A few weeks ago, I made a patient who lost 100 pounds following a sleeve gastrectomy 9 months prior feel bad because I told her she lost too much weight. As I spoke to her, I realized that she found it hard to make life changes and that the surgery was a huge aide in changing her life and her lifestyle. I ended up apologizing for initially saying she lost too much weight.

For the first time in her life, she was successful in losing weight and keeping it off. The surgery allowed her body to defend a lower body weight by altering the secretion of gut hormones that lead to satiety in the brain. It’s not her fault that her body responded so well!

I asked her to be on my next orientation virtual meeting with prospective weight management patients to urge those with a body mass index (BMI) > 40 to consider bariatric surgery as the most effective durable and safe treatment for their degree of obesity.

Metabolic bariatric surgery, primarily sleeve gastrectomy and Roux-en-Y gastric bypass , alters the gut hormone milieu such that the body defends a lower mass of adipose tissue and a lower weight. We have learned what it takes to alter body weight defense to a healthy lower weight by studying why metabolic bariatric surgery works so well. It turns out that there are several hormones secreted by the gut that allow the brain to register fullness.

One of these gut hormones, glucagon-like peptide (GLP)-1, has been researched as an analog to help reduce body weight by 16% and has also been shown to reduce cardiovascular risk in the SELECT trial, as published in The New England Journal of Medicine (NEJM).

It’s the first weight loss medication to be shown in a cardiovascular outcomes trial to be superior to placebo in reduction of major cardiovascular events, including cardiovascular deaths, nonfatal myocardial infarction, and nonfatal stroke. The results presented at the 2023 American Heart Association meetings in Philadelphia ended in wholehearted applause by a “standing only” audience even before the presentation’s conclusion.

As we pave the way for nutrient-stimulated hormone (NuSH) therapies to be prescribed to all Americans with a BMI > 30 to improve health, we need to remember what these medications actually do. We used to think that metabolic bariatric surgery worked by restricting the stomach contents and malabsorbing nutrients. We now know that the surgeries work by altering NuSH secretion, allowing for less secretion of the hunger hormone ghrelin and more secretion of GLP-1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), oxyntomodulin (OXM), and other satiety hormones with less food ingestion.

They have pleiotropic effects on many organ systems in the body, including the brain, heart, adipose tissue, and liver. They decrease inflammation and also increase satiety and delay gastric emptying. None of these effects automatically produce weight loss, but they certainly aid in the adoption of a healthier body weight and better health. The weight loss occurs because these medications steer the body toward behavioral changes that promote weight loss.

As we delve into the SELECT trial results, a 20% reduction in major cardiovascular events was accompanied by an average weight loss of 9.6%, without a behavioral component added to either the placebo or intervention arms, as is usual in antiobesity agent trials.

Does this mean that primary care providers (PCPs) don’t have to educate patients on behavior change, diet, and exercise therapy? Well, if we consider obesity a disease as we do type 2 diabetes and dyslipidemia or hypertension, then no — PCPs don’t have to, just like they don’t in treating these other diseases.

However, we should rethink this practice. The recently published SURMOUNT-3 trial looked at another NuSH, tirzepatide, with intensive behavioral therapy; it resulted in a 26.6% weight loss, which is comparable to results with bariatric surgery. The SURMOUNT-1 trial of tirzepatide with nonintensive behavioral therapy resulted in a 20.9% weight loss, which is still substantial, but SURMOUNT-3 showed how much more is achievable with robust behavior-change therapy.

In other words, it’s time that PCPs provide education on behavior change to maximize the power of the medications prescribed in practice for the most common diseases suffered in the United States: obesity, type 2 diabetes, cardiovascular disease, and hypertension. These are all chronic, relapsing diseases. Medication alone will improve numbers (weight, blood glucose, A1c, and blood pressure), but a relapsing disease continues relentlessly as patients age to overcome the medications prescribed.

Today I made another patient feel bad because she lost over 100 pounds on semaglutide (Wegovy) 2.4 mg over 1 year, reducing her BMI from 57 to 36. She wanted to keep losing, so I recommended sleeve gastrectomy to lose more weight. I told her she could always restart the Wegovy after the procedure if needed.

We really don’t have an answer to this issue of NuSH therapy not getting to goal and bariatric surgery following medication therapy. The reality is that bariatric surgery should be considered a safe, effective treatment for extreme obesity somewhere along the trajectory of treatments starting with behavior (diet, exercise) and medications. It is still considered a last resort, and for some, just too aggressive.

We have learned much about the incretin hormones and what they can accomplish for obesity from studying bariatric — now called metabolic — surgery. Surgery should be seen as we see stent placement for angina, only more effective for longevity. The COURAGE trial, published in 2007 in NEJM, showed that when compared with medication treatment alone for angina, stent placement plus medications resulted in no difference in mortality after a 7-year follow-up period. Compare this to bariatric surgery, which in many retrospective analyses shows a 20% reduction in cardiovascular mortality after 20-year follow-up (Swedish Obesity Study). In the United States, there are 2 million stent procedures performed per year vs 250,000 bariatric surgical procedures. There are millions of Americans with a BMI > 40 and, yes, millions of Americans with angina. I think I make my point that we need to do more bariatric surgeries to effectively treat extreme obesity.

The solution to this negligent medical practice in obesity treatment is to empower PCPs to treat obesity (at least uncomplicated obesity) and refer to obesity medicine practices for complicated obesity with multiple complications, such as type 2 diabetes and cardiovascular disease, and to refer to obesity medicine practices with a surgical component for BMIs > 40 or > 35 with type 2 diabetes, sleep apnea, and/or cardiovascular disease or other serious conditions.

How do we empower PCPs? Insurance coverage of NuSH therapies due to life-saving properties — as evidenced by the SELECT trial — without prior authorizations; and education on how and why metabolic surgery works, as well as education on behavioral approaches, such as healthy diet and exercise, as a core therapy for all BMI categories.

It’s time.

Caroline Apovian, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Altimmune; Cowen and Company; Currax Pharmaceuticals; EPG Communication Holdings; Gelesis, Srl; L-Nutra; and NeuroBo Pharmaceuticals. Received research grant from: National Institutes of Health; Patient-Centered Outcomes Research Institute; and GI Dynamics. Received income in an amount equal to or greater than $250 from: Altimmune; Cowen and Company; NeuroBo Pharmaceuticals; and Novo Nordisk.

A version of this article appeared on Medscape.com.

A few weeks ago, I made a patient who lost 100 pounds following a sleeve gastrectomy 9 months prior feel bad because I told her she lost too much weight. As I spoke to her, I realized that she found it hard to make life changes and that the surgery was a huge aide in changing her life and her lifestyle. I ended up apologizing for initially saying she lost too much weight.

For the first time in her life, she was successful in losing weight and keeping it off. The surgery allowed her body to defend a lower body weight by altering the secretion of gut hormones that lead to satiety in the brain. It’s not her fault that her body responded so well!

I asked her to be on my next orientation virtual meeting with prospective weight management patients to urge those with a body mass index (BMI) > 40 to consider bariatric surgery as the most effective durable and safe treatment for their degree of obesity.

Metabolic bariatric surgery, primarily sleeve gastrectomy and Roux-en-Y gastric bypass , alters the gut hormone milieu such that the body defends a lower mass of adipose tissue and a lower weight. We have learned what it takes to alter body weight defense to a healthy lower weight by studying why metabolic bariatric surgery works so well. It turns out that there are several hormones secreted by the gut that allow the brain to register fullness.

One of these gut hormones, glucagon-like peptide (GLP)-1, has been researched as an analog to help reduce body weight by 16% and has also been shown to reduce cardiovascular risk in the SELECT trial, as published in The New England Journal of Medicine (NEJM).

It’s the first weight loss medication to be shown in a cardiovascular outcomes trial to be superior to placebo in reduction of major cardiovascular events, including cardiovascular deaths, nonfatal myocardial infarction, and nonfatal stroke. The results presented at the 2023 American Heart Association meetings in Philadelphia ended in wholehearted applause by a “standing only” audience even before the presentation’s conclusion.

As we pave the way for nutrient-stimulated hormone (NuSH) therapies to be prescribed to all Americans with a BMI > 30 to improve health, we need to remember what these medications actually do. We used to think that metabolic bariatric surgery worked by restricting the stomach contents and malabsorbing nutrients. We now know that the surgeries work by altering NuSH secretion, allowing for less secretion of the hunger hormone ghrelin and more secretion of GLP-1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), oxyntomodulin (OXM), and other satiety hormones with less food ingestion.

They have pleiotropic effects on many organ systems in the body, including the brain, heart, adipose tissue, and liver. They decrease inflammation and also increase satiety and delay gastric emptying. None of these effects automatically produce weight loss, but they certainly aid in the adoption of a healthier body weight and better health. The weight loss occurs because these medications steer the body toward behavioral changes that promote weight loss.

As we delve into the SELECT trial results, a 20% reduction in major cardiovascular events was accompanied by an average weight loss of 9.6%, without a behavioral component added to either the placebo or intervention arms, as is usual in antiobesity agent trials.

Does this mean that primary care providers (PCPs) don’t have to educate patients on behavior change, diet, and exercise therapy? Well, if we consider obesity a disease as we do type 2 diabetes and dyslipidemia or hypertension, then no — PCPs don’t have to, just like they don’t in treating these other diseases.

However, we should rethink this practice. The recently published SURMOUNT-3 trial looked at another NuSH, tirzepatide, with intensive behavioral therapy; it resulted in a 26.6% weight loss, which is comparable to results with bariatric surgery. The SURMOUNT-1 trial of tirzepatide with nonintensive behavioral therapy resulted in a 20.9% weight loss, which is still substantial, but SURMOUNT-3 showed how much more is achievable with robust behavior-change therapy.

In other words, it’s time that PCPs provide education on behavior change to maximize the power of the medications prescribed in practice for the most common diseases suffered in the United States: obesity, type 2 diabetes, cardiovascular disease, and hypertension. These are all chronic, relapsing diseases. Medication alone will improve numbers (weight, blood glucose, A1c, and blood pressure), but a relapsing disease continues relentlessly as patients age to overcome the medications prescribed.

Today I made another patient feel bad because she lost over 100 pounds on semaglutide (Wegovy) 2.4 mg over 1 year, reducing her BMI from 57 to 36. She wanted to keep losing, so I recommended sleeve gastrectomy to lose more weight. I told her she could always restart the Wegovy after the procedure if needed.

We really don’t have an answer to this issue of NuSH therapy not getting to goal and bariatric surgery following medication therapy. The reality is that bariatric surgery should be considered a safe, effective treatment for extreme obesity somewhere along the trajectory of treatments starting with behavior (diet, exercise) and medications. It is still considered a last resort, and for some, just too aggressive.

