Clinician Reviews

 The U.S. Food and Drug Administration has approved risankizumab-rzaa (Skyrizi, AbbVie) for a third indication – treatment of moderately to severely active Crohn’s disease in adults – making it the first specific anti–interleukin-23 monoclonal antibody indicated for Crohn’s disease.

The safety and efficacy of risankizumab in Crohn’s disease is supported by data from two induction clinical trials (ADVANCE and MOTIVATE) and one maintenance clinical trial (FORTIFY).

Results of the three studies were presented at the annual scientific meeting of the American College of Gastroenterology in 2021.

“In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo,” Marla Dubinsky, MD, gastroenterologist with the Mount Sinai Health System and codirector of the IBD Center at Mount Sinai, New York, said in a news release from AbbVie.

“This approval provides health care professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease,” Dr. Dubinsky said.

For the treatment of Crohn’s disease, risankizumab is dosed at 600 mg administered by intravenous infusion over at least 1 hour at week 0, 4, and 8, followed by 360 mg self-administered by subcutaneous injection at week 12, and every 8 weeks thereafter.

Risankizumab is already approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

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

 The U.S. Food and Drug Administration has approved risankizumab-rzaa (Skyrizi, AbbVie) for a third indication – treatment of moderately to severely active Crohn’s disease in adults – making it the first specific anti–interleukin-23 monoclonal antibody indicated for Crohn’s disease.

The safety and efficacy of risankizumab in Crohn’s disease is supported by data from two induction clinical trials (ADVANCE and MOTIVATE) and one maintenance clinical trial (FORTIFY).

Results of the three studies were presented at the annual scientific meeting of the American College of Gastroenterology in 2021.

“In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo,” Marla Dubinsky, MD, gastroenterologist with the Mount Sinai Health System and codirector of the IBD Center at Mount Sinai, New York, said in a news release from AbbVie.

“This approval provides health care professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease,” Dr. Dubinsky said.

For the treatment of Crohn’s disease, risankizumab is dosed at 600 mg administered by intravenous infusion over at least 1 hour at week 0, 4, and 8, followed by 360 mg self-administered by subcutaneous injection at week 12, and every 8 weeks thereafter.

Risankizumab is already approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

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

 The U.S. Food and Drug Administration has approved risankizumab-rzaa (Skyrizi, AbbVie) for a third indication – treatment of moderately to severely active Crohn’s disease in adults – making it the first specific anti–interleukin-23 monoclonal antibody indicated for Crohn’s disease.

The safety and efficacy of risankizumab in Crohn’s disease is supported by data from two induction clinical trials (ADVANCE and MOTIVATE) and one maintenance clinical trial (FORTIFY).

Results of the three studies were presented at the annual scientific meeting of the American College of Gastroenterology in 2021.

“In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo,” Marla Dubinsky, MD, gastroenterologist with the Mount Sinai Health System and codirector of the IBD Center at Mount Sinai, New York, said in a news release from AbbVie.

“This approval provides health care professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease,” Dr. Dubinsky said.

For the treatment of Crohn’s disease, risankizumab is dosed at 600 mg administered by intravenous infusion over at least 1 hour at week 0, 4, and 8, followed by 360 mg self-administered by subcutaneous injection at week 12, and every 8 weeks thereafter.

Risankizumab is already approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

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

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.

The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.

“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.

The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.

The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.

Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.

If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.

Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.

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

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.

The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.

“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.

The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.

The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.

Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.

If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.

Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.

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

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.

The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.

“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.

The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.

The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.

Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.

If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.

Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.

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

Simone Gold, MD, JD, a leader in the anti-vaccine movement and founder of noted anti-vaccine group America’s Frontline Doctors, has been sentenced to 2 months in prison for her role in the storming of the U.S. Capitol on January 6, 2021.

In March, the former emergency room physician pleaded guilty to unlawfully and knowingly entering and remaining in a restricted building or grounds. As a part of the plea agreement, additional charges of obstructing an official proceeding and intent to disrupt the orderly conduct of government business were dropped. Although she insisted at the time that her actions were peaceful, Dr. Gold did admit, according to news reports, that she witnessed the assault of a police officer while inside the building.

America’s Frontline Doctors is an organization noted for spreading misinformation about COVID-19 and promoting unproven and potentially dangerous drugs, including ivermectin, for treating the illness. The group issued a statement saying that while Dr. Gold did express regret for “being involved in a situation that later became unpredictable,” her sentence is an example of “selective prosecution.”

“Dr. Gold remains committed to her advocacy for physicians’ free speech,” the statement noted, adding that Dr. Gold has been targeted by attacks attempting to “cancel” her since July 2020, when the California Medical Board threatened to revoke her license for what the statement calls an “unfounded claim” that she was sharing dangerous disinformation.

According to Associated Press reporting, U.S. District Judge Christopher Cooper did not consider Dr. Gold’s anti-vaccine activity when determining the sentence. However, Judge Cooper did say that Dr. Gold was not a “casual bystander” on January 6 and criticized the organization for misleading its supporters into believing that her prosecution was a politically motivated violation of her free-speech rights.

Prosecutors accused Dr. Gold of trying to profit from her crime, according to AP reports, noting in a court filing that America’s Frontline Doctors has raised more than $430,000 for her defense. “It beggars belief that [Dr.] Gold could have incurred anywhere near $430,000 in costs for her criminal defense: After all, she pleaded guilty – in the face of indisputable evidence – without filing a single motion.”

In the past, Dr. Gold has worked at Providence St. Joseph Medical Center, Santa Monica, Calif., and Cedars-Sinai, Los Angeles. These institutions have disassociated themselves from her. Her medical license remains active, but she noted on her website that she “voluntarily refused” to renew her board certification last year “due to the unethical behavior of the medical boards.” Dr. Gold is also a licensed attorney, having earned a law degree in health policy analysis at Stanford Law School.

The AP reports that since her arrest, Dr. Gold has moved from California to Florida.

In addition to the prison time, Judge Cooper ordered Dr. Gold to pay a $9,500 fine, and she will be subject to 12 months of supervised release after completing her sentence, according to media reports. At press time, the U.S. Department of Justice has not released an official announcement on the sentencing.

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

Simone Gold, MD, JD, a leader in the anti-vaccine movement and founder of noted anti-vaccine group America’s Frontline Doctors, has been sentenced to 2 months in prison for her role in the storming of the U.S. Capitol on January 6, 2021.

In March, the former emergency room physician pleaded guilty to unlawfully and knowingly entering and remaining in a restricted building or grounds. As a part of the plea agreement, additional charges of obstructing an official proceeding and intent to disrupt the orderly conduct of government business were dropped. Although she insisted at the time that her actions were peaceful, Dr. Gold did admit, according to news reports, that she witnessed the assault of a police officer while inside the building.

America’s Frontline Doctors is an organization noted for spreading misinformation about COVID-19 and promoting unproven and potentially dangerous drugs, including ivermectin, for treating the illness. The group issued a statement saying that while Dr. Gold did express regret for “being involved in a situation that later became unpredictable,” her sentence is an example of “selective prosecution.”

“Dr. Gold remains committed to her advocacy for physicians’ free speech,” the statement noted, adding that Dr. Gold has been targeted by attacks attempting to “cancel” her since July 2020, when the California Medical Board threatened to revoke her license for what the statement calls an “unfounded claim” that she was sharing dangerous disinformation.

According to Associated Press reporting, U.S. District Judge Christopher Cooper did not consider Dr. Gold’s anti-vaccine activity when determining the sentence. However, Judge Cooper did say that Dr. Gold was not a “casual bystander” on January 6 and criticized the organization for misleading its supporters into believing that her prosecution was a politically motivated violation of her free-speech rights.

Prosecutors accused Dr. Gold of trying to profit from her crime, according to AP reports, noting in a court filing that America’s Frontline Doctors has raised more than $430,000 for her defense. “It beggars belief that [Dr.] Gold could have incurred anywhere near $430,000 in costs for her criminal defense: After all, she pleaded guilty – in the face of indisputable evidence – without filing a single motion.”

In the past, Dr. Gold has worked at Providence St. Joseph Medical Center, Santa Monica, Calif., and Cedars-Sinai, Los Angeles. These institutions have disassociated themselves from her. Her medical license remains active, but she noted on her website that she “voluntarily refused” to renew her board certification last year “due to the unethical behavior of the medical boards.” Dr. Gold is also a licensed attorney, having earned a law degree in health policy analysis at Stanford Law School.

The AP reports that since her arrest, Dr. Gold has moved from California to Florida.

In addition to the prison time, Judge Cooper ordered Dr. Gold to pay a $9,500 fine, and she will be subject to 12 months of supervised release after completing her sentence, according to media reports. At press time, the U.S. Department of Justice has not released an official announcement on the sentencing.

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

Simone Gold, MD, JD, a leader in the anti-vaccine movement and founder of noted anti-vaccine group America’s Frontline Doctors, has been sentenced to 2 months in prison for her role in the storming of the U.S. Capitol on January 6, 2021.

In March, the former emergency room physician pleaded guilty to unlawfully and knowingly entering and remaining in a restricted building or grounds. As a part of the plea agreement, additional charges of obstructing an official proceeding and intent to disrupt the orderly conduct of government business were dropped. Although she insisted at the time that her actions were peaceful, Dr. Gold did admit, according to news reports, that she witnessed the assault of a police officer while inside the building.

America’s Frontline Doctors is an organization noted for spreading misinformation about COVID-19 and promoting unproven and potentially dangerous drugs, including ivermectin, for treating the illness. The group issued a statement saying that while Dr. Gold did express regret for “being involved in a situation that later became unpredictable,” her sentence is an example of “selective prosecution.”

“Dr. Gold remains committed to her advocacy for physicians’ free speech,” the statement noted, adding that Dr. Gold has been targeted by attacks attempting to “cancel” her since July 2020, when the California Medical Board threatened to revoke her license for what the statement calls an “unfounded claim” that she was sharing dangerous disinformation.

According to Associated Press reporting, U.S. District Judge Christopher Cooper did not consider Dr. Gold’s anti-vaccine activity when determining the sentence. However, Judge Cooper did say that Dr. Gold was not a “casual bystander” on January 6 and criticized the organization for misleading its supporters into believing that her prosecution was a politically motivated violation of her free-speech rights.

