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FDA approves Qternmet XR as adjunct therapy for glycemic improvement in type 2 diabetes
The Food and Drug Administration has approved Qternmet XR (dapagliflozin/saxagliptin/metformin) as an oral adjunct therapy to diet and exercise for the improvement of glycemic control in patients with type 2 diabetes, according to AstraZeneca.
FDA approval is based on results from a pair of phase 3 trials that tested different combinations of dapagliflozin and saxagliptin in patients with inadequately controlled type 2 diabetes who were also receiving metformin over a 24-week period. In both trials, treatment with dapagliflozin/saxagliptin/metformin decreased hemoglobin A1c by statistically significant amounts, and increased the number of patients with HbA1c levels below 7%
The safety results of Qternmet XR was consistent with each component medication’s known profile.
The Food and Drug Administration has approved Qternmet XR (dapagliflozin/saxagliptin/metformin) as an oral adjunct therapy to diet and exercise for the improvement of glycemic control in patients with type 2 diabetes, according to AstraZeneca.
FDA approval is based on results from a pair of phase 3 trials that tested different combinations of dapagliflozin and saxagliptin in patients with inadequately controlled type 2 diabetes who were also receiving metformin over a 24-week period. In both trials, treatment with dapagliflozin/saxagliptin/metformin decreased hemoglobin A1c by statistically significant amounts, and increased the number of patients with HbA1c levels below 7%
The safety results of Qternmet XR was consistent with each component medication’s known profile.
The Food and Drug Administration has approved Qternmet XR (dapagliflozin/saxagliptin/metformin) as an oral adjunct therapy to diet and exercise for the improvement of glycemic control in patients with type 2 diabetes, according to AstraZeneca.
FDA approval is based on results from a pair of phase 3 trials that tested different combinations of dapagliflozin and saxagliptin in patients with inadequately controlled type 2 diabetes who were also receiving metformin over a 24-week period. In both trials, treatment with dapagliflozin/saxagliptin/metformin decreased hemoglobin A1c by statistically significant amounts, and increased the number of patients with HbA1c levels below 7%
The safety results of Qternmet XR was consistent with each component medication’s known profile.
Direct pharmacy dispensing of naloxone linked to drop in fatal overdoses
investigators reported.
By contrast, state laws that stopped short of allowing pharmacists to directly dispense the opioid antagonist did not appear to impact mortality, according to the report, which appears in JAMA Internal Medicine (2019 May 6. doi: 10.1001/jamainternmed.2019.0272).
The report, based on state-level trends tracked from 2005 to 2016, indicates that fatal opioid overdoses fell by nearly one-third in states that adopted direct dispensing laws as compared with states that adopted other naloxone laws.
That finding suggests that the policy type determines whether a naloxone law is useful in combating fatal opioid overdoses, said Rahi Abouk, PhD, of William Paterson University, Wayne, N.J. and co-authors of the paper.
“Enabling distribution through various sources, or requiring gatekeepers, will not be as beneficial,” Dr. Abouk and co-authors said in their report.
The current rate of deaths from fentanyl, heroin, and prescription analgesic overdose has outpaced all previous drug epidemics on record, and even surpasses the number of deaths in the peak year of the HIV epidemic of the 1980s, Dr. Abouk and colleagues wrote in their paper.
The number of states with naloxone access laws grew from just 2 in 2005 to 47 by 2016, including 9 states that granted direct authority to pharmacists and 38 that granted indirect authority, according to the researchers.
The analysis of overdose trends from 2005 to 2016 was based on naloxone distribution data from state Medicaid agencies and opioid-related mortality data from a national statistics system. Forty percent of nonelderly adults with an opioid addiction are covered by Medicaid, the researchers said.
They found that naloxone laws granting pharmacists direct dispensing authority were linked to a drop in opioid deaths that increased in magnitude over time, according to researchers. The mean number of opioid deaths dropped by 27% in the second year after adoption of direct authority laws, relative to opioid deaths in states with indirect access laws, while in subsequent years, deaths dropped by 34%.
Emergency department visits related to opioids increased by 15% in direct authority states 3 or more years after adoption, as compared to states that did not adopt direct authority laws. According to investigators, that translated into 15 additional opioid-related emergency department visits each month.
That increase suggests that, alongside direct dispensing laws, “useful interventions” and connections to treatment are needed for the emergency department, according to Dr. Abouk and colleagues.
“This is the location where such programs may be the most effective,” they said in their report.
Future research should be done to determine whether removing gatekeepers increases the value of naloxone distribution policies, they concluded in the report.
Dr. Abouk had no disclosures. Co-authors on the study reported funding and conflict of interest disclosures related to the National Institute on Drug Abuse and the Centers for Disease Control and Prevention.
SOURCE: Abouk R, et al. JAMA Intern Med. 2019 May 6. doi:10.1001/jamainternmed.2019.0272.
investigators reported.
By contrast, state laws that stopped short of allowing pharmacists to directly dispense the opioid antagonist did not appear to impact mortality, according to the report, which appears in JAMA Internal Medicine (2019 May 6. doi: 10.1001/jamainternmed.2019.0272).
The report, based on state-level trends tracked from 2005 to 2016, indicates that fatal opioid overdoses fell by nearly one-third in states that adopted direct dispensing laws as compared with states that adopted other naloxone laws.
That finding suggests that the policy type determines whether a naloxone law is useful in combating fatal opioid overdoses, said Rahi Abouk, PhD, of William Paterson University, Wayne, N.J. and co-authors of the paper.
“Enabling distribution through various sources, or requiring gatekeepers, will not be as beneficial,” Dr. Abouk and co-authors said in their report.
The current rate of deaths from fentanyl, heroin, and prescription analgesic overdose has outpaced all previous drug epidemics on record, and even surpasses the number of deaths in the peak year of the HIV epidemic of the 1980s, Dr. Abouk and colleagues wrote in their paper.
The number of states with naloxone access laws grew from just 2 in 2005 to 47 by 2016, including 9 states that granted direct authority to pharmacists and 38 that granted indirect authority, according to the researchers.
The analysis of overdose trends from 2005 to 2016 was based on naloxone distribution data from state Medicaid agencies and opioid-related mortality data from a national statistics system. Forty percent of nonelderly adults with an opioid addiction are covered by Medicaid, the researchers said.
They found that naloxone laws granting pharmacists direct dispensing authority were linked to a drop in opioid deaths that increased in magnitude over time, according to researchers. The mean number of opioid deaths dropped by 27% in the second year after adoption of direct authority laws, relative to opioid deaths in states with indirect access laws, while in subsequent years, deaths dropped by 34%.
Emergency department visits related to opioids increased by 15% in direct authority states 3 or more years after adoption, as compared to states that did not adopt direct authority laws. According to investigators, that translated into 15 additional opioid-related emergency department visits each month.
