach, family involvement, home delivery, and monetary incentives,” Dr. Vito said in an interview.
All of these components, in addition to extended-release naltrexone or extended-release buprenorphine, “have contributed to lower rates of opioid relapse, and the relapses are much later in the course of treatment if they do occur,” he said.
Overall, the findings demonstrate the importance of not giving up on these youths, he noted.
“Programs like YORS that provide wraparound support can help alleviate the opioid health care crisis by keeping these young adults in treatment,” Dr. Vito concluded.
The study was funded by the University of Maryland Center for Addiction Research, Education, and Service. Dr. Fishman has a financial relationship with Alkermes.
A version of this article first appeared on Medscape.com.
An intense and assertive “won’t take no for an answer” approach is effective for engaging in treatment young adults with substance abuse who have been in and out of various recovery programs for years, new research suggests.
The Youth Opioid Recovery Support (YORS) program is a team effort that includes home delivery of the prescribed medication, family engagement, assertive outreach, and contingency management.
In a new study of 42 patients in recovery for substance use disorder (SUD), those who were treated with extended-release naltrexone or extended-release buprenorphine plus YORS received more outpatient doses of their medication, and rates of opioid relapse at 12 and 24 weeks were lower compared with their peers who received only treatment as usual.
“ coinvestigator Marc Fishman, MD, director of the Maryland Treatment Centers, Johns Hopkins University, Baltimore, said in an interview.
The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
Treatment barriers
Young adults with SUD are difficult to reach, which leads to decreased addiction program retention, decreased medication adherence, early drop out, waxing and waning motivation, and worse outcomes, compared with older adults with SUD, Dr. Fishman said.
In July, positive results from a pilot trial conducted by the investigators of YORS were published online in Addiction.
In that study, 41 young adults aged 18-26 years who intended to undergo treatment for SUD with extended-release naltrexone were randomly assigned to also undergo YORS or treatment as usual, which consisted of a standard referral to outpatient care following an inpatient stay.
The primary outcomes were number of medication doses received over 24 weeks and relapse to opioid use, which was defined as 10 or more days of use within 28 days at 24 weeks.
Participants in the YORS group received more doses of extended-release naltrexone (mean, 4.28; standard deviation, 2.3) than participants in the treatment-as-usual group (mean, 0.70; SD, 1.2; P < .01).
In the YORS group, rates of relapse at both 12 and 24 weeks were lower, and there were fewer overall days of opioid use.
For the current study, the investigators wanted to test whether there was a possible effect when patients were given a choice of medication. In the earlier trial, patients did not have a choice – they had to take extended-release naltrexone. In this study, they could opt for it or extended-release buprenorphine.
The researchers recruited 22 young adults (aged 18-26 years) from their inpatient clinic to participate. Half the patients chose to take extended-release naltrexone, and the other half chose extended-release buprenorphine.
The groups were then compared to a historical group of 20 patients who received treatment as usual and served as the control group.
Positive outcomes
As in the first study, outcomes in the new study were better with YORS.
All participants who underwent YORS received more outpatient medication doses at 12 weeks and 24 weeks than those who received treatment as usual (1.91 vs. 0.40 and 3.76 vs. 0.70, respectively; P < .001).
For the YORS group, rates of opioid relapse were lower at 12 weeks (27.3% vs. 75.0%) and at 24 weeks (52.9% vs. 95.0%; P < .01.)
All components of YORS work together to improve retention, Dr. Fishman noted. Patients do much better if a relative such as a mother, father, or grandmother is closely involved, he added.
Also important is drug delivery.
“In some ways, this is similar to the assertive community treatment, or ACT, for schizophrenia. Like substance use disorder, schizophrenia requires long-acting injectable antipsychotics. When that is delivered to the patient through an organized delivery service like YORS, it improves outcomes,” said Dr. Fishman.
SUD is a chronic, relapsing illness in which an individual’s judgment is impaired, he added.
“ACT has become a relatively standard feature of treatment in most communities in this country and internationally and is sustainable under public sector funding, so it’s not an impossible leap to say it could be done. But it will not be cheap,” Dr. Fishman said.
Removing barriers
In a comment, Serra Akyar, MD, a psychiatry resident at Northwell Health’s Staten Island University Hospital, New York, said that the YORS program may appear to be labor intensive.
“However, the combination of medication-assisted treatment and support are essential to the treatment of opioid use disorder, especially for young adults. Developing effective interventions for young adults is particularly important, given the plasticity of their brains,” said Dr. Akyar, who was not involved with the research.
Inability to access medication and a lack of a supportive environment, both in everyday life and in regards to therapy, are barriers to successful treatment, she noted.
“The YORS intervention aims to remove these barriers to further enhance engagement to care through a combination of medication delivery and family engagement and assertive outreach via text messaging, a modality presumed to be well received by youth,” Dr. Akyar said.
Despite having a limited sample size, the study shows how a comprehensive intervention can have a large impact on the maintenance of medication adherence and reduction of relapse in young adults, she added.
“Its early success is encouraging and warrants further study on a larger scale to determine long-term effectiveness, overall costs and feasibility, generalizability, and whether certain independent factors exist that may predict medication adherence and reduction of relapse,” she said.
Wraparound support
The study is also a significant reminder that the opioid crisis has affected the young adult population, who are very vulnerable to OUD, said Jose Vito, MD, child, adolescent, and addiction psychiatrist at New York University.
“The study made me realize the importance of the four components of YORS, which were the outreach, family involvement, home delivery, and monetary incentives,” Dr. Vito said in an interview.
All of these components, in addition to extended-release naltrexone or extended-release buprenorphine, “have contributed to lower rates of opioid relapse, and the relapses are much later in the course of treatment if they do occur,” he said.
Overall, the findings demonstrate the importance of not giving up on these youths, he noted.
“Programs like YORS that provide wraparound support can help alleviate the opioid health care crisis by keeping these young adults in treatment,” Dr. Vito concluded.
The study was funded by the University of Maryland Center for Addiction Research, Education, and Service. Dr. Fishman has a financial relationship with Alkermes.
A version of this article first appeared on Medscape.com.
Shared medical appointments may bridge the opioid treatment gap
Shared medical appointments (SMAs) are an acceptable way to receive treatment for opioid use disorder (OUD), new research suggests.
In a survey study, participants attending an urban outpatient buprenorphine clinic reported a high degree of satisfaction with SMAs. However, the majority also reported they preferred individual appointments.
Still, SMAs may serve a role in providing comprehensive care for certain subpopulations with OUD who are prone to isolation and may also increase capacity to treat more patients with a substance use disorder (SUD), said coinvestigator Serra Akyar, MD, Northwell Health Staten Island University Hospital, New York.