Prosecutors accused Dr. Gold of trying to profit from her crime, according to AP reports, noting in a court filing that America’s Frontline Doctors has raised more than $430,000 for her defense. “It beggars belief that [Dr.] Gold could have incurred anywhere near $430,000 in costs for her criminal defense: After all, she pleaded guilty – in the face of indisputable evidence – without filing a single motion.”

In the past, Dr. Gold has worked at Providence St. Joseph Medical Center, Santa Monica, Calif., and Cedars-Sinai, Los Angeles. These institutions have disassociated themselves from her. Her medical license remains active, but she noted on her website that she “voluntarily refused” to renew her board certification last year “due to the unethical behavior of the medical boards.” Dr. Gold is also a licensed attorney, having earned a law degree in health policy analysis at Stanford Law School.

The AP reports that since her arrest, Dr. Gold has moved from California to Florida.

In addition to the prison time, Judge Cooper ordered Dr. Gold to pay a $9,500 fine, and she will be subject to 12 months of supervised release after completing her sentence, according to media reports. At press time, the U.S. Department of Justice has not released an official announcement on the sentencing.

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

A federal jury recently awarded more than $100 million to a college student whose left leg was permanently damaged as the result of care he received after a sports injury, according to a story from WCCO CBS Minnesota, among other news outlets. The award has been called the largest judgment of its kind in Minnesota history.

In January 2017, Nepalese immigrant Anuj Thapa was playing in an indoor soccer game at St. Cloud State University when another player tackled him. His left leg badly injured, Mr. Thapa was taken by ambulance to CentraCare’s St. Cloud Hospital. The orthopedic surgeon on call that day was Chad Holien, MD, who is affiliated with St. Cloud Orthopedics, a private clinic in nearby Sartell, Minn. Following preparations, and with the help of a physician assistant, Dr. Holien operated on the patient’s broken leg.

But Mr. Thapa experienced post-surgical complications – severe pain, numbness, burning, and muscle issues. Despite the complications, he was discharged from the hospital that afternoon and sent home.

Six days later, Mr. Thapa returned to St. Cloud Hospital, still complaining of severe pain. A second orthopedic surgeon operated and found that Mr. Thapa had “acute compartment syndrome,” the result of internal pressure that had built up in his leg muscles.

Over time, Mr. Thapa underwent more than 20 surgeries on his leg to deal with the ongoing pain and other complications, according to WCCO.

In 2019, he filed a medical malpractice suit in U.S. district court against St. Cloud Orthopedics, the private practice that employed the surgeon and the PA. (Under Minnesota law, an employer is responsible for the actions of its employees.)

In his complaint, Mr. Thapa alleged that in treating him, “the defendants departed from accepted standards of medical practice.” Among other things, he claimed that Dr. Holien and the PA had not properly evaluated his postoperative symptoms, failed to diagnose and treat his compartment syndrome, and improperly discharged him from the hospital. These lapses, Mr. Thapa said, led to his “severe, permanent, and disabling injuries.”

The federal jury agreed. After a weeklong trial, it awarded the plaintiff $100 million for future “pain, disability, disfigurement, embarrassment, and emotional distress.” It also gave him $10 million for past suffering and a little more than $1 million for past and future medical bills.

In a postverdict statement, Mr. Thapa’s attorney said that, while the surgeon and PA are undoubtedly good providers, they made mistakes in this case.

A defense attorney for St. Cloud Orthopedics disputes this: “We maintain the care provided in this case was in accordance with accepted standards of care.”

At press time, the defense had not determined whether to appeal the jury’s $111 million verdict. “St. Cloud continues to support its providers,” said the clinic’s defense attorney. “We are evaluating our options regarding this verdict.”

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

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

A federal jury recently awarded more than $100 million to a college student whose left leg was permanently damaged as the result of care he received after a sports injury, according to a story from WCCO CBS Minnesota, among other news outlets. The award has been called the largest judgment of its kind in Minnesota history.

In January 2017, Nepalese immigrant Anuj Thapa was playing in an indoor soccer game at St. Cloud State University when another player tackled him. His left leg badly injured, Mr. Thapa was taken by ambulance to CentraCare’s St. Cloud Hospital. The orthopedic surgeon on call that day was Chad Holien, MD, who is affiliated with St. Cloud Orthopedics, a private clinic in nearby Sartell, Minn. Following preparations, and with the help of a physician assistant, Dr. Holien operated on the patient’s broken leg.

But Mr. Thapa experienced post-surgical complications – severe pain, numbness, burning, and muscle issues. Despite the complications, he was discharged from the hospital that afternoon and sent home.

Six days later, Mr. Thapa returned to St. Cloud Hospital, still complaining of severe pain. A second orthopedic surgeon operated and found that Mr. Thapa had “acute compartment syndrome,” the result of internal pressure that had built up in his leg muscles.

Over time, Mr. Thapa underwent more than 20 surgeries on his leg to deal with the ongoing pain and other complications, according to WCCO.

In 2019, he filed a medical malpractice suit in U.S. district court against St. Cloud Orthopedics, the private practice that employed the surgeon and the PA. (Under Minnesota law, an employer is responsible for the actions of its employees.)

In his complaint, Mr. Thapa alleged that in treating him, “the defendants departed from accepted standards of medical practice.” Among other things, he claimed that Dr. Holien and the PA had not properly evaluated his postoperative symptoms, failed to diagnose and treat his compartment syndrome, and improperly discharged him from the hospital. These lapses, Mr. Thapa said, led to his “severe, permanent, and disabling injuries.”

The federal jury agreed. After a weeklong trial, it awarded the plaintiff $100 million for future “pain, disability, disfigurement, embarrassment, and emotional distress.” It also gave him $10 million for past suffering and a little more than $1 million for past and future medical bills.

In a postverdict statement, Mr. Thapa’s attorney said that, while the surgeon and PA are undoubtedly good providers, they made mistakes in this case.

A defense attorney for St. Cloud Orthopedics disputes this: “We maintain the care provided in this case was in accordance with accepted standards of care.”

At press time, the defense had not determined whether to appeal the jury’s $111 million verdict. “St. Cloud continues to support its providers,” said the clinic’s defense attorney. “We are evaluating our options regarding this verdict.”

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

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

A federal jury recently awarded more than $100 million to a college student whose left leg was permanently damaged as the result of care he received after a sports injury, according to a story from WCCO CBS Minnesota, among other news outlets. The award has been called the largest judgment of its kind in Minnesota history.

In January 2017, Nepalese immigrant Anuj Thapa was playing in an indoor soccer game at St. Cloud State University when another player tackled him. His left leg badly injured, Mr. Thapa was taken by ambulance to CentraCare’s St. Cloud Hospital. The orthopedic surgeon on call that day was Chad Holien, MD, who is affiliated with St. Cloud Orthopedics, a private clinic in nearby Sartell, Minn. Following preparations, and with the help of a physician assistant, Dr. Holien operated on the patient’s broken leg.

But Mr. Thapa experienced post-surgical complications – severe pain, numbness, burning, and muscle issues. Despite the complications, he was discharged from the hospital that afternoon and sent home.

Six days later, Mr. Thapa returned to St. Cloud Hospital, still complaining of severe pain. A second orthopedic surgeon operated and found that Mr. Thapa had “acute compartment syndrome,” the result of internal pressure that had built up in his leg muscles.

Over time, Mr. Thapa underwent more than 20 surgeries on his leg to deal with the ongoing pain and other complications, according to WCCO.

In 2019, he filed a medical malpractice suit in U.S. district court against St. Cloud Orthopedics, the private practice that employed the surgeon and the PA. (Under Minnesota law, an employer is responsible for the actions of its employees.)

In his complaint, Mr. Thapa alleged that in treating him, “the defendants departed from accepted standards of medical practice.” Among other things, he claimed that Dr. Holien and the PA had not properly evaluated his postoperative symptoms, failed to diagnose and treat his compartment syndrome, and improperly discharged him from the hospital. These lapses, Mr. Thapa said, led to his “severe, permanent, and disabling injuries.”

The federal jury agreed. After a weeklong trial, it awarded the plaintiff $100 million for future “pain, disability, disfigurement, embarrassment, and emotional distress.” It also gave him $10 million for past suffering and a little more than $1 million for past and future medical bills.

In a postverdict statement, Mr. Thapa’s attorney said that, while the surgeon and PA are undoubtedly good providers, they made mistakes in this case.

A defense attorney for St. Cloud Orthopedics disputes this: “We maintain the care provided in this case was in accordance with accepted standards of care.”

At press time, the defense had not determined whether to appeal the jury’s $111 million verdict. “St. Cloud continues to support its providers,” said the clinic’s defense attorney. “We are evaluating our options regarding this verdict.”

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

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

ATLANTA – U.S. clinicians caring for people with diabetes should take a more aggressive approach to using combined medical treatments proven to slow the otherwise relentless progression of chronic kidney disease (CKD), according to a new joint statement by the American Diabetes Association and a major international nephrology organization presented during the annual scientific sessions of the American Diabetes Association (ADA).

The statement elevates treatment with an agent from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class to first-line for people with diabetes and laboratory-based evidence of advancing CKD. It also re-emphasizes the key role of concurrent first-line treatment with a renin-angiotensin system inhibitor (an ACE inhibitor or angiotensin-receptor blocker), metformin, and a statin.

The new statement also urges clinicians to rapidly add treatment with the new nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) for further renal protection in the many patients suitable for treatment with this agent, and it recommends the second-line addition of a glucagon-like peptide-1 (GLP-1) receptor agonist as the best add-on for any patient who needs additional glycemic control on top of metformin and an SGLT2 inhibitor.

The consensus joint statement with these updates came from a nine-member writing group assembled by the ADA and the Kidney Disease: Improving Global Outcomes (KDIGO) organization.

“We’re going to try to make this feasible. We have to; I don’t think we have a choice,” commented Amy K. Mottl, MD, a nephrologist at the University of North Carolina, Chapel Hill. Dr. Mottl was not involved with writing the consensus statement but has been active in the Diabetic Kidney Disease Collaborative of the American Society of Nephrology, another group promoting a more aggressive multidrug-class approach to treating CKD in people with diabetes.
 

Wider use of costly drugs

Adoption of this evidence-based approach by U.S. clinicians will both increase the number of agents that many patients receive and drive a significant uptick in the cost and complexity of patient care, a consequence acknowledged by the authors of the joint statement as well as outside experts.