That increase suggests that, alongside direct dispensing laws, “useful interventions” and connections to treatment are needed for the emergency department, according to Dr. Abouk and colleagues.
“This is the location where such programs may be the most effective,” they said in their report.
Future research should be done to determine whether removing gatekeepers increases the value of naloxone distribution policies, they concluded in the report.
Dr. Abouk had no disclosures. Co-authors on the study reported funding and conflict of interest disclosures related to the National Institute on Drug Abuse and the Centers for Disease Control and Prevention.
SOURCE: Abouk R, et al. JAMA Intern Med. 2019 May 6. doi:10.1001/jamainternmed.2019.0272.
investigators reported.
By contrast, state laws that stopped short of allowing pharmacists to directly dispense the opioid antagonist did not appear to impact mortality, according to the report, which appears in JAMA Internal Medicine (2019 May 6. doi: 10.1001/jamainternmed.2019.0272).
The report, based on state-level trends tracked from 2005 to 2016, indicates that fatal opioid overdoses fell by nearly one-third in states that adopted direct dispensing laws as compared with states that adopted other naloxone laws.
That finding suggests that the policy type determines whether a naloxone law is useful in combating fatal opioid overdoses, said Rahi Abouk, PhD, of William Paterson University, Wayne, N.J. and co-authors of the paper.
“Enabling distribution through various sources, or requiring gatekeepers, will not be as beneficial,” Dr. Abouk and co-authors said in their report.
The current rate of deaths from fentanyl, heroin, and prescription analgesic overdose has outpaced all previous drug epidemics on record, and even surpasses the number of deaths in the peak year of the HIV epidemic of the 1980s, Dr. Abouk and colleagues wrote in their paper.
The number of states with naloxone access laws grew from just 2 in 2005 to 47 by 2016, including 9 states that granted direct authority to pharmacists and 38 that granted indirect authority, according to the researchers.
The analysis of overdose trends from 2005 to 2016 was based on naloxone distribution data from state Medicaid agencies and opioid-related mortality data from a national statistics system. Forty percent of nonelderly adults with an opioid addiction are covered by Medicaid, the researchers said.
They found that naloxone laws granting pharmacists direct dispensing authority were linked to a drop in opioid deaths that increased in magnitude over time, according to researchers. The mean number of opioid deaths dropped by 27% in the second year after adoption of direct authority laws, relative to opioid deaths in states with indirect access laws, while in subsequent years, deaths dropped by 34%.
Emergency department visits related to opioids increased by 15% in direct authority states 3 or more years after adoption, as compared to states that did not adopt direct authority laws. According to investigators, that translated into 15 additional opioid-related emergency department visits each month.
That increase suggests that, alongside direct dispensing laws, “useful interventions” and connections to treatment are needed for the emergency department, according to Dr. Abouk and colleagues.
“This is the location where such programs may be the most effective,” they said in their report.
Future research should be done to determine whether removing gatekeepers increases the value of naloxone distribution policies, they concluded in the report.
Dr. Abouk had no disclosures. Co-authors on the study reported funding and conflict of interest disclosures related to the National Institute on Drug Abuse and the Centers for Disease Control and Prevention.
SOURCE: Abouk R, et al. JAMA Intern Med. 2019 May 6. doi:10.1001/jamainternmed.2019.0272.
FROM JAMA Internal Medicine
Key clinical point: State laws granting pharmacists direct authority to dispense naloxone were linked to significant drops in opioid-related fatal overdoses.
Major finding: The mean number of opioid deaths dropped by 27% in the second year after adoption of direct authority laws relative to opioid deaths in states with indirect access laws, while in subsequent years, deaths dropped by 34%.
Study details: Analysis of naloxone distribution data and opioid-related mortality data from 2005 to 2016 for all 50 states and the District of Columbia.
Disclosures: Study authors reported funding and conflict of interest disclosures related to the National Institute on Drug Abuse and the Centers for Disease Control and Prevention.
Source: Abouk R, et al. JAMA Intern Med. 2019 May 6.
FDA approves ivosidenib frontline for certain AML patients
The Food and Drug Administration has approved ivosidenib (Tibsovo) for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation in patients who are at least 75 years old or have comorbidities preventing the use of intensive induction chemotherapy.
In July 2018, the FDA approved ivosidenib for adults with relapsed or refractory AML with a susceptible IDH1 mutation.
The latest approval was based on results from an open-label, single-arm, multicenter trial of patients with newly diagnosed AML with an IDH1 mutation. Patients were treated with 500 mg ivosidenib daily until disease progression, development of unacceptable toxicity, or hematopoietic stem cell transplantation; the median age of the 28 patients treated with ivosidenib was 77 years.
Of the 28 patients treated, 12 achieved complete remission or complete remission with partial hematologic recovery; 7 of the 17 transfusion-dependent patients achieved transfusion independence for at least 8 weeks.
The most common adverse events were diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia. The drug’s prescribing information includes a boxed warning on the risk of differentiation syndrome.
“The recommended ivosidenib dose is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treatment is recommended for a minimum of 6 months to allow time for clinical response,” the FDA noted.
Find the full press release on the FDA website.
The Food and Drug Administration has approved ivosidenib (Tibsovo) for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation in patients who are at least 75 years old or have comorbidities preventing the use of intensive induction chemotherapy.
In July 2018, the FDA approved ivosidenib for adults with relapsed or refractory AML with a susceptible IDH1 mutation.
The latest approval was based on results from an open-label, single-arm, multicenter trial of patients with newly diagnosed AML with an IDH1 mutation. Patients were treated with 500 mg ivosidenib daily until disease progression, development of unacceptable toxicity, or hematopoietic stem cell transplantation; the median age of the 28 patients treated with ivosidenib was 77 years.
Of the 28 patients treated, 12 achieved complete remission or complete remission with partial hematologic recovery; 7 of the 17 transfusion-dependent patients achieved transfusion independence for at least 8 weeks.
The most common adverse events were diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia. The drug’s prescribing information includes a boxed warning on the risk of differentiation syndrome.
“The recommended ivosidenib dose is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treatment is recommended for a minimum of 6 months to allow time for clinical response,” the FDA noted.
Find the full press release on the FDA website.
The Food and Drug Administration has approved ivosidenib (Tibsovo) for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation in patients who are at least 75 years old or have comorbidities preventing the use of intensive induction chemotherapy.
In July 2018, the FDA approved ivosidenib for adults with relapsed or refractory AML with a susceptible IDH1 mutation.