“By providing education and a forum for sharing, SMAs can lead to changes in behavior and enhance and reinforce coping and problem-solving skills,” Dr. Akyar said in an interview.
The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
SMA vs. group therapy
SMA is not a form of group therapy, Dr. Akyar noted. Group therapy has a psychotherapy component and is led by a therapist. SMAs do not have a psychotherapeutic or a behavioral therapy component but provide education and an opportunity for sharing personal experiences of recovery.
“For example, the doctor participating in the group describes what happens in the brain to drive addiction and fellow participants share their personal anecdotes of recovery, including their struggles and successes,” Dr. Akyar said.
“ given the differences in the type of care each group provides,” she added.
Recent research on SMAs for OUD is limited. Although previous studies have shown that the practice is highly acceptable and has comparable or better retention in care rates with buprenorphine versus individual appointments, these studies have been conducted in predominantly White populations and in suburban settings.
For the new study, the investigators wanted to examine how acceptable SMAs for OUD would be in an urban setting involving predominantly racial and ethnic minorities.
They administered a 15-minute survey to patients with OUD who were attending the Comprehensive Addiction Resources and Education Center, an outpatient psychiatry clinic located at New Jersey Medical School, from December 2019 to February 2020.
Of the 42 participants who initially consented, 39 completed the survey. The majority of the responders were Black (64.1%), had an annual income that was less than $20,000 (61.5%), and/or were unemployed or disabled (69.3%).
Most of the participants agreed or strongly agreed with the following statements:
- Scheduling appointments for SMAs is easy.
- I gain valuable information from the responses to other patients’ questions in SMAs.
- There is enough time for questions during SMAs.
- I gain valuable information from the doctor and social worker in SMAs.
- My medical needs are met during SMAs.
- I would recommend an SMA to other patients.
- Since starting SMAs, I find it easier to stick to my treatment plan.
- I have a lot of support outside of SMAs.
- People in SMAs give me the support I need to stick to my treatment plan.
Interestingly, despite the overall high satisfaction with SMAs, just 33% of participants said they preferred them to one-on-one visits, Dr. Akyar noted.
Further analyses showed that total satisfaction scores were positively associated with older age, being on disability, or being in retirement.
Bridging the gap
In a comment, Philip Wong, MD, New Jersey Medical School, Newark, noted that a more widespread use of SMAs could potentially bridge the treatment gap that currently exists in the United States.
“For providers, SMAs help reduce costs, improve productivity, prevent repeating of common advice, and increase outreach. These are all important at a time when the need for OUD treatment is increasing. This is especially true for places like Newark, which is one of the prime epicenters of the opioid epidemic,” said Dr. Wong.
Although he was not involved with this research, he and his colleagues recently conducted a literature review of publications relating to SMAs and found seven peer-reviewed articles. However, none was appropriately designed to compare SMAs with traditional one-on-one recovery treatment.
“We definitely need more clinical studies to further our understanding of SMAs as a tool for the medication-assisted treatment of opioid use disorder,” Dr. Wong said.
“There are currently a very limited number of physicians who can prescribe medication-assisted treatment in the first place. So, if that one provider can reach a larger community by doing these SMAs, then the potential is very great in terms of addressing the opioid epidemic,” he said.
David Kan, MD, chief medical officer of Bright Heart Health, San Ramon, Calif., agreed.
“SMAs are promising because they are efficient and allow more people to access treatment,” Dr. Kan said in an interview.
“Although the mechanism of SMA satisfaction is unclear, other research shows peer support and groups helpful for SUD treatment as a whole. SMA takes the best of many worlds and increases the potential number of patients treated for SUD,” he said.
Also asked to comment, Lewei (Allison) Lin, MD, University of Michigan, Ann Arbor, said SMAs “are one of a number of important interventions that should be considered” in order to increase availability and access to medication providers for OUD.
However, more research is needed “to examine the impact on treatment uptake and patient and provider experiences,” said Dr. Lin.
Dr. Akyar, Dr. Wong, Dr. Kan, and Dr. Lin disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Shared medical appointments (SMAs) are an acceptable way to receive treatment for opioid use disorder (OUD), new research suggests.
In a survey study, participants attending an urban outpatient buprenorphine clinic reported a high degree of satisfaction with SMAs. However, the majority also reported they preferred individual appointments.
Still, SMAs may serve a role in providing comprehensive care for certain subpopulations with OUD who are prone to isolation and may also increase capacity to treat more patients with a substance use disorder (SUD), said coinvestigator Serra Akyar, MD, Northwell Health Staten Island University Hospital, New York.
“By providing education and a forum for sharing, SMAs can lead to changes in behavior and enhance and reinforce coping and problem-solving skills,” Dr. Akyar said in an interview.
The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
SMA vs. group therapy
SMA is not a form of group therapy, Dr. Akyar noted. Group therapy has a psychotherapy component and is led by a therapist. SMAs do not have a psychotherapeutic or a behavioral therapy component but provide education and an opportunity for sharing personal experiences of recovery.
“For example, the doctor participating in the group describes what happens in the brain to drive addiction and fellow participants share their personal anecdotes of recovery, including their struggles and successes,” Dr. Akyar said.
“ given the differences in the type of care each group provides,” she added.
Recent research on SMAs for OUD is limited. Although previous studies have shown that the practice is highly acceptable and has comparable or better retention in care rates with buprenorphine versus individual appointments, these studies have been conducted in predominantly White populations and in suburban settings.
For the new study, the investigators wanted to examine how acceptable SMAs for OUD would be in an urban setting involving predominantly racial and ethnic minorities.
They administered a 15-minute survey to patients with OUD who were attending the Comprehensive Addiction Resources and Education Center, an outpatient psychiatry clinic located at New Jersey Medical School, from December 2019 to February 2020.
Of the 42 participants who initially consented, 39 completed the survey. The majority of the responders were Black (64.1%), had an annual income that was less than $20,000 (61.5%), and/or were unemployed or disabled (69.3%).
Most of the participants agreed or strongly agreed with the following statements:
- Scheduling appointments for SMAs is easy.
- I gain valuable information from the responses to other patients’ questions in SMAs.
- There is enough time for questions during SMAs.
- I gain valuable information from the doctor and social worker in SMAs.
- My medical needs are met during SMAs.
- I would recommend an SMA to other patients.
- Since starting SMAs, I find it easier to stick to my treatment plan.
- I have a lot of support outside of SMAs.
- People in SMAs give me the support I need to stick to my treatment plan.
