Federal Practitioner

TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

• The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
• Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
• They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
• Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
• The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

• Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
• Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
• At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
• IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

• The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
• Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
• They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
• Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
• The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

• Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
• Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
• At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
• IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite diabetes technology, many with type 1 diabetes (T1D) miss glycemic targets and experience severe hypoglycemia and impaired awareness of hypoglycemia (IAH). 

METHODOLOGY:

• The clinical management of T1D through technology is now recognized as the standard of care, but its real-world impact on glycemic targets and severe hypoglycemic events and IAH is unclear.
• Researchers assessed the self-reported prevalence of glycemic metrics, severe hypoglycemia, and hypoglycemia awareness according to the use of continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems.
• They enrolled 2044 individuals diagnosed with T1D for at least 2 years (mean age, 43.0 years; 72.1% women; 95.4% White) from the T1D Exchange Registry and online communities who filled an online survey.
• Participants were stratified on the basis of the presence or absence of CGM and different insulin delivery methods (multiple daily injections, conventional pumps, or AID systems).
• The primary outcome was the proportion of participants who achieved glycemic targets (self-reported A1c), had severe hypoglycemia (any low glucose incidence in 12 months), and/or IAH (a modified Gold score on a seven-point Likert scale).

TAKEAWAY:

• Most participants (91.7%) used CGM, and 50.8% of CGM users used an AID system.
• Despite advanced interventions, only 59.6% (95% CI, 57.3%-61.8%) of CGM users met the glycemic target (A1c < 7%), while nearly 40% of CGM users and 35.6% of AID users didn’t reach the target.
• At least one event of severe hypoglycemia in the previous 12 months was reported in 10.8% of CGM users and 16.6% of those using an AID system.
• IAH prevalence was seen in 31.1% (95% CI, 29.0%-33.2%) and 30.3% (95% CI, 17.5%-33.3%) of participants using CGM and CGM + AID, respectively.

IN PRACTICE:

“Educational initiatives continue to be important for all individuals with type 1 diabetes, and the development of novel therapeutic options and strategies, including bihormonal AID systems and beta-cell replacement, will be required to enable more of these individuals to meet treatment goals,” the authors wrote.

SOURCE:

The study, published online in Diabetes Care, was led by Jennifer L. Sherr, MD, PhD, Yale School of Medicine, New Haven, Connecticut.

LIMITATIONS:

The survey participants in this study were from the T1D Exchange online community, who tend to be highly involved, have technology experience, and are more likely to achieve glycemic targets. The data reported as part of the survey were based on self-reports by participants and may be subject to recall bias. Notably, severe hypoglycemic events may be overreported by individuals using CGM and AID systems due to sensor alarms.

DISCLOSURES:

The study was funded by Vertex Pharmaceuticals. Several authors disclosed financial relationships, including grants, consulting fees, honoraria, stock ownership, and employment with pharmaceutical and device companies and other entities.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral intragastric expandable capsules taken twice daily before meals reduce body weight in adults with overweight or obesity compared with placebo, with mild gastrointestinal adverse events.

METHODOLOGY:

• Numerous anti-obesity pharmacotherapies have demonstrated effectiveness in reducing weight, but they may lead to side effects.
• This 24-week phase 3 randomized placebo-controlled study evaluated 2.24 g oral intragastric expandable capsules for weight loss in 280 adults (ages 18-60 years) with overweight or obesity (body mass index ≥ 24 kg/m2).
• One capsule, taken before lunch and dinner with water, expands to fill about one quarter of average stomach volume and then passes through the body, similar to the US Food and Drug Administration–cleared device Plenity.
• Primary endpoints were the percentage change in body weight from baseline and the weight loss response rate (weight loss of at least 5% of baseline body weight) at week 24.
• Researchers analyzed efficacy outcomes in two ways: Intention to treat (a full analysis based on groups to which they were randomly assigned) and per protocol (based on data from participants who follow the protocol).

TAKEAWAY:

• At 24 weeks, the change in mean body weight was higher with intragastric expandable capsules than with placebo using the per protocol set (estimated treatment difference [ETD], −3.6%; P < .001), with similar results using the full analysis set.
• The weight loss response rate at 24 weeks was higher with intragastric expandable capsules than with placebo using the per protocol set (ETD, 29.6%; P < .001), with similar results using the full analysis set.
• Reduction in fasting insulin levels was higher with intragastric expandable capsules than with placebo (P = .008), while improvements in the lipid profile, fasting plasma glucose levels, and heart rate were similar between the groups.
• Gastrointestinal disorders were reported in 25.0% of participants in the intragastric expandable capsule group compared with 21.9% in the placebo group, with most being transient and mild in severity.

IN PRACTICE:

“As a mild and safe anti-obesity medication, intragastric expandable capsules provide a new therapeutic choice for individuals with overweight or obesity, helping them to enhance and maintain the effect of diet restriction,” wrote the authors.

SOURCE:

Difei Lu, MD, Department of Endocrinology, Peking University First Hospital, Beijing, China, led the study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study included individuals who were overweight or obese, who might have been more willing to lose weight than the general population. Moreover, only 3.25% of the participants had type 2 diabetes, and participants were relatively young. This may have reduced the potential to discover metabolic or cardiovascular improvement by the product.

DISCLOSURES:

This study was funded by Xiamen Junde Pharmaceutical Technology. The authors disclosed no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral intragastric expandable capsules taken twice daily before meals reduce body weight in adults with overweight or obesity compared with placebo, with mild gastrointestinal adverse events.

METHODOLOGY:

• Numerous anti-obesity pharmacotherapies have demonstrated effectiveness in reducing weight, but they may lead to side effects.
• This 24-week phase 3 randomized placebo-controlled study evaluated 2.24 g oral intragastric expandable capsules for weight loss in 280 adults (ages 18-60 years) with overweight or obesity (body mass index ≥ 24 kg/m2).
• One capsule, taken before lunch and dinner with water, expands to fill about one quarter of average stomach volume and then passes through the body, similar to the US Food and Drug Administration–cleared device Plenity.
• Primary endpoints were the percentage change in body weight from baseline and the weight loss response rate (weight loss of at least 5% of baseline body weight) at week 24.
• Researchers analyzed efficacy outcomes in two ways: Intention to treat (a full analysis based on groups to which they were randomly assigned) and per protocol (based on data from participants who follow the protocol).

TAKEAWAY:

• At 24 weeks, the change in mean body weight was higher with intragastric expandable capsules than with placebo using the per protocol set (estimated treatment difference [ETD], −3.6%; P < .001), with similar results using the full analysis set.
• The weight loss response rate at 24 weeks was higher with intragastric expandable capsules than with placebo using the per protocol set (ETD, 29.6%; P < .001), with similar results using the full analysis set.
• Reduction in fasting insulin levels was higher with intragastric expandable capsules than with placebo (P = .008), while improvements in the lipid profile, fasting plasma glucose levels, and heart rate were similar between the groups.
• Gastrointestinal disorders were reported in 25.0% of participants in the intragastric expandable capsule group compared with 21.9% in the placebo group, with most being transient and mild in severity.

IN PRACTICE:

“As a mild and safe anti-obesity medication, intragastric expandable capsules provide a new therapeutic choice for individuals with overweight or obesity, helping them to enhance and maintain the effect of diet restriction,” wrote the authors.

SOURCE:

Difei Lu, MD, Department of Endocrinology, Peking University First Hospital, Beijing, China, led the study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study included individuals who were overweight or obese, who might have been more willing to lose weight than the general population. Moreover, only 3.25% of the participants had type 2 diabetes, and participants were relatively young. This may have reduced the potential to discover metabolic or cardiovascular improvement by the product.

DISCLOSURES:

This study was funded by Xiamen Junde Pharmaceutical Technology. The authors disclosed no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral intragastric expandable capsules taken twice daily before meals reduce body weight in adults with overweight or obesity compared with placebo, with mild gastrointestinal adverse events.

METHODOLOGY:

• Numerous anti-obesity pharmacotherapies have demonstrated effectiveness in reducing weight, but they may lead to side effects.
• This 24-week phase 3 randomized placebo-controlled study evaluated 2.24 g oral intragastric expandable capsules for weight loss in 280 adults (ages 18-60 years) with overweight or obesity (body mass index ≥ 24 kg/m2).
• One capsule, taken before lunch and dinner with water, expands to fill about one quarter of average stomach volume and then passes through the body, similar to the US Food and Drug Administration–cleared device Plenity.
• Primary endpoints were the percentage change in body weight from baseline and the weight loss response rate (weight loss of at least 5% of baseline body weight) at week 24.
• Researchers analyzed efficacy outcomes in two ways: Intention to treat (a full analysis based on groups to which they were randomly assigned) and per protocol (based on data from participants who follow the protocol).

TAKEAWAY:

• At 24 weeks, the change in mean body weight was higher with intragastric expandable capsules than with placebo using the per protocol set (estimated treatment difference [ETD], −3.6%; P < .001), with similar results using the full analysis set.
• The weight loss response rate at 24 weeks was higher with intragastric expandable capsules than with placebo using the per protocol set (ETD, 29.6%; P < .001), with similar results using the full analysis set.
• Reduction in fasting insulin levels was higher with intragastric expandable capsules than with placebo (P = .008), while improvements in the lipid profile, fasting plasma glucose levels, and heart rate were similar between the groups.
• Gastrointestinal disorders were reported in 25.0% of participants in the intragastric expandable capsule group compared with 21.9% in the placebo group, with most being transient and mild in severity.

IN PRACTICE:

“As a mild and safe anti-obesity medication, intragastric expandable capsules provide a new therapeutic choice for individuals with overweight or obesity, helping them to enhance and maintain the effect of diet restriction,” wrote the authors.

SOURCE:

Difei Lu, MD, Department of Endocrinology, Peking University First Hospital, Beijing, China, led the study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study included individuals who were overweight or obese, who might have been more willing to lose weight than the general population. Moreover, only 3.25% of the participants had type 2 diabetes, and participants were relatively young. This may have reduced the potential to discover metabolic or cardiovascular improvement by the product.

DISCLOSURES:

This study was funded by Xiamen Junde Pharmaceutical Technology. The authors disclosed no conflicts of interest.

A version of this article appeared on Medscape.com.

Prednisolone may be an effective bridge therapy to ease withdrawal symptoms and improve reversal for patients with migraine whose headaches persist despite them taking an abundance of acute headache medications, a condition known as medication-overuse headache (MOH), an observational study out of South Korea has found.

The study, a post-hoc analysis of the RELEASE multicenter observational cohort study of MOH patients in South Korea, found that patients who took prednisolone as a bridge therapy in the early phase of withdrawal from headache medications, or detoxification, had statistically significant higher rates of MOH reversal at 3 months after enrollment than those who did not, 73.8% versus 57.8% (P = .034)  

Seoul National Univeristy College of Medicine

The reversal trend also was noted at 1 month after treatment, the study authors, led by Mi Ji Lee, MD, PhD, an assistant professor at Seoul National University Hospital, Seoul, South Korea, wrote. “Although an observational study cannot draw a definitive conclusion, our study supports the use of prednisolone for the treatment of MOH in a real-world setting,” Dr. Lee and colleagues wrote.
 

Study methods

The study was a post hoc analysis of the RELEASE study, which stands for Registry for Load and Management of Medication Overuse Headache. RELEASE is a multicenter observational cohort study that has been ongoing in South Korea since April 2020. The post hoc analysis included 309 patients, 59 of whom received prednisolone at a varying dose of 10-40 mg a day, with a varying course of 5-14 days. About 74% of patients (228 of 309) completed the 3-month follow-up period, including 41 in the prednisolone group.

The study used three different forms of medication withdrawal before the patients started prednisolone therapy: abrupt discontinuation; gradual discontinuation concurrent with starting prednisolone; and no withdrawal.

Because of the observational nature of the RELEASE study, participating physicians prescribed prednisolone at their own discretion. The study authors noted prednisolone use was neither randomized nor controlled, which they acknowledged as a limitation.

Dr. Lee and colleagues also acknowledged that newer calcitonin gene–related peptide (CGRP) receptor antagonists may not require detoxification to reverse MOH, but that those therapies are not always available for a variety of reasons, such as reimbursement restrictions, regional distribution issues, and financial issues.