The latest approval was based on results from an open-label, single-arm, multicenter trial of patients with newly diagnosed AML with an IDH1 mutation. Patients were treated with 500 mg ivosidenib daily until disease progression, development of unacceptable toxicity, or hematopoietic stem cell transplantation; the median age of the 28 patients treated with ivosidenib was 77 years.
Of the 28 patients treated, 12 achieved complete remission or complete remission with partial hematologic recovery; 7 of the 17 transfusion-dependent patients achieved transfusion independence for at least 8 weeks.
The most common adverse events were diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia. The drug’s prescribing information includes a boxed warning on the risk of differentiation syndrome.
“The recommended ivosidenib dose is 500 mg orally once daily with or without food until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treatment is recommended for a minimum of 6 months to allow time for clinical response,” the FDA noted.
Find the full press release on the FDA website.
Mavyret approved for children with any HCV genotype
The Food and Drug Administration has approved glecaprevir/pibrentasvir tablets (Mavyret) for treating any of six identified genotypes of hepatitis C virus in children ages 12-17 years.
The agency noted in its press announcement that, Dosing information now will be provided for patients aged 12 years and older or weighing at least 99 lbs, without cirrhosis or who have compensated cirrhosis. It is not recommended for patients with moderate cirrhosis, and it is contraindicated in patients with severe cirrhosis, as well as patients taking atazanavir and rifampin.
In clinical trials of 47 patients with genotype 1, 2, 3, or 4 HCV without cirrhosis or with only mild cirrhosis, results at 12 weeks after 8 or 16 weeks’ treatment suggested patients’ infections had been cured – 100% had no virus detected in their blood. Adverse reactions observed were consistent with those previously observed in adults during clinical trials.
The most common reactions were headache and fatigue. Hepatitis B virus reactivation has been reported in coinfected adults during or after treatment with direct-acting antivirals, and in those who were not receiving HBV antiviral treatment. Full prescribing information can be found on the FDA website, and more information about this approval can be found in the agency’s announcement.
The Food and Drug Administration has approved glecaprevir/pibrentasvir tablets (Mavyret) for treating any of six identified genotypes of hepatitis C virus in children ages 12-17 years.
The agency noted in its press announcement that, Dosing information now will be provided for patients aged 12 years and older or weighing at least 99 lbs, without cirrhosis or who have compensated cirrhosis. It is not recommended for patients with moderate cirrhosis, and it is contraindicated in patients with severe cirrhosis, as well as patients taking atazanavir and rifampin.
In clinical trials of 47 patients with genotype 1, 2, 3, or 4 HCV without cirrhosis or with only mild cirrhosis, results at 12 weeks after 8 or 16 weeks’ treatment suggested patients’ infections had been cured – 100% had no virus detected in their blood. Adverse reactions observed were consistent with those previously observed in adults during clinical trials.
The most common reactions were headache and fatigue. Hepatitis B virus reactivation has been reported in coinfected adults during or after treatment with direct-acting antivirals, and in those who were not receiving HBV antiviral treatment. Full prescribing information can be found on the FDA website, and more information about this approval can be found in the agency’s announcement.
The Food and Drug Administration has approved glecaprevir/pibrentasvir tablets (Mavyret) for treating any of six identified genotypes of hepatitis C virus in children ages 12-17 years.
The agency noted in its press announcement that, Dosing information now will be provided for patients aged 12 years and older or weighing at least 99 lbs, without cirrhosis or who have compensated cirrhosis. It is not recommended for patients with moderate cirrhosis, and it is contraindicated in patients with severe cirrhosis, as well as patients taking atazanavir and rifampin.
In clinical trials of 47 patients with genotype 1, 2, 3, or 4 HCV without cirrhosis or with only mild cirrhosis, results at 12 weeks after 8 or 16 weeks’ treatment suggested patients’ infections had been cured – 100% had no virus detected in their blood. Adverse reactions observed were consistent with those previously observed in adults during clinical trials.
The most common reactions were headache and fatigue. Hepatitis B virus reactivation has been reported in coinfected adults during or after treatment with direct-acting antivirals, and in those who were not receiving HBV antiviral treatment. Full prescribing information can be found on the FDA website, and more information about this approval can be found in the agency’s announcement.
Long-term antibiotic use may heighten stroke, CHD risk
, according to a study in the European Heart Journal.
Women in the Nurses’ Health Study who used antibiotics for 2 or more months between ages 40 and 59 years or at age 60 years and older had a significantly increased risk of cardiovascular disease, compared with those who did not use antibiotics. Antibiotic use between 20 and 39 years old was not significantly related to cardiovascular disease.
Prior research has found that antibiotics may have long-lasting effects on gut microbiota and relate to cardiovascular disease risk.
“Antibiotic use is the most critical factor in altering the balance of microorganisms in the gut,” said lead investigator Lu Qi, MD, PhD, in a news release. “Previous studies have shown a link between alterations in the microbiotic environment of the gut and inflammation and narrowing of the blood vessels, stroke, and heart disease,” said Dr. Qi, who is the director of the Tulane University Obesity Research Center in New Orleans and an adjunct professor of nutrition at Harvard T.C. Chan School of Public Health in Boston.
To evaluate associations between life stage, antibiotic exposure, and subsequent cardiovascular disease, researchers analyzed data from 36,429 participants in the Nurses’ Health Study. The women were at least 60 years old and had no history of cardiovascular disease or cancer when they completed a 2004 questionnaire about antibiotic usage during young, middle, and late adulthood. The questionnaire asked participants to indicate the total time using antibiotics with eight categories ranging from none to 5 or more years.
The researchers defined incident cardiovascular disease as a composite endpoint of coronary heart disease (nonfatal myocardial infarction or fatal coronary heart disease) and stroke (nonfatal or fatal). They calculated person-years of follow-up from the questionnaire return date until date of cardiovascular disease diagnosis, death, or end of follow-up in 2012.
Women with longer duration of antibiotic use were more likely to use other medications and have unfavorable cardiovascular risk profiles, including family history of myocardial infarction and higher body mass index. Antibiotics most often were used to treat respiratory infections. During an average follow-up of 7.6 years, 1,056 participants developed cardiovascular disease.
In a multivariable model that adjusted for demographics, diet, lifestyle, reason for antibiotic use, medications, overweight status, and other factors, long-term antibiotic use – 2 months or more – in late adulthood was associated with significantly increased risk of cardiovascular disease (hazard ratio, 1.32), as was long-term antibiotic use in middle adulthood (HR, 1.28).
Although antibiotic use was self-reported, which could lead to misclassification, the participants were health professionals, which may mitigate this limitation, the authors noted. Whether these findings apply to men and other populations requires further study, they said.
Because of the study’s observational design, the results “cannot show that antibiotics cause heart disease and stroke, only that there is a link between them,” Dr. Qi said. “It’s possible that women who reported more antibiotic use might be sicker in other ways that we were unable to measure, or there may be other factors that could affect the results that we have not been able take account of.”