But they view this as unavoidable given what’s now known about the high incidence of worsening CKD in patients with diabetes and the types of interventions proven to blunt this.

Much of the financial implication stems from the price of agents from the new drug classes now emphasized in the consensus recommendations – SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists. All these drugs currently remain on-patent with relatively expensive retail prices in the range of about $600 to $1,000/month.

Commenting on the cost concerns, Dr. Mottl highlighted that she currently has several patients in her practice on agents from two or more of these newer classes, and she has generally found it possible for patients to get much of their expenses covered by insurers and through drug-company assistance programs.

“The major gap is patients on Medicare,” she noted in an interview, because the Federal health insurance program does not allow beneficiaries to receive rebates for their drug costs. “The Diabetic Kidney Disease Collaborative is currently lobbying members of Congress to lift that barrier,” she emphasized.
 

Improved alignment

Details of the KDIGO recommendations feature in a guideline from that organization that appeared as a draft document online in March 2022. The ADA’s version recently appeared as an update to its Standards of Medical Care in Diabetes – 2022, as reported by this news organization. A panel of five KDIGO representatives and four members appointed by the ADA produced the harmonization statement.

Recommendations from both organizations were largely in agreement at the outset, but following the panel’s review, the two groups are now “very well-aligned,” said Peter Rossing, MD, DMSc, a diabetologist and professor at the Steno Diabetes Center, Copenhagen, and a KDIGO representative to the writing committee, who presented the joint statement at the ADA meeting.

“These are very important drugs that are vastly underused,” commented Josef Coresh, MD, PhD, an epidemiologist and professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, who specializes in CKD and was not involved with the new statement.

“Coherence and simplicity are what we need so that there are no excuses about moving forward” with the recommended combination treatment, he stressed.

Moving too slow

“No one is resisting using these new medications, but they are just moving too slowly, and data now show that it’s moving more slowly in the United States than elsewhere. That may be partly because U.S. patients are charged much more for these drugs, and partly because U.S. health care is so much more fragmented,” Dr. Coresh said in an interview.

The new joint consensus statement may help, “but the fragmentation of the United States system and COVID-19 are big enemies” for any short-term increased use of the highlighted agents, he added.

Evidence for low U.S. use of SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists is becoming well known.

Dr. Rossing cited a 2019 report from the CURE-CKD registry of more than 600,000 U.S. patients with CKD showing that less than 1% received an SGLT2 inhibitor and less than 1% a GLP-1 receptor agonist. Not all these patients had diabetes, but a subgroup analysis of those with diabetes, prediabetes, or hypertension showed that usage of each of these two classes remained at less than 1% even in this group.

A separate report at the ADA meeting documented that of more than 1.3 million people with type 2 diabetes in the U.S. Veterans Affairs Healthcare System during 2019 and 2020, just 10% received an SGLT2 inhibitor and 7% a GLP-1 receptor agonist. And this is in a setting where drug cost is not a limiting factor.

In addition to focusing on the updated scheme for drug intervention in the consensus statement, Dr. Rossing highlighted several other important points that the writing committee emphasized.

Lifestyle optimization is a core first-line element of managing patients with diabetes and CKD, including a healthy diet, exercise, smoking cessation, and weight control. Other key steps for management include optimization of blood pressure, glucose, and lipids. The statement also calls out a potentially helpful role for continuous glucose monitoring in patients with type 1 or type 2 diabetes and CKD.

The statement notes that patients who also have atherosclerotic cardiovascular disease usually qualify for and could potentially benefit from more intensified lipid management with ezetimibe or a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, as well as a potential role for treatment with antiplatelet agents.
 

‘If you don’t screen, you won’t find it’

Dr. Rossing also stressed the importance of regular screening for the onset of advanced CKD in patients. Patients whose estimated glomerular filtration rate (eGFR) drops below 60 mL/min/1.73m2, as well as those who develop microalbuminuria with a urinary albumin-to-creatinine ratio of at least 30 mg/g (30 mg/mmol), have a stage of CKD that warrants the drug interventions he outlined.

Guidelines from both the ADA and KDIGO were already in place, recommending annual screening of patients with diabetes for both these parameters starting at diagnosis of type 2 diabetes or 5 years following initial diagnosis of type 1 diabetes.

“If you don’t screen, you won’t find it, and you won’t be able to treat,” Dr. Rossing warned. He also highlighted the panel’s recommendation to treat these patients with an SGLT2 inhibitor as long as their eGFR is at least 20 mL/min/1.73m2. Treatment can then continue even when their eGFR drops lower.

Starting treatment with finerenone requires that patients have a normal level of serum potassium, he emphasized.

One reason for developing the new ADA and KDIGO statement is that “discrepancies in clinical practice guideline recommendations from various professional organizations add to confusion that impedes understanding of best practices,” write Katherine R. Tuttle, MD, and associates in a recent commentary.

The goal of the new statement is to harmonize and promote the shared recommendations of the two organizations, added Dr. Tuttle, who is executive director for research at Providence Healthcare, Spokane, Washington, and a KDIGO representative on the statement writing panel.

Dr. Mottl has reported being a consultant to Bayer. Dr. Rossing has reported being a consultant to or speaker on behalf of Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, MSD, Mundipharma, Novo Nordisk, Sanofi Aventis, and Vifor, as well as receiving research grants from AstraZeneca and Novo Nordisk. Dr. Coresh has reported no relevant financial relationships. Dr. Tuttle has reported being a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, Goldfinch Bio, Janssen, Novo Nordisk, and Travere; receiving honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Goldfinch Bio, Novo Nordisk, and Travere; and receiving research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, Goldfinch Bio, Novo Nordisk, and Travere.

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

ATLANTA – U.S. clinicians caring for people with diabetes should take a more aggressive approach to using combined medical treatments proven to slow the otherwise relentless progression of chronic kidney disease (CKD), according to a new joint statement by the American Diabetes Association and a major international nephrology organization presented during the annual scientific sessions of the American Diabetes Association (ADA).

The statement elevates treatment with an agent from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class to first-line for people with diabetes and laboratory-based evidence of advancing CKD. It also re-emphasizes the key role of concurrent first-line treatment with a renin-angiotensin system inhibitor (an ACE inhibitor or angiotensin-receptor blocker), metformin, and a statin.

The new statement also urges clinicians to rapidly add treatment with the new nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) for further renal protection in the many patients suitable for treatment with this agent, and it recommends the second-line addition of a glucagon-like peptide-1 (GLP-1) receptor agonist as the best add-on for any patient who needs additional glycemic control on top of metformin and an SGLT2 inhibitor.

The consensus joint statement with these updates came from a nine-member writing group assembled by the ADA and the Kidney Disease: Improving Global Outcomes (KDIGO) organization.

“We’re going to try to make this feasible. We have to; I don’t think we have a choice,” commented Amy K. Mottl, MD, a nephrologist at the University of North Carolina, Chapel Hill. Dr. Mottl was not involved with writing the consensus statement but has been active in the Diabetic Kidney Disease Collaborative of the American Society of Nephrology, another group promoting a more aggressive multidrug-class approach to treating CKD in people with diabetes.
 

Wider use of costly drugs

Adoption of this evidence-based approach by U.S. clinicians will both increase the number of agents that many patients receive and drive a significant uptick in the cost and complexity of patient care, a consequence acknowledged by the authors of the joint statement as well as outside experts.

But they view this as unavoidable given what’s now known about the high incidence of worsening CKD in patients with diabetes and the types of interventions proven to blunt this.

Much of the financial implication stems from the price of agents from the new drug classes now emphasized in the consensus recommendations – SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists. All these drugs currently remain on-patent with relatively expensive retail prices in the range of about $600 to $1,000/month.

Commenting on the cost concerns, Dr. Mottl highlighted that she currently has several patients in her practice on agents from two or more of these newer classes, and she has generally found it possible for patients to get much of their expenses covered by insurers and through drug-company assistance programs.

“The major gap is patients on Medicare,” she noted in an interview, because the Federal health insurance program does not allow beneficiaries to receive rebates for their drug costs. “The Diabetic Kidney Disease Collaborative is currently lobbying members of Congress to lift that barrier,” she emphasized.
 

Improved alignment

Details of the KDIGO recommendations feature in a guideline from that organization that appeared as a draft document online in March 2022. The ADA’s version recently appeared as an update to its Standards of Medical Care in Diabetes – 2022, as reported by this news organization. A panel of five KDIGO representatives and four members appointed by the ADA produced the harmonization statement.

Recommendations from both organizations were largely in agreement at the outset, but following the panel’s review, the two groups are now “very well-aligned,” said Peter Rossing, MD, DMSc, a diabetologist and professor at the Steno Diabetes Center, Copenhagen, and a KDIGO representative to the writing committee, who presented the joint statement at the ADA meeting.

“These are very important drugs that are vastly underused,” commented Josef Coresh, MD, PhD, an epidemiologist and professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, who specializes in CKD and was not involved with the new statement.

“Coherence and simplicity are what we need so that there are no excuses about moving forward” with the recommended combination treatment, he stressed.

Moving too slow

“No one is resisting using these new medications, but they are just moving too slowly, and data now show that it’s moving more slowly in the United States than elsewhere. That may be partly because U.S. patients are charged much more for these drugs, and partly because U.S. health care is so much more fragmented,” Dr. Coresh said in an interview.

The new joint consensus statement may help, “but the fragmentation of the United States system and COVID-19 are big enemies” for any short-term increased use of the highlighted agents, he added.

Evidence for low U.S. use of SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists is becoming well known.

Dr. Rossing cited a 2019 report from the CURE-CKD registry of more than 600,000 U.S. patients with CKD showing that less than 1% received an SGLT2 inhibitor and less than 1% a GLP-1 receptor agonist. Not all these patients had diabetes, but a subgroup analysis of those with diabetes, prediabetes, or hypertension showed that usage of each of these two classes remained at less than 1% even in this group.

A separate report at the ADA meeting documented that of more than 1.3 million people with type 2 diabetes in the U.S. Veterans Affairs Healthcare System during 2019 and 2020, just 10% received an SGLT2 inhibitor and 7% a GLP-1 receptor agonist. And this is in a setting where drug cost is not a limiting factor.

In addition to focusing on the updated scheme for drug intervention in the consensus statement, Dr. Rossing highlighted several other important points that the writing committee emphasized.