We have learned much about the incretin hormones and what they can accomplish for obesity from studying bariatric — now called metabolic — surgery. Surgery should be seen as we see stent placement for angina, only more effective for longevity. The COURAGE trial, published in 2007 in NEJM, showed that when compared with medication treatment alone for angina, stent placement plus medications resulted in no difference in mortality after a 7-year follow-up period. Compare this to bariatric surgery, which in many retrospective analyses shows a 20% reduction in cardiovascular mortality after 20-year follow-up (Swedish Obesity Study). In the United States, there are 2 million stent procedures performed per year vs 250,000 bariatric surgical procedures. There are millions of Americans with a BMI > 40 and, yes, millions of Americans with angina. I think I make my point that we need to do more bariatric surgeries to effectively treat extreme obesity.

The solution to this negligent medical practice in obesity treatment is to empower PCPs to treat obesity (at least uncomplicated obesity) and refer to obesity medicine practices for complicated obesity with multiple complications, such as type 2 diabetes and cardiovascular disease, and to refer to obesity medicine practices with a surgical component for BMIs > 40 or > 35 with type 2 diabetes, sleep apnea, and/or cardiovascular disease or other serious conditions.

How do we empower PCPs? Insurance coverage of NuSH therapies due to life-saving properties — as evidenced by the SELECT trial — without prior authorizations; and education on how and why metabolic surgery works, as well as education on behavioral approaches, such as healthy diet and exercise, as a core therapy for all BMI categories.

It’s time.

Caroline Apovian, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Altimmune; Cowen and Company; Currax Pharmaceuticals; EPG Communication Holdings; Gelesis, Srl; L-Nutra; and NeuroBo Pharmaceuticals. Received research grant from: National Institutes of Health; Patient-Centered Outcomes Research Institute; and GI Dynamics. Received income in an amount equal to or greater than $250 from: Altimmune; Cowen and Company; NeuroBo Pharmaceuticals; and Novo Nordisk.

A version of this article appeared on Medscape.com.

A few weeks ago, I made a patient who lost 100 pounds following a sleeve gastrectomy 9 months prior feel bad because I told her she lost too much weight. As I spoke to her, I realized that she found it hard to make life changes and that the surgery was a huge aide in changing her life and her lifestyle. I ended up apologizing for initially saying she lost too much weight.

For the first time in her life, she was successful in losing weight and keeping it off. The surgery allowed her body to defend a lower body weight by altering the secretion of gut hormones that lead to satiety in the brain. It’s not her fault that her body responded so well!

I asked her to be on my next orientation virtual meeting with prospective weight management patients to urge those with a body mass index (BMI) > 40 to consider bariatric surgery as the most effective durable and safe treatment for their degree of obesity.

Metabolic bariatric surgery, primarily sleeve gastrectomy and Roux-en-Y gastric bypass , alters the gut hormone milieu such that the body defends a lower mass of adipose tissue and a lower weight. We have learned what it takes to alter body weight defense to a healthy lower weight by studying why metabolic bariatric surgery works so well. It turns out that there are several hormones secreted by the gut that allow the brain to register fullness.

One of these gut hormones, glucagon-like peptide (GLP)-1, has been researched as an analog to help reduce body weight by 16% and has also been shown to reduce cardiovascular risk in the SELECT trial, as published in The New England Journal of Medicine (NEJM).

It’s the first weight loss medication to be shown in a cardiovascular outcomes trial to be superior to placebo in reduction of major cardiovascular events, including cardiovascular deaths, nonfatal myocardial infarction, and nonfatal stroke. The results presented at the 2023 American Heart Association meetings in Philadelphia ended in wholehearted applause by a “standing only” audience even before the presentation’s conclusion.

As we pave the way for nutrient-stimulated hormone (NuSH) therapies to be prescribed to all Americans with a BMI > 30 to improve health, we need to remember what these medications actually do. We used to think that metabolic bariatric surgery worked by restricting the stomach contents and malabsorbing nutrients. We now know that the surgeries work by altering NuSH secretion, allowing for less secretion of the hunger hormone ghrelin and more secretion of GLP-1, glucose-dependent insulinotropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), oxyntomodulin (OXM), and other satiety hormones with less food ingestion.

They have pleiotropic effects on many organ systems in the body, including the brain, heart, adipose tissue, and liver. They decrease inflammation and also increase satiety and delay gastric emptying. None of these effects automatically produce weight loss, but they certainly aid in the adoption of a healthier body weight and better health. The weight loss occurs because these medications steer the body toward behavioral changes that promote weight loss.

As we delve into the SELECT trial results, a 20% reduction in major cardiovascular events was accompanied by an average weight loss of 9.6%, without a behavioral component added to either the placebo or intervention arms, as is usual in antiobesity agent trials.

Does this mean that primary care providers (PCPs) don’t have to educate patients on behavior change, diet, and exercise therapy? Well, if we consider obesity a disease as we do type 2 diabetes and dyslipidemia or hypertension, then no — PCPs don’t have to, just like they don’t in treating these other diseases.

However, we should rethink this practice. The recently published SURMOUNT-3 trial looked at another NuSH, tirzepatide, with intensive behavioral therapy; it resulted in a 26.6% weight loss, which is comparable to results with bariatric surgery. The SURMOUNT-1 trial of tirzepatide with nonintensive behavioral therapy resulted in a 20.9% weight loss, which is still substantial, but SURMOUNT-3 showed how much more is achievable with robust behavior-change therapy.

In other words, it’s time that PCPs provide education on behavior change to maximize the power of the medications prescribed in practice for the most common diseases suffered in the United States: obesity, type 2 diabetes, cardiovascular disease, and hypertension. These are all chronic, relapsing diseases. Medication alone will improve numbers (weight, blood glucose, A1c, and blood pressure), but a relapsing disease continues relentlessly as patients age to overcome the medications prescribed.

Today I made another patient feel bad because she lost over 100 pounds on semaglutide (Wegovy) 2.4 mg over 1 year, reducing her BMI from 57 to 36. She wanted to keep losing, so I recommended sleeve gastrectomy to lose more weight. I told her she could always restart the Wegovy after the procedure if needed.

We really don’t have an answer to this issue of NuSH therapy not getting to goal and bariatric surgery following medication therapy. The reality is that bariatric surgery should be considered a safe, effective treatment for extreme obesity somewhere along the trajectory of treatments starting with behavior (diet, exercise) and medications. It is still considered a last resort, and for some, just too aggressive.

We have learned much about the incretin hormones and what they can accomplish for obesity from studying bariatric — now called metabolic — surgery. Surgery should be seen as we see stent placement for angina, only more effective for longevity. The COURAGE trial, published in 2007 in NEJM, showed that when compared with medication treatment alone for angina, stent placement plus medications resulted in no difference in mortality after a 7-year follow-up period. Compare this to bariatric surgery, which in many retrospective analyses shows a 20% reduction in cardiovascular mortality after 20-year follow-up (Swedish Obesity Study). In the United States, there are 2 million stent procedures performed per year vs 250,000 bariatric surgical procedures. There are millions of Americans with a BMI > 40 and, yes, millions of Americans with angina. I think I make my point that we need to do more bariatric surgeries to effectively treat extreme obesity.

The solution to this negligent medical practice in obesity treatment is to empower PCPs to treat obesity (at least uncomplicated obesity) and refer to obesity medicine practices for complicated obesity with multiple complications, such as type 2 diabetes and cardiovascular disease, and to refer to obesity medicine practices with a surgical component for BMIs > 40 or > 35 with type 2 diabetes, sleep apnea, and/or cardiovascular disease or other serious conditions.

How do we empower PCPs? Insurance coverage of NuSH therapies due to life-saving properties — as evidenced by the SELECT trial — without prior authorizations; and education on how and why metabolic surgery works, as well as education on behavioral approaches, such as healthy diet and exercise, as a core therapy for all BMI categories.

It’s time.

Caroline Apovian, MD, has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, adviser, consultant, or trustee for Altimmune; Cowen and Company; Currax Pharmaceuticals; EPG Communication Holdings; Gelesis, Srl; L-Nutra; and NeuroBo Pharmaceuticals. Received research grant from: National Institutes of Health; Patient-Centered Outcomes Research Institute; and GI Dynamics. Received income in an amount equal to or greater than $250 from: Altimmune; Cowen and Company; NeuroBo Pharmaceuticals; and Novo Nordisk.

A version of this article appeared on Medscape.com.

Iloperidone, a second-generation antipsychotic used to treat schizophrenia, appears to be safe and effective in the treatment of bipolar mania, new research suggested.

Results of the phase 3 randomized double-blind placebo-controlled trial show patients with bipolar mania who received iloperidone had significantly greater change from baseline to 4 weeks on the Young Mania Rating Scale (YMRS) compared with placebo, an improvement detected as early as 14 days from the initial dose.

The incidence of akathisia and extrapyramidal symptoms (EPS) was low in the treatment group, and the medication was well-tolerated.

“This study provides evidence that iloperidone improves the symptoms of bipolar mania in adults and can be a useful treatment option for people with bipolar disorder,” the investigators, led by Rosarelis Torres, PhD, of Vanda Pharmaceuticals, and colleagues wrote.

The study was published online in the Journal of Clinical Psychiatry.
 

Early Improvement

Iloperidone was first approved by the US Food and Drug Administration in 2009 for treatment of schizophrenia.

The current study included 414 participants (mean age, 43 years; 56% male) across 17 US and international sites. Patients with psychotic features received a fixed daily dose of 24 mg of iloperidone (n = 206) or placebo (n = 208).

Participants completed a screening period of up to 7 days before randomization, followed by a 1-day baseline evaluation period and a 28-day treatment phase.

The primary efficacy endpoint was change from baseline to week 4 on the YMRS (vs placebo), while secondary efficacy endpoints included change from baseline on the Clinical Global Impressions-Severity and Clinical Global Impression of Change scales (CGI-S and CGI-C, respectively).

Compared with placebo, iloperidone was associated with significant improvement of mania symptoms at week 4, with a mean reduction on the YMRS scale of −4.0 (P = .000008), and significant decreases on the CGI-S (mean, −0.4; P = .0005) and CGI-C scales (mean, −0.5; P = .0002).

Statistically significant differences between iloperidone and placebo were observed as early as day 14 and continued through days 21 and 28.

Post hoc analyses found no difference in efficacy even when patients who had received benzodiazepines were excluded, regardless of the presence or absence of psychotic features at baseline.
 

Favorable Akathisia Profile

As for safety, 68% of patients in the iloperidone group experienced at least one adverse event, compared with 49% of patients in the placebo group.

Patients in the treatment group had a higher rate of withdrawal from the study than those in the placebo group (32.9% vs 27.1%), and more patients in the iloperidone group experienced treatment-emergent adverse events (TEAEs) leading to study drug discontinuation (8.7% vs 5.3%). However, no TEAEs associated with discontinuation occurred in more than two patients in either group, and none of the participants experienced any AE leading to death.