“Our study suggests that antibiotics should be used only when they are absolutely needed,” he concluded. “Considering the potentially cumulative adverse effects, the shorter time of antibiotic use the better.”
The study was supported by National Institutes of Health grants, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. One author received support from the Japan Society for the Promotion of Science. The authors had no conflicts of interest.
SOURCE: Heianza Y et al. Eur Heart J. 2019 Apr 24. doi: 10.1093/eurheartj/ehz231.
, according to a study in the European Heart Journal.
Women in the Nurses’ Health Study who used antibiotics for 2 or more months between ages 40 and 59 years or at age 60 years and older had a significantly increased risk of cardiovascular disease, compared with those who did not use antibiotics. Antibiotic use between 20 and 39 years old was not significantly related to cardiovascular disease.
Prior research has found that antibiotics may have long-lasting effects on gut microbiota and relate to cardiovascular disease risk.
“Antibiotic use is the most critical factor in altering the balance of microorganisms in the gut,” said lead investigator Lu Qi, MD, PhD, in a news release. “Previous studies have shown a link between alterations in the microbiotic environment of the gut and inflammation and narrowing of the blood vessels, stroke, and heart disease,” said Dr. Qi, who is the director of the Tulane University Obesity Research Center in New Orleans and an adjunct professor of nutrition at Harvard T.C. Chan School of Public Health in Boston.
To evaluate associations between life stage, antibiotic exposure, and subsequent cardiovascular disease, researchers analyzed data from 36,429 participants in the Nurses’ Health Study. The women were at least 60 years old and had no history of cardiovascular disease or cancer when they completed a 2004 questionnaire about antibiotic usage during young, middle, and late adulthood. The questionnaire asked participants to indicate the total time using antibiotics with eight categories ranging from none to 5 or more years.
The researchers defined incident cardiovascular disease as a composite endpoint of coronary heart disease (nonfatal myocardial infarction or fatal coronary heart disease) and stroke (nonfatal or fatal). They calculated person-years of follow-up from the questionnaire return date until date of cardiovascular disease diagnosis, death, or end of follow-up in 2012.
Women with longer duration of antibiotic use were more likely to use other medications and have unfavorable cardiovascular risk profiles, including family history of myocardial infarction and higher body mass index. Antibiotics most often were used to treat respiratory infections. During an average follow-up of 7.6 years, 1,056 participants developed cardiovascular disease.
In a multivariable model that adjusted for demographics, diet, lifestyle, reason for antibiotic use, medications, overweight status, and other factors, long-term antibiotic use – 2 months or more – in late adulthood was associated with significantly increased risk of cardiovascular disease (hazard ratio, 1.32), as was long-term antibiotic use in middle adulthood (HR, 1.28).
Although antibiotic use was self-reported, which could lead to misclassification, the participants were health professionals, which may mitigate this limitation, the authors noted. Whether these findings apply to men and other populations requires further study, they said.
Because of the study’s observational design, the results “cannot show that antibiotics cause heart disease and stroke, only that there is a link between them,” Dr. Qi said. “It’s possible that women who reported more antibiotic use might be sicker in other ways that we were unable to measure, or there may be other factors that could affect the results that we have not been able take account of.”
“Our study suggests that antibiotics should be used only when they are absolutely needed,” he concluded. “Considering the potentially cumulative adverse effects, the shorter time of antibiotic use the better.”
The study was supported by National Institutes of Health grants, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. One author received support from the Japan Society for the Promotion of Science. The authors had no conflicts of interest.
SOURCE: Heianza Y et al. Eur Heart J. 2019 Apr 24. doi: 10.1093/eurheartj/ehz231.
, according to a study in the European Heart Journal.
Women in the Nurses’ Health Study who used antibiotics for 2 or more months between ages 40 and 59 years or at age 60 years and older had a significantly increased risk of cardiovascular disease, compared with those who did not use antibiotics. Antibiotic use between 20 and 39 years old was not significantly related to cardiovascular disease.
Prior research has found that antibiotics may have long-lasting effects on gut microbiota and relate to cardiovascular disease risk.
“Antibiotic use is the most critical factor in altering the balance of microorganisms in the gut,” said lead investigator Lu Qi, MD, PhD, in a news release. “Previous studies have shown a link between alterations in the microbiotic environment of the gut and inflammation and narrowing of the blood vessels, stroke, and heart disease,” said Dr. Qi, who is the director of the Tulane University Obesity Research Center in New Orleans and an adjunct professor of nutrition at Harvard T.C. Chan School of Public Health in Boston.
To evaluate associations between life stage, antibiotic exposure, and subsequent cardiovascular disease, researchers analyzed data from 36,429 participants in the Nurses’ Health Study. The women were at least 60 years old and had no history of cardiovascular disease or cancer when they completed a 2004 questionnaire about antibiotic usage during young, middle, and late adulthood. The questionnaire asked participants to indicate the total time using antibiotics with eight categories ranging from none to 5 or more years.
The researchers defined incident cardiovascular disease as a composite endpoint of coronary heart disease (nonfatal myocardial infarction or fatal coronary heart disease) and stroke (nonfatal or fatal). They calculated person-years of follow-up from the questionnaire return date until date of cardiovascular disease diagnosis, death, or end of follow-up in 2012.
Women with longer duration of antibiotic use were more likely to use other medications and have unfavorable cardiovascular risk profiles, including family history of myocardial infarction and higher body mass index. Antibiotics most often were used to treat respiratory infections. During an average follow-up of 7.6 years, 1,056 participants developed cardiovascular disease.
In a multivariable model that adjusted for demographics, diet, lifestyle, reason for antibiotic use, medications, overweight status, and other factors, long-term antibiotic use – 2 months or more – in late adulthood was associated with significantly increased risk of cardiovascular disease (hazard ratio, 1.32), as was long-term antibiotic use in middle adulthood (HR, 1.28).
Although antibiotic use was self-reported, which could lead to misclassification, the participants were health professionals, which may mitigate this limitation, the authors noted. Whether these findings apply to men and other populations requires further study, they said.
Because of the study’s observational design, the results “cannot show that antibiotics cause heart disease and stroke, only that there is a link between them,” Dr. Qi said. “It’s possible that women who reported more antibiotic use might be sicker in other ways that we were unable to measure, or there may be other factors that could affect the results that we have not been able take account of.”
“Our study suggests that antibiotics should be used only when they are absolutely needed,” he concluded. “Considering the potentially cumulative adverse effects, the shorter time of antibiotic use the better.”
The study was supported by National Institutes of Health grants, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. One author received support from the Japan Society for the Promotion of Science. The authors had no conflicts of interest.