The study also evaluated a number of secondary outcomes. For example, 72% of prednisolone patients achieved MOH reversal 1 month after starting treatment versus 54.9% of the nonprednisolone patients. (P = .33). Prednisolone users also had greater reductions in acute medication days (AMD) at 1 month and scores on headache impact test-6 (HIT-6) at 6 months.

Dr. Lee and colleagues noted that the concept of detoxification, or discontinuing medication overuse, as a treatment for MOH has been controversial due to a lack of high-quality evidence to support the approach. “Nevertheless,” they wrote, “several experts still put withdrawal of medication overuse as an important step of MOH treatment in clinical practice despite limited evidence.”
 

Commentary

Alan Rapoport, MD, a clinical professor of neurology at the David Geffen School of Medicine at University of California, Los Angeles, noted a number of limitations with the study. “It wasn’t a unified population of patients,” he said, “which makes it a little harder to say this medicine worked — worked on whom?” The lack of a treatment regimen — the varied dosing and treatment durations, along with the different withdrawal approaches — are further limitations, Dr. Rapoport said.

Nonetheless, the study is an important addition to the evidence on how to manage medication withdrawal in MOH, said Dr. Rapoport, a past president of the International Headache Society and founder and director emeritus of the New England Center for Headache in Stamford, Connecticut, who has a keen interest in MOH research.

“I think this shows to some extent, although it doesn’t prove it because it’s a whole mixture of patients who were all treated differently by different doctors, but when you put them all together the patients who took steroids did better than the patients who did not,” he said. “The study authors did the best they could with the information they had.”

He termed the study “well-done by well-known authors in South Korea.” As medications such as CGRP receptor antagonists and monoclonal antibodies that target CGRP and its receptors become more available, MOH patients “may not need actual detoxification or steroids in their treatment,” Dr. Rapoport said.

Dr. Lee and co-authors have no disclosures. Dr. Rapoport is editor-in-chief of Neurology Reviews. He disclosed relationships with AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica.

Prednisolone may be an effective bridge therapy to ease withdrawal symptoms and improve reversal for patients with migraine whose headaches persist despite them taking an abundance of acute headache medications, a condition known as medication-overuse headache (MOH), an observational study out of South Korea has found.

The study, a post-hoc analysis of the RELEASE multicenter observational cohort study of MOH patients in South Korea, found that patients who took prednisolone as a bridge therapy in the early phase of withdrawal from headache medications, or detoxification, had statistically significant higher rates of MOH reversal at 3 months after enrollment than those who did not, 73.8% versus 57.8% (P = .034)  

Seoul National Univeristy College of Medicine

The reversal trend also was noted at 1 month after treatment, the study authors, led by Mi Ji Lee, MD, PhD, an assistant professor at Seoul National University Hospital, Seoul, South Korea, wrote. “Although an observational study cannot draw a definitive conclusion, our study supports the use of prednisolone for the treatment of MOH in a real-world setting,” Dr. Lee and colleagues wrote.
 

Study methods

The study was a post hoc analysis of the RELEASE study, which stands for Registry for Load and Management of Medication Overuse Headache. RELEASE is a multicenter observational cohort study that has been ongoing in South Korea since April 2020. The post hoc analysis included 309 patients, 59 of whom received prednisolone at a varying dose of 10-40 mg a day, with a varying course of 5-14 days. About 74% of patients (228 of 309) completed the 3-month follow-up period, including 41 in the prednisolone group.

The study used three different forms of medication withdrawal before the patients started prednisolone therapy: abrupt discontinuation; gradual discontinuation concurrent with starting prednisolone; and no withdrawal.

Because of the observational nature of the RELEASE study, participating physicians prescribed prednisolone at their own discretion. The study authors noted prednisolone use was neither randomized nor controlled, which they acknowledged as a limitation.

Dr. Lee and colleagues also acknowledged that newer calcitonin gene–related peptide (CGRP) receptor antagonists may not require detoxification to reverse MOH, but that those therapies are not always available for a variety of reasons, such as reimbursement restrictions, regional distribution issues, and financial issues.

The study also evaluated a number of secondary outcomes. For example, 72% of prednisolone patients achieved MOH reversal 1 month after starting treatment versus 54.9% of the nonprednisolone patients. (P = .33). Prednisolone users also had greater reductions in acute medication days (AMD) at 1 month and scores on headache impact test-6 (HIT-6) at 6 months.

Dr. Lee and colleagues noted that the concept of detoxification, or discontinuing medication overuse, as a treatment for MOH has been controversial due to a lack of high-quality evidence to support the approach. “Nevertheless,” they wrote, “several experts still put withdrawal of medication overuse as an important step of MOH treatment in clinical practice despite limited evidence.”
 

Commentary

Alan Rapoport, MD, a clinical professor of neurology at the David Geffen School of Medicine at University of California, Los Angeles, noted a number of limitations with the study. “It wasn’t a unified population of patients,” he said, “which makes it a little harder to say this medicine worked — worked on whom?” The lack of a treatment regimen — the varied dosing and treatment durations, along with the different withdrawal approaches — are further limitations, Dr. Rapoport said.

Nonetheless, the study is an important addition to the evidence on how to manage medication withdrawal in MOH, said Dr. Rapoport, a past president of the International Headache Society and founder and director emeritus of the New England Center for Headache in Stamford, Connecticut, who has a keen interest in MOH research.

“I think this shows to some extent, although it doesn’t prove it because it’s a whole mixture of patients who were all treated differently by different doctors, but when you put them all together the patients who took steroids did better than the patients who did not,” he said. “The study authors did the best they could with the information they had.”

He termed the study “well-done by well-known authors in South Korea.” As medications such as CGRP receptor antagonists and monoclonal antibodies that target CGRP and its receptors become more available, MOH patients “may not need actual detoxification or steroids in their treatment,” Dr. Rapoport said.

Dr. Lee and co-authors have no disclosures. Dr. Rapoport is editor-in-chief of Neurology Reviews. He disclosed relationships with AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica.

Prednisolone may be an effective bridge therapy to ease withdrawal symptoms and improve reversal for patients with migraine whose headaches persist despite them taking an abundance of acute headache medications, a condition known as medication-overuse headache (MOH), an observational study out of South Korea has found.

The study, a post-hoc analysis of the RELEASE multicenter observational cohort study of MOH patients in South Korea, found that patients who took prednisolone as a bridge therapy in the early phase of withdrawal from headache medications, or detoxification, had statistically significant higher rates of MOH reversal at 3 months after enrollment than those who did not, 73.8% versus 57.8% (P = .034)  

Seoul National Univeristy College of Medicine

The reversal trend also was noted at 1 month after treatment, the study authors, led by Mi Ji Lee, MD, PhD, an assistant professor at Seoul National University Hospital, Seoul, South Korea, wrote. “Although an observational study cannot draw a definitive conclusion, our study supports the use of prednisolone for the treatment of MOH in a real-world setting,” Dr. Lee and colleagues wrote.
 

Study methods

The study was a post hoc analysis of the RELEASE study, which stands for Registry for Load and Management of Medication Overuse Headache. RELEASE is a multicenter observational cohort study that has been ongoing in South Korea since April 2020. The post hoc analysis included 309 patients, 59 of whom received prednisolone at a varying dose of 10-40 mg a day, with a varying course of 5-14 days. About 74% of patients (228 of 309) completed the 3-month follow-up period, including 41 in the prednisolone group.

The study used three different forms of medication withdrawal before the patients started prednisolone therapy: abrupt discontinuation; gradual discontinuation concurrent with starting prednisolone; and no withdrawal.

Because of the observational nature of the RELEASE study, participating physicians prescribed prednisolone at their own discretion. The study authors noted prednisolone use was neither randomized nor controlled, which they acknowledged as a limitation.

Dr. Lee and colleagues also acknowledged that newer calcitonin gene–related peptide (CGRP) receptor antagonists may not require detoxification to reverse MOH, but that those therapies are not always available for a variety of reasons, such as reimbursement restrictions, regional distribution issues, and financial issues.

The study also evaluated a number of secondary outcomes. For example, 72% of prednisolone patients achieved MOH reversal 1 month after starting treatment versus 54.9% of the nonprednisolone patients. (P = .33). Prednisolone users also had greater reductions in acute medication days (AMD) at 1 month and scores on headache impact test-6 (HIT-6) at 6 months.

Dr. Lee and colleagues noted that the concept of detoxification, or discontinuing medication overuse, as a treatment for MOH has been controversial due to a lack of high-quality evidence to support the approach. “Nevertheless,” they wrote, “several experts still put withdrawal of medication overuse as an important step of MOH treatment in clinical practice despite limited evidence.”
 

Commentary

Alan Rapoport, MD, a clinical professor of neurology at the David Geffen School of Medicine at University of California, Los Angeles, noted a number of limitations with the study. “It wasn’t a unified population of patients,” he said, “which makes it a little harder to say this medicine worked — worked on whom?” The lack of a treatment regimen — the varied dosing and treatment durations, along with the different withdrawal approaches — are further limitations, Dr. Rapoport said.

Nonetheless, the study is an important addition to the evidence on how to manage medication withdrawal in MOH, said Dr. Rapoport, a past president of the International Headache Society and founder and director emeritus of the New England Center for Headache in Stamford, Connecticut, who has a keen interest in MOH research.

“I think this shows to some extent, although it doesn’t prove it because it’s a whole mixture of patients who were all treated differently by different doctors, but when you put them all together the patients who took steroids did better than the patients who did not,” he said. “The study authors did the best they could with the information they had.”

He termed the study “well-done by well-known authors in South Korea.” As medications such as CGRP receptor antagonists and monoclonal antibodies that target CGRP and its receptors become more available, MOH patients “may not need actual detoxification or steroids in their treatment,” Dr. Rapoport said.

Dr. Lee and co-authors have no disclosures. Dr. Rapoport is editor-in-chief of Neurology Reviews. He disclosed relationships with AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica.

Has COVID replaced syphilis as the great imitator? At the turn of the 20th century, Sir William Osler was quoted as saying, “He who knows syphilis knows medicine.”

If you have any doubts about the “imitator” analogy, simply use any broad search engine or AI portal and enter “what is the differential diagnosis of primary syphilis, or secondary syphilis, or tertiary syphilis?” A plethora of diseases across many body systems appears.
 

Another Great Pretender?

Did you or do you now have long COVID? How do you know? Do you even know what long COVID is? How would you diagnosis it?

When asked about long COVID, this is what large language model source bard.google.com had to say:

Long COVID, also known as post-COVID conditions or PASC, is a complex condition that can occur in people who have had COVID-19, even if their initial illness was mild or even asymptomatic. It’s characterized by a wide range of symptoms that can last for weeks, months, or even years after the initial infection.

Symptoms of long COVID can include: fatigue, shortness of breath, brain fog (trouble thinking or concentrating), loss of smell or taste, sleep problems, muscle pain, joint pain, headache, dizziness, depression or anxiety, heart palpitations, gastrointestinal problems.

Duh!!! It reads much like a continuation of the symptoms of acute COVID. Bard continued:

The exact cause of long COVID is still unknown, but there are several theories. One possibility is that the virus itself can damage organs and tissues, leading to ongoing symptoms. Another possibility is that the immune system’s response to the virus can continue to cause inflammation even after the virus is gone.

Human intelligence source Wikipedia says this:

Long COVID or long-haul COVID is a group of health problems persisting or developing after an initial COVID-19 infection. Symptoms can last weeks, months or years and are often debilitating. The World Health Organization defines long COVID as starting three months after infection, but other definitions put the start of long COVID at four weeks.

Highly varied, including post-exertional malaise (symptoms made worse with effort), fatigue, muscle pain, shortness of breath, chest pain, and cognitive dysfunction (brain fog).
 

Acute COVID to Long COVID

The World Health Organization estimates that 36 million people in the European region have developed long COVID in the first 3 years of the pandemic. That›s a lot.