The most common adverse events (AEs) were tachycardia (18%), dizziness (11%), dry mouth (9%), increased alanine aminotransferase (7%), nasal congestion (6%), weight gain (6%), and somnolence (5%).

Five serious AEs were reported in four participants in the treatment group and one in the placebo group. Two were identified as related to the study medication. These included sedation and spontaneous penile erection.

Changes from baseline in clinical laboratory parameters were not largely different between the groups, but there were post-randomization changes in QT interval in three iloperidone patients. The incidence of orthostatic response was also higher for iloperidone vs placebo.

Although “much improved compared to early antipsychotics, SGAs can still cause considerable adverse motor side effects,” the authors wrote. “However, among all SGAs, iloperidone’s akathisia profile is favorable.”

Antipsychotic-induced akathisia has been reported more frequently in patients with bipolar disorder than in those with schizophrenia treated with the same medication, investigators noted.

One study limitation is the fact that long-term efficacy in the prevention of manic or depressive episodes was not assessed.
 

Potential Second-Line Treatment

Commenting on the study, Richard Louis Price, MD, assistant professor of psychiatry, at Weill Cornell Medical College, New York City, said the findings suggest iloperidone may be “modestly effective” for patients with bipolar 1 mania or mixed episodes.

“It’s helpful to have new treatment options, especially for patients who have difficulty tolerating other agents,” said Dr. Price, who was not involved with the study.

Also commenting on the research, Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Toronto, Ontario, Canada, noted iloperidone’s “interesting antipsychotic pharmacodynamic,” highlighting the drug’s high-binding affinity for serotonin 5HT_2A and dopamine D₂ and D₃ receptors, as well as the noradrenergic α₁ receptors.

The drug’s profile “suggests benefit in manic features and agitation, perhaps with a lower propensity to EPS, which is especially important in persons at higher risk, like persons living with bipolar disorder,” Dr. McIntyre said.

Dr. McIntyre, who was not involved with the study, added iloperidone could be a second-line therapy because of its tolerability profile, provided the study results can be replicated.

“When considering alternatives with similar efficacy, absence of titration (or simple titration) minimal to no weight gain, no orthostatic hypotension, and no potential concerns with QT, those alternatives would have to be considered first-line, assuming that the study results are replicated,” he said.

This study was funded by Vanda Pharmaceuticals. The authors’ disclosures are listed in the original paper. Dr. McIntyre had received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine Biosciences, Sunovion, Bausch Health, Axsome Therapeutics, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular Therapies Inc., NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences. McIntyre is the CEO of Braxia Scientific Corp. Dr. Price had received honoraria from AbbVie, Alkermes, Allergan, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus.

A version of this article appeared on Medscape.com.

Iloperidone, a second-generation antipsychotic used to treat schizophrenia, appears to be safe and effective in the treatment of bipolar mania, new research suggested.

Results of the phase 3 randomized double-blind placebo-controlled trial show patients with bipolar mania who received iloperidone had significantly greater change from baseline to 4 weeks on the Young Mania Rating Scale (YMRS) compared with placebo, an improvement detected as early as 14 days from the initial dose.

The incidence of akathisia and extrapyramidal symptoms (EPS) was low in the treatment group, and the medication was well-tolerated.

“This study provides evidence that iloperidone improves the symptoms of bipolar mania in adults and can be a useful treatment option for people with bipolar disorder,” the investigators, led by Rosarelis Torres, PhD, of Vanda Pharmaceuticals, and colleagues wrote.

The study was published online in the Journal of Clinical Psychiatry.
 

Early Improvement

Iloperidone was first approved by the US Food and Drug Administration in 2009 for treatment of schizophrenia.

The current study included 414 participants (mean age, 43 years; 56% male) across 17 US and international sites. Patients with psychotic features received a fixed daily dose of 24 mg of iloperidone (n = 206) or placebo (n = 208).

Participants completed a screening period of up to 7 days before randomization, followed by a 1-day baseline evaluation period and a 28-day treatment phase.

The primary efficacy endpoint was change from baseline to week 4 on the YMRS (vs placebo), while secondary efficacy endpoints included change from baseline on the Clinical Global Impressions-Severity and Clinical Global Impression of Change scales (CGI-S and CGI-C, respectively).

Compared with placebo, iloperidone was associated with significant improvement of mania symptoms at week 4, with a mean reduction on the YMRS scale of −4.0 (P = .000008), and significant decreases on the CGI-S (mean, −0.4; P = .0005) and CGI-C scales (mean, −0.5; P = .0002).

Statistically significant differences between iloperidone and placebo were observed as early as day 14 and continued through days 21 and 28.

Post hoc analyses found no difference in efficacy even when patients who had received benzodiazepines were excluded, regardless of the presence or absence of psychotic features at baseline.
 

Favorable Akathisia Profile

As for safety, 68% of patients in the iloperidone group experienced at least one adverse event, compared with 49% of patients in the placebo group.

Patients in the treatment group had a higher rate of withdrawal from the study than those in the placebo group (32.9% vs 27.1%), and more patients in the iloperidone group experienced treatment-emergent adverse events (TEAEs) leading to study drug discontinuation (8.7% vs 5.3%). However, no TEAEs associated with discontinuation occurred in more than two patients in either group, and none of the participants experienced any AE leading to death.

The most common adverse events (AEs) were tachycardia (18%), dizziness (11%), dry mouth (9%), increased alanine aminotransferase (7%), nasal congestion (6%), weight gain (6%), and somnolence (5%).

Five serious AEs were reported in four participants in the treatment group and one in the placebo group. Two were identified as related to the study medication. These included sedation and spontaneous penile erection.

Changes from baseline in clinical laboratory parameters were not largely different between the groups, but there were post-randomization changes in QT interval in three iloperidone patients. The incidence of orthostatic response was also higher for iloperidone vs placebo.

Although “much improved compared to early antipsychotics, SGAs can still cause considerable adverse motor side effects,” the authors wrote. “However, among all SGAs, iloperidone’s akathisia profile is favorable.”

Antipsychotic-induced akathisia has been reported more frequently in patients with bipolar disorder than in those with schizophrenia treated with the same medication, investigators noted.

One study limitation is the fact that long-term efficacy in the prevention of manic or depressive episodes was not assessed.
 

Potential Second-Line Treatment

Commenting on the study, Richard Louis Price, MD, assistant professor of psychiatry, at Weill Cornell Medical College, New York City, said the findings suggest iloperidone may be “modestly effective” for patients with bipolar 1 mania or mixed episodes.

“It’s helpful to have new treatment options, especially for patients who have difficulty tolerating other agents,” said Dr. Price, who was not involved with the study.

Also commenting on the research, Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Toronto, Ontario, Canada, noted iloperidone’s “interesting antipsychotic pharmacodynamic,” highlighting the drug’s high-binding affinity for serotonin 5HT_2A and dopamine D₂ and D₃ receptors, as well as the noradrenergic α₁ receptors.

The drug’s profile “suggests benefit in manic features and agitation, perhaps with a lower propensity to EPS, which is especially important in persons at higher risk, like persons living with bipolar disorder,” Dr. McIntyre said.

Dr. McIntyre, who was not involved with the study, added iloperidone could be a second-line therapy because of its tolerability profile, provided the study results can be replicated.

“When considering alternatives with similar efficacy, absence of titration (or simple titration) minimal to no weight gain, no orthostatic hypotension, and no potential concerns with QT, those alternatives would have to be considered first-line, assuming that the study results are replicated,” he said.

This study was funded by Vanda Pharmaceuticals. The authors’ disclosures are listed in the original paper. Dr. McIntyre had received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine Biosciences, Sunovion, Bausch Health, Axsome Therapeutics, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular Therapies Inc., NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences. McIntyre is the CEO of Braxia Scientific Corp. Dr. Price had received honoraria from AbbVie, Alkermes, Allergan, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus.

A version of this article appeared on Medscape.com.

Iloperidone, a second-generation antipsychotic used to treat schizophrenia, appears to be safe and effective in the treatment of bipolar mania, new research suggested.

Results of the phase 3 randomized double-blind placebo-controlled trial show patients with bipolar mania who received iloperidone had significantly greater change from baseline to 4 weeks on the Young Mania Rating Scale (YMRS) compared with placebo, an improvement detected as early as 14 days from the initial dose.

The incidence of akathisia and extrapyramidal symptoms (EPS) was low in the treatment group, and the medication was well-tolerated.

“This study provides evidence that iloperidone improves the symptoms of bipolar mania in adults and can be a useful treatment option for people with bipolar disorder,” the investigators, led by Rosarelis Torres, PhD, of Vanda Pharmaceuticals, and colleagues wrote.

The study was published online in the Journal of Clinical Psychiatry.
 

Early Improvement

Iloperidone was first approved by the US Food and Drug Administration in 2009 for treatment of schizophrenia.

The current study included 414 participants (mean age, 43 years; 56% male) across 17 US and international sites. Patients with psychotic features received a fixed daily dose of 24 mg of iloperidone (n = 206) or placebo (n = 208).

Participants completed a screening period of up to 7 days before randomization, followed by a 1-day baseline evaluation period and a 28-day treatment phase.

The primary efficacy endpoint was change from baseline to week 4 on the YMRS (vs placebo), while secondary efficacy endpoints included change from baseline on the Clinical Global Impressions-Severity and Clinical Global Impression of Change scales (CGI-S and CGI-C, respectively).

Compared with placebo, iloperidone was associated with significant improvement of mania symptoms at week 4, with a mean reduction on the YMRS scale of −4.0 (P = .000008), and significant decreases on the CGI-S (mean, −0.4; P = .0005) and CGI-C scales (mean, −0.5; P = .0002).

Statistically significant differences between iloperidone and placebo were observed as early as day 14 and continued through days 21 and 28.

Post hoc analyses found no difference in efficacy even when patients who had received benzodiazepines were excluded, regardless of the presence or absence of psychotic features at baseline.
 

Favorable Akathisia Profile

As for safety, 68% of patients in the iloperidone group experienced at least one adverse event, compared with 49% of patients in the placebo group.

Patients in the treatment group had a higher rate of withdrawal from the study than those in the placebo group (32.9% vs 27.1%), and more patients in the iloperidone group experienced treatment-emergent adverse events (TEAEs) leading to study drug discontinuation (8.7% vs 5.3%). However, no TEAEs associated with discontinuation occurred in more than two patients in either group, and none of the participants experienced any AE leading to death.

The most common adverse events (AEs) were tachycardia (18%), dizziness (11%), dry mouth (9%), increased alanine aminotransferase (7%), nasal congestion (6%), weight gain (6%), and somnolence (5%).

Five serious AEs were reported in four participants in the treatment group and one in the placebo group. Two were identified as related to the study medication. These included sedation and spontaneous penile erection.

Changes from baseline in clinical laboratory parameters were not largely different between the groups, but there were post-randomization changes in QT interval in three iloperidone patients. The incidence of orthostatic response was also higher for iloperidone vs placebo.