SOURCE: Heianza Y et al. Eur Heart J. 2019 Apr 24. doi: 10.1093/eurheartj/ehz231.
FROM THE EUROPEAN HEART JOURNAL
Key clinical point: Among middle-aged and older women, 2 or more months’ exposure to antibiotics is associated with an increased risk of coronary heart disease or stroke.
Major finding: Long-term antibiotic use in late adulthood was associated with significantly increased risk of cardiovascular disease (hazard ratio, 1.32), as was long-term antibiotic use in middle adulthood (HR, 1.28).
Study details: An analysis of data from nearly 36,500 women in the Nurses’ Health Study.
Disclosures: The study was supported by National Institutes of Health grants, the Boston Obesity Nutrition Research Center, and the United States–Israel Binational Science Foundation. One author received support from the Japan Society for the Promotion of Science. The authors had no conflicts of interest.
Source: Heianza Y et al. Eur Heart J. 2019 Apr 24. doi: 10.1093/eurheartj/ehz231.
Medical cannabis relieved pain, decreased opioid use in elderly
results of a recent retrospective chart review suggest. Treatment with medical cannabis improved pain, sleep, anxiety, and neuropathy in patients aged 75 years of age and older, and was associated with reduced use of opioids in about one-third of cases, according to authors of the study, which will be presented at the annual meeting of the American Academy of Neurology.
“Our findings are promising and can help fuel further research into medical marijuana as an additional option for this group of people who often have chronic conditions,” said lead investigator Laszlo Mechtler, MD, of Dent Neurologic Institute in Buffalo, N.Y., in a news release. However, additional randomized, placebo-controlled studies are needed to confirm results of this study, Dr. Mechtler added.
The chart review focused on 204 elderly patients who participated in New York State’s medical marijuana program and were followed in a neurologic outpatient setting. The cohort included 129 female and 75 male patients, ranging in age from 75 to 102 years, with a mean age of 81 years. The medical marijuana was taken by mouth as a liquid extract tincture, capsule, or in an electronic vaporizer.
With an average exposure time of 16.8 weeks, 69% of patients experienced symptomatic benefit, according to patient self-report. The most commonly reported benefit was relief of chronic pain in 49%, while improvements in sleep, neuropathy, and anxiety were reported in 18%, 15%, and 10%, respectively. Reductions in opioid pain medication were noted in about one-third of cases, they found.
While 34% of patients had adverse effects on medical marijuana, only 21% reported adverse effects after cannabinoid doses were adjusted, investigators said. Adverse effects led to discontinuation of medical cannabis in seven patients, or 3.4% of the overall cohort. Somnolence, disequilibrium, and gastrointestinal disturbance were the most common adverse effects, occurring in 13%, 7%, and 7% of patients, respectively. Euphoria was reported in 3% of patients.
Among patients who had no reported adverse effects, the most commonly used formulation was a balanced 1:1 tincture of tetrahydrocannabinol to cannabidiol, investigators said.
Further trials could explore optimal dosing of medical cannabis in elderly patients and shed more light on adverse effects such as somnolence and disequilibrium, according to Dr. Mechtler and colleagues.
The study was supported by the Dent Family Foundation.
SOURCE: Bargnes V et al. AAN 2019, Abstract P4.1-014.
results of a recent retrospective chart review suggest. Treatment with medical cannabis improved pain, sleep, anxiety, and neuropathy in patients aged 75 years of age and older, and was associated with reduced use of opioids in about one-third of cases, according to authors of the study, which will be presented at the annual meeting of the American Academy of Neurology.
“Our findings are promising and can help fuel further research into medical marijuana as an additional option for this group of people who often have chronic conditions,” said lead investigator Laszlo Mechtler, MD, of Dent Neurologic Institute in Buffalo, N.Y., in a news release. However, additional randomized, placebo-controlled studies are needed to confirm results of this study, Dr. Mechtler added.
The chart review focused on 204 elderly patients who participated in New York State’s medical marijuana program and were followed in a neurologic outpatient setting. The cohort included 129 female and 75 male patients, ranging in age from 75 to 102 years, with a mean age of 81 years. The medical marijuana was taken by mouth as a liquid extract tincture, capsule, or in an electronic vaporizer.
With an average exposure time of 16.8 weeks, 69% of patients experienced symptomatic benefit, according to patient self-report. The most commonly reported benefit was relief of chronic pain in 49%, while improvements in sleep, neuropathy, and anxiety were reported in 18%, 15%, and 10%, respectively. Reductions in opioid pain medication were noted in about one-third of cases, they found.
While 34% of patients had adverse effects on medical marijuana, only 21% reported adverse effects after cannabinoid doses were adjusted, investigators said. Adverse effects led to discontinuation of medical cannabis in seven patients, or 3.4% of the overall cohort. Somnolence, disequilibrium, and gastrointestinal disturbance were the most common adverse effects, occurring in 13%, 7%, and 7% of patients, respectively. Euphoria was reported in 3% of patients.
Among patients who had no reported adverse effects, the most commonly used formulation was a balanced 1:1 tincture of tetrahydrocannabinol to cannabidiol, investigators said.
Further trials could explore optimal dosing of medical cannabis in elderly patients and shed more light on adverse effects such as somnolence and disequilibrium, according to Dr. Mechtler and colleagues.
The study was supported by the Dent Family Foundation.
SOURCE: Bargnes V et al. AAN 2019, Abstract P4.1-014.
results of a recent retrospective chart review suggest. Treatment with medical cannabis improved pain, sleep, anxiety, and neuropathy in patients aged 75 years of age and older, and was associated with reduced use of opioids in about one-third of cases, according to authors of the study, which will be presented at the annual meeting of the American Academy of Neurology.
“Our findings are promising and can help fuel further research into medical marijuana as an additional option for this group of people who often have chronic conditions,” said lead investigator Laszlo Mechtler, MD, of Dent Neurologic Institute in Buffalo, N.Y., in a news release. However, additional randomized, placebo-controlled studies are needed to confirm results of this study, Dr. Mechtler added.
The chart review focused on 204 elderly patients who participated in New York State’s medical marijuana program and were followed in a neurologic outpatient setting. The cohort included 129 female and 75 male patients, ranging in age from 75 to 102 years, with a mean age of 81 years. The medical marijuana was taken by mouth as a liquid extract tincture, capsule, or in an electronic vaporizer.
With an average exposure time of 16.8 weeks, 69% of patients experienced symptomatic benefit, according to patient self-report. The most commonly reported benefit was relief of chronic pain in 49%, while improvements in sleep, neuropathy, and anxiety were reported in 18%, 15%, and 10%, respectively. Reductions in opioid pain medication were noted in about one-third of cases, they found.