Lifestyle optimization is a core first-line element of managing patients with diabetes and CKD, including a healthy diet, exercise, smoking cessation, and weight control. Other key steps for management include optimization of blood pressure, glucose, and lipids. The statement also calls out a potentially helpful role for continuous glucose monitoring in patients with type 1 or type 2 diabetes and CKD.

The statement notes that patients who also have atherosclerotic cardiovascular disease usually qualify for and could potentially benefit from more intensified lipid management with ezetimibe or a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, as well as a potential role for treatment with antiplatelet agents.
 

‘If you don’t screen, you won’t find it’

Dr. Rossing also stressed the importance of regular screening for the onset of advanced CKD in patients. Patients whose estimated glomerular filtration rate (eGFR) drops below 60 mL/min/1.73m2, as well as those who develop microalbuminuria with a urinary albumin-to-creatinine ratio of at least 30 mg/g (30 mg/mmol), have a stage of CKD that warrants the drug interventions he outlined.

Guidelines from both the ADA and KDIGO were already in place, recommending annual screening of patients with diabetes for both these parameters starting at diagnosis of type 2 diabetes or 5 years following initial diagnosis of type 1 diabetes.

“If you don’t screen, you won’t find it, and you won’t be able to treat,” Dr. Rossing warned. He also highlighted the panel’s recommendation to treat these patients with an SGLT2 inhibitor as long as their eGFR is at least 20 mL/min/1.73m2. Treatment can then continue even when their eGFR drops lower.

Starting treatment with finerenone requires that patients have a normal level of serum potassium, he emphasized.

One reason for developing the new ADA and KDIGO statement is that “discrepancies in clinical practice guideline recommendations from various professional organizations add to confusion that impedes understanding of best practices,” write Katherine R. Tuttle, MD, and associates in a recent commentary.

The goal of the new statement is to harmonize and promote the shared recommendations of the two organizations, added Dr. Tuttle, who is executive director for research at Providence Healthcare, Spokane, Washington, and a KDIGO representative on the statement writing panel.

Dr. Mottl has reported being a consultant to Bayer. Dr. Rossing has reported being a consultant to or speaker on behalf of Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, MSD, Mundipharma, Novo Nordisk, Sanofi Aventis, and Vifor, as well as receiving research grants from AstraZeneca and Novo Nordisk. Dr. Coresh has reported no relevant financial relationships. Dr. Tuttle has reported being a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, Goldfinch Bio, Janssen, Novo Nordisk, and Travere; receiving honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Goldfinch Bio, Novo Nordisk, and Travere; and receiving research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, Goldfinch Bio, Novo Nordisk, and Travere.

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

ATLANTA – U.S. clinicians caring for people with diabetes should take a more aggressive approach to using combined medical treatments proven to slow the otherwise relentless progression of chronic kidney disease (CKD), according to a new joint statement by the American Diabetes Association and a major international nephrology organization presented during the annual scientific sessions of the American Diabetes Association (ADA).

The statement elevates treatment with an agent from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class to first-line for people with diabetes and laboratory-based evidence of advancing CKD. It also re-emphasizes the key role of concurrent first-line treatment with a renin-angiotensin system inhibitor (an ACE inhibitor or angiotensin-receptor blocker), metformin, and a statin.

The new statement also urges clinicians to rapidly add treatment with the new nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) for further renal protection in the many patients suitable for treatment with this agent, and it recommends the second-line addition of a glucagon-like peptide-1 (GLP-1) receptor agonist as the best add-on for any patient who needs additional glycemic control on top of metformin and an SGLT2 inhibitor.

The consensus joint statement with these updates came from a nine-member writing group assembled by the ADA and the Kidney Disease: Improving Global Outcomes (KDIGO) organization.

“We’re going to try to make this feasible. We have to; I don’t think we have a choice,” commented Amy K. Mottl, MD, a nephrologist at the University of North Carolina, Chapel Hill. Dr. Mottl was not involved with writing the consensus statement but has been active in the Diabetic Kidney Disease Collaborative of the American Society of Nephrology, another group promoting a more aggressive multidrug-class approach to treating CKD in people with diabetes.
 

Wider use of costly drugs

Adoption of this evidence-based approach by U.S. clinicians will both increase the number of agents that many patients receive and drive a significant uptick in the cost and complexity of patient care, a consequence acknowledged by the authors of the joint statement as well as outside experts.

But they view this as unavoidable given what’s now known about the high incidence of worsening CKD in patients with diabetes and the types of interventions proven to blunt this.

Much of the financial implication stems from the price of agents from the new drug classes now emphasized in the consensus recommendations – SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists. All these drugs currently remain on-patent with relatively expensive retail prices in the range of about $600 to $1,000/month.

Commenting on the cost concerns, Dr. Mottl highlighted that she currently has several patients in her practice on agents from two or more of these newer classes, and she has generally found it possible for patients to get much of their expenses covered by insurers and through drug-company assistance programs.

“The major gap is patients on Medicare,” she noted in an interview, because the Federal health insurance program does not allow beneficiaries to receive rebates for their drug costs. “The Diabetic Kidney Disease Collaborative is currently lobbying members of Congress to lift that barrier,” she emphasized.
 

Improved alignment

Details of the KDIGO recommendations feature in a guideline from that organization that appeared as a draft document online in March 2022. The ADA’s version recently appeared as an update to its Standards of Medical Care in Diabetes – 2022, as reported by this news organization. A panel of five KDIGO representatives and four members appointed by the ADA produced the harmonization statement.

Recommendations from both organizations were largely in agreement at the outset, but following the panel’s review, the two groups are now “very well-aligned,” said Peter Rossing, MD, DMSc, a diabetologist and professor at the Steno Diabetes Center, Copenhagen, and a KDIGO representative to the writing committee, who presented the joint statement at the ADA meeting.

“These are very important drugs that are vastly underused,” commented Josef Coresh, MD, PhD, an epidemiologist and professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, who specializes in CKD and was not involved with the new statement.

“Coherence and simplicity are what we need so that there are no excuses about moving forward” with the recommended combination treatment, he stressed.

Moving too slow

“No one is resisting using these new medications, but they are just moving too slowly, and data now show that it’s moving more slowly in the United States than elsewhere. That may be partly because U.S. patients are charged much more for these drugs, and partly because U.S. health care is so much more fragmented,” Dr. Coresh said in an interview.

The new joint consensus statement may help, “but the fragmentation of the United States system and COVID-19 are big enemies” for any short-term increased use of the highlighted agents, he added.

Evidence for low U.S. use of SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists is becoming well known.

Dr. Rossing cited a 2019 report from the CURE-CKD registry of more than 600,000 U.S. patients with CKD showing that less than 1% received an SGLT2 inhibitor and less than 1% a GLP-1 receptor agonist. Not all these patients had diabetes, but a subgroup analysis of those with diabetes, prediabetes, or hypertension showed that usage of each of these two classes remained at less than 1% even in this group.

A separate report at the ADA meeting documented that of more than 1.3 million people with type 2 diabetes in the U.S. Veterans Affairs Healthcare System during 2019 and 2020, just 10% received an SGLT2 inhibitor and 7% a GLP-1 receptor agonist. And this is in a setting where drug cost is not a limiting factor.

In addition to focusing on the updated scheme for drug intervention in the consensus statement, Dr. Rossing highlighted several other important points that the writing committee emphasized.

Lifestyle optimization is a core first-line element of managing patients with diabetes and CKD, including a healthy diet, exercise, smoking cessation, and weight control. Other key steps for management include optimization of blood pressure, glucose, and lipids. The statement also calls out a potentially helpful role for continuous glucose monitoring in patients with type 1 or type 2 diabetes and CKD.

The statement notes that patients who also have atherosclerotic cardiovascular disease usually qualify for and could potentially benefit from more intensified lipid management with ezetimibe or a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, as well as a potential role for treatment with antiplatelet agents.
 

‘If you don’t screen, you won’t find it’

Dr. Rossing also stressed the importance of regular screening for the onset of advanced CKD in patients. Patients whose estimated glomerular filtration rate (eGFR) drops below 60 mL/min/1.73m2, as well as those who develop microalbuminuria with a urinary albumin-to-creatinine ratio of at least 30 mg/g (30 mg/mmol), have a stage of CKD that warrants the drug interventions he outlined.

Guidelines from both the ADA and KDIGO were already in place, recommending annual screening of patients with diabetes for both these parameters starting at diagnosis of type 2 diabetes or 5 years following initial diagnosis of type 1 diabetes.

“If you don’t screen, you won’t find it, and you won’t be able to treat,” Dr. Rossing warned. He also highlighted the panel’s recommendation to treat these patients with an SGLT2 inhibitor as long as their eGFR is at least 20 mL/min/1.73m2. Treatment can then continue even when their eGFR drops lower.

Starting treatment with finerenone requires that patients have a normal level of serum potassium, he emphasized.

One reason for developing the new ADA and KDIGO statement is that “discrepancies in clinical practice guideline recommendations from various professional organizations add to confusion that impedes understanding of best practices,” write Katherine R. Tuttle, MD, and associates in a recent commentary.

The goal of the new statement is to harmonize and promote the shared recommendations of the two organizations, added Dr. Tuttle, who is executive director for research at Providence Healthcare, Spokane, Washington, and a KDIGO representative on the statement writing panel.

Dr. Mottl has reported being a consultant to Bayer. Dr. Rossing has reported being a consultant to or speaker on behalf of Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, MSD, Mundipharma, Novo Nordisk, Sanofi Aventis, and Vifor, as well as receiving research grants from AstraZeneca and Novo Nordisk. Dr. Coresh has reported no relevant financial relationships. Dr. Tuttle has reported being a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, Goldfinch Bio, Janssen, Novo Nordisk, and Travere; receiving honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Goldfinch Bio, Novo Nordisk, and Travere; and receiving research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, Goldfinch Bio, Novo Nordisk, and Travere.

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

There may be a link between the recent unexplained cases of hepatitis in children and prior coronavirus infections, according to new research from Israel.

The study involves five children in Israel who had mild cases of COVID-19 who went on to develop hepatitis; two of these children required liver transplants. But clinicians are cautious about drawing conclusions from such a small study.

“All you can say is that these five cases seem to have proximity to COVID-19, and COVID-19 may be able to cause pediatric liver complications,” said Nancy Reau, MD, section chief of hepatology at Rush University in Chicago. She was not involved with the study.