Interestingly, despite the overall high satisfaction with SMAs, just 33% of participants said they preferred them to one-on-one visits, Dr. Akyar noted.
Further analyses showed that total satisfaction scores were positively associated with older age, being on disability, or being in retirement.
Bridging the gap
In a comment, Philip Wong, MD, New Jersey Medical School, Newark, noted that a more widespread use of SMAs could potentially bridge the treatment gap that currently exists in the United States.
“For providers, SMAs help reduce costs, improve productivity, prevent repeating of common advice, and increase outreach. These are all important at a time when the need for OUD treatment is increasing. This is especially true for places like Newark, which is one of the prime epicenters of the opioid epidemic,” said Dr. Wong.
Although he was not involved with this research, he and his colleagues recently conducted a literature review of publications relating to SMAs and found seven peer-reviewed articles. However, none was appropriately designed to compare SMAs with traditional one-on-one recovery treatment.
“We definitely need more clinical studies to further our understanding of SMAs as a tool for the medication-assisted treatment of opioid use disorder,” Dr. Wong said.
“There are currently a very limited number of physicians who can prescribe medication-assisted treatment in the first place. So, if that one provider can reach a larger community by doing these SMAs, then the potential is very great in terms of addressing the opioid epidemic,” he said.
David Kan, MD, chief medical officer of Bright Heart Health, San Ramon, Calif., agreed.
“SMAs are promising because they are efficient and allow more people to access treatment,” Dr. Kan said in an interview.
“Although the mechanism of SMA satisfaction is unclear, other research shows peer support and groups helpful for SUD treatment as a whole. SMA takes the best of many worlds and increases the potential number of patients treated for SUD,” he said.
Also asked to comment, Lewei (Allison) Lin, MD, University of Michigan, Ann Arbor, said SMAs “are one of a number of important interventions that should be considered” in order to increase availability and access to medication providers for OUD.
However, more research is needed “to examine the impact on treatment uptake and patient and provider experiences,” said Dr. Lin.
Dr. Akyar, Dr. Wong, Dr. Kan, and Dr. Lin disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Shared medical appointments (SMAs) are an acceptable way to receive treatment for opioid use disorder (OUD), new research suggests.
In a survey study, participants attending an urban outpatient buprenorphine clinic reported a high degree of satisfaction with SMAs. However, the majority also reported they preferred individual appointments.
Still, SMAs may serve a role in providing comprehensive care for certain subpopulations with OUD who are prone to isolation and may also increase capacity to treat more patients with a substance use disorder (SUD), said coinvestigator Serra Akyar, MD, Northwell Health Staten Island University Hospital, New York.
“By providing education and a forum for sharing, SMAs can lead to changes in behavior and enhance and reinforce coping and problem-solving skills,” Dr. Akyar said in an interview.
The findings were presented at the virtual American Academy of Addiction Psychiatry 31st Annual Meeting.
SMA vs. group therapy
SMA is not a form of group therapy, Dr. Akyar noted. Group therapy has a psychotherapy component and is led by a therapist. SMAs do not have a psychotherapeutic or a behavioral therapy component but provide education and an opportunity for sharing personal experiences of recovery.
“For example, the doctor participating in the group describes what happens in the brain to drive addiction and fellow participants share their personal anecdotes of recovery, including their struggles and successes,” Dr. Akyar said.
“ given the differences in the type of care each group provides,” she added.
Recent research on SMAs for OUD is limited. Although previous studies have shown that the practice is highly acceptable and has comparable or better retention in care rates with buprenorphine versus individual appointments, these studies have been conducted in predominantly White populations and in suburban settings.
For the new study, the investigators wanted to examine how acceptable SMAs for OUD would be in an urban setting involving predominantly racial and ethnic minorities.
They administered a 15-minute survey to patients with OUD who were attending the Comprehensive Addiction Resources and Education Center, an outpatient psychiatry clinic located at New Jersey Medical School, from December 2019 to February 2020.
Of the 42 participants who initially consented, 39 completed the survey. The majority of the responders were Black (64.1%), had an annual income that was less than $20,000 (61.5%), and/or were unemployed or disabled (69.3%).
Most of the participants agreed or strongly agreed with the following statements:
- Scheduling appointments for SMAs is easy.
- I gain valuable information from the responses to other patients’ questions in SMAs.
- There is enough time for questions during SMAs.
- I gain valuable information from the doctor and social worker in SMAs.
- My medical needs are met during SMAs.
- I would recommend an SMA to other patients.
- Since starting SMAs, I find it easier to stick to my treatment plan.
- I have a lot of support outside of SMAs.
- People in SMAs give me the support I need to stick to my treatment plan.
Interestingly, despite the overall high satisfaction with SMAs, just 33% of participants said they preferred them to one-on-one visits, Dr. Akyar noted.
Further analyses showed that total satisfaction scores were positively associated with older age, being on disability, or being in retirement.
Bridging the gap
In a comment, Philip Wong, MD, New Jersey Medical School, Newark, noted that a more widespread use of SMAs could potentially bridge the treatment gap that currently exists in the United States.
“For providers, SMAs help reduce costs, improve productivity, prevent repeating of common advice, and increase outreach. These are all important at a time when the need for OUD treatment is increasing. This is especially true for places like Newark, which is one of the prime epicenters of the opioid epidemic,” said Dr. Wong.
Although he was not involved with this research, he and his colleagues recently conducted a literature review of publications relating to SMAs and found seven peer-reviewed articles. However, none was appropriately designed to compare SMAs with traditional one-on-one recovery treatment.
“We definitely need more clinical studies to further our understanding of SMAs as a tool for the medication-assisted treatment of opioid use disorder,” Dr. Wong said.
“There are currently a very limited number of physicians who can prescribe medication-assisted treatment in the first place. So, if that one provider can reach a larger community by doing these SMAs, then the potential is very great in terms of addressing the opioid epidemic,” he said.
David Kan, MD, chief medical officer of Bright Heart Health, San Ramon, Calif., agreed.
“SMAs are promising because they are efficient and allow more people to access treatment,” Dr. Kan said in an interview.
“Although the mechanism of SMA satisfaction is unclear, other research shows peer support and groups helpful for SUD treatment as a whole. SMA takes the best of many worlds and increases the potential number of patients treated for SUD,” he said.
Also asked to comment, Lewei (Allison) Lin, MD, University of Michigan, Ann Arbor, said SMAs “are one of a number of important interventions that should be considered” in order to increase availability and access to medication providers for OUD.
However, more research is needed “to examine the impact on treatment uptake and patient and provider experiences,” said Dr. Lin.