While 34% of patients had adverse effects on medical marijuana, only 21% reported adverse effects after cannabinoid doses were adjusted, investigators said. Adverse effects led to discontinuation of medical cannabis in seven patients, or 3.4% of the overall cohort. Somnolence, disequilibrium, and gastrointestinal disturbance were the most common adverse effects, occurring in 13%, 7%, and 7% of patients, respectively. Euphoria was reported in 3% of patients.
Among patients who had no reported adverse effects, the most commonly used formulation was a balanced 1:1 tincture of tetrahydrocannabinol to cannabidiol, investigators said.
Further trials could explore optimal dosing of medical cannabis in elderly patients and shed more light on adverse effects such as somnolence and disequilibrium, according to Dr. Mechtler and colleagues.
The study was supported by the Dent Family Foundation.
SOURCE: Bargnes V et al. AAN 2019, Abstract P4.1-014.
FROM AAN 2019
FDA approves IL-23 inhibitor risankizumab for treating plaque psoriasis
Risankizumab, an interleukin-23 inhibitor, has been approved by the Food and Drug Administration for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the manufacturer announced on April 23.
Risankizumab selectively inhibits interleukin-23 (IL-23), a key inflammatory protein, by binding to its p19 subunit. The drug is administered at a dose of 150 mg, in two subcutaneous injections, every 12 weeks, after starting doses at weeks 0 and 4. It will be available in early May, according to an AbbVie press release announcing the approval.
The approval was based in part on data from two phase 3, 2-year studies, In UltIMMA-1 and UltIMMA-2, at 16 weeks, 75% of risankizumab patients in both studies achieved a Psoriasis Area and Severity Index (PASI 90), compared with 5% and 2% of those on placebo, respectively. These results were published in 2018 (Lancet. 2018 Aug 25;392[10148]:650-61).
At 1 year, 82% and 81% of those treated with risankizumab in the two studies achieved a PASI 90, and 56% and 60% achieved a PASI 100, respectively, according to the company.
Approval was also based on additional phase 3 studies, IMMhance and IMMvent.
Upper respiratory infections were among the most common adverse events associated with risankizumab in trials, reported in 13%, according to the company. Other adverse events associated with treatment included headache (3.5 %), fatigue (2.5 %), injection site reactions (1.5%) and tinea infections (1.1%). The AbbVie release states that candidates for treatment should be evaluated for tuberculosis before starting therapy, and patients should be instructed to report signs and symptoms of infection.
Risankizumab, which will be marketed as Skyrizi, was recently approved in Canada for the same indication, and in Japan, for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults. It currently is under review in Europe.
AbbVie and Boehringer Ingelheim are collaborating on the development of risankizumab, according to an AbbVie press release. Studies of risankizumab for treatment of psoriatic arthritis and Crohn’s disease are underway.
Risankizumab, an interleukin-23 inhibitor, has been approved by the Food and Drug Administration for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the manufacturer announced on April 23.
Risankizumab selectively inhibits interleukin-23 (IL-23), a key inflammatory protein, by binding to its p19 subunit. The drug is administered at a dose of 150 mg, in two subcutaneous injections, every 12 weeks, after starting doses at weeks 0 and 4. It will be available in early May, according to an AbbVie press release announcing the approval.
The approval was based in part on data from two phase 3, 2-year studies, In UltIMMA-1 and UltIMMA-2, at 16 weeks, 75% of risankizumab patients in both studies achieved a Psoriasis Area and Severity Index (PASI 90), compared with 5% and 2% of those on placebo, respectively. These results were published in 2018 (Lancet. 2018 Aug 25;392[10148]:650-61).
At 1 year, 82% and 81% of those treated with risankizumab in the two studies achieved a PASI 90, and 56% and 60% achieved a PASI 100, respectively, according to the company.
Approval was also based on additional phase 3 studies, IMMhance and IMMvent.
Upper respiratory infections were among the most common adverse events associated with risankizumab in trials, reported in 13%, according to the company. Other adverse events associated with treatment included headache (3.5 %), fatigue (2.5 %), injection site reactions (1.5%) and tinea infections (1.1%). The AbbVie release states that candidates for treatment should be evaluated for tuberculosis before starting therapy, and patients should be instructed to report signs and symptoms of infection.
Risankizumab, which will be marketed as Skyrizi, was recently approved in Canada for the same indication, and in Japan, for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults. It currently is under review in Europe.
AbbVie and Boehringer Ingelheim are collaborating on the development of risankizumab, according to an AbbVie press release. Studies of risankizumab for treatment of psoriatic arthritis and Crohn’s disease are underway.
Risankizumab, an interleukin-23 inhibitor, has been approved by the Food and Drug Administration for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, the manufacturer announced on April 23.
Risankizumab selectively inhibits interleukin-23 (IL-23), a key inflammatory protein, by binding to its p19 subunit. The drug is administered at a dose of 150 mg, in two subcutaneous injections, every 12 weeks, after starting doses at weeks 0 and 4. It will be available in early May, according to an AbbVie press release announcing the approval.
The approval was based in part on data from two phase 3, 2-year studies, In UltIMMA-1 and UltIMMA-2, at 16 weeks, 75% of risankizumab patients in both studies achieved a Psoriasis Area and Severity Index (PASI 90), compared with 5% and 2% of those on placebo, respectively. These results were published in 2018 (Lancet. 2018 Aug 25;392[10148]:650-61).
At 1 year, 82% and 81% of those treated with risankizumab in the two studies achieved a PASI 90, and 56% and 60% achieved a PASI 100, respectively, according to the company.
Approval was also based on additional phase 3 studies, IMMhance and IMMvent.
Upper respiratory infections were among the most common adverse events associated with risankizumab in trials, reported in 13%, according to the company. Other adverse events associated with treatment included headache (3.5 %), fatigue (2.5 %), injection site reactions (1.5%) and tinea infections (1.1%). The AbbVie release states that candidates for treatment should be evaluated for tuberculosis before starting therapy, and patients should be instructed to report signs and symptoms of infection.
Risankizumab, which will be marketed as Skyrizi, was recently approved in Canada for the same indication, and in Japan, for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults. It currently is under review in Europe.
AbbVie and Boehringer Ingelheim are collaborating on the development of risankizumab, according to an AbbVie press release. Studies of risankizumab for treatment of psoriatic arthritis and Crohn’s disease are underway.
Alvogen issues recall for mislabeled fentanyl patches
Alvogen has issued a voluntary recall of two lots of its Fentanyl Transdermal System 12-mcg/h transdermal patches because of a product mislabeling, according to the Food and Drug Administration.
The recall was issued because a small number of cartons labeled as containing 12-mcg/h patches contained 50-mcg/h patches. The 50-mcg/h patches were labeled as such within the package.