While COVID-19 could be one explanation for these hepatitis cases, it is also possible that the two are unrelated, said William Balistreri, MD, director emeritus of the Pediatric Liver Care Center at Cincinnati Children’s Hospital Medical Center. He also is unaffiliated with the study.

Hepatitis is rare in children, and between 30% and 50% of these pediatric cases have no known cause, according to the CDC.

Since April 2022, children with hepatitis of an unexplained cause have garnered global attention. The United Kingdom now has 240 confirmed cases, the United States is investigating 290 cases, and Israel has reported 12 cases to the World Health Organization. Many investigators think that these liver problems could be related to adenovirus – a common infection in children that normally causes cold or flu-like symptoms – because more than half of global cases tested for the virus have been positive, according to the WHO. About 12% of children with unexplained hepatitis have tested positive for SARS-CoV-2, the virus that causes COVID-19, but investigators are considering the possibility that some cases may be related to prior infections.

The study documents five patients, 3-months to 13 years old, with prior  coronavirus infection who later developed hepatitis. All were treated at Schneider Children’s Medical Hospital in Petah Tikva, Israel, during 2021. The paper was published in the Journal of Pediatric Gastroenterology and Nutrition. Two patients, a 3-month-old and 5-month-old, needed liver transplants. The other three patients (two 8-year-olds and a 13-year-old) were treated with steroids. None of the five children had received any vaccinations against COVID-19. The time between COVID-19 infection and liver problems ranged from 21 to 130 days.

“It took time to be convinced that this could be COVID-related,” said senior study author Orith Waisbourd-Zinman, MD, director of pediatric liver disease service at Schneider Children’s Medical Hospital. “It’s something that wasn’t described.”

Sudden-onset hepatitis after COVID-19 has been recorded in adults, and the virus has been associated with multisystem inflammatory syndrome in children (MIS-C). The condition causes inflammation through the body, including the heart, lungs, and kidneys.

“We know that COVID can be mischievous, and children are no more exempt from that than adults,” Dr. Reau said.

Liver samples taken from these five patients did not test positive for COVID-19, similar to how liver samples have tested negative for adenovirus in more recent hepatitis cases around the world. Dr. Waisbourd-Zinman suggested that in these patients, hepatitis may have been brought on by an inflammatory response that was triggered by the virus. 

Still, there are notable differences between these five cases and current cases internationally. These five children became sick during the period of December 2020 to September 2021, whereas all current counted cases in the United Kingdom occurred after January 2022. The first cases in the United States took place in October 2021. It could be that there were similar hepatitis cases before that were not identified, Dr. Reau said.

The ages of the Israeli children with hepatitis also differ from the cases seen globally. More than three-fourths of these reported hepatitis cases occurred in children under 5, the WHO reports, though affected individuals have been as young as 1-month-old up to 16 years old. In the United Kingdom, which accounts for about a third of cases reported to the WHO, most children with unexplained hepatitis have been between 3 and 5 years old.

More research is needed to tease out any relationship between prior COVID-19 infection and liver inflammation, Dr. Balistreri said.

“I’m not sure what to make of any of it yet. We know that SARS-CoV-2 can alter immune responses ... so it wouldn’t surprise me,” if COVID-19 and these hepatitis cases were linked, he said. “It’s just that we need more information.”

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

There may be a link between the recent unexplained cases of hepatitis in children and prior coronavirus infections, according to new research from Israel.

The study involves five children in Israel who had mild cases of COVID-19 who went on to develop hepatitis; two of these children required liver transplants. But clinicians are cautious about drawing conclusions from such a small study.

“All you can say is that these five cases seem to have proximity to COVID-19, and COVID-19 may be able to cause pediatric liver complications,” said Nancy Reau, MD, section chief of hepatology at Rush University in Chicago. She was not involved with the study.

While COVID-19 could be one explanation for these hepatitis cases, it is also possible that the two are unrelated, said William Balistreri, MD, director emeritus of the Pediatric Liver Care Center at Cincinnati Children’s Hospital Medical Center. He also is unaffiliated with the study.

Hepatitis is rare in children, and between 30% and 50% of these pediatric cases have no known cause, according to the CDC.

Since April 2022, children with hepatitis of an unexplained cause have garnered global attention. The United Kingdom now has 240 confirmed cases, the United States is investigating 290 cases, and Israel has reported 12 cases to the World Health Organization. Many investigators think that these liver problems could be related to adenovirus – a common infection in children that normally causes cold or flu-like symptoms – because more than half of global cases tested for the virus have been positive, according to the WHO. About 12% of children with unexplained hepatitis have tested positive for SARS-CoV-2, the virus that causes COVID-19, but investigators are considering the possibility that some cases may be related to prior infections.

The study documents five patients, 3-months to 13 years old, with prior  coronavirus infection who later developed hepatitis. All were treated at Schneider Children’s Medical Hospital in Petah Tikva, Israel, during 2021. The paper was published in the Journal of Pediatric Gastroenterology and Nutrition. Two patients, a 3-month-old and 5-month-old, needed liver transplants. The other three patients (two 8-year-olds and a 13-year-old) were treated with steroids. None of the five children had received any vaccinations against COVID-19. The time between COVID-19 infection and liver problems ranged from 21 to 130 days.

“It took time to be convinced that this could be COVID-related,” said senior study author Orith Waisbourd-Zinman, MD, director of pediatric liver disease service at Schneider Children’s Medical Hospital. “It’s something that wasn’t described.”

Sudden-onset hepatitis after COVID-19 has been recorded in adults, and the virus has been associated with multisystem inflammatory syndrome in children (MIS-C). The condition causes inflammation through the body, including the heart, lungs, and kidneys.

“We know that COVID can be mischievous, and children are no more exempt from that than adults,” Dr. Reau said.

Liver samples taken from these five patients did not test positive for COVID-19, similar to how liver samples have tested negative for adenovirus in more recent hepatitis cases around the world. Dr. Waisbourd-Zinman suggested that in these patients, hepatitis may have been brought on by an inflammatory response that was triggered by the virus. 

Still, there are notable differences between these five cases and current cases internationally. These five children became sick during the period of December 2020 to September 2021, whereas all current counted cases in the United Kingdom occurred after January 2022. The first cases in the United States took place in October 2021. It could be that there were similar hepatitis cases before that were not identified, Dr. Reau said.

The ages of the Israeli children with hepatitis also differ from the cases seen globally. More than three-fourths of these reported hepatitis cases occurred in children under 5, the WHO reports, though affected individuals have been as young as 1-month-old up to 16 years old. In the United Kingdom, which accounts for about a third of cases reported to the WHO, most children with unexplained hepatitis have been between 3 and 5 years old.

More research is needed to tease out any relationship between prior COVID-19 infection and liver inflammation, Dr. Balistreri said.

“I’m not sure what to make of any of it yet. We know that SARS-CoV-2 can alter immune responses ... so it wouldn’t surprise me,” if COVID-19 and these hepatitis cases were linked, he said. “It’s just that we need more information.”

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

There may be a link between the recent unexplained cases of hepatitis in children and prior coronavirus infections, according to new research from Israel.

The study involves five children in Israel who had mild cases of COVID-19 who went on to develop hepatitis; two of these children required liver transplants. But clinicians are cautious about drawing conclusions from such a small study.

“All you can say is that these five cases seem to have proximity to COVID-19, and COVID-19 may be able to cause pediatric liver complications,” said Nancy Reau, MD, section chief of hepatology at Rush University in Chicago. She was not involved with the study.

While COVID-19 could be one explanation for these hepatitis cases, it is also possible that the two are unrelated, said William Balistreri, MD, director emeritus of the Pediatric Liver Care Center at Cincinnati Children’s Hospital Medical Center. He also is unaffiliated with the study.

Hepatitis is rare in children, and between 30% and 50% of these pediatric cases have no known cause, according to the CDC.

Since April 2022, children with hepatitis of an unexplained cause have garnered global attention. The United Kingdom now has 240 confirmed cases, the United States is investigating 290 cases, and Israel has reported 12 cases to the World Health Organization. Many investigators think that these liver problems could be related to adenovirus – a common infection in children that normally causes cold or flu-like symptoms – because more than half of global cases tested for the virus have been positive, according to the WHO. About 12% of children with unexplained hepatitis have tested positive for SARS-CoV-2, the virus that causes COVID-19, but investigators are considering the possibility that some cases may be related to prior infections.

The study documents five patients, 3-months to 13 years old, with prior  coronavirus infection who later developed hepatitis. All were treated at Schneider Children’s Medical Hospital in Petah Tikva, Israel, during 2021. The paper was published in the Journal of Pediatric Gastroenterology and Nutrition. Two patients, a 3-month-old and 5-month-old, needed liver transplants. The other three patients (two 8-year-olds and a 13-year-old) were treated with steroids. None of the five children had received any vaccinations against COVID-19. The time between COVID-19 infection and liver problems ranged from 21 to 130 days.

“It took time to be convinced that this could be COVID-related,” said senior study author Orith Waisbourd-Zinman, MD, director of pediatric liver disease service at Schneider Children’s Medical Hospital. “It’s something that wasn’t described.”

Sudden-onset hepatitis after COVID-19 has been recorded in adults, and the virus has been associated with multisystem inflammatory syndrome in children (MIS-C). The condition causes inflammation through the body, including the heart, lungs, and kidneys.

“We know that COVID can be mischievous, and children are no more exempt from that than adults,” Dr. Reau said.

Liver samples taken from these five patients did not test positive for COVID-19, similar to how liver samples have tested negative for adenovirus in more recent hepatitis cases around the world. Dr. Waisbourd-Zinman suggested that in these patients, hepatitis may have been brought on by an inflammatory response that was triggered by the virus. 

Still, there are notable differences between these five cases and current cases internationally. These five children became sick during the period of December 2020 to September 2021, whereas all current counted cases in the United Kingdom occurred after January 2022. The first cases in the United States took place in October 2021. It could be that there were similar hepatitis cases before that were not identified, Dr. Reau said.

The ages of the Israeli children with hepatitis also differ from the cases seen globally. More than three-fourths of these reported hepatitis cases occurred in children under 5, the WHO reports, though affected individuals have been as young as 1-month-old up to 16 years old. In the United Kingdom, which accounts for about a third of cases reported to the WHO, most children with unexplained hepatitis have been between 3 and 5 years old.