We all know that the common signs and symptoms of acute COVID-19 include fever or chills, a dry cough and shortness of breath, feeling very tired, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, runny nose, nausea, vomiting, and diarrhea. Except for the taste and smell findings, every one of these symptoms or signs could indicate a different virus infection or even some type of allergy. My point is the nonspecificity in this list.

Uncommon signs and symptoms of acute COVID include a flat skin rash covered with small bumps, discolored swollen areas on the fingers and toes (COVID toes), and hives. The skin of hands, wrists, or ankles also can be affected. Blisters, itchiness, rough skin, or pus can be seen.

Severe confusion (delirium) might be the main or only symptom of COVID-19 in older people. This COVID-19 symptom is linked with a high risk for poor outcomes, including death. Pink eye (conjunctivitis) can be a COVID-19 symptom. Other eye problems linked to COVID-19 are light sensitivity, sore eyes, and itchy eyes. Acute myocarditis, tinnitus, vertigo, and hearing loss have been reported. And 1-4 weeks after the onset of COVID-19 infection, a patient may experience de novo reactive synovitis and arthritis of any joints.

So, take your pick. Myriad symptoms, signs, diseases, diagnoses, and organ systems — still present, recurring, just appearing, apparently de novo, or after asymptomatic infection. We have so much still to learn.

What big-time symptoms, signs, and major diseases are not on any of these lists? Obviously, cancer, atherosclerotic cardiovascular diseases, obesity, bone diseases, and competitive infections. But be patient; the lingering effects of direct tissue invasion by the virus as well as a wide range of immunologic reactions may just be getting started. Mitochondrial damage, especially in muscles, is increasingly a pathophysiologic suspect.

Human diseases can be physical or mental; and in COVID, that twain not only meet but mix and mingle freely, and may even merge into psychosoma. Don’t ever forget that. Consider “fatigue.” Who among us, COVID or NOVID, does not experience that from time to time?

Or consider brain fog as a common reported symptom of COVID. What on earth is that actually? How can a person know they have brain fog, or whether they had it and are over it?

We need one or more lab or other diagnostic tests that can objectively confirm the diagnosis of long COVID.
 

Useful Progress?

A recent research paper in Science reported intriguing chemical findings that seemed to point a finger at some form of complement dysregulation as a potential disease marker for long COVID. Unfortunately, some critics have pointed out that this entire study may be invalid or irrelevant because the New York cohort was recruited in 2020, before vaccines were available. The Zurich cohort was recruited up until April 2021, so some may have been vaccinated.

Then this news organization came along in early January 2024 with an article about COVID causing not only more than a million American deaths but also more than 5000 deaths from long COVID. We physicians don’t really know what long COVID even is, but we have to sign death certificates blaming thousands of deaths on it anyway? And rolling back the clock to 2020: Are patients dying from COVID or with COVID, according to death certificates?Now, armed with the knowledge that “documented serious post–COVID-19 conditions include cardiovascular, pulmonary, neurological, renal, endocrine, hematological, and gastrointestinal complications, as well as death,” CDC has published clear and fairly concise instructions on how to address post-acute COVID sequelae on death certificates.

In late January, this news organization painted a hopeful picture by naming four phenotypes of long COVID, suggesting that such divisions might further our understanding, including prognosis, and even therapy for this condition. Among the clinical phenotypes of (1) chronic fatigue–like syndrome, headache, and memory loss; (2) respiratory syndrome (which includes cough and difficulty breathing); (3) chronic pain; and (4) neurosensorial syndrome (which causes an altered sense of taste and smell), overlap is clearly possible but isn›t addressed.

I see these recent developments as needed and useful progress, but we are still left with…not much. So, when you tell me that you do or do not have long COVID, I will say to you, “How do you know?”

I also say: She/he/they who know COVID know medicine.

A version of this article first appeared on Medscape.com.

Has COVID replaced syphilis as the great imitator? At the turn of the 20th century, Sir William Osler was quoted as saying, “He who knows syphilis knows medicine.”

If you have any doubts about the “imitator” analogy, simply use any broad search engine or AI portal and enter “what is the differential diagnosis of primary syphilis, or secondary syphilis, or tertiary syphilis?” A plethora of diseases across many body systems appears.
 

Another Great Pretender?

Did you or do you now have long COVID? How do you know? Do you even know what long COVID is? How would you diagnosis it?

When asked about long COVID, this is what large language model source bard.google.com had to say:

Long COVID, also known as post-COVID conditions or PASC, is a complex condition that can occur in people who have had COVID-19, even if their initial illness was mild or even asymptomatic. It’s characterized by a wide range of symptoms that can last for weeks, months, or even years after the initial infection.

Symptoms of long COVID can include: fatigue, shortness of breath, brain fog (trouble thinking or concentrating), loss of smell or taste, sleep problems, muscle pain, joint pain, headache, dizziness, depression or anxiety, heart palpitations, gastrointestinal problems.

Duh!!! It reads much like a continuation of the symptoms of acute COVID. Bard continued:

The exact cause of long COVID is still unknown, but there are several theories. One possibility is that the virus itself can damage organs and tissues, leading to ongoing symptoms. Another possibility is that the immune system’s response to the virus can continue to cause inflammation even after the virus is gone.

Human intelligence source Wikipedia says this:

Long COVID or long-haul COVID is a group of health problems persisting or developing after an initial COVID-19 infection. Symptoms can last weeks, months or years and are often debilitating. The World Health Organization defines long COVID as starting three months after infection, but other definitions put the start of long COVID at four weeks.

Highly varied, including post-exertional malaise (symptoms made worse with effort), fatigue, muscle pain, shortness of breath, chest pain, and cognitive dysfunction (brain fog).
 

Acute COVID to Long COVID

The World Health Organization estimates that 36 million people in the European region have developed long COVID in the first 3 years of the pandemic. That›s a lot.

We all know that the common signs and symptoms of acute COVID-19 include fever or chills, a dry cough and shortness of breath, feeling very tired, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, runny nose, nausea, vomiting, and diarrhea. Except for the taste and smell findings, every one of these symptoms or signs could indicate a different virus infection or even some type of allergy. My point is the nonspecificity in this list.

Uncommon signs and symptoms of acute COVID include a flat skin rash covered with small bumps, discolored swollen areas on the fingers and toes (COVID toes), and hives. The skin of hands, wrists, or ankles also can be affected. Blisters, itchiness, rough skin, or pus can be seen.

Severe confusion (delirium) might be the main or only symptom of COVID-19 in older people. This COVID-19 symptom is linked with a high risk for poor outcomes, including death. Pink eye (conjunctivitis) can be a COVID-19 symptom. Other eye problems linked to COVID-19 are light sensitivity, sore eyes, and itchy eyes. Acute myocarditis, tinnitus, vertigo, and hearing loss have been reported. And 1-4 weeks after the onset of COVID-19 infection, a patient may experience de novo reactive synovitis and arthritis of any joints.

So, take your pick. Myriad symptoms, signs, diseases, diagnoses, and organ systems — still present, recurring, just appearing, apparently de novo, or after asymptomatic infection. We have so much still to learn.

What big-time symptoms, signs, and major diseases are not on any of these lists? Obviously, cancer, atherosclerotic cardiovascular diseases, obesity, bone diseases, and competitive infections. But be patient; the lingering effects of direct tissue invasion by the virus as well as a wide range of immunologic reactions may just be getting started. Mitochondrial damage, especially in muscles, is increasingly a pathophysiologic suspect.

Human diseases can be physical or mental; and in COVID, that twain not only meet but mix and mingle freely, and may even merge into psychosoma. Don’t ever forget that. Consider “fatigue.” Who among us, COVID or NOVID, does not experience that from time to time?

Or consider brain fog as a common reported symptom of COVID. What on earth is that actually? How can a person know they have brain fog, or whether they had it and are over it?

We need one or more lab or other diagnostic tests that can objectively confirm the diagnosis of long COVID.
 

Useful Progress?

A recent research paper in Science reported intriguing chemical findings that seemed to point a finger at some form of complement dysregulation as a potential disease marker for long COVID. Unfortunately, some critics have pointed out that this entire study may be invalid or irrelevant because the New York cohort was recruited in 2020, before vaccines were available. The Zurich cohort was recruited up until April 2021, so some may have been vaccinated.

Then this news organization came along in early January 2024 with an article about COVID causing not only more than a million American deaths but also more than 5000 deaths from long COVID. We physicians don’t really know what long COVID even is, but we have to sign death certificates blaming thousands of deaths on it anyway? And rolling back the clock to 2020: Are patients dying from COVID or with COVID, according to death certificates?Now, armed with the knowledge that “documented serious post–COVID-19 conditions include cardiovascular, pulmonary, neurological, renal, endocrine, hematological, and gastrointestinal complications, as well as death,” CDC has published clear and fairly concise instructions on how to address post-acute COVID sequelae on death certificates.

In late January, this news organization painted a hopeful picture by naming four phenotypes of long COVID, suggesting that such divisions might further our understanding, including prognosis, and even therapy for this condition. Among the clinical phenotypes of (1) chronic fatigue–like syndrome, headache, and memory loss; (2) respiratory syndrome (which includes cough and difficulty breathing); (3) chronic pain; and (4) neurosensorial syndrome (which causes an altered sense of taste and smell), overlap is clearly possible but isn›t addressed.

I see these recent developments as needed and useful progress, but we are still left with…not much. So, when you tell me that you do or do not have long COVID, I will say to you, “How do you know?”

I also say: She/he/they who know COVID know medicine.

A version of this article first appeared on Medscape.com.

Has COVID replaced syphilis as the great imitator? At the turn of the 20th century, Sir William Osler was quoted as saying, “He who knows syphilis knows medicine.”

If you have any doubts about the “imitator” analogy, simply use any broad search engine or AI portal and enter “what is the differential diagnosis of primary syphilis, or secondary syphilis, or tertiary syphilis?” A plethora of diseases across many body systems appears.
 

Another Great Pretender?

Did you or do you now have long COVID? How do you know? Do you even know what long COVID is? How would you diagnosis it?

When asked about long COVID, this is what large language model source bard.google.com had to say:

Long COVID, also known as post-COVID conditions or PASC, is a complex condition that can occur in people who have had COVID-19, even if their initial illness was mild or even asymptomatic. It’s characterized by a wide range of symptoms that can last for weeks, months, or even years after the initial infection.

Symptoms of long COVID can include: fatigue, shortness of breath, brain fog (trouble thinking or concentrating), loss of smell or taste, sleep problems, muscle pain, joint pain, headache, dizziness, depression or anxiety, heart palpitations, gastrointestinal problems.

Duh!!! It reads much like a continuation of the symptoms of acute COVID. Bard continued:

The exact cause of long COVID is still unknown, but there are several theories. One possibility is that the virus itself can damage organs and tissues, leading to ongoing symptoms. Another possibility is that the immune system’s response to the virus can continue to cause inflammation even after the virus is gone.

Human intelligence source Wikipedia says this:

Long COVID or long-haul COVID is a group of health problems persisting or developing after an initial COVID-19 infection. Symptoms can last weeks, months or years and are often debilitating. The World Health Organization defines long COVID as starting three months after infection, but other definitions put the start of long COVID at four weeks.

Highly varied, including post-exertional malaise (symptoms made worse with effort), fatigue, muscle pain, shortness of breath, chest pain, and cognitive dysfunction (brain fog).
 

Acute COVID to Long COVID

The World Health Organization estimates that 36 million people in the European region have developed long COVID in the first 3 years of the pandemic. That›s a lot.

We all know that the common signs and symptoms of acute COVID-19 include fever or chills, a dry cough and shortness of breath, feeling very tired, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, runny nose, nausea, vomiting, and diarrhea. Except for the taste and smell findings, every one of these symptoms or signs could indicate a different virus infection or even some type of allergy. My point is the nonspecificity in this list.

Uncommon signs and symptoms of acute COVID include a flat skin rash covered with small bumps, discolored swollen areas on the fingers and toes (COVID toes), and hives. The skin of hands, wrists, or ankles also can be affected. Blisters, itchiness, rough skin, or pus can be seen.