Application of a 50-mcg/h patch instead of a 12-mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potential risk for such adverse events include first-time users of the patch, children, and the elderly. No reports of serious adverse events have yet been reported.
“Pharmacies are requested not to dispense any product subject to this recall,” the FDA said in a press release. Patients who “have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement.”
Find more information on the recall at the FDA website.
Alvogen has issued a voluntary recall of two lots of its Fentanyl Transdermal System 12-mcg/h transdermal patches because of a product mislabeling, according to the Food and Drug Administration.
The recall was issued because a small number of cartons labeled as containing 12-mcg/h patches contained 50-mcg/h patches. The 50-mcg/h patches were labeled as such within the package.
Application of a 50-mcg/h patch instead of a 12-mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potential risk for such adverse events include first-time users of the patch, children, and the elderly. No reports of serious adverse events have yet been reported.
“Pharmacies are requested not to dispense any product subject to this recall,” the FDA said in a press release. Patients who “have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement.”
Find more information on the recall at the FDA website.
Alvogen has issued a voluntary recall of two lots of its Fentanyl Transdermal System 12-mcg/h transdermal patches because of a product mislabeling, according to the Food and Drug Administration.
The recall was issued because a small number of cartons labeled as containing 12-mcg/h patches contained 50-mcg/h patches. The 50-mcg/h patches were labeled as such within the package.
Application of a 50-mcg/h patch instead of a 12-mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potential risk for such adverse events include first-time users of the patch, children, and the elderly. No reports of serious adverse events have yet been reported.
“Pharmacies are requested not to dispense any product subject to this recall,” the FDA said in a press release. Patients who “have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement.”
Find more information on the recall at the FDA website.
Restricting opioids after knee surgery did not increase refills
according to a study in the Journal of Arthroplasty.
Contrary to concerns that restrictive opioid prescribing might increase the number of patient call-ins and refill requests, one academic institution had significantly fewer call-ins and refills after it implemented a strict postoperative opioid prescribing protocol on Jan. 1, 2018.
“Orthopedic surgeons might be reluctant to change practice without evidence that new, more-restrictive practice will not impede patient care,” the researchers wrote. “As the current study demonstrates, there is room to significantly decrease postoperative opioid prescriptions in total joint arthroplasty. This places patients at lower risk of opioid abuse and diversion without significantly altering the risk of postoperative complications or compromising postoperative pain control.”
Opioid overuse is a major public health concern, and orthopedic surgeons may overprescribe opioids after surgery. The University of Iowa Hospitals and Clinics in Iowa City implemented strict postoperative opioid prescription guidelines that are based on the American Academy of Orthopedic Surgeons Clinical Practice Guidelines. As part of the protocol, patients receive a preoperative education session that emphasizes risks associated with opioid use. Before initiating this protocol, postoperative drug choice and quantity had not been standardized.
To examine changes in opioid prescriptions and the number of call-ins, postoperative complications, and prescription refill requests after the implementation of the restrictive opioid prescribing protocol, investigators at the institution conducted a retrospective study.
Andrew J. Holte, a researcher in the department of orthopedics and rehabilitation, and his colleagues reviewed cases from June 2017 to February 2018. Their analysis included 399 patients who underwent total hip arthroplasty or total knee arthroplasty.
In all, 282 patients underwent surgery before the restrictive protocol (the historical cohort) and 117 after (the restrictive cohort). In the historical cohort, about 48% of the patients underwent total knee arthroplasty. In the restrictive cohort, about 44% underwent total knee arthroplasty. Patients had an average age of about 61 years, and approximately 52% were women.
According to comparisons of morphine mg equivalents (MME), the historical cohort received significantly larger mean initial opioid prescriptions (752 MME vs. 387 MME), significantly more refills per patient (0.5 vs. 0.3), and significantly more medication through refills (253 MME vs. 84 MME).
“For reference, 50 pills of 5 mg oxycodone is equivalent to 300 MMEs,” the authors noted.
A multivariable model found that younger age and total knee arthroplasty, compared with total hip arthroplasty, were associated with increased likelihood of requests for refills and patient call-ins.
“Surprisingly, there were significantly more patient call-ins and requests for refills of opioids in the historical cohort,” Mr. Holte and his colleagues said. “Although this study did not collect direct data on patient pain scores, we believe that call-ins and requests for refills are sufficient surrogate markers for inadequate pain control.”
The study does not account for prescriptions from other providers or whether patients took none, some, or all of their filled prescriptions. Future studies are needed to assess how reduced opioid prescriptions affect pain and functional outcomes in the long term, the researchers said.
One or more study authors disclosed potential conflicts of interest. The disclosures can be found in Appendix A, Supplementary Data, at the end of the journal article.
SOURCE: Holte AJ et al. J Arthroplasty. 2019 Feb 20. doi: 10.1016/j.arth.2019.02.022.
according to a study in the Journal of Arthroplasty.
Contrary to concerns that restrictive opioid prescribing might increase the number of patient call-ins and refill requests, one academic institution had significantly fewer call-ins and refills after it implemented a strict postoperative opioid prescribing protocol on Jan. 1, 2018.
“Orthopedic surgeons might be reluctant to change practice without evidence that new, more-restrictive practice will not impede patient care,” the researchers wrote. “As the current study demonstrates, there is room to significantly decrease postoperative opioid prescriptions in total joint arthroplasty. This places patients at lower risk of opioid abuse and diversion without significantly altering the risk of postoperative complications or compromising postoperative pain control.”
Opioid overuse is a major public health concern, and orthopedic surgeons may overprescribe opioids after surgery. The University of Iowa Hospitals and Clinics in Iowa City implemented strict postoperative opioid prescription guidelines that are based on the American Academy of Orthopedic Surgeons Clinical Practice Guidelines. As part of the protocol, patients receive a preoperative education session that emphasizes risks associated with opioid use. Before initiating this protocol, postoperative drug choice and quantity had not been standardized.
To examine changes in opioid prescriptions and the number of call-ins, postoperative complications, and prescription refill requests after the implementation of the restrictive opioid prescribing protocol, investigators at the institution conducted a retrospective study.
Andrew J. Holte, a researcher in the department of orthopedics and rehabilitation, and his colleagues reviewed cases from June 2017 to February 2018. Their analysis included 399 patients who underwent total hip arthroplasty or total knee arthroplasty.
In all, 282 patients underwent surgery before the restrictive protocol (the historical cohort) and 117 after (the restrictive cohort). In the historical cohort, about 48% of the patients underwent total knee arthroplasty. In the restrictive cohort, about 44% underwent total knee arthroplasty. Patients had an average age of about 61 years, and approximately 52% were women.