Although “much improved compared to early antipsychotics, SGAs can still cause considerable adverse motor side effects,” the authors wrote. “However, among all SGAs, iloperidone’s akathisia profile is favorable.”

Antipsychotic-induced akathisia has been reported more frequently in patients with bipolar disorder than in those with schizophrenia treated with the same medication, investigators noted.

One study limitation is the fact that long-term efficacy in the prevention of manic or depressive episodes was not assessed.
 

Potential Second-Line Treatment

Commenting on the study, Richard Louis Price, MD, assistant professor of psychiatry, at Weill Cornell Medical College, New York City, said the findings suggest iloperidone may be “modestly effective” for patients with bipolar 1 mania or mixed episodes.

“It’s helpful to have new treatment options, especially for patients who have difficulty tolerating other agents,” said Dr. Price, who was not involved with the study.

Also commenting on the research, Roger S. McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Toronto, Ontario, Canada, noted iloperidone’s “interesting antipsychotic pharmacodynamic,” highlighting the drug’s high-binding affinity for serotonin 5HT_2A and dopamine D₂ and D₃ receptors, as well as the noradrenergic α₁ receptors.

The drug’s profile “suggests benefit in manic features and agitation, perhaps with a lower propensity to EPS, which is especially important in persons at higher risk, like persons living with bipolar disorder,” Dr. McIntyre said.

Dr. McIntyre, who was not involved with the study, added iloperidone could be a second-line therapy because of its tolerability profile, provided the study results can be replicated.

“When considering alternatives with similar efficacy, absence of titration (or simple titration) minimal to no weight gain, no orthostatic hypotension, and no potential concerns with QT, those alternatives would have to be considered first-line, assuming that the study results are replicated,” he said.

This study was funded by Vanda Pharmaceuticals. The authors’ disclosures are listed in the original paper. Dr. McIntyre had received research grant support from CIHR/GACD/National Natural Science Foundation of China and the Milken Institute; speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine Biosciences, Sunovion, Bausch Health, Axsome Therapeutics, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular Therapies Inc., NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences. McIntyre is the CEO of Braxia Scientific Corp. Dr. Price had received honoraria from AbbVie, Alkermes, Allergan, Intra-Cellular Therapies, Janssen, Jazz, Lundbeck, Neuronetics, Otsuka, and Supernus.

A version of this article appeared on Medscape.com.

A former colleague once told me that there are few primary care procedures more satisfying for the patient and physician than removing part of an ingrown toenail. I disagree, but I performed this procedure quite a few times during my residency and first few years in practice. The patient would usually have been in pain for days to weeks and have tried soaking their foot or putting wisps of cotton under the ingrown nail edge, without relief. I would draw up a syringe of lidocaine with epinephrine and perform a digital block on the affected toe. After waiting 5-10 minutes for the toe to become numb, I would clean the area, use a nail elevator to push the cuticle off the nail plate, and lift up the lateral edge of the plate. I would then cut the lateral edge with a nail splitter and remove the cut nail fragment with a hemostat. Finally, after an inspection to make sure that I hadn›t left any pieces behind, I or my nurse would apply petrolatum gauze and a bandage.

I don’t do toenails anymore. Because this procedure was requested every several weeks at most, the offices where I worked weren’t organized to make it easy to do; sometimes my medical assistants didn’t know what supplies were needed or where to find them. Adding up the time it took to obtain consent, wait for the local anesthetic to take effect, and do the procedure, it was more efficient for me to see two or three patients for medication checkups and refer toenail problems to a podiatrist instead. The same thing happened with circumcisions on infants who, for whatever reason, hadn›t had them done in the hospital. After a few years of doing these, I decided it would be easier to send these patients to pediatric urologists.

My choice to reduce my scope of practice during the early part of my career mirrored a national trend among graduating family medicine residents. I value the joint injections, laceration repairs, biopsies, and other skin procedures that remain in my repertoire for the change of pace and saving my patients more costly visits to specialists with long waiting lists. In fact, a previous study showed that family physicians who provide more comprehensive care generate lower healthcare spending and fewer hospitalizations than those with a narrower scope of practice.

A recent evaluation of Comprehensive Primary Care Plus, one of several alternative payment models that the Centers for Medicare & Medicaid Services has piloted over the past decade, found that it modestly reduced emergency department visits and inpatient costs but didn’t save money after accounting for additional dollars going to primary care. However, when researchers looked at six specific services — immunizations, behavioral counseling, laceration management, skin lesion removal, joint or tendon injections, and point-of-care ultrasound — they found that patients who saw physicians who provided more of these had lower care costs and sought less acute care outside of the office. On average, independent-practice physicians provided more services than physicians who practiced at sites affiliated with hospitals or health systems. That makes sense: While health systems bring in more income for procedures performed in their operating rooms and subspecialists› offices, private practices do better by keeping services in-house.

Supporting physicians in maintaining the broadest possible scope of practice is, in my opinion, the missing piece in the federal government’s initiatives to strengthen primary care. Investing in primary care training programs and paying practices for care coordination are necessary but insufficient steps if family physicians are expected to improve population health and bend the cost curve.

Dr. Lin is Associate Director, Family Medicine Residency Program, Lancaster General Hospital, Lancaster, Pennsylvania. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

A former colleague once told me that there are few primary care procedures more satisfying for the patient and physician than removing part of an ingrown toenail. I disagree, but I performed this procedure quite a few times during my residency and first few years in practice. The patient would usually have been in pain for days to weeks and have tried soaking their foot or putting wisps of cotton under the ingrown nail edge, without relief. I would draw up a syringe of lidocaine with epinephrine and perform a digital block on the affected toe. After waiting 5-10 minutes for the toe to become numb, I would clean the area, use a nail elevator to push the cuticle off the nail plate, and lift up the lateral edge of the plate. I would then cut the lateral edge with a nail splitter and remove the cut nail fragment with a hemostat. Finally, after an inspection to make sure that I hadn›t left any pieces behind, I or my nurse would apply petrolatum gauze and a bandage.

I don’t do toenails anymore. Because this procedure was requested every several weeks at most, the offices where I worked weren’t organized to make it easy to do; sometimes my medical assistants didn’t know what supplies were needed or where to find them. Adding up the time it took to obtain consent, wait for the local anesthetic to take effect, and do the procedure, it was more efficient for me to see two or three patients for medication checkups and refer toenail problems to a podiatrist instead. The same thing happened with circumcisions on infants who, for whatever reason, hadn›t had them done in the hospital. After a few years of doing these, I decided it would be easier to send these patients to pediatric urologists.

My choice to reduce my scope of practice during the early part of my career mirrored a national trend among graduating family medicine residents. I value the joint injections, laceration repairs, biopsies, and other skin procedures that remain in my repertoire for the change of pace and saving my patients more costly visits to specialists with long waiting lists. In fact, a previous study showed that family physicians who provide more comprehensive care generate lower healthcare spending and fewer hospitalizations than those with a narrower scope of practice.

A recent evaluation of Comprehensive Primary Care Plus, one of several alternative payment models that the Centers for Medicare & Medicaid Services has piloted over the past decade, found that it modestly reduced emergency department visits and inpatient costs but didn’t save money after accounting for additional dollars going to primary care. However, when researchers looked at six specific services — immunizations, behavioral counseling, laceration management, skin lesion removal, joint or tendon injections, and point-of-care ultrasound — they found that patients who saw physicians who provided more of these had lower care costs and sought less acute care outside of the office. On average, independent-practice physicians provided more services than physicians who practiced at sites affiliated with hospitals or health systems. That makes sense: While health systems bring in more income for procedures performed in their operating rooms and subspecialists› offices, private practices do better by keeping services in-house.

Supporting physicians in maintaining the broadest possible scope of practice is, in my opinion, the missing piece in the federal government’s initiatives to strengthen primary care. Investing in primary care training programs and paying practices for care coordination are necessary but insufficient steps if family physicians are expected to improve population health and bend the cost curve.

Dr. Lin is Associate Director, Family Medicine Residency Program, Lancaster General Hospital, Lancaster, Pennsylvania. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

A former colleague once told me that there are few primary care procedures more satisfying for the patient and physician than removing part of an ingrown toenail. I disagree, but I performed this procedure quite a few times during my residency and first few years in practice. The patient would usually have been in pain for days to weeks and have tried soaking their foot or putting wisps of cotton under the ingrown nail edge, without relief. I would draw up a syringe of lidocaine with epinephrine and perform a digital block on the affected toe. After waiting 5-10 minutes for the toe to become numb, I would clean the area, use a nail elevator to push the cuticle off the nail plate, and lift up the lateral edge of the plate. I would then cut the lateral edge with a nail splitter and remove the cut nail fragment with a hemostat. Finally, after an inspection to make sure that I hadn›t left any pieces behind, I or my nurse would apply petrolatum gauze and a bandage.

I don’t do toenails anymore. Because this procedure was requested every several weeks at most, the offices where I worked weren’t organized to make it easy to do; sometimes my medical assistants didn’t know what supplies were needed or where to find them. Adding up the time it took to obtain consent, wait for the local anesthetic to take effect, and do the procedure, it was more efficient for me to see two or three patients for medication checkups and refer toenail problems to a podiatrist instead. The same thing happened with circumcisions on infants who, for whatever reason, hadn›t had them done in the hospital. After a few years of doing these, I decided it would be easier to send these patients to pediatric urologists.

My choice to reduce my scope of practice during the early part of my career mirrored a national trend among graduating family medicine residents. I value the joint injections, laceration repairs, biopsies, and other skin procedures that remain in my repertoire for the change of pace and saving my patients more costly visits to specialists with long waiting lists. In fact, a previous study showed that family physicians who provide more comprehensive care generate lower healthcare spending and fewer hospitalizations than those with a narrower scope of practice.

A recent evaluation of Comprehensive Primary Care Plus, one of several alternative payment models that the Centers for Medicare & Medicaid Services has piloted over the past decade, found that it modestly reduced emergency department visits and inpatient costs but didn’t save money after accounting for additional dollars going to primary care. However, when researchers looked at six specific services — immunizations, behavioral counseling, laceration management, skin lesion removal, joint or tendon injections, and point-of-care ultrasound — they found that patients who saw physicians who provided more of these had lower care costs and sought less acute care outside of the office. On average, independent-practice physicians provided more services than physicians who practiced at sites affiliated with hospitals or health systems. That makes sense: While health systems bring in more income for procedures performed in their operating rooms and subspecialists› offices, private practices do better by keeping services in-house.

Supporting physicians in maintaining the broadest possible scope of practice is, in my opinion, the missing piece in the federal government’s initiatives to strengthen primary care. Investing in primary care training programs and paying practices for care coordination are necessary but insufficient steps if family physicians are expected to improve population health and bend the cost curve.