Severe confusion (delirium) might be the main or only symptom of COVID-19 in older people. This COVID-19 symptom is linked with a high risk for poor outcomes, including death. Pink eye (conjunctivitis) can be a COVID-19 symptom. Other eye problems linked to COVID-19 are light sensitivity, sore eyes, and itchy eyes. Acute myocarditis, tinnitus, vertigo, and hearing loss have been reported. And 1-4 weeks after the onset of COVID-19 infection, a patient may experience de novo reactive synovitis and arthritis of any joints.

So, take your pick. Myriad symptoms, signs, diseases, diagnoses, and organ systems — still present, recurring, just appearing, apparently de novo, or after asymptomatic infection. We have so much still to learn.

What big-time symptoms, signs, and major diseases are not on any of these lists? Obviously, cancer, atherosclerotic cardiovascular diseases, obesity, bone diseases, and competitive infections. But be patient; the lingering effects of direct tissue invasion by the virus as well as a wide range of immunologic reactions may just be getting started. Mitochondrial damage, especially in muscles, is increasingly a pathophysiologic suspect.

Human diseases can be physical or mental; and in COVID, that twain not only meet but mix and mingle freely, and may even merge into psychosoma. Don’t ever forget that. Consider “fatigue.” Who among us, COVID or NOVID, does not experience that from time to time?

Or consider brain fog as a common reported symptom of COVID. What on earth is that actually? How can a person know they have brain fog, or whether they had it and are over it?

We need one or more lab or other diagnostic tests that can objectively confirm the diagnosis of long COVID.
 

Useful Progress?

A recent research paper in Science reported intriguing chemical findings that seemed to point a finger at some form of complement dysregulation as a potential disease marker for long COVID. Unfortunately, some critics have pointed out that this entire study may be invalid or irrelevant because the New York cohort was recruited in 2020, before vaccines were available. The Zurich cohort was recruited up until April 2021, so some may have been vaccinated.

Then this news organization came along in early January 2024 with an article about COVID causing not only more than a million American deaths but also more than 5000 deaths from long COVID. We physicians don’t really know what long COVID even is, but we have to sign death certificates blaming thousands of deaths on it anyway? And rolling back the clock to 2020: Are patients dying from COVID or with COVID, according to death certificates?Now, armed with the knowledge that “documented serious post–COVID-19 conditions include cardiovascular, pulmonary, neurological, renal, endocrine, hematological, and gastrointestinal complications, as well as death,” CDC has published clear and fairly concise instructions on how to address post-acute COVID sequelae on death certificates.

In late January, this news organization painted a hopeful picture by naming four phenotypes of long COVID, suggesting that such divisions might further our understanding, including prognosis, and even therapy for this condition. Among the clinical phenotypes of (1) chronic fatigue–like syndrome, headache, and memory loss; (2) respiratory syndrome (which includes cough and difficulty breathing); (3) chronic pain; and (4) neurosensorial syndrome (which causes an altered sense of taste and smell), overlap is clearly possible but isn›t addressed.

I see these recent developments as needed and useful progress, but we are still left with…not much. So, when you tell me that you do or do not have long COVID, I will say to you, “How do you know?”

I also say: She/he/they who know COVID know medicine.

A version of this article first appeared on Medscape.com.

The number of state psychiatric hospital beds has hit a historic low with about 11 beds per 100,000 population, a new report showed.

More than half of those beds (52%) were occupied by forensic patients, individuals with serious mental illness (SMI) who were committed to the state hospital through the criminal legal system to help establish competency for trial.

“The shortage of psychiatric beds has real consequences for people with SMI — some will wait months in jail despite not yet being found guilty of a crime, others will be denied admission despite being critically ill, and others still will be discharged prematurely onto the streets to free up beds, where they may grow sicker and be at an elevated risk of mortality,” wrote report coauthors Shanti Silver of the Treatment Advocacy Center (TAC) in Arlington and Elizabeth Sinclair Hanq of the National Association of State Mental Health Program Directors in Alexandria, Virginia.

Published online on January 24, Prevention Over Punishment: Finding the Right Balance of Civil and Forensic State Psychiatric Hospital Beds recommends that state and local governments work together to open additional state psychiatric hospital beds for civil and forensic patients with SMI.

To obtain data about the availability of state psychiatric hospital beds, TAC surveyed state officials from April to August 2023. Official responses were provided by 41 states and the District of Columbia.

Information for the remaining states was gathered from state websites, media articles, preexisting reports, hospital admission staff, or personal contacts living in those states.

The median occupancy rate for state-run hospitals in the new report was 90%, well above the 85% level investigators say usually signals a bed shortage. Overall, 73% of states reported occupancy rates above that level, with 11 states operating at 95% capacity.

The proportion of state psychiatric beds occupied by forensic patients has increased by 12% since 2016, largely driven by the growing number of individuals awaiting a competency determination to stand trial. Before they occupy these beds, however, people with SMI can languish in jail for months or even years, waiting for a bed to open.

About 15% of all state hospital beds and 31% of forensic beds across 34 states were occupied by individuals who had been found not guilty of a crime by reasons of insanity.

“The prioritization of admission of forensic patients has effectively created a system where someone must be arrested to access a state hospital bed,” report coauthor Lisa Dailey, TAC executive director, told this news organization. “But there are not enough beds for forensic patients either; thousands of inmates are waiting in jail on any given day for a bed to open up.”

There are several factors contributing to the scarcity of beds, including an existing hospital staffing shortage made worse by the COVID-19 pandemic and a lack of appropriate discharge facilities.

Report authors offered a number of recommendations to federal, state, and local officials to increase the availability of state-run psychiatric hospital beds, including infrastructure changes involving recruiting and retaining staff for state hospitals and funding new discharge or step-down facilities so that patients have a place to recover when they leave the hospital.

Policy changes could also help, the report noted. Policymakers should consider “dismiss and transfer” procedures to address the backlog of nearly 6000 people with SMI waiting for a state hospital bed to achieve competency to stand trial. With “dismiss and transfer,” criminal charges are dismissed or suspended while an application for civil commitment is filed in the probate court. Once a civil commitment order has been issued, the individual is released to an outpatient commitment program for treatment.

“States must strive for prevention over punishment,” the report concluded.

There was no study funding reported, nor were disclosures available.
 

A version of this article appeared on Medscape.com.

The number of state psychiatric hospital beds has hit a historic low with about 11 beds per 100,000 population, a new report showed.

More than half of those beds (52%) were occupied by forensic patients, individuals with serious mental illness (SMI) who were committed to the state hospital through the criminal legal system to help establish competency for trial.

“The shortage of psychiatric beds has real consequences for people with SMI — some will wait months in jail despite not yet being found guilty of a crime, others will be denied admission despite being critically ill, and others still will be discharged prematurely onto the streets to free up beds, where they may grow sicker and be at an elevated risk of mortality,” wrote report coauthors Shanti Silver of the Treatment Advocacy Center (TAC) in Arlington and Elizabeth Sinclair Hanq of the National Association of State Mental Health Program Directors in Alexandria, Virginia.

Published online on January 24, Prevention Over Punishment: Finding the Right Balance of Civil and Forensic State Psychiatric Hospital Beds recommends that state and local governments work together to open additional state psychiatric hospital beds for civil and forensic patients with SMI.

To obtain data about the availability of state psychiatric hospital beds, TAC surveyed state officials from April to August 2023. Official responses were provided by 41 states and the District of Columbia.

Information for the remaining states was gathered from state websites, media articles, preexisting reports, hospital admission staff, or personal contacts living in those states.

The median occupancy rate for state-run hospitals in the new report was 90%, well above the 85% level investigators say usually signals a bed shortage. Overall, 73% of states reported occupancy rates above that level, with 11 states operating at 95% capacity.

The proportion of state psychiatric beds occupied by forensic patients has increased by 12% since 2016, largely driven by the growing number of individuals awaiting a competency determination to stand trial. Before they occupy these beds, however, people with SMI can languish in jail for months or even years, waiting for a bed to open.

About 15% of all state hospital beds and 31% of forensic beds across 34 states were occupied by individuals who had been found not guilty of a crime by reasons of insanity.

“The prioritization of admission of forensic patients has effectively created a system where someone must be arrested to access a state hospital bed,” report coauthor Lisa Dailey, TAC executive director, told this news organization. “But there are not enough beds for forensic patients either; thousands of inmates are waiting in jail on any given day for a bed to open up.”

There are several factors contributing to the scarcity of beds, including an existing hospital staffing shortage made worse by the COVID-19 pandemic and a lack of appropriate discharge facilities.

Report authors offered a number of recommendations to federal, state, and local officials to increase the availability of state-run psychiatric hospital beds, including infrastructure changes involving recruiting and retaining staff for state hospitals and funding new discharge or step-down facilities so that patients have a place to recover when they leave the hospital.

Policy changes could also help, the report noted. Policymakers should consider “dismiss and transfer” procedures to address the backlog of nearly 6000 people with SMI waiting for a state hospital bed to achieve competency to stand trial. With “dismiss and transfer,” criminal charges are dismissed or suspended while an application for civil commitment is filed in the probate court. Once a civil commitment order has been issued, the individual is released to an outpatient commitment program for treatment.

“States must strive for prevention over punishment,” the report concluded.

There was no study funding reported, nor were disclosures available.
 

A version of this article appeared on Medscape.com.

The number of state psychiatric hospital beds has hit a historic low with about 11 beds per 100,000 population, a new report showed.

More than half of those beds (52%) were occupied by forensic patients, individuals with serious mental illness (SMI) who were committed to the state hospital through the criminal legal system to help establish competency for trial.

“The shortage of psychiatric beds has real consequences for people with SMI — some will wait months in jail despite not yet being found guilty of a crime, others will be denied admission despite being critically ill, and others still will be discharged prematurely onto the streets to free up beds, where they may grow sicker and be at an elevated risk of mortality,” wrote report coauthors Shanti Silver of the Treatment Advocacy Center (TAC) in Arlington and Elizabeth Sinclair Hanq of the National Association of State Mental Health Program Directors in Alexandria, Virginia.

Published online on January 24, Prevention Over Punishment: Finding the Right Balance of Civil and Forensic State Psychiatric Hospital Beds recommends that state and local governments work together to open additional state psychiatric hospital beds for civil and forensic patients with SMI.

To obtain data about the availability of state psychiatric hospital beds, TAC surveyed state officials from April to August 2023. Official responses were provided by 41 states and the District of Columbia.

Information for the remaining states was gathered from state websites, media articles, preexisting reports, hospital admission staff, or personal contacts living in those states.

The median occupancy rate for state-run hospitals in the new report was 90%, well above the 85% level investigators say usually signals a bed shortage. Overall, 73% of states reported occupancy rates above that level, with 11 states operating at 95% capacity.

The proportion of state psychiatric beds occupied by forensic patients has increased by 12% since 2016, largely driven by the growing number of individuals awaiting a competency determination to stand trial. Before they occupy these beds, however, people with SMI can languish in jail for months or even years, waiting for a bed to open.

About 15% of all state hospital beds and 31% of forensic beds across 34 states were occupied by individuals who had been found not guilty of a crime by reasons of insanity.

“The prioritization of admission of forensic patients has effectively created a system where someone must be arrested to access a state hospital bed,” report coauthor Lisa Dailey, TAC executive director, told this news organization. “But there are not enough beds for forensic patients either; thousands of inmates are waiting in jail on any given day for a bed to open up.”

There are several factors contributing to the scarcity of beds, including an existing hospital staffing shortage made worse by the COVID-19 pandemic and a lack of appropriate discharge facilities.

Report authors offered a number of recommendations to federal, state, and local officials to increase the availability of state-run psychiatric hospital beds, including infrastructure changes involving recruiting and retaining staff for state hospitals and funding new discharge or step-down facilities so that patients have a place to recover when they leave the hospital.

Policy changes could also help, the report noted. Policymakers should consider “dismiss and transfer” procedures to address the backlog of nearly 6000 people with SMI waiting for a state hospital bed to achieve competency to stand trial. With “dismiss and transfer,” criminal charges are dismissed or suspended while an application for civil commitment is filed in the probate court. Once a civil commitment order has been issued, the individual is released to an outpatient commitment program for treatment.

“States must strive for prevention over punishment,” the report concluded.