Dr. Akyar, Dr. Wong, Dr. Kan, and Dr. Lin disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
No benefit of cannabis on depression in pregnant women with OUD
Cannabis is ineffective at alleviating depression in pregnant women undergoing opioid agonist therapy (OAT), new research shows.
A study of more than 120 pregnant women undergoing treatment of opioid use disorder (OUD) showed that those who used cannabis to alleviate their depressive symptoms while undergoing OAT continued to have high depression scores at the end of opioid treatment.
In addition, depression scores improved for those who abstained from cannabis use after their first positive screen. Interestingly, cannabis use did not affect patient retention in treatment for OUD, the investigators note.
“To our knowledge, this is the first time looking at the impact of cannabis on the specific population of pregnant women with opioid use disorder, who are very vulnerable to depression,” lead author Abigail Richison, MD, University of Arkansas for Medical Sciences, Little Rock, said in an interview.
The findings were presented at the American Academy of Addiction Psychiatry (AAAP) 31st Annual Meeting, which was held online this year because of the COVID-19 pandemic.
A safer alternative?
Data from the National Survey on Drug Use and Health show that perinatal cannabis use increased by 62% between 2002 and 2014. Many women try to ameliorate their depression symptoms by using cannabis in the mistaken belief that it will help their depression, the investigators noted.
In addition, many women consider cannabis safer during pregnancy than prescribed medications for improving mood, said Dr. Richison. She said that cannabis does not alleviate depression and may even worsen it.
Dr. Richison noted that at her center, which has a women’s health program that treats pregnant women with OUDs, she was seeing a lot of patients who reported using cannabis to improve their mood.
“However, it didn’t seem like it was really helping, so I started researching about cannabis and depression,” Dr. Richison said.
“ and can be accused of perinatal substance use. I think it is very important to screen for depression as well as cannabis use in this population,” she added.
To shed some light on the impact of cannabis use by pregnant patients with OUD, the investigators conducted a retrospective chart review of 121 pregnant women with OUD who attended outpatient OAT. All were prescribed buprenorphine.
At each visit, Beck Depression Inventory (BDI) scores were obtained and urine drug screens were administered. The primary outcome was BDI score. Other measures included retention, urinary drug screen results, and antidepressant use.
The women were divided into two groups. The first comprised cannabis users, defined as having more than one urine drug screen that was positive for cannabis (n = 35). The other group comprised nonusers, defined as having urine drug screens that were negative for cannabis (n = 86).
Cannabis users were a little younger (mean age, 27 years) than non–cannabis users (mean age, 29.5 years; P = .006). Most of the participants were White (80.2%). Roughly half were on Medicaid, and most of the other participants had private insurance; a small number of women had no insurance.
Results showed that cannabis users had significantly higher BDI scores than non–cannabis users (mean scores, 16 vs. 9.3; P < .001).
Cannabis use continued to be associated with elevated scores for depression when controlling for opioid misuse and antidepressant use. There were no significant differences in retention or lapse to opioid misuse between the two groups.
More evidence of risk
Commenting on the findings in an interview, Carla Marienfeld, MD, professor of psychiatry at the University of California, San Diego, said there is a growing body of evidence about risks from cannabis use during pregnancy, “a time where we already know the endocannabinoid system is very active in the developing fetus.”
She noted that the current study’s design makes it hard to know whether marijuana use causes worse depression.
However, “it clearly is not associated with helping to improve mood the way people who are using it believe or hope for,” said Dr. Marienfeld, who was not part of the research.
“The risk for harm in terms of worse mood for the pregnant woman or risks for harm to the developing fetus are being better understood with many new studies,” she added.
Yet as more and more states legalize medical marijuana, cannabis use during pregnancy is only going to rise, experts fear.
Cornel Stanciu, MD, of Dartmouth-Hitchcock Medical Center, Lebanon, N.H., who was asked for comment, noted that public endorsement for potential benefits of the marijuana plant is at an all-time high.
“To date, 33 states and the District of Columbia have responded by legalizing medical marijuana, with 10 states also having legalized recreational use of marijuana. The current practice is said to be ahead of science, as robust research has been hindered by strict regulations – and most epidemiological studies point toward harmful associations,” Dr. Stanciu said in an interview.
“Given the decreased perception of harm by the general public, women are certainly compelled to seek what they perceive as more natural self-management remedies,” he said.
A harmful habit
Dr. Stanciu cited a recent study conducted in Colorado in which researchers contacted cannabis dispensaries, identified themselves as being pregnant, and asked for guidance in managing pregnancy-related symptoms.
Almost 70% of dispensaries recommended products to treat symptoms, particularly in the vulnerable first trimester; 36% of them also provided reassurance of the safety profile. Very few encouraged a discussion with the physician.
“Consumption of cannabis during pregnancy results in cannabinoid placental crossing and accumulation in the fetal brain, as well as other organs, where it interferes with neurodevelopment and the endocannabinoid system,” he said.
In addition, retrospective studies have shown an association between prenatal cannabis ingestion and anemia in the mothers, low birth weight, greater risk for preterm and stillbirths, and increased need for neonatal ICU admissions.
“Children born to mothers who used cannabis during pregnancy have higher rates of impulsivity, delinquency, learning and memory impairment, as well as executive function deficits. There is also an increased association with proneness to psychosis during middle childhood,” Dr. Stanciu said.
When used during pregnancy, cannabis has been associated with increased anxiety in mothers, as well as increased risk for depressive disorders, incidence of suicidal ideations and behavior, and symptoms of mania and psychosis among those with bipolar and schizophrenia spectrum conditions. Cannabis has also been linked to coingestion of other substances and with alcohol use.
“So cannabis can pose harm, especially when used by those with affective disorders,” Dr. Stanciu said.
The study was funded by the National Institute on Drug Abuse. Dr. Richison, Dr. Marienfeld, and Dr. Stanciu have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com
Cannabis is ineffective at alleviating depression in pregnant women undergoing opioid agonist therapy (OAT), new research shows.
A study of more than 120 pregnant women undergoing treatment of opioid use disorder (OUD) showed that those who used cannabis to alleviate their depressive symptoms while undergoing OAT continued to have high depression scores at the end of opioid treatment.
In addition, depression scores improved for those who abstained from cannabis use after their first positive screen. Interestingly, cannabis use did not affect patient retention in treatment for OUD, the investigators note.
“To our knowledge, this is the first time looking at the impact of cannabis on the specific population of pregnant women with opioid use disorder, who are very vulnerable to depression,” lead author Abigail Richison, MD, University of Arkansas for Medical Sciences, Little Rock, said in an interview.