Dr. Lin is Associate Director, Family Medicine Residency Program, Lancaster General Hospital, Lancaster, Pennsylvania. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Juices made of 100% fruit can have a slight impact on children’s body mass index (BMI), which increases with each serving consumed. In addition, an effect on weight is noticeable in adults. These are some of the conclusions drawn from a literature review and meta-analysis published in JAMA Pediatrics.

“Consumption of 100% fruit juice can serve as a convenient means to meet daily fruit recommendations and offers many of the nutrients found in whole fruit including essential vitamins, antioxidants, and polyphenols that can contribute to a healthy dietary pattern. However, there is concern that intake of 100% fruit juice may contribute to weight gain due to the high amounts of free sugars and energy,” wrote the authors, led by Michelle Nguyen, research assistant at the University of Toronto.

As the authors point out, available data on the subject are conflicting, and recommendations in national and international guidelines are not perfectly aligned. “With the rising overweight and obesity rates in children and adults worldwide, evidence-based recommendations for 100% fruit juice consumption are needed,” wrote the authors.
 

What the Literature Says

To shed light on such a crucial topic, researchers conducted a literature review with a meta-analysis of prospective cohort studies lasting at least 6 months and randomized controlled trials (RCTs) lasting at least 2 weeks. The analysis included 42 studies: 17 on the pediatric population (only cohort studies; totaling 45,851 children) and 25 on the adult population (6 cohort studies and 19 RCTs; 268,095 adults involved).

In children, each daily serving of 100% fruit juice (equivalent to a glass of about 230 mL) was associated with a 0.03 increase in BMI, with a higher increase in younger children (0.15 in those under 11 years) compared with older ones (−0.001).

As for adults, the overall analysis of cohort studies did not show significant associations. Further analyses without adjusting for energy intake showed a significant association between 100% fruit juices and weight gain (0.21 kg), whereas after adjustment, an inverse association with weight gain (−0.08 kg) emerged. This finding suggests that the association may be mediated by calorie intake, wrote the researchers, adding that no association was found in the analysis of randomized controlled trials.
 

A Closer Look 

“Our comprehensive systematic review and meta-analysis provides a novel analysis of 100% fruit juice and weight gain assessing children and adults using data from both prospective cohort studies and RCTs,” explained the authors, commenting on some of the obtained results.

Regarding the observed differences between children of different age groups, the researchers explained that a standard glass of fruit juice represents a higher proportion of the daily energy intake for a younger child compared with an older one. “Our findings are in line with American Academy of Pediatrics guidelines that children younger than 6 years should consume less than a glass of fruit juice per day,” they wrote. “Limiting intake of fruit juice among children is an important strategy for them to develop healthy weight trajectories.”

Experts also state that high-quality RCTs are needed in children and adults to explore the effect of fruit juice consumption on body weight at different intake levels and with different types of juice. “Our findings are in support of public health guidance to limit consumption of 100% fruit juice to prevent overweight and obesity,” the authors wrote. 
 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Juices made of 100% fruit can have a slight impact on children’s body mass index (BMI), which increases with each serving consumed. In addition, an effect on weight is noticeable in adults. These are some of the conclusions drawn from a literature review and meta-analysis published in JAMA Pediatrics.

“Consumption of 100% fruit juice can serve as a convenient means to meet daily fruit recommendations and offers many of the nutrients found in whole fruit including essential vitamins, antioxidants, and polyphenols that can contribute to a healthy dietary pattern. However, there is concern that intake of 100% fruit juice may contribute to weight gain due to the high amounts of free sugars and energy,” wrote the authors, led by Michelle Nguyen, research assistant at the University of Toronto.

As the authors point out, available data on the subject are conflicting, and recommendations in national and international guidelines are not perfectly aligned. “With the rising overweight and obesity rates in children and adults worldwide, evidence-based recommendations for 100% fruit juice consumption are needed,” wrote the authors.
 

What the Literature Says

To shed light on such a crucial topic, researchers conducted a literature review with a meta-analysis of prospective cohort studies lasting at least 6 months and randomized controlled trials (RCTs) lasting at least 2 weeks. The analysis included 42 studies: 17 on the pediatric population (only cohort studies; totaling 45,851 children) and 25 on the adult population (6 cohort studies and 19 RCTs; 268,095 adults involved).

In children, each daily serving of 100% fruit juice (equivalent to a glass of about 230 mL) was associated with a 0.03 increase in BMI, with a higher increase in younger children (0.15 in those under 11 years) compared with older ones (−0.001).

As for adults, the overall analysis of cohort studies did not show significant associations. Further analyses without adjusting for energy intake showed a significant association between 100% fruit juices and weight gain (0.21 kg), whereas after adjustment, an inverse association with weight gain (−0.08 kg) emerged. This finding suggests that the association may be mediated by calorie intake, wrote the researchers, adding that no association was found in the analysis of randomized controlled trials.
 

A Closer Look 

“Our comprehensive systematic review and meta-analysis provides a novel analysis of 100% fruit juice and weight gain assessing children and adults using data from both prospective cohort studies and RCTs,” explained the authors, commenting on some of the obtained results.

Regarding the observed differences between children of different age groups, the researchers explained that a standard glass of fruit juice represents a higher proportion of the daily energy intake for a younger child compared with an older one. “Our findings are in line with American Academy of Pediatrics guidelines that children younger than 6 years should consume less than a glass of fruit juice per day,” they wrote. “Limiting intake of fruit juice among children is an important strategy for them to develop healthy weight trajectories.”

Experts also state that high-quality RCTs are needed in children and adults to explore the effect of fruit juice consumption on body weight at different intake levels and with different types of juice. “Our findings are in support of public health guidance to limit consumption of 100% fruit juice to prevent overweight and obesity,” the authors wrote. 
 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Juices made of 100% fruit can have a slight impact on children’s body mass index (BMI), which increases with each serving consumed. In addition, an effect on weight is noticeable in adults. These are some of the conclusions drawn from a literature review and meta-analysis published in JAMA Pediatrics.

“Consumption of 100% fruit juice can serve as a convenient means to meet daily fruit recommendations and offers many of the nutrients found in whole fruit including essential vitamins, antioxidants, and polyphenols that can contribute to a healthy dietary pattern. However, there is concern that intake of 100% fruit juice may contribute to weight gain due to the high amounts of free sugars and energy,” wrote the authors, led by Michelle Nguyen, research assistant at the University of Toronto.

As the authors point out, available data on the subject are conflicting, and recommendations in national and international guidelines are not perfectly aligned. “With the rising overweight and obesity rates in children and adults worldwide, evidence-based recommendations for 100% fruit juice consumption are needed,” wrote the authors.
 

What the Literature Says

To shed light on such a crucial topic, researchers conducted a literature review with a meta-analysis of prospective cohort studies lasting at least 6 months and randomized controlled trials (RCTs) lasting at least 2 weeks. The analysis included 42 studies: 17 on the pediatric population (only cohort studies; totaling 45,851 children) and 25 on the adult population (6 cohort studies and 19 RCTs; 268,095 adults involved).

In children, each daily serving of 100% fruit juice (equivalent to a glass of about 230 mL) was associated with a 0.03 increase in BMI, with a higher increase in younger children (0.15 in those under 11 years) compared with older ones (−0.001).

As for adults, the overall analysis of cohort studies did not show significant associations. Further analyses without adjusting for energy intake showed a significant association between 100% fruit juices and weight gain (0.21 kg), whereas after adjustment, an inverse association with weight gain (−0.08 kg) emerged. This finding suggests that the association may be mediated by calorie intake, wrote the researchers, adding that no association was found in the analysis of randomized controlled trials.
 

A Closer Look 

“Our comprehensive systematic review and meta-analysis provides a novel analysis of 100% fruit juice and weight gain assessing children and adults using data from both prospective cohort studies and RCTs,” explained the authors, commenting on some of the obtained results.

Regarding the observed differences between children of different age groups, the researchers explained that a standard glass of fruit juice represents a higher proportion of the daily energy intake for a younger child compared with an older one. “Our findings are in line with American Academy of Pediatrics guidelines that children younger than 6 years should consume less than a glass of fruit juice per day,” they wrote. “Limiting intake of fruit juice among children is an important strategy for them to develop healthy weight trajectories.”

Experts also state that high-quality RCTs are needed in children and adults to explore the effect of fruit juice consumption on body weight at different intake levels and with different types of juice. “Our findings are in support of public health guidance to limit consumption of 100% fruit juice to prevent overweight and obesity,” the authors wrote. 
 

This article was translated from Univadis Italy, which is part of the Medscape Professional Network. A version of this article appeared on Medscape.com.

Biogen’s announcement on January 31 that it will discontinue development and commercialization of the anti-amyloid agent, aducanumab (Aduhelm), for Alzheimer’s disease came as no surprise to many experts in the field. 

“Clearly, the drug was a commercial failure,” Dave Knopman, MD, professor of neurology, Mayo Clinic, Rochester, Minnesota, said. “Despite the accelerated approval, the uncertainty of clinical benefits was transparent, and the public failed to generate any enthusiasm for the drug.”

Aducanumab received accelerated approval from the US Food and Drug Administration (FDA) in June 2021 despite a recommendation by its own advisory panel not to approve the drug. Dr. Knopman was a member of that panel and one of three members who resigned after the agency’s decision to approve the drug. 

“The decision by Biogen to cancel the aducanumab program was not surprising, as the company steadily withdrew their engagement in the program over the past year,” Dr. Knopman noted. 

“This was a commercial decision — not so much a scientific decision,” Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, said. 

“The process by which the [aducanumab] program was handled and some of the conflicting opinions at the FDA led to uncertainty about the efficacy of the drug, and it wasn’t being prescribed,” Dr. Fillit said. 

After its approval, the Centers for Medicare & Medicaid Services restricted coverage of aducanumab to patients enrolled in clinical trials, which experts say likely contributed to Biogen’s decision to ditch the drug. 

It also limited the number of people living with Alzheimer’s disease who could get access to the treatment and “created significant confusion for patients and doctors,” the Alzheimer’s Association said in a statement on Biogen’s decision. 

Biogen will also terminate the post-approval clinical trial known as ENVISION, which sought to confirm aducanumab’s benefits in patients with early Alzheimer’s disease. 

Going forward, Biogen said that it will now focus on advancing lecanemab (Leqembi), the first anti-amyloid to receive traditional FDA approval.

“We have learned much from the mistakes and misjudgments that plagued aducanumab, but the field has moved on and is a little the wiser,” Dr. Knopman said. “With the standard approval of lecanemab, which showed clear, albeit modest, clinical benefits, we are focusing on providing safe and efficient access to lecanemab.” 

Biogen plans to accelerate the development of potential new treatment modalities. These include BIIB080, an investigational antisense oligonucleotide therapy targeting tau, and BIIB113, an oral small-molecule inhibitor of tau aggregation.

Dr. Fillit said that he’s “very excited” about the current pipeline of Alzheimer’s disease drugs, starting with donanemab, which is currently under review at the FDA, and “looks like it has somewhat better efficacy data than lecanemab.”