There was no study funding reported, nor were disclosures available.
 

A version of this article appeared on Medscape.com.

For years, people living and working at Camp Lejeune in Jacksonville, N.C., drank and showered in water contaminated with trichloroethylene (TCE) and other industrial solvents. Now, a Centers for Disease Control and Prevention (CDC) study has determined that the exposure markedly increased their risk for certain cancers.

In one of the largest cohort cancer incidence studies ever completed in the US, researchers compared cancer risk between 161,315 military personnel and civilian workers at Camp Lejeune and 169,281 military personnel and civilian workers at Camp Pendleton in Oceanside, Calif., where the water was not contaminated.

Data from diagnoses between 1996 and 2017 documented 12,083 cancers among Camp Lejeune Marine and Navy personnel and 1,563 among civilian workers. By comparison, 12,144 cancers were documented among Camp Pendleton personnel and 1,372 among civilian workers. However, personnel stationed at Camp Lejeune between 1975 and 1985 had at least a 20% higher risk for all myeloid cancers including polycythemia vera, acute myeloid leukemia, myelodysplastic and myeloproliferative syndromes, and cancers of the esophagus, larynx, soft tissue, and thyroid. Civilian workers had a higher risk for all myeloid cancers, squamous cell lung cancer, and female ductal breast cancer.

The water exposures included contributions to total internal body dose from 3 routes: ingestion, inhalation, and dermal. The researchers note that a Marine in training may consume as much as 6 liters a day of drinking water, but the combined dose from inhalation and dermal routes could be as high or higher than that from ingestion. For example, they note that an internal dose via inhalation to TCE during a 10-minute shower could equal the internal dose via ingestion of 2 liters of contaminated drinking water.

Health risks at Camp Lejeune have been studied before, but this study “more fully establishes the scope,” Richard Clapp, a Boston University emeritus public health professor, told the Associated Press.

For years, people living and working at Camp Lejeune in Jacksonville, N.C., drank and showered in water contaminated with trichloroethylene (TCE) and other industrial solvents. Now, a Centers for Disease Control and Prevention (CDC) study has determined that the exposure markedly increased their risk for certain cancers.

In one of the largest cohort cancer incidence studies ever completed in the US, researchers compared cancer risk between 161,315 military personnel and civilian workers at Camp Lejeune and 169,281 military personnel and civilian workers at Camp Pendleton in Oceanside, Calif., where the water was not contaminated.

Data from diagnoses between 1996 and 2017 documented 12,083 cancers among Camp Lejeune Marine and Navy personnel and 1,563 among civilian workers. By comparison, 12,144 cancers were documented among Camp Pendleton personnel and 1,372 among civilian workers. However, personnel stationed at Camp Lejeune between 1975 and 1985 had at least a 20% higher risk for all myeloid cancers including polycythemia vera, acute myeloid leukemia, myelodysplastic and myeloproliferative syndromes, and cancers of the esophagus, larynx, soft tissue, and thyroid. Civilian workers had a higher risk for all myeloid cancers, squamous cell lung cancer, and female ductal breast cancer.

The water exposures included contributions to total internal body dose from 3 routes: ingestion, inhalation, and dermal. The researchers note that a Marine in training may consume as much as 6 liters a day of drinking water, but the combined dose from inhalation and dermal routes could be as high or higher than that from ingestion. For example, they note that an internal dose via inhalation to TCE during a 10-minute shower could equal the internal dose via ingestion of 2 liters of contaminated drinking water.

Health risks at Camp Lejeune have been studied before, but this study “more fully establishes the scope,” Richard Clapp, a Boston University emeritus public health professor, told the Associated Press.

For years, people living and working at Camp Lejeune in Jacksonville, N.C., drank and showered in water contaminated with trichloroethylene (TCE) and other industrial solvents. Now, a Centers for Disease Control and Prevention (CDC) study has determined that the exposure markedly increased their risk for certain cancers.

In one of the largest cohort cancer incidence studies ever completed in the US, researchers compared cancer risk between 161,315 military personnel and civilian workers at Camp Lejeune and 169,281 military personnel and civilian workers at Camp Pendleton in Oceanside, Calif., where the water was not contaminated.

Data from diagnoses between 1996 and 2017 documented 12,083 cancers among Camp Lejeune Marine and Navy personnel and 1,563 among civilian workers. By comparison, 12,144 cancers were documented among Camp Pendleton personnel and 1,372 among civilian workers. However, personnel stationed at Camp Lejeune between 1975 and 1985 had at least a 20% higher risk for all myeloid cancers including polycythemia vera, acute myeloid leukemia, myelodysplastic and myeloproliferative syndromes, and cancers of the esophagus, larynx, soft tissue, and thyroid. Civilian workers had a higher risk for all myeloid cancers, squamous cell lung cancer, and female ductal breast cancer.

The water exposures included contributions to total internal body dose from 3 routes: ingestion, inhalation, and dermal. The researchers note that a Marine in training may consume as much as 6 liters a day of drinking water, but the combined dose from inhalation and dermal routes could be as high or higher than that from ingestion. For example, they note that an internal dose via inhalation to TCE during a 10-minute shower could equal the internal dose via ingestion of 2 liters of contaminated drinking water.

Health risks at Camp Lejeune have been studied before, but this study “more fully establishes the scope,” Richard Clapp, a Boston University emeritus public health professor, told the Associated Press.

Dry January has come to an end — at least for those who jumped on the trendy post-holiday no-booze wagon.

The benefits of drinking less alcohol are well documented. A systematic review of 63 studies, for example, found that reducing or giving up alcohol reduced people’s risk for hospitalization, injuries, and death. The lifestyle change also improved people’s physical and mental health as well as their quality of life.

When it comes to cancer risk, however, the benefits of quitting or cutting back on alcohol remain much less clear, according to a new report from the cancer agency of the World Health Organization (WHO).

After reviewing dozens of studies, the International Agency for Research on Cancer (IARC) concluded that, for most alcohol-related cancers, there is limited evidence to support a link between eliminating or reducing alcohol consumption and lowering of cancer risk.

More specifically, the IARC Working Group, which included 15 scientists from eight countries, reported “limited” evidence on this association for laryngeal, colorectal (CRC), and breast cancer as well as «inadequate» evidence for pharyngeal and liver cancer.

The report did highlight two exceptions: Reducing or quitting alcohol was associated with a lower risk for both oral and esophageal cancer. The IARC working group based this conclusion on large studies of long-term alcohol cessation in these cancer types.

Still, the authors noted, “significant scientific gaps” exist for most alcohol-related cancers.

Take the data on CRC. Two studies found that reducing alcohol consumption did appear to lower CRC risk, while two others — which focused on the duration of quitting — did not suggest a reduced risk for CRC.

“Given the inconsistencies among studies and the few studies on duration of cessation, the Working Group concluded that there was limited evidence that alcohol reduction or cessation reduces colorectal cancer risk,” the authors wrote.

For liver cancer, the experts did note an association between quitting alcohol and lower cancer risk, but that cohort study only included individuals with alcohol-related liver disease. Outside of this study, the IARC group found no clear association between quitting drinking and liver cancer among people without alcohol-related liver disease in the other 11 studies evaluated.

For pharyngeal cancer, the evidence was limited overall, but one analysis looking at long-term cessation and oropharyngeal or hypopharyngeal cancer found a 26% lower risk (95% CI, 0.50-1.09). That association went away, however, after adjusting for detailed smoking history (odds ratio, 0.95; 95% CI, 0.56-1.61), and the working group concluded, overall, that «there was inadequate evidence that alcohol reduction or cessation reduces pharyngeal cancer risk.”

The IARC working group did find sufficient evidence linking drinking cessation and reduced risk for oral and esophageal cancers.

For instance, an international pooled analysis, which included 12 studies assessing a link between quitting smoking and alcohol and oral cancer risk, found that longer duration since quitting was associated with lower risk. Not drinking for up to 4 years was associated with a 19% lower risk for oral cancer, quitting for 5-9 years was associated with a 23% lower risk, while quitting for 20 years was associated with 55% lower risk. 

“Given the consistent evidence of a reduced risk of oral cancer associated with long-term alcohol cessation,” the IARC working group concluded that there was “sufficient evidence that alcohol reduction or cessation reduces oral cancer risk.”

The working group also found “sufficient evidence from mechanistic studies that alcohol cessation reduces alcohol-related carcinogenesis.” In other words, quitting drinking appeared to reverse certain cancer-promoting biological mechanisms. 

Outside the recent IARC report, some individual studies have suggested that quitting or cutting back on alcohol can reduce the risk for certain cancers. 

For example, a large population-based study of about 4.5 million individuals in Korea found a lower risk for alcohol-related cancers among mild drinkers who quit (adjusted hazard ratio [aHR], 0.96) and heavy drinkers who reduced their drinking levels to mild (aHR, 0.92) or moderate (aHR, 0.91). These findings, however, may not be generalizable beyond East Asian populations.

Addressing the existing evidence gaps could help “support alcohol-control measures to reduce consumption,” the IARC working group concluded.

The Case for Limiting Alcohol

While the evidence linking reducing or stopping drinking and lower cancer risk remains limited, the opposite association is well-established — greater alcohol consumption does increase cancer risk. 

A previous IARC analysis estimated that alcohol consumption accounts for about 4% of newly diagnosed cancers worldwide, most commonly esophagus, liver, and breast cancer. The IARC has even classified alcohol as a group 1 carcinogen, highlighting the strong evidence demonstrating that alcohol can cause cancer in humans.

Experts also recommend following existing guidelines for alcohol intake. Guidelines from the American Cancer Society and from the US Department of Agriculture and Department of Health and Human Services specify limiting alcohol intake to one drink or less for women and two drinks or less for men on any given day. 

In a January 9, 2023, blog post, National Institute on Alcohol Abuse and Alcoholism director George F. Koob, PhD, touted the known benefits of limiting drinking.

“Research shows that even small amounts of alcohol can carry health risks, including for certain cancers and cardiovascular issues,” Dr. Koob said. 

A version of this article appeared on Medscape.com.

Dry January has come to an end — at least for those who jumped on the trendy post-holiday no-booze wagon.

The benefits of drinking less alcohol are well documented. A systematic review of 63 studies, for example, found that reducing or giving up alcohol reduced people’s risk for hospitalization, injuries, and death. The lifestyle change also improved people’s physical and mental health as well as their quality of life.

When it comes to cancer risk, however, the benefits of quitting or cutting back on alcohol remain much less clear, according to a new report from the cancer agency of the World Health Organization (WHO).

After reviewing dozens of studies, the International Agency for Research on Cancer (IARC) concluded that, for most alcohol-related cancers, there is limited evidence to support a link between eliminating or reducing alcohol consumption and lowering of cancer risk.

More specifically, the IARC Working Group, which included 15 scientists from eight countries, reported “limited” evidence on this association for laryngeal, colorectal (CRC), and breast cancer as well as «inadequate» evidence for pharyngeal and liver cancer.

The report did highlight two exceptions: Reducing or quitting alcohol was associated with a lower risk for both oral and esophageal cancer. The IARC working group based this conclusion on large studies of long-term alcohol cessation in these cancer types.

Still, the authors noted, “significant scientific gaps” exist for most alcohol-related cancers.

Take the data on CRC. Two studies found that reducing alcohol consumption did appear to lower CRC risk, while two others — which focused on the duration of quitting — did not suggest a reduced risk for CRC.

“Given the inconsistencies among studies and the few studies on duration of cessation, the Working Group concluded that there was limited evidence that alcohol reduction or cessation reduces colorectal cancer risk,” the authors wrote.

For liver cancer, the experts did note an association between quitting alcohol and lower cancer risk, but that cohort study only included individuals with alcohol-related liver disease. Outside of this study, the IARC group found no clear association between quitting drinking and liver cancer among people without alcohol-related liver disease in the other 11 studies evaluated.

For pharyngeal cancer, the evidence was limited overall, but one analysis looking at long-term cessation and oropharyngeal or hypopharyngeal cancer found a 26% lower risk (95% CI, 0.50-1.09). That association went away, however, after adjusting for detailed smoking history (odds ratio, 0.95; 95% CI, 0.56-1.61), and the working group concluded, overall, that «there was inadequate evidence that alcohol reduction or cessation reduces pharyngeal cancer risk.”