The findings were presented at the American Academy of Addiction Psychiatry (AAAP) 31st Annual Meeting, which was held online this year because of the COVID-19 pandemic.
A safer alternative?
Data from the National Survey on Drug Use and Health show that perinatal cannabis use increased by 62% between 2002 and 2014. Many women try to ameliorate their depression symptoms by using cannabis in the mistaken belief that it will help their depression, the investigators noted.
In addition, many women consider cannabis safer during pregnancy than prescribed medications for improving mood, said Dr. Richison. She said that cannabis does not alleviate depression and may even worsen it.
Dr. Richison noted that at her center, which has a women’s health program that treats pregnant women with OUDs, she was seeing a lot of patients who reported using cannabis to improve their mood.
“However, it didn’t seem like it was really helping, so I started researching about cannabis and depression,” Dr. Richison said.
“ and can be accused of perinatal substance use. I think it is very important to screen for depression as well as cannabis use in this population,” she added.
To shed some light on the impact of cannabis use by pregnant patients with OUD, the investigators conducted a retrospective chart review of 121 pregnant women with OUD who attended outpatient OAT. All were prescribed buprenorphine.
At each visit, Beck Depression Inventory (BDI) scores were obtained and urine drug screens were administered. The primary outcome was BDI score. Other measures included retention, urinary drug screen results, and antidepressant use.
The women were divided into two groups. The first comprised cannabis users, defined as having more than one urine drug screen that was positive for cannabis (n = 35). The other group comprised nonusers, defined as having urine drug screens that were negative for cannabis (n = 86).
Cannabis users were a little younger (mean age, 27 years) than non–cannabis users (mean age, 29.5 years; P = .006). Most of the participants were White (80.2%). Roughly half were on Medicaid, and most of the other participants had private insurance; a small number of women had no insurance.
Results showed that cannabis users had significantly higher BDI scores than non–cannabis users (mean scores, 16 vs. 9.3; P < .001).
Cannabis use continued to be associated with elevated scores for depression when controlling for opioid misuse and antidepressant use. There were no significant differences in retention or lapse to opioid misuse between the two groups.
More evidence of risk
Commenting on the findings in an interview, Carla Marienfeld, MD, professor of psychiatry at the University of California, San Diego, said there is a growing body of evidence about risks from cannabis use during pregnancy, “a time where we already know the endocannabinoid system is very active in the developing fetus.”
She noted that the current study’s design makes it hard to know whether marijuana use causes worse depression.
However, “it clearly is not associated with helping to improve mood the way people who are using it believe or hope for,” said Dr. Marienfeld, who was not part of the research.
“The risk for harm in terms of worse mood for the pregnant woman or risks for harm to the developing fetus are being better understood with many new studies,” she added.
Yet as more and more states legalize medical marijuana, cannabis use during pregnancy is only going to rise, experts fear.
Cornel Stanciu, MD, of Dartmouth-Hitchcock Medical Center, Lebanon, N.H., who was asked for comment, noted that public endorsement for potential benefits of the marijuana plant is at an all-time high.
“To date, 33 states and the District of Columbia have responded by legalizing medical marijuana, with 10 states also having legalized recreational use of marijuana. The current practice is said to be ahead of science, as robust research has been hindered by strict regulations – and most epidemiological studies point toward harmful associations,” Dr. Stanciu said in an interview.
“Given the decreased perception of harm by the general public, women are certainly compelled to seek what they perceive as more natural self-management remedies,” he said.
A harmful habit
Dr. Stanciu cited a recent study conducted in Colorado in which researchers contacted cannabis dispensaries, identified themselves as being pregnant, and asked for guidance in managing pregnancy-related symptoms.
Almost 70% of dispensaries recommended products to treat symptoms, particularly in the vulnerable first trimester; 36% of them also provided reassurance of the safety profile. Very few encouraged a discussion with the physician.
“Consumption of cannabis during pregnancy results in cannabinoid placental crossing and accumulation in the fetal brain, as well as other organs, where it interferes with neurodevelopment and the endocannabinoid system,” he said.
In addition, retrospective studies have shown an association between prenatal cannabis ingestion and anemia in the mothers, low birth weight, greater risk for preterm and stillbirths, and increased need for neonatal ICU admissions.
“Children born to mothers who used cannabis during pregnancy have higher rates of impulsivity, delinquency, learning and memory impairment, as well as executive function deficits. There is also an increased association with proneness to psychosis during middle childhood,” Dr. Stanciu said.
When used during pregnancy, cannabis has been associated with increased anxiety in mothers, as well as increased risk for depressive disorders, incidence of suicidal ideations and behavior, and symptoms of mania and psychosis among those with bipolar and schizophrenia spectrum conditions. Cannabis has also been linked to coingestion of other substances and with alcohol use.
“So cannabis can pose harm, especially when used by those with affective disorders,” Dr. Stanciu said.
The study was funded by the National Institute on Drug Abuse. Dr. Richison, Dr. Marienfeld, and Dr. Stanciu have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com
Cannabis is ineffective at alleviating depression in pregnant women undergoing opioid agonist therapy (OAT), new research shows.
A study of more than 120 pregnant women undergoing treatment of opioid use disorder (OUD) showed that those who used cannabis to alleviate their depressive symptoms while undergoing OAT continued to have high depression scores at the end of opioid treatment.
In addition, depression scores improved for those who abstained from cannabis use after their first positive screen. Interestingly, cannabis use did not affect patient retention in treatment for OUD, the investigators note.
“To our knowledge, this is the first time looking at the impact of cannabis on the specific population of pregnant women with opioid use disorder, who are very vulnerable to depression,” lead author Abigail Richison, MD, University of Arkansas for Medical Sciences, Little Rock, said in an interview.
The findings were presented at the American Academy of Addiction Psychiatry (AAAP) 31st Annual Meeting, which was held online this year because of the COVID-19 pandemic.
A safer alternative?
Data from the National Survey on Drug Use and Health show that perinatal cannabis use increased by 62% between 2002 and 2014. Many women try to ameliorate their depression symptoms by using cannabis in the mistaken belief that it will help their depression, the investigators noted.
In addition, many women consider cannabis safer during pregnancy than prescribed medications for improving mood, said Dr. Richison. She said that cannabis does not alleviate depression and may even worsen it.
Dr. Richison noted that at her center, which has a women’s health program that treats pregnant women with OUDs, she was seeing a lot of patients who reported using cannabis to improve their mood.
“However, it didn’t seem like it was really helping, so I started researching about cannabis and depression,” Dr. Richison said.
“ and can be accused of perinatal substance use. I think it is very important to screen for depression as well as cannabis use in this population,” she added.