More research is needed to tease out any relationship between prior COVID-19 infection and liver inflammation, Dr. Balistreri said.

“I’m not sure what to make of any of it yet. We know that SARS-CoV-2 can alter immune responses ... so it wouldn’t surprise me,” if COVID-19 and these hepatitis cases were linked, he said. “It’s just that we need more information.”

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

Individuals with diabetes who experience COVID-19 are at increased risk for long COVID compared to individuals without diabetes, according to data from a literature review of seven studies.

Diabetes remains a risk factor for severe COVID-19, but whether it is a risk factor for postacute sequelae of COVID-19 (PASC), also known as long COVID, remains unclear, Jessica L. Harding, PhD, of Emory University, said in a late-breaking poster session at the annual scientific sessions of the American Diabetes Association.

Long COVID is generally defined as “sequelae that extend beyond the 4 weeks after initial infection” and may include a range of symptoms that affect multiple organs, Dr. Harding said. A study conducted in January of 2022 suggested that type 2 diabetes was one of several strong risk factors for long COVID, she noted.

Dr. Harding and colleagues reviewed data from seven studies published from Jan. 1, 2020, to Jan. 27, 2022, on the risk of PASC in people with and without diabetes. The studies included patients with a minimum of 4 weeks’ follow-up after COVID-19 diagnosis. All seven studies had a longitudinal cohort design, and included adults from high-income countries, with study populations ranging from 104 to 4,182.

Across the studies, long COVID definitions varied, but included ongoing symptoms of fatigue, cough, and dyspnea, with follow-up periods of 4 weeks to 7 months.

Overall, three of the seven studies indicated that diabetes was a risk factor for long COVID (odds ratio [OR] greater than 4 for all) and four studies indicated that diabetes was not a risk factor for long COVID (OR, 0.5-2.2).

One of the three studies showing increased risk included 2,334 individuals hospitalized with COVID-19; of these about 5% had diabetes. The odds ratio for PASC for individuals with diabetes was 4.18. In another study of 209 persons with COVID-19, of whom 22% had diabetes, diabetes was significantly correlated with respiratory viral disease (meaning at least two respiratory symptoms). The third study showing an increased risk of long COVID in diabetes patients included 104 kidney transplant patients, of whom 20% had diabetes; the odds ratio for PASC was 4.42.

The findings were limited by several factors, including the relatively small number of studies and the heterogeneity of studies regarding definitions of long COVID, specific populations at risk, follow-up times, and risk adjustment, Dr. Harding noted.

More high-quality studies across multiple populations and settings are needed to determine if diabetes is indeed a risk factor for long COVID, she said.

In the meantime, “careful monitoring of people with diabetes for development of PASC may be advised,” Dr. Harding concluded.
 

Findings support need for screening

“Given the devastating impact of COVID on people with diabetes, it’s important to know what data has been accumulated on long COVID for future research and discoveries in this area,” Robert A. Gabbay, MD, chief science and medical officer for the American Diabetes Association, said in an interview. “The more information we have, the better we can understand the implications.”

Courtesy Joslin Diabetes Center

Dr. Gabbay said he was surprised by the current study findings. “We know very little on this subject, so yes, I am surprised to see just how significant the risk of long COVID for people with diabetes seems to be, but clearly, more research needs to be done to understand long COVID,” he emphasized.

The take-home message for clinicians is the importance of screening patients for PASC; also “ask your patients if they had COVID, to better understand any symptoms they might have that could be related to PACS,” he noted. 

“It is crucial that we confirm these results and then look at risk factors in people with diabetes that might explain who is at highest risk and ultimately understand the causes and potential cure,” Dr. Gabbay added.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Harding and Dr. Gabbay had no financial conflicts to disclose.

Individuals with diabetes who experience COVID-19 are at increased risk for long COVID compared to individuals without diabetes, according to data from a literature review of seven studies.

Diabetes remains a risk factor for severe COVID-19, but whether it is a risk factor for postacute sequelae of COVID-19 (PASC), also known as long COVID, remains unclear, Jessica L. Harding, PhD, of Emory University, said in a late-breaking poster session at the annual scientific sessions of the American Diabetes Association.

Long COVID is generally defined as “sequelae that extend beyond the 4 weeks after initial infection” and may include a range of symptoms that affect multiple organs, Dr. Harding said. A study conducted in January of 2022 suggested that type 2 diabetes was one of several strong risk factors for long COVID, she noted.

Dr. Harding and colleagues reviewed data from seven studies published from Jan. 1, 2020, to Jan. 27, 2022, on the risk of PASC in people with and without diabetes. The studies included patients with a minimum of 4 weeks’ follow-up after COVID-19 diagnosis. All seven studies had a longitudinal cohort design, and included adults from high-income countries, with study populations ranging from 104 to 4,182.

Across the studies, long COVID definitions varied, but included ongoing symptoms of fatigue, cough, and dyspnea, with follow-up periods of 4 weeks to 7 months.

Overall, three of the seven studies indicated that diabetes was a risk factor for long COVID (odds ratio [OR] greater than 4 for all) and four studies indicated that diabetes was not a risk factor for long COVID (OR, 0.5-2.2).

One of the three studies showing increased risk included 2,334 individuals hospitalized with COVID-19; of these about 5% had diabetes. The odds ratio for PASC for individuals with diabetes was 4.18. In another study of 209 persons with COVID-19, of whom 22% had diabetes, diabetes was significantly correlated with respiratory viral disease (meaning at least two respiratory symptoms). The third study showing an increased risk of long COVID in diabetes patients included 104 kidney transplant patients, of whom 20% had diabetes; the odds ratio for PASC was 4.42.

The findings were limited by several factors, including the relatively small number of studies and the heterogeneity of studies regarding definitions of long COVID, specific populations at risk, follow-up times, and risk adjustment, Dr. Harding noted.

More high-quality studies across multiple populations and settings are needed to determine if diabetes is indeed a risk factor for long COVID, she said.

In the meantime, “careful monitoring of people with diabetes for development of PASC may be advised,” Dr. Harding concluded.
 

Findings support need for screening

“Given the devastating impact of COVID on people with diabetes, it’s important to know what data has been accumulated on long COVID for future research and discoveries in this area,” Robert A. Gabbay, MD, chief science and medical officer for the American Diabetes Association, said in an interview. “The more information we have, the better we can understand the implications.”

Courtesy Joslin Diabetes Center

Dr. Gabbay said he was surprised by the current study findings. “We know very little on this subject, so yes, I am surprised to see just how significant the risk of long COVID for people with diabetes seems to be, but clearly, more research needs to be done to understand long COVID,” he emphasized.

The take-home message for clinicians is the importance of screening patients for PASC; also “ask your patients if they had COVID, to better understand any symptoms they might have that could be related to PACS,” he noted. 

“It is crucial that we confirm these results and then look at risk factors in people with diabetes that might explain who is at highest risk and ultimately understand the causes and potential cure,” Dr. Gabbay added.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Harding and Dr. Gabbay had no financial conflicts to disclose.

Individuals with diabetes who experience COVID-19 are at increased risk for long COVID compared to individuals without diabetes, according to data from a literature review of seven studies.

Diabetes remains a risk factor for severe COVID-19, but whether it is a risk factor for postacute sequelae of COVID-19 (PASC), also known as long COVID, remains unclear, Jessica L. Harding, PhD, of Emory University, said in a late-breaking poster session at the annual scientific sessions of the American Diabetes Association.

Long COVID is generally defined as “sequelae that extend beyond the 4 weeks after initial infection” and may include a range of symptoms that affect multiple organs, Dr. Harding said. A study conducted in January of 2022 suggested that type 2 diabetes was one of several strong risk factors for long COVID, she noted.

Dr. Harding and colleagues reviewed data from seven studies published from Jan. 1, 2020, to Jan. 27, 2022, on the risk of PASC in people with and without diabetes. The studies included patients with a minimum of 4 weeks’ follow-up after COVID-19 diagnosis. All seven studies had a longitudinal cohort design, and included adults from high-income countries, with study populations ranging from 104 to 4,182.

Across the studies, long COVID definitions varied, but included ongoing symptoms of fatigue, cough, and dyspnea, with follow-up periods of 4 weeks to 7 months.

Overall, three of the seven studies indicated that diabetes was a risk factor for long COVID (odds ratio [OR] greater than 4 for all) and four studies indicated that diabetes was not a risk factor for long COVID (OR, 0.5-2.2).

One of the three studies showing increased risk included 2,334 individuals hospitalized with COVID-19; of these about 5% had diabetes. The odds ratio for PASC for individuals with diabetes was 4.18. In another study of 209 persons with COVID-19, of whom 22% had diabetes, diabetes was significantly correlated with respiratory viral disease (meaning at least two respiratory symptoms). The third study showing an increased risk of long COVID in diabetes patients included 104 kidney transplant patients, of whom 20% had diabetes; the odds ratio for PASC was 4.42.

The findings were limited by several factors, including the relatively small number of studies and the heterogeneity of studies regarding definitions of long COVID, specific populations at risk, follow-up times, and risk adjustment, Dr. Harding noted.

More high-quality studies across multiple populations and settings are needed to determine if diabetes is indeed a risk factor for long COVID, she said.

In the meantime, “careful monitoring of people with diabetes for development of PASC may be advised,” Dr. Harding concluded.
 

Findings support need for screening

“Given the devastating impact of COVID on people with diabetes, it’s important to know what data has been accumulated on long COVID for future research and discoveries in this area,” Robert A. Gabbay, MD, chief science and medical officer for the American Diabetes Association, said in an interview. “The more information we have, the better we can understand the implications.”

Courtesy Joslin Diabetes Center

Dr. Gabbay said he was surprised by the current study findings. “We know very little on this subject, so yes, I am surprised to see just how significant the risk of long COVID for people with diabetes seems to be, but clearly, more research needs to be done to understand long COVID,” he emphasized.

The take-home message for clinicians is the importance of screening patients for PASC; also “ask your patients if they had COVID, to better understand any symptoms they might have that could be related to PACS,” he noted. 

“It is crucial that we confirm these results and then look at risk factors in people with diabetes that might explain who is at highest risk and ultimately understand the causes and potential cure,” Dr. Gabbay added.

The study was supported by the National Heart, Lung, and Blood Institute. Dr. Harding and Dr. Gabbay had no financial conflicts to disclose.