The IARC working group did find sufficient evidence linking drinking cessation and reduced risk for oral and esophageal cancers.

For instance, an international pooled analysis, which included 12 studies assessing a link between quitting smoking and alcohol and oral cancer risk, found that longer duration since quitting was associated with lower risk. Not drinking for up to 4 years was associated with a 19% lower risk for oral cancer, quitting for 5-9 years was associated with a 23% lower risk, while quitting for 20 years was associated with 55% lower risk. 

“Given the consistent evidence of a reduced risk of oral cancer associated with long-term alcohol cessation,” the IARC working group concluded that there was “sufficient evidence that alcohol reduction or cessation reduces oral cancer risk.”

The working group also found “sufficient evidence from mechanistic studies that alcohol cessation reduces alcohol-related carcinogenesis.” In other words, quitting drinking appeared to reverse certain cancer-promoting biological mechanisms. 

Outside the recent IARC report, some individual studies have suggested that quitting or cutting back on alcohol can reduce the risk for certain cancers. 

For example, a large population-based study of about 4.5 million individuals in Korea found a lower risk for alcohol-related cancers among mild drinkers who quit (adjusted hazard ratio [aHR], 0.96) and heavy drinkers who reduced their drinking levels to mild (aHR, 0.92) or moderate (aHR, 0.91). These findings, however, may not be generalizable beyond East Asian populations.

Addressing the existing evidence gaps could help “support alcohol-control measures to reduce consumption,” the IARC working group concluded.

The Case for Limiting Alcohol

While the evidence linking reducing or stopping drinking and lower cancer risk remains limited, the opposite association is well-established — greater alcohol consumption does increase cancer risk. 

A previous IARC analysis estimated that alcohol consumption accounts for about 4% of newly diagnosed cancers worldwide, most commonly esophagus, liver, and breast cancer. The IARC has even classified alcohol as a group 1 carcinogen, highlighting the strong evidence demonstrating that alcohol can cause cancer in humans.

Experts also recommend following existing guidelines for alcohol intake. Guidelines from the American Cancer Society and from the US Department of Agriculture and Department of Health and Human Services specify limiting alcohol intake to one drink or less for women and two drinks or less for men on any given day. 

In a January 9, 2023, blog post, National Institute on Alcohol Abuse and Alcoholism director George F. Koob, PhD, touted the known benefits of limiting drinking.

“Research shows that even small amounts of alcohol can carry health risks, including for certain cancers and cardiovascular issues,” Dr. Koob said. 

A version of this article appeared on Medscape.com.

Dry January has come to an end — at least for those who jumped on the trendy post-holiday no-booze wagon.

The benefits of drinking less alcohol are well documented. A systematic review of 63 studies, for example, found that reducing or giving up alcohol reduced people’s risk for hospitalization, injuries, and death. The lifestyle change also improved people’s physical and mental health as well as their quality of life.

When it comes to cancer risk, however, the benefits of quitting or cutting back on alcohol remain much less clear, according to a new report from the cancer agency of the World Health Organization (WHO).

After reviewing dozens of studies, the International Agency for Research on Cancer (IARC) concluded that, for most alcohol-related cancers, there is limited evidence to support a link between eliminating or reducing alcohol consumption and lowering of cancer risk.

More specifically, the IARC Working Group, which included 15 scientists from eight countries, reported “limited” evidence on this association for laryngeal, colorectal (CRC), and breast cancer as well as «inadequate» evidence for pharyngeal and liver cancer.

The report did highlight two exceptions: Reducing or quitting alcohol was associated with a lower risk for both oral and esophageal cancer. The IARC working group based this conclusion on large studies of long-term alcohol cessation in these cancer types.

Still, the authors noted, “significant scientific gaps” exist for most alcohol-related cancers.

Take the data on CRC. Two studies found that reducing alcohol consumption did appear to lower CRC risk, while two others — which focused on the duration of quitting — did not suggest a reduced risk for CRC.

“Given the inconsistencies among studies and the few studies on duration of cessation, the Working Group concluded that there was limited evidence that alcohol reduction or cessation reduces colorectal cancer risk,” the authors wrote.

For liver cancer, the experts did note an association between quitting alcohol and lower cancer risk, but that cohort study only included individuals with alcohol-related liver disease. Outside of this study, the IARC group found no clear association between quitting drinking and liver cancer among people without alcohol-related liver disease in the other 11 studies evaluated.

For pharyngeal cancer, the evidence was limited overall, but one analysis looking at long-term cessation and oropharyngeal or hypopharyngeal cancer found a 26% lower risk (95% CI, 0.50-1.09). That association went away, however, after adjusting for detailed smoking history (odds ratio, 0.95; 95% CI, 0.56-1.61), and the working group concluded, overall, that «there was inadequate evidence that alcohol reduction or cessation reduces pharyngeal cancer risk.”

The IARC working group did find sufficient evidence linking drinking cessation and reduced risk for oral and esophageal cancers.

For instance, an international pooled analysis, which included 12 studies assessing a link between quitting smoking and alcohol and oral cancer risk, found that longer duration since quitting was associated with lower risk. Not drinking for up to 4 years was associated with a 19% lower risk for oral cancer, quitting for 5-9 years was associated with a 23% lower risk, while quitting for 20 years was associated with 55% lower risk. 

“Given the consistent evidence of a reduced risk of oral cancer associated with long-term alcohol cessation,” the IARC working group concluded that there was “sufficient evidence that alcohol reduction or cessation reduces oral cancer risk.”

The working group also found “sufficient evidence from mechanistic studies that alcohol cessation reduces alcohol-related carcinogenesis.” In other words, quitting drinking appeared to reverse certain cancer-promoting biological mechanisms. 

Outside the recent IARC report, some individual studies have suggested that quitting or cutting back on alcohol can reduce the risk for certain cancers. 

For example, a large population-based study of about 4.5 million individuals in Korea found a lower risk for alcohol-related cancers among mild drinkers who quit (adjusted hazard ratio [aHR], 0.96) and heavy drinkers who reduced their drinking levels to mild (aHR, 0.92) or moderate (aHR, 0.91). These findings, however, may not be generalizable beyond East Asian populations.

Addressing the existing evidence gaps could help “support alcohol-control measures to reduce consumption,” the IARC working group concluded.

The Case for Limiting Alcohol

While the evidence linking reducing or stopping drinking and lower cancer risk remains limited, the opposite association is well-established — greater alcohol consumption does increase cancer risk. 

A previous IARC analysis estimated that alcohol consumption accounts for about 4% of newly diagnosed cancers worldwide, most commonly esophagus, liver, and breast cancer. The IARC has even classified alcohol as a group 1 carcinogen, highlighting the strong evidence demonstrating that alcohol can cause cancer in humans.

Experts also recommend following existing guidelines for alcohol intake. Guidelines from the American Cancer Society and from the US Department of Agriculture and Department of Health and Human Services specify limiting alcohol intake to one drink or less for women and two drinks or less for men on any given day. 

In a January 9, 2023, blog post, National Institute on Alcohol Abuse and Alcoholism director George F. Koob, PhD, touted the known benefits of limiting drinking.

“Research shows that even small amounts of alcohol can carry health risks, including for certain cancers and cardiovascular issues,” Dr. Koob said. 

A version of this article appeared on Medscape.com.

Dr. Richard: The first thing we as physicians are worried about is patients with PV developing thrombosis. We start prophylaxis with aspirin, as aspirin remains the best treatment for reducing this risk. It is essential to make sure patients with PV understand the importance of taking an aspirin, even at a low dosage.

The second step is trying to control patients’ red blood cell counts. Phlebotomy has been used for this purpose for many decades and continues to be effective. You will find some experts in the field who consider phlebotomy to be the mainstay of treatment for patients with PV, and that it has benefits in and of itself.

However, despite the benefits, phlebotomy can be a little tough on patients. For instance, patients with PV cannot donate blood at a traditional blood center such as Red Cross, and therefore need to go to an actual infusion center. They also must stop their day and travel to a site to receive therapeutic phlebotomy treatment, which is most effective for patients with a blood disorder. I work in Seattle taking care of patients throughout the Northwest, and it is not always easy to find a close location to send patients for phlebotomy. Nevertheless, phlebotomy should be part of the treatment options for patients with PV, especially patients in the high-risk range who have high hemoglobin and hematocrit values.

The third step is controlling hemoglobin and hematocrit levels. Hydroxyurea is our standard of care with strong beneficial data for this purpose.

These are the 3 approaches to treatment we initially discuss with our patients during their first visit. These 3 strategies can improve a patient's life and reduce their risk for thrombosis.

Which treatment do you recommend depending on the patient’s symptoms?

Dr. Richard: The treatment that we offer can vary. The first thing I want to know is how their symptoms respond to aspirin. For instance, symptoms such as erythromelalgia oftentimes respond beautifully to aspirin. Most patients do not have massive splenomegaly—that would give me a high suspicion for myelofibrosis—but they can develop and present with some level of splenomegaly.

If the symptoms are bothersome to the patient, I will probably want to get them on some kind of cytoreduction to see if that is effective. Hydroxyurea, although not as effective as aspirin and associated with adverse effects in some patients, is a good medication to start cytoreductive therapy. The National Comprehensive Cancer Network® (NCCN®) Guidelines suggest that if a patient taking hydroxyurea experiences severe gastrointestinal (GI) toxicity, go ahead and move to a Janus kinase 2 (JAK2) inhibitor or try interferon. JAK2 inhibition with ruxolitinib, in this case, is effective, at least initially for treating splenomegaly. Unfortunately, symptoms sometimes get confused with effects from the medications. You have to use an individualized treatment approach and see what works for each patient.
 

What are some of the common adverse effects of treatment?

Dr. Richard: As you probably can tell, I never skip aspirin since it is such an important part of treatment for patients with PV. However, I do talk to patients about GI upset and the bleeding risks, such as the potential for GI bleed. Obviously, clotting is what causes an increase in morbidity and mortality, but bleeding can be an important adverse effect with platelets that do not function, or for other issues.

Hydroxyurea is generally well tolerated, but some patients can develop skin issues or ulcers due to GI toxicity. I have a lot of confidence in the use of hydroxyurea, and I use it without hesitation. However, you may have a patient who already has a relatively low neutrophil count or has some level of thrombocytopenia from either liver disease or some other issue, and they just cannot tolerate hydroxyurea. Some other bothersome symptoms include change of taste, skin changes, and brittle nails. It can be tricky. I will attempt hydroxyurea, if needed, but sometimes they just cannot tolerate it.

What happens when a patient cannot tolerate one or all the medications you mentioned?

Dr. Richard: Now that we have JAK2 inhibitors, ruxolitinib is generally my choice for patients who cannot tolerate hydroxyurea, which is more common than maybe we would like. Other problems with hydroxyurea include that it might not work, or phlebotomy combined with hydroxyurea results in cytopenias, or patients have a particularly aggressive form of PV.

There are numerous other JAK2 drug inhibitors on the market for myelofibrosis. The assumption is they probably work as well as ruxolitinib for PV, but right now ruxolitinib is what is approved by the US Food and Drug Administration for these patients.

The other drug that we do not use much is interferon, or now, pegylated interferon. It is a drug that has been around for a long time and worked well in chronic myelogenous leukemia before we had the tyrosine kinase inhibitors. Pegylated interferon is a well-tolerated drug that can be used for patients with PV who are pregnant or could get pregnant. It is not the interferon of our parents or grandparents. We now have options for controlling the disease and its complications, but the hardest thing is to tell patients that none of these treatments are going to cure them or reverse the overproduction of red blood cells in their bone marrow. There has always been discussion about whether there could be some effect of interferon on the actual tumor burden, but that remains to be proven.

Can you go a little bit more into your recommended approach to managing newly diagnosed patients with PV in your day-to-day practice?

Dr. Richard: Oftentimes these patients are identified through our consultation service. It can be hard on the primary care physician to identify whether a patient has secondary or primary PV.