According to comparisons of morphine mg equivalents (MME), the historical cohort received significantly larger mean initial opioid prescriptions (752 MME vs. 387 MME), significantly more refills per patient (0.5 vs. 0.3), and significantly more medication through refills (253 MME vs. 84 MME).
“For reference, 50 pills of 5 mg oxycodone is equivalent to 300 MMEs,” the authors noted.
A multivariable model found that younger age and total knee arthroplasty, compared with total hip arthroplasty, were associated with increased likelihood of requests for refills and patient call-ins.
“Surprisingly, there were significantly more patient call-ins and requests for refills of opioids in the historical cohort,” Mr. Holte and his colleagues said. “Although this study did not collect direct data on patient pain scores, we believe that call-ins and requests for refills are sufficient surrogate markers for inadequate pain control.”
The study does not account for prescriptions from other providers or whether patients took none, some, or all of their filled prescriptions. Future studies are needed to assess how reduced opioid prescriptions affect pain and functional outcomes in the long term, the researchers said.
One or more study authors disclosed potential conflicts of interest. The disclosures can be found in Appendix A, Supplementary Data, at the end of the journal article.
SOURCE: Holte AJ et al. J Arthroplasty. 2019 Feb 20. doi: 10.1016/j.arth.2019.02.022.
according to a study in the Journal of Arthroplasty.
Contrary to concerns that restrictive opioid prescribing might increase the number of patient call-ins and refill requests, one academic institution had significantly fewer call-ins and refills after it implemented a strict postoperative opioid prescribing protocol on Jan. 1, 2018.
“Orthopedic surgeons might be reluctant to change practice without evidence that new, more-restrictive practice will not impede patient care,” the researchers wrote. “As the current study demonstrates, there is room to significantly decrease postoperative opioid prescriptions in total joint arthroplasty. This places patients at lower risk of opioid abuse and diversion without significantly altering the risk of postoperative complications or compromising postoperative pain control.”
Opioid overuse is a major public health concern, and orthopedic surgeons may overprescribe opioids after surgery. The University of Iowa Hospitals and Clinics in Iowa City implemented strict postoperative opioid prescription guidelines that are based on the American Academy of Orthopedic Surgeons Clinical Practice Guidelines. As part of the protocol, patients receive a preoperative education session that emphasizes risks associated with opioid use. Before initiating this protocol, postoperative drug choice and quantity had not been standardized.
To examine changes in opioid prescriptions and the number of call-ins, postoperative complications, and prescription refill requests after the implementation of the restrictive opioid prescribing protocol, investigators at the institution conducted a retrospective study.
Andrew J. Holte, a researcher in the department of orthopedics and rehabilitation, and his colleagues reviewed cases from June 2017 to February 2018. Their analysis included 399 patients who underwent total hip arthroplasty or total knee arthroplasty.
In all, 282 patients underwent surgery before the restrictive protocol (the historical cohort) and 117 after (the restrictive cohort). In the historical cohort, about 48% of the patients underwent total knee arthroplasty. In the restrictive cohort, about 44% underwent total knee arthroplasty. Patients had an average age of about 61 years, and approximately 52% were women.
According to comparisons of morphine mg equivalents (MME), the historical cohort received significantly larger mean initial opioid prescriptions (752 MME vs. 387 MME), significantly more refills per patient (0.5 vs. 0.3), and significantly more medication through refills (253 MME vs. 84 MME).
“For reference, 50 pills of 5 mg oxycodone is equivalent to 300 MMEs,” the authors noted.
A multivariable model found that younger age and total knee arthroplasty, compared with total hip arthroplasty, were associated with increased likelihood of requests for refills and patient call-ins.
“Surprisingly, there were significantly more patient call-ins and requests for refills of opioids in the historical cohort,” Mr. Holte and his colleagues said. “Although this study did not collect direct data on patient pain scores, we believe that call-ins and requests for refills are sufficient surrogate markers for inadequate pain control.”
The study does not account for prescriptions from other providers or whether patients took none, some, or all of their filled prescriptions. Future studies are needed to assess how reduced opioid prescriptions affect pain and functional outcomes in the long term, the researchers said.
One or more study authors disclosed potential conflicts of interest. The disclosures can be found in Appendix A, Supplementary Data, at the end of the journal article.
SOURCE: Holte AJ et al. J Arthroplasty. 2019 Feb 20. doi: 10.1016/j.arth.2019.02.022.
FROM THE JOURNAL OF ARTHROPLASTY
FDA approves generic naloxone spray for opioid overdose treatment
The Food and Drug Administration on April 19 approved the first generic naloxone hydrochloride nasal spray (Narcan) as treatment for stopping or reversing an opioid overdose.
“In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible,” said Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, in a press release. “In addition to this approval of the first generic naloxone nasal spray, moving forward, we will prioritize our review of generic drug applications for naloxone.”
The agency said the naloxone nasal spray does not need assembly and can be used by anyone, regardless of medical training. If the spray is administered quickly after the overdose begins, the effect of the opioid will be countered, often within minutes. However, patients should still seek immediate medical attention.
The FDA cautioned that, when used on a patient with an opioid dependence, naloxone can cause severe opioid withdrawal, characterized by symptoms such as body aches, diarrhea, tachycardia, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.
Find the full press release on the FDA website.
The Food and Drug Administration on April 19 approved the first generic naloxone hydrochloride nasal spray (Narcan) as treatment for stopping or reversing an opioid overdose.
“In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible,” said Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, in a press release. “In addition to this approval of the first generic naloxone nasal spray, moving forward, we will prioritize our review of generic drug applications for naloxone.”
The agency said the naloxone nasal spray does not need assembly and can be used by anyone, regardless of medical training. If the spray is administered quickly after the overdose begins, the effect of the opioid will be countered, often within minutes. However, patients should still seek immediate medical attention.
The FDA cautioned that, when used on a patient with an opioid dependence, naloxone can cause severe opioid withdrawal, characterized by symptoms such as body aches, diarrhea, tachycardia, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.
Find the full press release on the FDA website.
The Food and Drug Administration on April 19 approved the first generic naloxone hydrochloride nasal spray (Narcan) as treatment for stopping or reversing an opioid overdose.
“In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible,” said Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research, in a press release. “In addition to this approval of the first generic naloxone nasal spray, moving forward, we will prioritize our review of generic drug applications for naloxone.”
The agency said the naloxone nasal spray does not need assembly and can be used by anyone, regardless of medical training. If the spray is administered quickly after the overdose begins, the effect of the opioid will be countered, often within minutes. However, patients should still seek immediate medical attention.
The FDA cautioned that, when used on a patient with an opioid dependence, naloxone can cause severe opioid withdrawal, characterized by symptoms such as body aches, diarrhea, tachycardia, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.
Find the full press release on the FDA website.