Menopause gets a bad rap in medical literature and throughout society, say authors of a new analysis. And they argue that the negativity undermines women’s health outlook in the years that should be a natural life transition.

Menopause has been medicalized over centuries and talked about as if it were a disease, they say, and that may increase women’s anxiety and apprehension about the midlife stage.

It’s time to change the narrative, says Martha Hickey, MD, with the department of obstetrics and gynaecology at the Royal Women’s Hospital in Victoria, Australia, and her coauthors. Their analysis was published online in the BMJ.

“The message that menopause signals decay and decline, which can potentially be delayed or reversed by hormonal treatments, persists and is reinforced by the media, medical literature, and information for women, often driven by marketing interests,” they write.

Such messages may chip away at women’s confidence. Dr. Hickey and colleagues cite surveys in the United States and Ireland that found that most women (65%-77%) feel unprepared for menopause.

“Together with limited public discussion and education and shame attached to ageing in women, this may contribute to embarrassment and negative expectations about menopause,” the authors write.
 

The ‘untold misery of oestrogen-starved women’

These messages have deep roots. Take for instance, gynecologist Robert Wilson’s words in his 1966 book “Feminine Forever.” The authors note he recommended estrogen for all menopausal women “to treat their ‘serious, painful and often crippling disease’ and avoid the ‘untold misery of alcoholism, drug addiction, divorce, and broken

homes caused by these unstable, oestrogen-starved women.’ ”

Women experience menopause in very different ways. Experience with menopause also differs by country, the authors explain. “Women’s experience of menopause is also strongly influenced by social values around reproduction and ageing, with positive or negative ramifications,” they write.

“For example, women tend to have worse experiences of menopause in countries where their value is predicated on youth and reproductive capacity and ageing is associated with decline.”

The authors argue that the medicalization of menopause has condensed the wide range of women’s experiences at a typical age into “a narrowly defined disease requiring treatment.”
 

Promoting exercise, stopping smoking among positive messages

An editorial by Haitham Hamoda, MD, and Sara Moger, with the British Menopause Society, notes that more than 75% of women experiencing menopause report symptoms, and more than 25% describe severe symptoms.

The editorialists point out that the National Institute of Health and Care Excellence and others recommend an individualized approach to addressing menopause that includes a comprehensive approach – advice on exercise, weight management, stopping smoking, and reducing alcohol as well as options such as hormone therapy (HT).

The literature says the main indication for HT is for severe symptoms and not as a preventive measure. “Evidence does not support use of HT to reduce the risk of dementia,” they point out.

While some women may benefit from HT, that should not be explored to the exclusion of other avenues of help, Dr. Hickey and colleagues write. Risks must also be considered.
 

Menopause blamed in a difficult time of life

Jennifer Howell, MD, an obstetrician/gynecologist and certified menopause provider at Duke University in Durham, N.C., told this news organization that menopause is often blamed in a time of life when women naturally are experiencing an array of stressful and emotional changes.

It often coincides with children heading to college, navigating midlife challenges in marriage, helping aging parents, managing demanding careers, and health issues.

People want a reason for changes women experience, and too often the finger gets pointed at menopause, Dr. Howell said.

The message women hear has always been, “It’s got to be your hormones. And people want to hear that there’s a hormonal solution.”

Making menopause the target also has led to nonevidence-based “snake-oil” type remedies sold in unregulated powders, creams, and pellets, Dr. Howell noted.

Dr. Howell has treated thousands of menopausal women in her clinic and she says she spends a good deal of time with them explaining a holistic view of the process, much like what the authors describe, with lifestyle changes and treatment options.

Sometimes HT is the solution, Dr. Howell says, but “it’s become a crutch. Hormones are not a panacea.”

She is frustrated with the amount of disinformation circulating online. Groups like the North American Menopause Society put out reliable evidence-based information, but they compete “with a lot of nonsense,” she says.

The message that women should hear, she says is that “[menopause] is a natural part of aging and there may or may not be symptoms that come along with it. If there are, there are things we can do,” she says.

Menopause gets a bad rap in medical literature and throughout society, say authors of a new analysis. And they argue that the negativity undermines women’s health outlook in the years that should be a natural life transition.

Menopause has been medicalized over centuries and talked about as if it were a disease, they say, and that may increase women’s anxiety and apprehension about the midlife stage.

It’s time to change the narrative, says Martha Hickey, MD, with the department of obstetrics and gynaecology at the Royal Women’s Hospital in Victoria, Australia, and her coauthors. Their analysis was published online in the BMJ.

“The message that menopause signals decay and decline, which can potentially be delayed or reversed by hormonal treatments, persists and is reinforced by the media, medical literature, and information for women, often driven by marketing interests,” they write.

Such messages may chip away at women’s confidence. Dr. Hickey and colleagues cite surveys in the United States and Ireland that found that most women (65%-77%) feel unprepared for menopause.

“Together with limited public discussion and education and shame attached to ageing in women, this may contribute to embarrassment and negative expectations about menopause,” the authors write.
 

The ‘untold misery of oestrogen-starved women’

These messages have deep roots. Take for instance, gynecologist Robert Wilson’s words in his 1966 book “Feminine Forever.” The authors note he recommended estrogen for all menopausal women “to treat their ‘serious, painful and often crippling disease’ and avoid the ‘untold misery of alcoholism, drug addiction, divorce, and broken

homes caused by these unstable, oestrogen-starved women.’ ”

Women experience menopause in very different ways. Experience with menopause also differs by country, the authors explain. “Women’s experience of menopause is also strongly influenced by social values around reproduction and ageing, with positive or negative ramifications,” they write.

“For example, women tend to have worse experiences of menopause in countries where their value is predicated on youth and reproductive capacity and ageing is associated with decline.”

The authors argue that the medicalization of menopause has condensed the wide range of women’s experiences at a typical age into “a narrowly defined disease requiring treatment.”
 

Promoting exercise, stopping smoking among positive messages

An editorial by Haitham Hamoda, MD, and Sara Moger, with the British Menopause Society, notes that more than 75% of women experiencing menopause report symptoms, and more than 25% describe severe symptoms.

The editorialists point out that the National Institute of Health and Care Excellence and others recommend an individualized approach to addressing menopause that includes a comprehensive approach – advice on exercise, weight management, stopping smoking, and reducing alcohol as well as options such as hormone therapy (HT).

The literature says the main indication for HT is for severe symptoms and not as a preventive measure. “Evidence does not support use of HT to reduce the risk of dementia,” they point out.

While some women may benefit from HT, that should not be explored to the exclusion of other avenues of help, Dr. Hickey and colleagues write. Risks must also be considered.
 

Menopause blamed in a difficult time of life

Jennifer Howell, MD, an obstetrician/gynecologist and certified menopause provider at Duke University in Durham, N.C., told this news organization that menopause is often blamed in a time of life when women naturally are experiencing an array of stressful and emotional changes.

It often coincides with children heading to college, navigating midlife challenges in marriage, helping aging parents, managing demanding careers, and health issues.

People want a reason for changes women experience, and too often the finger gets pointed at menopause, Dr. Howell said.

The message women hear has always been, “It’s got to be your hormones. And people want to hear that there’s a hormonal solution.”

Making menopause the target also has led to nonevidence-based “snake-oil” type remedies sold in unregulated powders, creams, and pellets, Dr. Howell noted.

Dr. Howell has treated thousands of menopausal women in her clinic and she says she spends a good deal of time with them explaining a holistic view of the process, much like what the authors describe, with lifestyle changes and treatment options.

Sometimes HT is the solution, Dr. Howell says, but “it’s become a crutch. Hormones are not a panacea.”

She is frustrated with the amount of disinformation circulating online. Groups like the North American Menopause Society put out reliable evidence-based information, but they compete “with a lot of nonsense,” she says.

The message that women should hear, she says is that “[menopause] is a natural part of aging and there may or may not be symptoms that come along with it. If there are, there are things we can do,” she says.

Menopause gets a bad rap in medical literature and throughout society, say authors of a new analysis. And they argue that the negativity undermines women’s health outlook in the years that should be a natural life transition.

Menopause has been medicalized over centuries and talked about as if it were a disease, they say, and that may increase women’s anxiety and apprehension about the midlife stage.

It’s time to change the narrative, says Martha Hickey, MD, with the department of obstetrics and gynaecology at the Royal Women’s Hospital in Victoria, Australia, and her coauthors. Their analysis was published online in the BMJ.

“The message that menopause signals decay and decline, which can potentially be delayed or reversed by hormonal treatments, persists and is reinforced by the media, medical literature, and information for women, often driven by marketing interests,” they write.

Such messages may chip away at women’s confidence. Dr. Hickey and colleagues cite surveys in the United States and Ireland that found that most women (65%-77%) feel unprepared for menopause.

“Together with limited public discussion and education and shame attached to ageing in women, this may contribute to embarrassment and negative expectations about menopause,” the authors write.
 

The ‘untold misery of oestrogen-starved women’

These messages have deep roots. Take for instance, gynecologist Robert Wilson’s words in his 1966 book “Feminine Forever.” The authors note he recommended estrogen for all menopausal women “to treat their ‘serious, painful and often crippling disease’ and avoid the ‘untold misery of alcoholism, drug addiction, divorce, and broken

homes caused by these unstable, oestrogen-starved women.’ ”

Women experience menopause in very different ways. Experience with menopause also differs by country, the authors explain. “Women’s experience of menopause is also strongly influenced by social values around reproduction and ageing, with positive or negative ramifications,” they write.

“For example, women tend to have worse experiences of menopause in countries where their value is predicated on youth and reproductive capacity and ageing is associated with decline.”

The authors argue that the medicalization of menopause has condensed the wide range of women’s experiences at a typical age into “a narrowly defined disease requiring treatment.”
 

Promoting exercise, stopping smoking among positive messages

An editorial by Haitham Hamoda, MD, and Sara Moger, with the British Menopause Society, notes that more than 75% of women experiencing menopause report symptoms, and more than 25% describe severe symptoms.

The editorialists point out that the National Institute of Health and Care Excellence and others recommend an individualized approach to addressing menopause that includes a comprehensive approach – advice on exercise, weight management, stopping smoking, and reducing alcohol as well as options such as hormone therapy (HT).

The literature says the main indication for HT is for severe symptoms and not as a preventive measure. “Evidence does not support use of HT to reduce the risk of dementia,” they point out.