We are lucky now that JAK2 has been identified. The JAK2-V617F and the other exon 12 mutations were identified back in 2006 by several groups and is a great test. With JAK2 along with an erythropoietin test, you can feel confident whether you have identified PV.

PV encompasses a wide variety of syndromes. Patients can come into the office with terrible symptoms, including aquagenic pruritus or erythromelalgia. I have seen young people in their 30s who happen to have a slightly elevated hematocrit and a positive JAK2 test. When this occurs, you try to understand how much the disease is affecting their life, whether they are going to be in a high-risk category or a low-risk category, whether they have had thrombosis, and how their age figures into all of it. To try to figure out this high-risk versus low-risk factor, we use a simple staging system to help determine whether they are going to need cytoreductive therapy or whether you can just start with phlebotomy and see how they do.

Oftentimes in the first visit, I recommend a bone marrow study. Is that going to be true 5 years from now? I am not sure. You know, next-generation sequencing (NGS) is turning into such an important part of determining prognosis in these patients. It helps if you have a great colleague down in hematopathology who can look at the bone marrow as it relates to megakaryocyte morphology, or whether there is early fibrosis.

Although these techniques may not be as prominent in practice today for determining diagnosis, they help us understand the prognosis. A bone marrow study or NGS is particularly useful when you have patients who you are convinced have PV, but it turns out they already have extensive fibrosis and are actually moving more toward the post-polycythemia phase a little faster than you think. While we do not use an allogeneic transplant often, in this scenario we may recommend it. Our primary goal at this point is to try to determine which patients would benefit from a transplant early on and to prepare the patient for this option.

What socioeconomic disparities have you observed in newly diagnosed patients?

Dr. Richard: There are definitely social disparities for people who have low income. I work in a veteran’s hospital where we take care of a lot of people who do not have health insurance, but who come to the VA because they do have benefits. If they are in our system, they get identified and their care is great. However, if they have been out in the regular system without health insurance, oftentimes they get diagnosed late. Identifying and treating patients from low socioeconomic backgrounds is an issue. I think everyone can agree with that.

We have a delicate situation with women veterans. Something that is incredibly painful that I think people should be aware of is the amount of military sexual trauma (MST) that has occurred over the years. These patients are in a unique place of trust with their care providers. They have spent a lot of time not being listened to in a variety of arenas. I see this in young military women who no one expects to have a stem cell disorder. We as health care providers do them a disservice if their complaints lead to referral to a psychotherapist or being prescribed a nonsteroidal anti-inflammatory drug or something like that. As health care providers, we are in a unique position to listen to and accurately evaluate these patients. We have a large population of veterans and, increasingly more women veterans, but I think we can all agree that they need better care, especially if they have suffered from MST. That is what I see in my patient population.

When I was a resident in Baltimore, it was Black people with lower income who did not trust doctors. We still have a lot of work to do.

Dr. Richard: The first thing we as physicians are worried about is patients with PV developing thrombosis. We start prophylaxis with aspirin, as aspirin remains the best treatment for reducing this risk. It is essential to make sure patients with PV understand the importance of taking an aspirin, even at a low dosage.

The second step is trying to control patients’ red blood cell counts. Phlebotomy has been used for this purpose for many decades and continues to be effective. You will find some experts in the field who consider phlebotomy to be the mainstay of treatment for patients with PV, and that it has benefits in and of itself.

However, despite the benefits, phlebotomy can be a little tough on patients. For instance, patients with PV cannot donate blood at a traditional blood center such as Red Cross, and therefore need to go to an actual infusion center. They also must stop their day and travel to a site to receive therapeutic phlebotomy treatment, which is most effective for patients with a blood disorder. I work in Seattle taking care of patients throughout the Northwest, and it is not always easy to find a close location to send patients for phlebotomy. Nevertheless, phlebotomy should be part of the treatment options for patients with PV, especially patients in the high-risk range who have high hemoglobin and hematocrit values.

The third step is controlling hemoglobin and hematocrit levels. Hydroxyurea is our standard of care with strong beneficial data for this purpose.

These are the 3 approaches to treatment we initially discuss with our patients during their first visit. These 3 strategies can improve a patient's life and reduce their risk for thrombosis.

Which treatment do you recommend depending on the patient’s symptoms?

Dr. Richard: The treatment that we offer can vary. The first thing I want to know is how their symptoms respond to aspirin. For instance, symptoms such as erythromelalgia oftentimes respond beautifully to aspirin. Most patients do not have massive splenomegaly—that would give me a high suspicion for myelofibrosis—but they can develop and present with some level of splenomegaly.

If the symptoms are bothersome to the patient, I will probably want to get them on some kind of cytoreduction to see if that is effective. Hydroxyurea, although not as effective as aspirin and associated with adverse effects in some patients, is a good medication to start cytoreductive therapy. The National Comprehensive Cancer Network® (NCCN®) Guidelines suggest that if a patient taking hydroxyurea experiences severe gastrointestinal (GI) toxicity, go ahead and move to a Janus kinase 2 (JAK2) inhibitor or try interferon. JAK2 inhibition with ruxolitinib, in this case, is effective, at least initially for treating splenomegaly. Unfortunately, symptoms sometimes get confused with effects from the medications. You have to use an individualized treatment approach and see what works for each patient.
 

What are some of the common adverse effects of treatment?

Dr. Richard: As you probably can tell, I never skip aspirin since it is such an important part of treatment for patients with PV. However, I do talk to patients about GI upset and the bleeding risks, such as the potential for GI bleed. Obviously, clotting is what causes an increase in morbidity and mortality, but bleeding can be an important adverse effect with platelets that do not function, or for other issues.

Hydroxyurea is generally well tolerated, but some patients can develop skin issues or ulcers due to GI toxicity. I have a lot of confidence in the use of hydroxyurea, and I use it without hesitation. However, you may have a patient who already has a relatively low neutrophil count or has some level of thrombocytopenia from either liver disease or some other issue, and they just cannot tolerate hydroxyurea. Some other bothersome symptoms include change of taste, skin changes, and brittle nails. It can be tricky. I will attempt hydroxyurea, if needed, but sometimes they just cannot tolerate it.

What happens when a patient cannot tolerate one or all the medications you mentioned?

Dr. Richard: Now that we have JAK2 inhibitors, ruxolitinib is generally my choice for patients who cannot tolerate hydroxyurea, which is more common than maybe we would like. Other problems with hydroxyurea include that it might not work, or phlebotomy combined with hydroxyurea results in cytopenias, or patients have a particularly aggressive form of PV.

There are numerous other JAK2 drug inhibitors on the market for myelofibrosis. The assumption is they probably work as well as ruxolitinib for PV, but right now ruxolitinib is what is approved by the US Food and Drug Administration for these patients.

The other drug that we do not use much is interferon, or now, pegylated interferon. It is a drug that has been around for a long time and worked well in chronic myelogenous leukemia before we had the tyrosine kinase inhibitors. Pegylated interferon is a well-tolerated drug that can be used for patients with PV who are pregnant or could get pregnant. It is not the interferon of our parents or grandparents. We now have options for controlling the disease and its complications, but the hardest thing is to tell patients that none of these treatments are going to cure them or reverse the overproduction of red blood cells in their bone marrow. There has always been discussion about whether there could be some effect of interferon on the actual tumor burden, but that remains to be proven.

Can you go a little bit more into your recommended approach to managing newly diagnosed patients with PV in your day-to-day practice?

Dr. Richard: Oftentimes these patients are identified through our consultation service. It can be hard on the primary care physician to identify whether a patient has secondary or primary PV.

We are lucky now that JAK2 has been identified. The JAK2-V617F and the other exon 12 mutations were identified back in 2006 by several groups and is a great test. With JAK2 along with an erythropoietin test, you can feel confident whether you have identified PV.

PV encompasses a wide variety of syndromes. Patients can come into the office with terrible symptoms, including aquagenic pruritus or erythromelalgia. I have seen young people in their 30s who happen to have a slightly elevated hematocrit and a positive JAK2 test. When this occurs, you try to understand how much the disease is affecting their life, whether they are going to be in a high-risk category or a low-risk category, whether they have had thrombosis, and how their age figures into all of it. To try to figure out this high-risk versus low-risk factor, we use a simple staging system to help determine whether they are going to need cytoreductive therapy or whether you can just start with phlebotomy and see how they do.

Oftentimes in the first visit, I recommend a bone marrow study. Is that going to be true 5 years from now? I am not sure. You know, next-generation sequencing (NGS) is turning into such an important part of determining prognosis in these patients. It helps if you have a great colleague down in hematopathology who can look at the bone marrow as it relates to megakaryocyte morphology, or whether there is early fibrosis.

Although these techniques may not be as prominent in practice today for determining diagnosis, they help us understand the prognosis. A bone marrow study or NGS is particularly useful when you have patients who you are convinced have PV, but it turns out they already have extensive fibrosis and are actually moving more toward the post-polycythemia phase a little faster than you think. While we do not use an allogeneic transplant often, in this scenario we may recommend it. Our primary goal at this point is to try to determine which patients would benefit from a transplant early on and to prepare the patient for this option.

What socioeconomic disparities have you observed in newly diagnosed patients?

Dr. Richard: There are definitely social disparities for people who have low income. I work in a veteran’s hospital where we take care of a lot of people who do not have health insurance, but who come to the VA because they do have benefits. If they are in our system, they get identified and their care is great. However, if they have been out in the regular system without health insurance, oftentimes they get diagnosed late. Identifying and treating patients from low socioeconomic backgrounds is an issue. I think everyone can agree with that.

We have a delicate situation with women veterans. Something that is incredibly painful that I think people should be aware of is the amount of military sexual trauma (MST) that has occurred over the years. These patients are in a unique place of trust with their care providers. They have spent a lot of time not being listened to in a variety of arenas. I see this in young military women who no one expects to have a stem cell disorder. We as health care providers do them a disservice if their complaints lead to referral to a psychotherapist or being prescribed a nonsteroidal anti-inflammatory drug or something like that. As health care providers, we are in a unique position to listen to and accurately evaluate these patients. We have a large population of veterans and, increasingly more women veterans, but I think we can all agree that they need better care, especially if they have suffered from MST. That is what I see in my patient population.

When I was a resident in Baltimore, it was Black people with lower income who did not trust doctors. We still have a lot of work to do.

Dr. Richard: The first thing we as physicians are worried about is patients with PV developing thrombosis. We start prophylaxis with aspirin, as aspirin remains the best treatment for reducing this risk. It is essential to make sure patients with PV understand the importance of taking an aspirin, even at a low dosage.

The second step is trying to control patients’ red blood cell counts. Phlebotomy has been used for this purpose for many decades and continues to be effective. You will find some experts in the field who consider phlebotomy to be the mainstay of treatment for patients with PV, and that it has benefits in and of itself.

However, despite the benefits, phlebotomy can be a little tough on patients. For instance, patients with PV cannot donate blood at a traditional blood center such as Red Cross, and therefore need to go to an actual infusion center. They also must stop their day and travel to a site to receive therapeutic phlebotomy treatment, which is most effective for patients with a blood disorder. I work in Seattle taking care of patients throughout the Northwest, and it is not always easy to find a close location to send patients for phlebotomy. Nevertheless, phlebotomy should be part of the treatment options for patients with PV, especially patients in the high-risk range who have high hemoglobin and hematocrit values.

The third step is controlling hemoglobin and hematocrit levels. Hydroxyurea is our standard of care with strong beneficial data for this purpose.

These are the 3 approaches to treatment we initially discuss with our patients during their first visit. These 3 strategies can improve a patient's life and reduce their risk for thrombosis.

Which treatment do you recommend depending on the patient’s symptoms?

Dr. Richard: The treatment that we offer can vary. The first thing I want to know is how their symptoms respond to aspirin. For instance, symptoms such as erythromelalgia oftentimes respond beautifully to aspirin. Most patients do not have massive splenomegaly—that would give me a high suspicion for myelofibrosis—but they can develop and present with some level of splenomegaly.