A version of this article appeared on Medscape.com.

Biogen’s announcement on January 31 that it will discontinue development and commercialization of the anti-amyloid agent, aducanumab (Aduhelm), for Alzheimer’s disease came as no surprise to many experts in the field. 

“Clearly, the drug was a commercial failure,” Dave Knopman, MD, professor of neurology, Mayo Clinic, Rochester, Minnesota, said. “Despite the accelerated approval, the uncertainty of clinical benefits was transparent, and the public failed to generate any enthusiasm for the drug.”

Aducanumab received accelerated approval from the US Food and Drug Administration (FDA) in June 2021 despite a recommendation by its own advisory panel not to approve the drug. Dr. Knopman was a member of that panel and one of three members who resigned after the agency’s decision to approve the drug. 

“The decision by Biogen to cancel the aducanumab program was not surprising, as the company steadily withdrew their engagement in the program over the past year,” Dr. Knopman noted. 

“This was a commercial decision — not so much a scientific decision,” Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, said. 

“The process by which the [aducanumab] program was handled and some of the conflicting opinions at the FDA led to uncertainty about the efficacy of the drug, and it wasn’t being prescribed,” Dr. Fillit said. 

After its approval, the Centers for Medicare & Medicaid Services restricted coverage of aducanumab to patients enrolled in clinical trials, which experts say likely contributed to Biogen’s decision to ditch the drug. 

It also limited the number of people living with Alzheimer’s disease who could get access to the treatment and “created significant confusion for patients and doctors,” the Alzheimer’s Association said in a statement on Biogen’s decision. 

Biogen will also terminate the post-approval clinical trial known as ENVISION, which sought to confirm aducanumab’s benefits in patients with early Alzheimer’s disease. 

Going forward, Biogen said that it will now focus on advancing lecanemab (Leqembi), the first anti-amyloid to receive traditional FDA approval.

“We have learned much from the mistakes and misjudgments that plagued aducanumab, but the field has moved on and is a little the wiser,” Dr. Knopman said. “With the standard approval of lecanemab, which showed clear, albeit modest, clinical benefits, we are focusing on providing safe and efficient access to lecanemab.” 

Biogen plans to accelerate the development of potential new treatment modalities. These include BIIB080, an investigational antisense oligonucleotide therapy targeting tau, and BIIB113, an oral small-molecule inhibitor of tau aggregation.

Dr. Fillit said that he’s “very excited” about the current pipeline of Alzheimer’s disease drugs, starting with donanemab, which is currently under review at the FDA, and “looks like it has somewhat better efficacy data than lecanemab.”

A version of this article appeared on Medscape.com.

Biogen’s announcement on January 31 that it will discontinue development and commercialization of the anti-amyloid agent, aducanumab (Aduhelm), for Alzheimer’s disease came as no surprise to many experts in the field. 

“Clearly, the drug was a commercial failure,” Dave Knopman, MD, professor of neurology, Mayo Clinic, Rochester, Minnesota, said. “Despite the accelerated approval, the uncertainty of clinical benefits was transparent, and the public failed to generate any enthusiasm for the drug.”

Aducanumab received accelerated approval from the US Food and Drug Administration (FDA) in June 2021 despite a recommendation by its own advisory panel not to approve the drug. Dr. Knopman was a member of that panel and one of three members who resigned after the agency’s decision to approve the drug. 

“The decision by Biogen to cancel the aducanumab program was not surprising, as the company steadily withdrew their engagement in the program over the past year,” Dr. Knopman noted. 

“This was a commercial decision — not so much a scientific decision,” Howard Fillit, MD, founding executive director of the Alzheimer’s Drug Discovery Foundation, said. 

“The process by which the [aducanumab] program was handled and some of the conflicting opinions at the FDA led to uncertainty about the efficacy of the drug, and it wasn’t being prescribed,” Dr. Fillit said. 

After its approval, the Centers for Medicare & Medicaid Services restricted coverage of aducanumab to patients enrolled in clinical trials, which experts say likely contributed to Biogen’s decision to ditch the drug. 

It also limited the number of people living with Alzheimer’s disease who could get access to the treatment and “created significant confusion for patients and doctors,” the Alzheimer’s Association said in a statement on Biogen’s decision. 

Biogen will also terminate the post-approval clinical trial known as ENVISION, which sought to confirm aducanumab’s benefits in patients with early Alzheimer’s disease. 

Going forward, Biogen said that it will now focus on advancing lecanemab (Leqembi), the first anti-amyloid to receive traditional FDA approval.

“We have learned much from the mistakes and misjudgments that plagued aducanumab, but the field has moved on and is a little the wiser,” Dr. Knopman said. “With the standard approval of lecanemab, which showed clear, albeit modest, clinical benefits, we are focusing on providing safe and efficient access to lecanemab.” 

Biogen plans to accelerate the development of potential new treatment modalities. These include BIIB080, an investigational antisense oligonucleotide therapy targeting tau, and BIIB113, an oral small-molecule inhibitor of tau aggregation.

Dr. Fillit said that he’s “very excited” about the current pipeline of Alzheimer’s disease drugs, starting with donanemab, which is currently under review at the FDA, and “looks like it has somewhat better efficacy data than lecanemab.”

A version of this article appeared on Medscape.com.

Children and adolescents ages 5-17 who received a bivalent COVID-19 mRNA vaccine were less likely to become infected with SARS-CoV-2 compared with those who were unvaccinated or received only the monovalent COVID-19 vaccine, according to new data published February 6 in JAMA.

“All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations,” wrote the authors, led by Leora R. Feldstein, PhD, with the US Centers for Disease Control and Prevention (CDC) in Atlanta.

By the end of 2023, at least 911 youths ages 5-17 had died from COVID-related causes.

Researchers found that compared with participants who did not receive the COVID-19 vaccine or got monovalent-only doses 180 days or more before, the adjusted vaccine effectiveness of a bivalent COVID-19 vaccine dose against SARS-CoV-2 infection was 51.3% (95% confidence interval [CI], 23.6%-71.9%) 7-60 days after vaccination. Relative effectiveness was 62.4% (95% CI, 38.5%-81.1%) 61-150 days after vaccination. The researchers said the confidence intervals were wide because of the small sample size.

The information can help inform public health strategies, the authors noted, especially as new variants emerge.
 

Bivalent Dose Recommended in Fall of 2022

Bivalent mRNA COVID vaccines were recommended in the United States for children and adolescents ages 12 years or older on Sept. 1, 2022, and for children ages 5-11 on Oct. 12, 2022, when Omicron BA.4/5 types were the predominant circulating variant.

The study included 2,959 participants who completed periodic surveys (answering questions on demographics, household details, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (whether or not they had symptoms). Those in the study submitted additional nasal swabs if they developed any symptoms.

Median adherence to weekly upper respiratory specimen swabbing was high throughout the study period at 93.8%.

Data from Sept. 4, 2022, to Jan. 31, 2023, were combined from three prospective US cohort studies at six sites. In addition to the surveys, researchers used information from state immunization information systems and electronic medical records.
 

Most of the Infected Were Unvaccinated or Had Monovalent Vax

Of the 426 participants (14.4% of the combined cohorts) infected with SARS-CoV-2, 383 (89.9%) were either unvaccinated or received monovalent vaccine doses only.

Calculations were adjusted for age, sex, race, ethnicity, health conditions, prior SARS-CoV-2 infections, geographic location, proportion of circulating variants by site, and local virus prevalence.

Participants living in Oregon, for example, had the highest uptake of bivalent COVID-19 vaccine (56.2%), whereas those in Texas had the lowest (2.4%). Participants reporting Hispanic ethnicity had lower bivalent uptake (17.1%) compared with non-Hispanic participants of all races (27.1%).

Of the 2,207 participants who did not receive a bivalent dose, 24.2% were unvaccinated and 1,672 (75.8%) received at least 1 monovalent dose.

The researchers said they saw no sign of waning effectiveness 61-150 days (the limit for this analysis) after receipt of the bivalent COVID-19 vaccine.

They wrote that continuation of the cohorts will allow study of waning patterns, which could help inform vaccine recommendations.

Among the limitations of the study are that testing methods and the COVID-19 symptoms surveyed varied among the three cohorts, so there may be some differences in defining infection or symptomatic COVID. In addition, the researchers were not able to account for the social vulnerability index and immunocompromised status, which could have affected vaccine uptake and risk of SARS-CoV-2 infection.

This study was supported by the National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention, and by the National Institute of Allergy and Infectious Diseases. Coauthor Dr. Caban-Martinez reported grants from the Florida Firefighter Cancer Initiative and the Florida Department of Health. Coauthors Dr. Chu, Dr. Englund, Dr. Martin, and Dr. Monto reported receiving personal fees or grants from multiple pharmaceutical companies. Dr. Hegmann reported being the editor of the American College of Occupational and Environmental Medicine practice guidelines. Coauthor Dr. Gaglani reported serving as cochair of the infectious diseases and immunization committee and the respiratory syncytial virus task force lead for the Texas Pediatric Society and the Texas Chapter of the American Academy of Pediatrics. No other disclosures were reported.

Children and adolescents ages 5-17 who received a bivalent COVID-19 mRNA vaccine were less likely to become infected with SARS-CoV-2 compared with those who were unvaccinated or received only the monovalent COVID-19 vaccine, according to new data published February 6 in JAMA.

“All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations,” wrote the authors, led by Leora R. Feldstein, PhD, with the US Centers for Disease Control and Prevention (CDC) in Atlanta.

By the end of 2023, at least 911 youths ages 5-17 had died from COVID-related causes.

Researchers found that compared with participants who did not receive the COVID-19 vaccine or got monovalent-only doses 180 days or more before, the adjusted vaccine effectiveness of a bivalent COVID-19 vaccine dose against SARS-CoV-2 infection was 51.3% (95% confidence interval [CI], 23.6%-71.9%) 7-60 days after vaccination. Relative effectiveness was 62.4% (95% CI, 38.5%-81.1%) 61-150 days after vaccination. The researchers said the confidence intervals were wide because of the small sample size.

The information can help inform public health strategies, the authors noted, especially as new variants emerge.
 

Bivalent Dose Recommended in Fall of 2022

Bivalent mRNA COVID vaccines were recommended in the United States for children and adolescents ages 12 years or older on Sept. 1, 2022, and for children ages 5-11 on Oct. 12, 2022, when Omicron BA.4/5 types were the predominant circulating variant.

The study included 2,959 participants who completed periodic surveys (answering questions on demographics, household details, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (whether or not they had symptoms). Those in the study submitted additional nasal swabs if they developed any symptoms.

Median adherence to weekly upper respiratory specimen swabbing was high throughout the study period at 93.8%.

Data from Sept. 4, 2022, to Jan. 31, 2023, were combined from three prospective US cohort studies at six sites. In addition to the surveys, researchers used information from state immunization information systems and electronic medical records.
 