To shed some light on the impact of cannabis use by pregnant patients with OUD, the investigators conducted a retrospective chart review of 121 pregnant women with OUD who attended outpatient OAT. All were prescribed buprenorphine.
At each visit, Beck Depression Inventory (BDI) scores were obtained and urine drug screens were administered. The primary outcome was BDI score. Other measures included retention, urinary drug screen results, and antidepressant use.
The women were divided into two groups. The first comprised cannabis users, defined as having more than one urine drug screen that was positive for cannabis (n = 35). The other group comprised nonusers, defined as having urine drug screens that were negative for cannabis (n = 86).
Cannabis users were a little younger (mean age, 27 years) than non–cannabis users (mean age, 29.5 years; P = .006). Most of the participants were White (80.2%). Roughly half were on Medicaid, and most of the other participants had private insurance; a small number of women had no insurance.
Results showed that cannabis users had significantly higher BDI scores than non–cannabis users (mean scores, 16 vs. 9.3; P < .001).
Cannabis use continued to be associated with elevated scores for depression when controlling for opioid misuse and antidepressant use. There were no significant differences in retention or lapse to opioid misuse between the two groups.
More evidence of risk
Commenting on the findings in an interview, Carla Marienfeld, MD, professor of psychiatry at the University of California, San Diego, said there is a growing body of evidence about risks from cannabis use during pregnancy, “a time where we already know the endocannabinoid system is very active in the developing fetus.”
She noted that the current study’s design makes it hard to know whether marijuana use causes worse depression.
However, “it clearly is not associated with helping to improve mood the way people who are using it believe or hope for,” said Dr. Marienfeld, who was not part of the research.
“The risk for harm in terms of worse mood for the pregnant woman or risks for harm to the developing fetus are being better understood with many new studies,” she added.
Yet as more and more states legalize medical marijuana, cannabis use during pregnancy is only going to rise, experts fear.
Cornel Stanciu, MD, of Dartmouth-Hitchcock Medical Center, Lebanon, N.H., who was asked for comment, noted that public endorsement for potential benefits of the marijuana plant is at an all-time high.
“To date, 33 states and the District of Columbia have responded by legalizing medical marijuana, with 10 states also having legalized recreational use of marijuana. The current practice is said to be ahead of science, as robust research has been hindered by strict regulations – and most epidemiological studies point toward harmful associations,” Dr. Stanciu said in an interview.
“Given the decreased perception of harm by the general public, women are certainly compelled to seek what they perceive as more natural self-management remedies,” he said.
A harmful habit
Dr. Stanciu cited a recent study conducted in Colorado in which researchers contacted cannabis dispensaries, identified themselves as being pregnant, and asked for guidance in managing pregnancy-related symptoms.
Almost 70% of dispensaries recommended products to treat symptoms, particularly in the vulnerable first trimester; 36% of them also provided reassurance of the safety profile. Very few encouraged a discussion with the physician.
“Consumption of cannabis during pregnancy results in cannabinoid placental crossing and accumulation in the fetal brain, as well as other organs, where it interferes with neurodevelopment and the endocannabinoid system,” he said.
In addition, retrospective studies have shown an association between prenatal cannabis ingestion and anemia in the mothers, low birth weight, greater risk for preterm and stillbirths, and increased need for neonatal ICU admissions.
“Children born to mothers who used cannabis during pregnancy have higher rates of impulsivity, delinquency, learning and memory impairment, as well as executive function deficits. There is also an increased association with proneness to psychosis during middle childhood,” Dr. Stanciu said.
When used during pregnancy, cannabis has been associated with increased anxiety in mothers, as well as increased risk for depressive disorders, incidence of suicidal ideations and behavior, and symptoms of mania and psychosis among those with bipolar and schizophrenia spectrum conditions. Cannabis has also been linked to coingestion of other substances and with alcohol use.
“So cannabis can pose harm, especially when used by those with affective disorders,” Dr. Stanciu said.
The study was funded by the National Institute on Drug Abuse. Dr. Richison, Dr. Marienfeld, and Dr. Stanciu have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com
ADHD meds may boost treatment retention in comorbid addiction
Judicious use of stimulants may help patients with attention-deficit hyperactivity disorder (ADHD) and comorbid substance use disorder (SUD) stay in addiction treatment programs, research shows.
Results of a 5-year retrospective cohort study showed adult patients with ADHD attending an addiction recovery program were five times less likely to drop out of care if they were receiving stimulant medication within the first 90 days, compared with their peers who received no medication.
“When considering the risks and benefits of ADHD pharmacotherapy and particularly stimulant therapy in the addiction clinic, we should really be thinking about the risk of treatment dropout and poor retention if we do not treat the ADHD syndrome,” study investigator Kristopher A. Kast, MD, Vanderbilt University, Nashville, Tenn., told this news organization.
The findings were presented at the American Academy of Addiction Psychiatry annual meeting, which was held online this year.
Comorbidity common
“This study matters because this clinical situation comes up a lot, where you have patients who are presenting in the substance use disorder clinic who are experiencing symptoms of ADHD and who have been on stimulant therapy either as a child or young adult in the past,” said Dr. Kast, who conducted this study while he was at Massachusetts General Hospital in Boston.
About 25% of patients presenting to outpatient substance use care meet criteria for an ADHD diagnosis, and having both conditions worsens ADHD and SUD outcomes, he noted.
“ADHD treatment would be helpful to these people, but often clinicians are reluctant to prescribe stimulant medication because it’s a controlled substance. Especially early on in treatment, we’re often worried that such a medication could destabilize the patient,” said Dr. Kast.
To examine the relationship between ADHD pharmacotherapy and retention in SUD treatment participants, the investigators assessed electronic medical record data from Mass General over a period of 5.5 years, from July 2014 to January 2020.
The data included information on 2,163 patients (63% men; mean age, 44 years) admitted to the addiction clinic. A total of 203 had a clinical diagnosis of ADHD (9.4%). Of these 203 participants, 171 were receiving ADHD pharmacotherapy and 32 were untreated.
Among all participants, the group with ADHD was significantly younger than the non-ADHD group (mean age, 38 vs. 45 years, respectively) and more likely to use cocaine (31% vs. 12%) and have private insurance (64% vs. 44%) (P < .001 for all comparisons).
Results showed ADHD stimulant therapy within the first 90 days of SUD treatment was a robust indication of retention. After adjusting for several variables, only ADHD pharmacotherapy was significantly associated with retention (hazard ratio, 0.59; 95% confidence interval, 0.4-0.9; P = .008).