If the symptoms are bothersome to the patient, I will probably want to get them on some kind of cytoreduction to see if that is effective. Hydroxyurea, although not as effective as aspirin and associated with adverse effects in some patients, is a good medication to start cytoreductive therapy. The National Comprehensive Cancer Network® (NCCN®) Guidelines suggest that if a patient taking hydroxyurea experiences severe gastrointestinal (GI) toxicity, go ahead and move to a Janus kinase 2 (JAK2) inhibitor or try interferon. JAK2 inhibition with ruxolitinib, in this case, is effective, at least initially for treating splenomegaly. Unfortunately, symptoms sometimes get confused with effects from the medications. You have to use an individualized treatment approach and see what works for each patient.
 

What are some of the common adverse effects of treatment?

Dr. Richard: As you probably can tell, I never skip aspirin since it is such an important part of treatment for patients with PV. However, I do talk to patients about GI upset and the bleeding risks, such as the potential for GI bleed. Obviously, clotting is what causes an increase in morbidity and mortality, but bleeding can be an important adverse effect with platelets that do not function, or for other issues.

Hydroxyurea is generally well tolerated, but some patients can develop skin issues or ulcers due to GI toxicity. I have a lot of confidence in the use of hydroxyurea, and I use it without hesitation. However, you may have a patient who already has a relatively low neutrophil count or has some level of thrombocytopenia from either liver disease or some other issue, and they just cannot tolerate hydroxyurea. Some other bothersome symptoms include change of taste, skin changes, and brittle nails. It can be tricky. I will attempt hydroxyurea, if needed, but sometimes they just cannot tolerate it.

What happens when a patient cannot tolerate one or all the medications you mentioned?

Dr. Richard: Now that we have JAK2 inhibitors, ruxolitinib is generally my choice for patients who cannot tolerate hydroxyurea, which is more common than maybe we would like. Other problems with hydroxyurea include that it might not work, or phlebotomy combined with hydroxyurea results in cytopenias, or patients have a particularly aggressive form of PV.

There are numerous other JAK2 drug inhibitors on the market for myelofibrosis. The assumption is they probably work as well as ruxolitinib for PV, but right now ruxolitinib is what is approved by the US Food and Drug Administration for these patients.

The other drug that we do not use much is interferon, or now, pegylated interferon. It is a drug that has been around for a long time and worked well in chronic myelogenous leukemia before we had the tyrosine kinase inhibitors. Pegylated interferon is a well-tolerated drug that can be used for patients with PV who are pregnant or could get pregnant. It is not the interferon of our parents or grandparents. We now have options for controlling the disease and its complications, but the hardest thing is to tell patients that none of these treatments are going to cure them or reverse the overproduction of red blood cells in their bone marrow. There has always been discussion about whether there could be some effect of interferon on the actual tumor burden, but that remains to be proven.

Can you go a little bit more into your recommended approach to managing newly diagnosed patients with PV in your day-to-day practice?

Dr. Richard: Oftentimes these patients are identified through our consultation service. It can be hard on the primary care physician to identify whether a patient has secondary or primary PV.

We are lucky now that JAK2 has been identified. The JAK2-V617F and the other exon 12 mutations were identified back in 2006 by several groups and is a great test. With JAK2 along with an erythropoietin test, you can feel confident whether you have identified PV.

PV encompasses a wide variety of syndromes. Patients can come into the office with terrible symptoms, including aquagenic pruritus or erythromelalgia. I have seen young people in their 30s who happen to have a slightly elevated hematocrit and a positive JAK2 test. When this occurs, you try to understand how much the disease is affecting their life, whether they are going to be in a high-risk category or a low-risk category, whether they have had thrombosis, and how their age figures into all of it. To try to figure out this high-risk versus low-risk factor, we use a simple staging system to help determine whether they are going to need cytoreductive therapy or whether you can just start with phlebotomy and see how they do.

Oftentimes in the first visit, I recommend a bone marrow study. Is that going to be true 5 years from now? I am not sure. You know, next-generation sequencing (NGS) is turning into such an important part of determining prognosis in these patients. It helps if you have a great colleague down in hematopathology who can look at the bone marrow as it relates to megakaryocyte morphology, or whether there is early fibrosis.

Although these techniques may not be as prominent in practice today for determining diagnosis, they help us understand the prognosis. A bone marrow study or NGS is particularly useful when you have patients who you are convinced have PV, but it turns out they already have extensive fibrosis and are actually moving more toward the post-polycythemia phase a little faster than you think. While we do not use an allogeneic transplant often, in this scenario we may recommend it. Our primary goal at this point is to try to determine which patients would benefit from a transplant early on and to prepare the patient for this option.

What socioeconomic disparities have you observed in newly diagnosed patients?

Dr. Richard: There are definitely social disparities for people who have low income. I work in a veteran’s hospital where we take care of a lot of people who do not have health insurance, but who come to the VA because they do have benefits. If they are in our system, they get identified and their care is great. However, if they have been out in the regular system without health insurance, oftentimes they get diagnosed late. Identifying and treating patients from low socioeconomic backgrounds is an issue. I think everyone can agree with that.

We have a delicate situation with women veterans. Something that is incredibly painful that I think people should be aware of is the amount of military sexual trauma (MST) that has occurred over the years. These patients are in a unique place of trust with their care providers. They have spent a lot of time not being listened to in a variety of arenas. I see this in young military women who no one expects to have a stem cell disorder. We as health care providers do them a disservice if their complaints lead to referral to a psychotherapist or being prescribed a nonsteroidal anti-inflammatory drug or something like that. As health care providers, we are in a unique position to listen to and accurately evaluate these patients. We have a large population of veterans and, increasingly more women veterans, but I think we can all agree that they need better care, especially if they have suffered from MST. That is what I see in my patient population.

When I was a resident in Baltimore, it was Black people with lower income who did not trust doctors. We still have a lot of work to do.

TOPLINE:

A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.

METHODOLOGY:

• Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
• They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
• Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
• —Clinical risk score (WATCH-DM risk score)
• —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
• —Echocardiography
• They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
• The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.

TAKEAWAY:

• Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
• Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
• The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
• Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.

IN PRACTICE:

“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.

SOURCE:

The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.

LIMITATIONS:

The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.

DISCLOSURES:

Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.

METHODOLOGY:

• Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
• They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
• Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
• —Clinical risk score (WATCH-DM risk score)
• —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
• —Echocardiography
• They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
• The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.

TAKEAWAY:

• Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
• Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
• The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
• Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.

IN PRACTICE:

“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.

SOURCE:

The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.

LIMITATIONS:

The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.

DISCLOSURES:

Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.

A version of this article appeared on Medscape.com.

TOPLINE:

A two-step screening, using a risk score and biomarkers, can identify patients with diabetes at a higher risk for heart failure who will most likely benefit from preventive drugs.

METHODOLOGY:

• Researchers compared screening methods and downstream risk for heart failure in 5 years, particularly those without atherosclerotic cardiovascular disease (ASCVD).
• They pooled data from 4889 patients (age ≥ 40 years, about half women) with diabetes, no heart failure at baseline, and no signs of ASCVD. All patients had undergone screening to determine their heart failure risk level.
• Researchers assessed the heart failure risk for patients without ASCVD with one-step screening strategies:
• —Clinical risk score (WATCH-DM risk score)
• —Biomarker tests (N-terminal pro-B-type natriuretic peptide [NT-proBNP]) or high-sensitivity cardiac troponin [hs-cTn)
• —Echocardiography
• They next assessed a sequential two-step strategy, using the second test only for those deemed low risk by the first, with a combination of two tests (WATCH-DM/NT-proBNP, NT-proBNP/hs-cTn, or NT-proBNP/echocardiography), the second used for those deemed low-risk by the first test.
• The primary outcome was incident heart failure during the 5-year follow-up. The researchers also assessed the cost-effectiveness of screening and subsequent treatment of high-risk patients with a sodium-glucose cotransporter 2 inhibitor.

TAKEAWAY:

• Overall, 301 (6.2%) heart failure events occurred among participants without ASCVD.
• Of the heart failure events, 53%-71% occurred among participants deemed high risk by a one-step screening strategy, but 75%-89% occurred among patients assessed as high risk in two steps.
• The risk for incident heart failure was 3.0- to 3.6-fold higher in the high- vs low-risk group identified using a two-step screening approach.
• Among the two-step strategies, the WATCH-DM score first, followed by selective NT-proBNP testing for patients deemed low risk by the first test, was the most efficient, with the fewest tests and lowest screening cost.

IN PRACTICE:

“Matching effective but expensive preventive therapies to the highest-risk individuals who are most likely to benefit would be an efficient and cost-effective strategy for heart failure prevention,” the authors wrote.

SOURCE:

The study, led by Kershaw Patel of the Houston Methodist Academic Institute, was published online in Circulation.

LIMITATIONS:

The study findings may not be generalized, as the study included older adults with a high burden of comorbidities. This study may have missed some individuals with diabetes by defining it with fasting plasma glucose, which was consistently available across cohort studies, instead of with the limited A1c data. Moreover, the screening strategies used did not consider other important prognostic factors, such as diabetes duration and socioeconomic status.

DISCLOSURES:

Two authors declared receiving research support from the National Heart, Lung, and Blood Institute. Several authors disclosed financial relationships with multiple pharmaceutical device and medical publishing companies in the form of receiving personal fees; serving in various capacities such as consultants, members of advisory boards, steering committees, or executive committees; and other ties.

A version of this article appeared on Medscape.com.

TOPLINE:

Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.

METHODOLOGY:

The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.

The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.

Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.

TAKEAWAY: 

After 4 weeks, 30.9% of patients with axSpA and 29.1% of patients with non-axSpA back pain had any response, and 23.5% and 16.4% of patients with axSpA and non-axSpA back pain, respectively, had a good response.

The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.

No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.

IN PRACTICE:

“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.

SOURCE: 

The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”

DISCLOSURES:

The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.

METHODOLOGY:

The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.

The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.

Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.

TAKEAWAY: 

After 4 weeks, 30.9% of patients with axSpA and 29.1% of patients with non-axSpA back pain had any response, and 23.5% and 16.4% of patients with axSpA and non-axSpA back pain, respectively, had a good response.

The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.

No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.

IN PRACTICE:

“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.

SOURCE: 

The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”

DISCLOSURES:

The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

TOPLINE:

Adults with axial spondyloarthritis (axSpA) with longstanding back pain symptoms had response rates to nonsteroidal anti-inflammatory drugs (NSAIDs) that were no different from patients with non-axSpA back pain of similar duration, according to findings from a prospective study.

METHODOLOGY:

The researchers recruited 233 consecutive outpatients with chronic back pain, including 68 with axSpA and 165 with non-axSpA back pain.

The mean ages of the participants in the axSpA and non-axSpA groups were 42.7 years and 49.3 years, respectively; symptom durations were approximately 15 years in both groups.

Participants were given NSAIDs and “any response” was defined as back pain improvement of more than two units on the Numerical Rating Scale, while “good response” was defined as an improvement of > 50% compared with baseline.

TAKEAWAY: 

After 4 weeks, 30.9% of patients with axSpA and 29.1% of patients with non-axSpA back pain had any response, and 23.5% and 16.4% of patients with axSpA and non-axSpA back pain, respectively, had a good response.

The proportion of patients showing improvement ranged from 19% to 31% in both groups after 4 weeks of treatment.

No significant differences in response appeared in subgroups of patients based on inflammatory back pain stage or in different axSpA stages.

IN PRACTICE:

“We think that this information has an effect on clinical practice since a response to NSAIDs is an important criterion in the ASAS [Assessment of SpondyloArthritis international Society]/European Alliance of Associations for Rheumatology treatment recommendations that may influence decisions to initiate treatment with biologic or targeted-synthetic DMARDs [disease-modifying antirheumatic drugs]. Further, a good response to NSAIDs is also an important clinical feature in the ASAS classification criteria,” the researchers wrote.

SOURCE: 

The lead author on the study was Xenofon Baraliakos, MD, of Ruhr University Bochum, Germany. The study was published online on January 15, 2024, in The Journal of Rheumatology.

LIMITATIONS:

The uneven sex match in the diagnoses and the history of NSAID treatment among patients in both groups were potential limiting factors. The researchers also noted that a similarly conducted study in patients with early disease could have findings that are “much different.”

DISCLOSURES:

The study was sponsored in part by Novartis. The researchers reported no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.