Most of the Infected Were Unvaccinated or Had Monovalent Vax

Of the 426 participants (14.4% of the combined cohorts) infected with SARS-CoV-2, 383 (89.9%) were either unvaccinated or received monovalent vaccine doses only.

Calculations were adjusted for age, sex, race, ethnicity, health conditions, prior SARS-CoV-2 infections, geographic location, proportion of circulating variants by site, and local virus prevalence.

Participants living in Oregon, for example, had the highest uptake of bivalent COVID-19 vaccine (56.2%), whereas those in Texas had the lowest (2.4%). Participants reporting Hispanic ethnicity had lower bivalent uptake (17.1%) compared with non-Hispanic participants of all races (27.1%).

Of the 2,207 participants who did not receive a bivalent dose, 24.2% were unvaccinated and 1,672 (75.8%) received at least 1 monovalent dose.

The researchers said they saw no sign of waning effectiveness 61-150 days (the limit for this analysis) after receipt of the bivalent COVID-19 vaccine.

They wrote that continuation of the cohorts will allow study of waning patterns, which could help inform vaccine recommendations.

Among the limitations of the study are that testing methods and the COVID-19 symptoms surveyed varied among the three cohorts, so there may be some differences in defining infection or symptomatic COVID. In addition, the researchers were not able to account for the social vulnerability index and immunocompromised status, which could have affected vaccine uptake and risk of SARS-CoV-2 infection.

This study was supported by the National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention, and by the National Institute of Allergy and Infectious Diseases. Coauthor Dr. Caban-Martinez reported grants from the Florida Firefighter Cancer Initiative and the Florida Department of Health. Coauthors Dr. Chu, Dr. Englund, Dr. Martin, and Dr. Monto reported receiving personal fees or grants from multiple pharmaceutical companies. Dr. Hegmann reported being the editor of the American College of Occupational and Environmental Medicine practice guidelines. Coauthor Dr. Gaglani reported serving as cochair of the infectious diseases and immunization committee and the respiratory syncytial virus task force lead for the Texas Pediatric Society and the Texas Chapter of the American Academy of Pediatrics. No other disclosures were reported.

Children and adolescents ages 5-17 who received a bivalent COVID-19 mRNA vaccine were less likely to become infected with SARS-CoV-2 compared with those who were unvaccinated or received only the monovalent COVID-19 vaccine, according to new data published February 6 in JAMA.

“All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations,” wrote the authors, led by Leora R. Feldstein, PhD, with the US Centers for Disease Control and Prevention (CDC) in Atlanta.

By the end of 2023, at least 911 youths ages 5-17 had died from COVID-related causes.

Researchers found that compared with participants who did not receive the COVID-19 vaccine or got monovalent-only doses 180 days or more before, the adjusted vaccine effectiveness of a bivalent COVID-19 vaccine dose against SARS-CoV-2 infection was 51.3% (95% confidence interval [CI], 23.6%-71.9%) 7-60 days after vaccination. Relative effectiveness was 62.4% (95% CI, 38.5%-81.1%) 61-150 days after vaccination. The researchers said the confidence intervals were wide because of the small sample size.

The information can help inform public health strategies, the authors noted, especially as new variants emerge.
 

Bivalent Dose Recommended in Fall of 2022

Bivalent mRNA COVID vaccines were recommended in the United States for children and adolescents ages 12 years or older on Sept. 1, 2022, and for children ages 5-11 on Oct. 12, 2022, when Omicron BA.4/5 types were the predominant circulating variant.

The study included 2,959 participants who completed periodic surveys (answering questions on demographics, household details, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (whether or not they had symptoms). Those in the study submitted additional nasal swabs if they developed any symptoms.

Median adherence to weekly upper respiratory specimen swabbing was high throughout the study period at 93.8%.

Data from Sept. 4, 2022, to Jan. 31, 2023, were combined from three prospective US cohort studies at six sites. In addition to the surveys, researchers used information from state immunization information systems and electronic medical records.
 

Most of the Infected Were Unvaccinated or Had Monovalent Vax

Of the 426 participants (14.4% of the combined cohorts) infected with SARS-CoV-2, 383 (89.9%) were either unvaccinated or received monovalent vaccine doses only.

Calculations were adjusted for age, sex, race, ethnicity, health conditions, prior SARS-CoV-2 infections, geographic location, proportion of circulating variants by site, and local virus prevalence.

Participants living in Oregon, for example, had the highest uptake of bivalent COVID-19 vaccine (56.2%), whereas those in Texas had the lowest (2.4%). Participants reporting Hispanic ethnicity had lower bivalent uptake (17.1%) compared with non-Hispanic participants of all races (27.1%).

Of the 2,207 participants who did not receive a bivalent dose, 24.2% were unvaccinated and 1,672 (75.8%) received at least 1 monovalent dose.

The researchers said they saw no sign of waning effectiveness 61-150 days (the limit for this analysis) after receipt of the bivalent COVID-19 vaccine.

They wrote that continuation of the cohorts will allow study of waning patterns, which could help inform vaccine recommendations.

Among the limitations of the study are that testing methods and the COVID-19 symptoms surveyed varied among the three cohorts, so there may be some differences in defining infection or symptomatic COVID. In addition, the researchers were not able to account for the social vulnerability index and immunocompromised status, which could have affected vaccine uptake and risk of SARS-CoV-2 infection.

This study was supported by the National Center for Immunization and Respiratory Diseases, US Centers for Disease Control and Prevention, and by the National Institute of Allergy and Infectious Diseases. Coauthor Dr. Caban-Martinez reported grants from the Florida Firefighter Cancer Initiative and the Florida Department of Health. Coauthors Dr. Chu, Dr. Englund, Dr. Martin, and Dr. Monto reported receiving personal fees or grants from multiple pharmaceutical companies. Dr. Hegmann reported being the editor of the American College of Occupational and Environmental Medicine practice guidelines. Coauthor Dr. Gaglani reported serving as cochair of the infectious diseases and immunization committee and the respiratory syncytial virus task force lead for the Texas Pediatric Society and the Texas Chapter of the American Academy of Pediatrics. No other disclosures were reported.

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.

The supervising physician for the California nurse practitioner (NP) “Dr. Sarah,” who illegally presented herself as a doctor, has been fined $25,000. The case highlights the liability concerns doctors face when they oversee NPs.

According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.

Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.

A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.

For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.

Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.

Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.

However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.

Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.

Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.

Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.

“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.

“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
 

A version of this article appeared on Medscape.com .

The supervising physician for the California nurse practitioner (NP) “Dr. Sarah,” who illegally presented herself as a doctor, has been fined $25,000. The case highlights the liability concerns doctors face when they oversee NPs.

According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.

Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.

A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.

For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.

Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.

Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.

However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.

Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.

Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.

Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.

“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.

“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
 

A version of this article appeared on Medscape.com .

The supervising physician for the California nurse practitioner (NP) “Dr. Sarah,” who illegally presented herself as a doctor, has been fined $25,000. The case highlights the liability concerns doctors face when they oversee NPs.

According to the complaint, ob.gyn. Anika Moore, MD, FACOP, agreed to pay the civil penalty but admitted no fault related to allegations of unlawful supervision of Sarah Erny, DNP. Dr. Moore did not respond to an emailed request for comment.

Ms. Erny was fined nearly $20,000 after an investigation in November by the San Luis Obispo County, California, district attorney found she had committed false advertising and fraud by regularly calling herself “Doctor” on social media and with patients.

A group of California DNPs, including Ms. Erny, pushed back against those regulations last year by suing the state, alleging a law restricting the use of the honorific title violates their right to free speech.

For collaborative agreements, California law requires physicians and the NPs they supervise to adhere to specific roles and prescribing privileges as outlined in the written document. Supervising physicians must routinely review the terms of the agreement and the nurse’s performance and skills.

Even as more states loosen supervision restrictions for NPs, physicians who still do so face added risks. Medical boards may sanction them for improper supervision, and the majority of patients who sue their NP for malpractice also sue the supervising doctor.

Dr. Moore lived in Massachusetts in 2018 when she entered the agreement with Ms. Erny, but she only skimmed the document and did no further research on her supervising responsibilities, court records said. Although Dr. Moore was not compensated for the oversight role, she said she made herself available over the next 2 years to answer Ms. Erny’s questions.

However, an investigation by the California Department of Consumer Affairs and the San Luis Obispo County District Attorney’s Office found that Dr. Moore never reviewed any physical medical records of Ms. Erny’s patients.

Instead, without Dr. Moore’s knowledge, Ms. Erny opened an independent medical practice near San Luis Obispo, called Holistic Women’s Health, where she provided medical services and drug supplements, including prescribing controlled substances like testosterone.

Meanwhile, Dr. Moore believed Ms. Erny was practicing in a clinical setting with other physicians, court documents said.

Ms. Erny and Dr. Moore agreed to terminate the collaborative agreement in March 2021.

“As a supervising physician, Dr. Moore accepted a professional commitment to collaborate and supervise Nurse Practitioner Erny,” Assistant District Attorney Eric Dobroth said in a statement.

“Our office seeks to ensure that every physician that consents to supervise a nurse will comply with California requirements and take great care to routinely evaluate whether the terms of the agreement are being met and to evaluate the nurse’s performance to ensure best patient care.”
 

A version of this article appeared on Medscape.com .

In a significant victory for patients and healthcare providers, Blue Cross Blue Shield of Massachusetts (BCBSMA) has officially postponed its restrictive anesthesia policy until further notice. The change is retroactive to Jan. 1, 2024, so no claims will be rejected for payment.

The decision follows intense advocacy efforts by a coalition that included AGA, the American Society of Anesthesiologists (ASA), and the American College of Surgeons (ACS), with the Massachusetts Gastroenterology Association demonstrating exceptional leadership and the Massachusetts Society of Anesthesiologists (MSA) persevering throughout the process. The BCBSMA heeded the coalition’s warnings about the potential impact on cancer screening access and patient choice in GI care.

Physician leaders representing the societies played a crucial role in meetings with BCBSMA, contributing to this positive outcome. Member engagement, including contacting legislators, media outreach, and participation in the #Noto154 campaign, had a substantial impact.

BCBSMA informed the societies that all claims will be paid; however, documentation will still be required for patients presenting with ASA 1 and ASA 2. Providers may download a list of commonly used diagnosis codes documented with the administration of propofol. The AGA encourages members to still be mindful that BCBSMA will be monitoring the use of these codes for propofol administration. Members can see BCBSMA policy 154 for the complete list of diagnosis codes that support use of MAC. The societies have requested that BCBSMA provide education to providers on this requirement.

The AGA intends to closely monitor developments to ensure similar policies are not introduced nationally.

In a significant victory for patients and healthcare providers, Blue Cross Blue Shield of Massachusetts (BCBSMA) has officially postponed its restrictive anesthesia policy until further notice. The change is retroactive to Jan. 1, 2024, so no claims will be rejected for payment.