“It was the only variable in a multivariate regression analysis that predicted longer-term retention. It was an even stronger predictor than Suboxone [buprenorphine and naloxone] therapy, with is traditionally strongly associated with retention,” Dr. Kast noted.
He added that, because this was a retrospective, nonrandomized study, it limited the ability to address confounding and unmeasured covariates.
“Our findings may not generalize to the undiagnosed group of patients who would be identified by standardized diagnostic instruments,” Kast said. “Future studies should address risk and number-needed-to-harm associated with ADHD pharmacotherapy.”
High dropout rate
Commenting on the findings for this news organization, Frances Levin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, noted that previous research has shown that patients with ADHD tend to do less well in addiction treatment and drop out of programs more frequently.
What has not been shown as effectively, at least in substance use treatment settings, is that treating ADHD makes a difference in terms of retention, she said.
Although Dr. Levin wasn’t involved in this study, she is currently part of a European study that is assessing SUD treatment-retention outcomes in patients with ADHD who have been randomly assigned to receive either stimulant or nonstimulant medication.
Clinicians are too often focused on risks for overtreatment, diversion, and misuse but what is underappreciated is the risk for undertreatment, Dr. Levin noted.
“ Not using the right drugs may make people less likely to stay in treatment and continue their drug use,” she said.
“Misuse and diversion are much higher with immediate-release preparations, and for this reason it’s important to use the long-acting stimulants in this population. Often people do not make that distinction,” Dr. Levin added.
As an expert in the field for more than 2 decades, Dr. Levin said she has learned a lot about treating this type of patient. “You have to monitor them very closely, and never prescribe in a cavalier way,” she said.
“I have the same discussion with these patients that I have when I talk about buprenorphine for opioid use disorder. It is a tremendously powerful medication, saves many lives and prevents overdose, but there is a risk of misuse and diversion, albeit pretty low. It’s there, and you have to use it carefully, but I think being careful vs. never prescribing are two different things,” Dr. Levin said.
‘Guidance and reassurance’
The traditional belief among the general medical community that controlled substances should always be avoided in patients with SUD has hindered treatment for many with comorbid ADHD, said Cornel Stanciu, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., when asked for comment.
“I have encountered many non–addiction-trained physicians who provide buprenorphine treatment for OUD, and they hesitate not only to assess for ADHD but also to implement standard of care treatment when such a diagnosis is made,” Dr. Stanciu told said in an interview.
He added that this practice often stems from fear of “being under the radar” of the U.S. Drug Enforcement Administration for what it might consider an aberrant prescribing pattern involving two controlled substances.
“Hopefully, studies such as Dr. Kast’s will continue to shine light on this issue and offer guidance and reassurance to those treating addictive disorders,” Dr. Stanciu said.
Dr. Kast, Dr. Levin, and Dr. Stanciu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Judicious use of stimulants may help patients with attention-deficit hyperactivity disorder (ADHD) and comorbid substance use disorder (SUD) stay in addiction treatment programs, research shows.
Results of a 5-year retrospective cohort study showed adult patients with ADHD attending an addiction recovery program were five times less likely to drop out of care if they were receiving stimulant medication within the first 90 days, compared with their peers who received no medication.
“When considering the risks and benefits of ADHD pharmacotherapy and particularly stimulant therapy in the addiction clinic, we should really be thinking about the risk of treatment dropout and poor retention if we do not treat the ADHD syndrome,” study investigator Kristopher A. Kast, MD, Vanderbilt University, Nashville, Tenn., told this news organization.
The findings were presented at the American Academy of Addiction Psychiatry annual meeting, which was held online this year.
Comorbidity common
“This study matters because this clinical situation comes up a lot, where you have patients who are presenting in the substance use disorder clinic who are experiencing symptoms of ADHD and who have been on stimulant therapy either as a child or young adult in the past,” said Dr. Kast, who conducted this study while he was at Massachusetts General Hospital in Boston.
About 25% of patients presenting to outpatient substance use care meet criteria for an ADHD diagnosis, and having both conditions worsens ADHD and SUD outcomes, he noted.
“ADHD treatment would be helpful to these people, but often clinicians are reluctant to prescribe stimulant medication because it’s a controlled substance. Especially early on in treatment, we’re often worried that such a medication could destabilize the patient,” said Dr. Kast.
To examine the relationship between ADHD pharmacotherapy and retention in SUD treatment participants, the investigators assessed electronic medical record data from Mass General over a period of 5.5 years, from July 2014 to January 2020.
The data included information on 2,163 patients (63% men; mean age, 44 years) admitted to the addiction clinic. A total of 203 had a clinical diagnosis of ADHD (9.4%). Of these 203 participants, 171 were receiving ADHD pharmacotherapy and 32 were untreated.
Among all participants, the group with ADHD was significantly younger than the non-ADHD group (mean age, 38 vs. 45 years, respectively) and more likely to use cocaine (31% vs. 12%) and have private insurance (64% vs. 44%) (P < .001 for all comparisons).
Results showed ADHD stimulant therapy within the first 90 days of SUD treatment was a robust indication of retention. After adjusting for several variables, only ADHD pharmacotherapy was significantly associated with retention (hazard ratio, 0.59; 95% confidence interval, 0.4-0.9; P = .008).
“It was the only variable in a multivariate regression analysis that predicted longer-term retention. It was an even stronger predictor than Suboxone [buprenorphine and naloxone] therapy, with is traditionally strongly associated with retention,” Dr. Kast noted.
He added that, because this was a retrospective, nonrandomized study, it limited the ability to address confounding and unmeasured covariates.
“Our findings may not generalize to the undiagnosed group of patients who would be identified by standardized diagnostic instruments,” Kast said. “Future studies should address risk and number-needed-to-harm associated with ADHD pharmacotherapy.”
High dropout rate
Commenting on the findings for this news organization, Frances Levin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, noted that previous research has shown that patients with ADHD tend to do less well in addiction treatment and drop out of programs more frequently.
What has not been shown as effectively, at least in substance use treatment settings, is that treating ADHD makes a difference in terms of retention, she said.
Although Dr. Levin wasn’t involved in this study, she is currently part of a European study that is assessing SUD treatment-retention outcomes in patients with ADHD who have been randomly assigned to receive either stimulant or nonstimulant medication.
Clinicians are too often focused on risks for overtreatment, diversion, and misuse but what is underappreciated is the risk for undertreatment, Dr. Levin noted.
“ Not using the right drugs may make people less likely to stay in treatment and continue their drug use,” she said.
“Misuse and diversion are much higher with immediate-release preparations, and for this reason it’s important to use the long-acting stimulants in this population. Often people do not make that distinction,” Dr. Levin added.