The decision follows intense advocacy efforts by a coalition that included AGA, the American Society of Anesthesiologists (ASA), and the American College of Surgeons (ACS), with the Massachusetts Gastroenterology Association demonstrating exceptional leadership and the Massachusetts Society of Anesthesiologists (MSA) persevering throughout the process. The BCBSMA heeded the coalition’s warnings about the potential impact on cancer screening access and patient choice in GI care.

Physician leaders representing the societies played a crucial role in meetings with BCBSMA, contributing to this positive outcome. Member engagement, including contacting legislators, media outreach, and participation in the #Noto154 campaign, had a substantial impact.

BCBSMA informed the societies that all claims will be paid; however, documentation will still be required for patients presenting with ASA 1 and ASA 2. Providers may download a list of commonly used diagnosis codes documented with the administration of propofol. The AGA encourages members to still be mindful that BCBSMA will be monitoring the use of these codes for propofol administration. Members can see BCBSMA policy 154 for the complete list of diagnosis codes that support use of MAC. The societies have requested that BCBSMA provide education to providers on this requirement.

The AGA intends to closely monitor developments to ensure similar policies are not introduced nationally.

In a significant victory for patients and healthcare providers, Blue Cross Blue Shield of Massachusetts (BCBSMA) has officially postponed its restrictive anesthesia policy until further notice. The change is retroactive to Jan. 1, 2024, so no claims will be rejected for payment.

The decision follows intense advocacy efforts by a coalition that included AGA, the American Society of Anesthesiologists (ASA), and the American College of Surgeons (ACS), with the Massachusetts Gastroenterology Association demonstrating exceptional leadership and the Massachusetts Society of Anesthesiologists (MSA) persevering throughout the process. The BCBSMA heeded the coalition’s warnings about the potential impact on cancer screening access and patient choice in GI care.

Physician leaders representing the societies played a crucial role in meetings with BCBSMA, contributing to this positive outcome. Member engagement, including contacting legislators, media outreach, and participation in the #Noto154 campaign, had a substantial impact.

BCBSMA informed the societies that all claims will be paid; however, documentation will still be required for patients presenting with ASA 1 and ASA 2. Providers may download a list of commonly used diagnosis codes documented with the administration of propofol. The AGA encourages members to still be mindful that BCBSMA will be monitoring the use of these codes for propofol administration. Members can see BCBSMA policy 154 for the complete list of diagnosis codes that support use of MAC. The societies have requested that BCBSMA provide education to providers on this requirement.

The AGA intends to closely monitor developments to ensure similar policies are not introduced nationally.

Two species of gut bacteria modulate the immune system and even the survival of one another to impact the progression of chronic hepatitis B (CHB), according to investigators.

While Ruminococcus gnavus promotes immune tolerance and therefore HBV persistence, Akkermansia muciniphila stimulates the immune system, promoting viral clearance, reported lead author Huey-Huey Chua, MD, of the National Taiwan University College of Medicine and Children’s Hospital, Taipei, and colleagues.

These findings could lead to new therapeutic strategies, such as administration of the secretory products of A. muciniphila, or provision of probiotics and prebiotics that tip the balance toward this more beneficial bacterium, the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology.

Their study, which included data from both human patients and mouse models of CHB, was grounded in prior research showing a link between gut microbiota and the age-dependence of HBV immunity.

“Sterilization of the gut microbiota using antibiotics prevents adult mice from rapidly clearing HBV and restores the tolerance phenotype, implying that the gut microbiota may transmit signals to break liver tolerance and evoke rapid HBV clearance,” Dr. Chua and colleagues wrote. “We hypothesized that the wax and wane of gut microbiota signatures may determine the progression of CHB. We aimed to delineate what the pivotal bacteria are and how they manipulate the progression of CHB.”

They began by analyzing fecal samples from 102 patients with CHB either in the immune-tolerant (IT) or immune-active (IA) phase of infection.

R. gnavus was the most abundant species among IT patients, whereas A. muciniphila was most abundant among patients in the IA phase. Higher levels of A. muciniphila were also associated with early hepatitis B e-antigen (HBeAG) loss, HBeAG seroconversion, and flares of aminotransferase. A mouse model echoed these findings.

Further experiments with mouse models revealed that R. gnavus modulates bile acids to promote HBV persistence and prolongation of the IT course. In opposition, A. muciniphila removes cholesterol and secretes metabolites that inhibit growth and function of R. gnavus.

“These novel findings will certainly confer a groundbreaking impact on the future therapy of CHB,” Dr. Chua and colleagues wrote.

They went on to describe several therapeutic strategies worth further investigation.

“A key step to promote switching from the IT to IA phase is to lessen the richness of R. gnavus and bile acid bioconversion from cholesterol,” they wrote. The secretory products of A. muciniphila that successfully ameliorate the burden of R. gnavus outgrowth can be provided as useful means to induce anti-HBV efficacy. Also, the development of targeted probiotics or prebiotics that can modulate the gut microbiota composition to favor the beneficial effects of A. muciniphila while inhibiting the detrimental effects of R. gnavus may have translational value for CHB.”

The study was supported by the Ministry of Science and Technology, Executive Yuan, Taiwan and the Center of Precision Medicine from Featured Areas Research Center Program within the Framework of the Higher Education Sprout Project by the Ministry of Education in Taiwan. The investigators disclosed no conflicts of interest.

Two species of gut bacteria modulate the immune system and even the survival of one another to impact the progression of chronic hepatitis B (CHB), according to investigators.

While Ruminococcus gnavus promotes immune tolerance and therefore HBV persistence, Akkermansia muciniphila stimulates the immune system, promoting viral clearance, reported lead author Huey-Huey Chua, MD, of the National Taiwan University College of Medicine and Children’s Hospital, Taipei, and colleagues.

These findings could lead to new therapeutic strategies, such as administration of the secretory products of A. muciniphila, or provision of probiotics and prebiotics that tip the balance toward this more beneficial bacterium, the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology.

Their study, which included data from both human patients and mouse models of CHB, was grounded in prior research showing a link between gut microbiota and the age-dependence of HBV immunity.

“Sterilization of the gut microbiota using antibiotics prevents adult mice from rapidly clearing HBV and restores the tolerance phenotype, implying that the gut microbiota may transmit signals to break liver tolerance and evoke rapid HBV clearance,” Dr. Chua and colleagues wrote. “We hypothesized that the wax and wane of gut microbiota signatures may determine the progression of CHB. We aimed to delineate what the pivotal bacteria are and how they manipulate the progression of CHB.”

They began by analyzing fecal samples from 102 patients with CHB either in the immune-tolerant (IT) or immune-active (IA) phase of infection.

R. gnavus was the most abundant species among IT patients, whereas A. muciniphila was most abundant among patients in the IA phase. Higher levels of A. muciniphila were also associated with early hepatitis B e-antigen (HBeAG) loss, HBeAG seroconversion, and flares of aminotransferase. A mouse model echoed these findings.

Further experiments with mouse models revealed that R. gnavus modulates bile acids to promote HBV persistence and prolongation of the IT course. In opposition, A. muciniphila removes cholesterol and secretes metabolites that inhibit growth and function of R. gnavus.

“These novel findings will certainly confer a groundbreaking impact on the future therapy of CHB,” Dr. Chua and colleagues wrote.

They went on to describe several therapeutic strategies worth further investigation.

“A key step to promote switching from the IT to IA phase is to lessen the richness of R. gnavus and bile acid bioconversion from cholesterol,” they wrote. The secretory products of A. muciniphila that successfully ameliorate the burden of R. gnavus outgrowth can be provided as useful means to induce anti-HBV efficacy. Also, the development of targeted probiotics or prebiotics that can modulate the gut microbiota composition to favor the beneficial effects of A. muciniphila while inhibiting the detrimental effects of R. gnavus may have translational value for CHB.”

The study was supported by the Ministry of Science and Technology, Executive Yuan, Taiwan and the Center of Precision Medicine from Featured Areas Research Center Program within the Framework of the Higher Education Sprout Project by the Ministry of Education in Taiwan. The investigators disclosed no conflicts of interest.

Two species of gut bacteria modulate the immune system and even the survival of one another to impact the progression of chronic hepatitis B (CHB), according to investigators.

While Ruminococcus gnavus promotes immune tolerance and therefore HBV persistence, Akkermansia muciniphila stimulates the immune system, promoting viral clearance, reported lead author Huey-Huey Chua, MD, of the National Taiwan University College of Medicine and Children’s Hospital, Taipei, and colleagues.

These findings could lead to new therapeutic strategies, such as administration of the secretory products of A. muciniphila, or provision of probiotics and prebiotics that tip the balance toward this more beneficial bacterium, the investigators wrote in Cellular and Molecular Gastroenterology and Hepatology.

Their study, which included data from both human patients and mouse models of CHB, was grounded in prior research showing a link between gut microbiota and the age-dependence of HBV immunity.

“Sterilization of the gut microbiota using antibiotics prevents adult mice from rapidly clearing HBV and restores the tolerance phenotype, implying that the gut microbiota may transmit signals to break liver tolerance and evoke rapid HBV clearance,” Dr. Chua and colleagues wrote. “We hypothesized that the wax and wane of gut microbiota signatures may determine the progression of CHB. We aimed to delineate what the pivotal bacteria are and how they manipulate the progression of CHB.”

They began by analyzing fecal samples from 102 patients with CHB either in the immune-tolerant (IT) or immune-active (IA) phase of infection.

R. gnavus was the most abundant species among IT patients, whereas A. muciniphila was most abundant among patients in the IA phase. Higher levels of A. muciniphila were also associated with early hepatitis B e-antigen (HBeAG) loss, HBeAG seroconversion, and flares of aminotransferase. A mouse model echoed these findings.

Further experiments with mouse models revealed that R. gnavus modulates bile acids to promote HBV persistence and prolongation of the IT course. In opposition, A. muciniphila removes cholesterol and secretes metabolites that inhibit growth and function of R. gnavus.

“These novel findings will certainly confer a groundbreaking impact on the future therapy of CHB,” Dr. Chua and colleagues wrote.

They went on to describe several therapeutic strategies worth further investigation.

“A key step to promote switching from the IT to IA phase is to lessen the richness of R. gnavus and bile acid bioconversion from cholesterol,” they wrote. The secretory products of A. muciniphila that successfully ameliorate the burden of R. gnavus outgrowth can be provided as useful means to induce anti-HBV efficacy. Also, the development of targeted probiotics or prebiotics that can modulate the gut microbiota composition to favor the beneficial effects of A. muciniphila while inhibiting the detrimental effects of R. gnavus may have translational value for CHB.”

The study was supported by the Ministry of Science and Technology, Executive Yuan, Taiwan and the Center of Precision Medicine from Featured Areas Research Center Program within the Framework of the Higher Education Sprout Project by the Ministry of Education in Taiwan. The investigators disclosed no conflicts of interest.