As an expert in the field for more than 2 decades, Dr. Levin said she has learned a lot about treating this type of patient. “You have to monitor them very closely, and never prescribe in a cavalier way,” she said.
“I have the same discussion with these patients that I have when I talk about buprenorphine for opioid use disorder. It is a tremendously powerful medication, saves many lives and prevents overdose, but there is a risk of misuse and diversion, albeit pretty low. It’s there, and you have to use it carefully, but I think being careful vs. never prescribing are two different things,” Dr. Levin said.
‘Guidance and reassurance’
The traditional belief among the general medical community that controlled substances should always be avoided in patients with SUD has hindered treatment for many with comorbid ADHD, said Cornel Stanciu, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., when asked for comment.
“I have encountered many non–addiction-trained physicians who provide buprenorphine treatment for OUD, and they hesitate not only to assess for ADHD but also to implement standard of care treatment when such a diagnosis is made,” Dr. Stanciu told said in an interview.
He added that this practice often stems from fear of “being under the radar” of the U.S. Drug Enforcement Administration for what it might consider an aberrant prescribing pattern involving two controlled substances.
“Hopefully, studies such as Dr. Kast’s will continue to shine light on this issue and offer guidance and reassurance to those treating addictive disorders,” Dr. Stanciu said.
Dr. Kast, Dr. Levin, and Dr. Stanciu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Judicious use of stimulants may help patients with attention-deficit hyperactivity disorder (ADHD) and comorbid substance use disorder (SUD) stay in addiction treatment programs, research shows.
Results of a 5-year retrospective cohort study showed adult patients with ADHD attending an addiction recovery program were five times less likely to drop out of care if they were receiving stimulant medication within the first 90 days, compared with their peers who received no medication.
“When considering the risks and benefits of ADHD pharmacotherapy and particularly stimulant therapy in the addiction clinic, we should really be thinking about the risk of treatment dropout and poor retention if we do not treat the ADHD syndrome,” study investigator Kristopher A. Kast, MD, Vanderbilt University, Nashville, Tenn., told this news organization.
The findings were presented at the American Academy of Addiction Psychiatry annual meeting, which was held online this year.
Comorbidity common
“This study matters because this clinical situation comes up a lot, where you have patients who are presenting in the substance use disorder clinic who are experiencing symptoms of ADHD and who have been on stimulant therapy either as a child or young adult in the past,” said Dr. Kast, who conducted this study while he was at Massachusetts General Hospital in Boston.
About 25% of patients presenting to outpatient substance use care meet criteria for an ADHD diagnosis, and having both conditions worsens ADHD and SUD outcomes, he noted.
“ADHD treatment would be helpful to these people, but often clinicians are reluctant to prescribe stimulant medication because it’s a controlled substance. Especially early on in treatment, we’re often worried that such a medication could destabilize the patient,” said Dr. Kast.
To examine the relationship between ADHD pharmacotherapy and retention in SUD treatment participants, the investigators assessed electronic medical record data from Mass General over a period of 5.5 years, from July 2014 to January 2020.
The data included information on 2,163 patients (63% men; mean age, 44 years) admitted to the addiction clinic. A total of 203 had a clinical diagnosis of ADHD (9.4%). Of these 203 participants, 171 were receiving ADHD pharmacotherapy and 32 were untreated.
Among all participants, the group with ADHD was significantly younger than the non-ADHD group (mean age, 38 vs. 45 years, respectively) and more likely to use cocaine (31% vs. 12%) and have private insurance (64% vs. 44%) (P < .001 for all comparisons).
Results showed ADHD stimulant therapy within the first 90 days of SUD treatment was a robust indication of retention. After adjusting for several variables, only ADHD pharmacotherapy was significantly associated with retention (hazard ratio, 0.59; 95% confidence interval, 0.4-0.9; P = .008).
“It was the only variable in a multivariate regression analysis that predicted longer-term retention. It was an even stronger predictor than Suboxone [buprenorphine and naloxone] therapy, with is traditionally strongly associated with retention,” Dr. Kast noted.
He added that, because this was a retrospective, nonrandomized study, it limited the ability to address confounding and unmeasured covariates.
“Our findings may not generalize to the undiagnosed group of patients who would be identified by standardized diagnostic instruments,” Kast said. “Future studies should address risk and number-needed-to-harm associated with ADHD pharmacotherapy.”
High dropout rate
Commenting on the findings for this news organization, Frances Levin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, noted that previous research has shown that patients with ADHD tend to do less well in addiction treatment and drop out of programs more frequently.
What has not been shown as effectively, at least in substance use treatment settings, is that treating ADHD makes a difference in terms of retention, she said.
Although Dr. Levin wasn’t involved in this study, she is currently part of a European study that is assessing SUD treatment-retention outcomes in patients with ADHD who have been randomly assigned to receive either stimulant or nonstimulant medication.
Clinicians are too often focused on risks for overtreatment, diversion, and misuse but what is underappreciated is the risk for undertreatment, Dr. Levin noted.
“ Not using the right drugs may make people less likely to stay in treatment and continue their drug use,” she said.
“Misuse and diversion are much higher with immediate-release preparations, and for this reason it’s important to use the long-acting stimulants in this population. Often people do not make that distinction,” Dr. Levin added.
As an expert in the field for more than 2 decades, Dr. Levin said she has learned a lot about treating this type of patient. “You have to monitor them very closely, and never prescribe in a cavalier way,” she said.
“I have the same discussion with these patients that I have when I talk about buprenorphine for opioid use disorder. It is a tremendously powerful medication, saves many lives and prevents overdose, but there is a risk of misuse and diversion, albeit pretty low. It’s there, and you have to use it carefully, but I think being careful vs. never prescribing are two different things,” Dr. Levin said.
‘Guidance and reassurance’
The traditional belief among the general medical community that controlled substances should always be avoided in patients with SUD has hindered treatment for many with comorbid ADHD, said Cornel Stanciu, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., when asked for comment.
“I have encountered many non–addiction-trained physicians who provide buprenorphine treatment for OUD, and they hesitate not only to assess for ADHD but also to implement standard of care treatment when such a diagnosis is made,” Dr. Stanciu told said in an interview.
He added that this practice often stems from fear of “being under the radar” of the U.S. Drug Enforcement Administration for what it might consider an aberrant prescribing pattern involving two controlled substances.
“Hopefully, studies such as Dr. Kast’s will continue to shine light on this issue and offer guidance and reassurance to those treating addictive disorders,” Dr. Stanciu said.
Dr. Kast, Dr. Levin, and Dr. Stanciu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.