While some women may benefit from HT, that should not be explored to the exclusion of other avenues of help, Dr. Hickey and colleagues write. Risks must also be considered.
 

Menopause blamed in a difficult time of life

Jennifer Howell, MD, an obstetrician/gynecologist and certified menopause provider at Duke University in Durham, N.C., told this news organization that menopause is often blamed in a time of life when women naturally are experiencing an array of stressful and emotional changes.

It often coincides with children heading to college, navigating midlife challenges in marriage, helping aging parents, managing demanding careers, and health issues.

People want a reason for changes women experience, and too often the finger gets pointed at menopause, Dr. Howell said.

The message women hear has always been, “It’s got to be your hormones. And people want to hear that there’s a hormonal solution.”

Making menopause the target also has led to nonevidence-based “snake-oil” type remedies sold in unregulated powders, creams, and pellets, Dr. Howell noted.

Dr. Howell has treated thousands of menopausal women in her clinic and she says she spends a good deal of time with them explaining a holistic view of the process, much like what the authors describe, with lifestyle changes and treatment options.

Sometimes HT is the solution, Dr. Howell says, but “it’s become a crutch. Hormones are not a panacea.”

She is frustrated with the amount of disinformation circulating online. Groups like the North American Menopause Society put out reliable evidence-based information, but they compete “with a lot of nonsense,” she says.

The message that women should hear, she says is that “[menopause] is a natural part of aging and there may or may not be symptoms that come along with it. If there are, there are things we can do,” she says.

The U.S. National Lipid Association has issued a new scientific statement on the management of patients with statin intolerance, which recommends different strategies to help patients stay on statin medications, and also suggests alternatives that can be used in patients who really cannot tolerate statin drugs.

The statement was published online in the Journal of Clinical Lipidology.  

It notes that, although statins are generally well tolerated, statin intolerance is reported in 5%-30% of patients and contributes to reduced statin adherence and persistence, as well as higher risk for adverse cardiovascular outcomes.

RogerAshford/Thinkstock

The statement acknowledges the importance of identifying modifiable risk factors for statin intolerance and recognizes the possibility of a “nocebo” effect, basically the patient expectation of harm resulting in perceived side effects.

To identify a tolerable statin regimen, it recommends that clinicians consider using several different strategies (different statin, dose, and/or dosing frequency), and to classify a patient as having statin intolerance, a minimum of two statins should have been attempted, including at least one at the lowest-approved daily dosage.

The statement says that nonstatin therapy may be required for patients who cannot reach therapeutic objectives with lifestyle and maximal tolerated statin therapy, and in these cases, therapies with outcomes data from randomized trials showing reduced cardiovascular events are favored.

In high and very high-risk patients who are statin intolerant, clinicians should consider initiating nonstatin therapy while additional attempts are made to identify a tolerable statin in order to limit the time of exposure to elevated levels of atherogenic lipoproteins, it suggests.

“There is strong evidence that statins reduce risk of cardiovascular events particularly in patients with atherosclerotic cardiovascular disease, but recent research shows that only about half of patients with ASCVD are on a statin,” Kevin C. Maki, PhD, coauthor of the statement and current president of the National Lipid Association, said in an interview.

“There is an urgent problem with underutilization of statins and undertreatment of ASCVD. And we know that perceived side effects associated with statins are a common reason for discontinuation of these drugs and the consequent failure to manage ASCVD adequately,” he said.  

Dr. Maki noted that the NLA’s first message is that, when experiencing symptoms taking statins, a large majority of patients can still tolerate a statin. “They can try a different agent or a different dose. But for those who still can’t tolerate a statin, we then recommend nonstatin therapies and we favor those therapies with evidence from randomized trials.”

He pointed out that many patients who believe they are experiencing side effects from taking statins still experience the same effects on a placebo, a condition known as the nocebo effect.

“Several studies have shown that the nocebo effect is very common and accounts for more than half of perceived statin side effects. It is therefore estimated that many of the complaints of statin intolerance are probably not directly related to the pharmacodynamic actions of the drugs,” Dr. Maki said.

One recent study on the nocebo effect, the SAMSON study, suggested that 90% of symptoms attributed to statins were elicited by placebo tablets too.

But Dr. Maki added that it can be a losing battle for the clinician if patients think their symptoms are related to taking a statin.

“We suggest that clinicians inform patients that most people can tolerate a statin – maybe with a different agent or an alternative dose – and it is really important to lower LDL cholesterol as that will lower the risk of MI and stroke, so we need to find a regimen that works for each individual,” he said. “Most people can find a regimen that works. If this means taking a lower dose of a statin, they can take some additional therapy as well. This is a better situation than stopping taking statins altogether and allowing ASCVD to progress.”

Dr. Maki stressed that statins should still be the first choice as they are effective, taken orally, and inexpensive.

“Other medications do not have all these advantages. For example, PCSK9 inhibitors are very effective but they are expensive and injectable,” he noted. “And while ezetimibe [Zetia] is now generic so inexpensive, it has a more modest effect on LDL-lowering compared to statins, so by itself it is not normally enough for most patients to get to their target LDL, but it is an option for use in combination with a statin.”

He added that the NLA message is to do everything possible to keep patients on a statin, especially patients with preexisting ASCVD.

“We would like these patients to be on high-intensity statins. If they really can’t tolerate this, then they could be on a low-intensity statin plus an additional agent.”

Commenting on the NLA statement, SAMSON study coauthor James Howard, MB BChir, PhD, Imperial College London, said he had reservations about some of the recommendations.

“Whilst I think it is great news that the existence and importance of the nocebo effect is increasingly recognized in international guidelines and statements, I think we need to be very careful about recommending reduced doses and frequencies of statins,” Dr. Howard said.

“Studies such as SAMSON and StatinWISE indicate the vast majority of side effects reported by patients taking statins are not caused by the statin molecule, but instead are caused by either the nocebo effect, or ever-present background symptoms that are wrongly attributed to the statins,” he commented. “Therefore, to recommend that the correct approach in a patient with a history of MI suffering symptoms on 80 mg of atorvastatin is to reduce the dose or try alternate daily dosing. This reinforces the view that these drugs are side-effect prone and need to be carefully titrated.”

Dr. Howard suggested that patients should be educated on the possibility of the nocebo effect or background symptoms and encouraged to retrial statins at the same dose. “If that doesn’t work, then formal recording with a symptom diary might help patients recognize background symptoms,” he added.

Dr. Howard noted that, if symptoms still persist, an “n-of-1” trial could be conducted, in which the patient rotates between multiple periods of taking a statin and a placebo, but he acknowledged that this is expensive and time consuming. 

Also commenting, Steve Nissen, MD, Cleveland Clinic, said he thought the NLA statement was “reasonable and thoughtful.”

“Regardless of whether the symptoms are due to the nocebo effect or not, some patients will just not take a statin no matter how hard you try to convince them to persevere, so we do need alternatives,” Dr. Nissen said.

He noted that current alternatives would include the PCSK9 inhibitors and ezetimibe, but a future candidate could be the oral bempedoic acid (Nexletol), which is currently being evaluated in a large outcomes trial (CLEAR Outcomes).

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

The U.S. National Lipid Association has issued a new scientific statement on the management of patients with statin intolerance, which recommends different strategies to help patients stay on statin medications, and also suggests alternatives that can be used in patients who really cannot tolerate statin drugs.

The statement was published online in the Journal of Clinical Lipidology.  

It notes that, although statins are generally well tolerated, statin intolerance is reported in 5%-30% of patients and contributes to reduced statin adherence and persistence, as well as higher risk for adverse cardiovascular outcomes.

RogerAshford/Thinkstock

The statement acknowledges the importance of identifying modifiable risk factors for statin intolerance and recognizes the possibility of a “nocebo” effect, basically the patient expectation of harm resulting in perceived side effects.

To identify a tolerable statin regimen, it recommends that clinicians consider using several different strategies (different statin, dose, and/or dosing frequency), and to classify a patient as having statin intolerance, a minimum of two statins should have been attempted, including at least one at the lowest-approved daily dosage.

The statement says that nonstatin therapy may be required for patients who cannot reach therapeutic objectives with lifestyle and maximal tolerated statin therapy, and in these cases, therapies with outcomes data from randomized trials showing reduced cardiovascular events are favored.

In high and very high-risk patients who are statin intolerant, clinicians should consider initiating nonstatin therapy while additional attempts are made to identify a tolerable statin in order to limit the time of exposure to elevated levels of atherogenic lipoproteins, it suggests.

“There is strong evidence that statins reduce risk of cardiovascular events particularly in patients with atherosclerotic cardiovascular disease, but recent research shows that only about half of patients with ASCVD are on a statin,” Kevin C. Maki, PhD, coauthor of the statement and current president of the National Lipid Association, said in an interview.

“There is an urgent problem with underutilization of statins and undertreatment of ASCVD. And we know that perceived side effects associated with statins are a common reason for discontinuation of these drugs and the consequent failure to manage ASCVD adequately,” he said.  

Dr. Maki noted that the NLA’s first message is that, when experiencing symptoms taking statins, a large majority of patients can still tolerate a statin. “They can try a different agent or a different dose. But for those who still can’t tolerate a statin, we then recommend nonstatin therapies and we favor those therapies with evidence from randomized trials.”

He pointed out that many patients who believe they are experiencing side effects from taking statins still experience the same effects on a placebo, a condition known as the nocebo effect.

“Several studies have shown that the nocebo effect is very common and accounts for more than half of perceived statin side effects. It is therefore estimated that many of the complaints of statin intolerance are probably not directly related to the pharmacodynamic actions of the drugs,” Dr. Maki said.

One recent study on the nocebo effect, the SAMSON study, suggested that 90% of symptoms attributed to statins were elicited by placebo tablets too.

But Dr. Maki added that it can be a losing battle for the clinician if patients think their symptoms are related to taking a statin.

“We suggest that clinicians inform patients that most people can tolerate a statin – maybe with a different agent or an alternative dose – and it is really important to lower LDL cholesterol as that will lower the risk of MI and stroke, so we need to find a regimen that works for each individual,” he said. “Most people can find a regimen that works. If this means taking a lower dose of a statin, they can take some additional therapy as well. This is a better situation than stopping taking statins altogether and allowing ASCVD to progress.”

Dr. Maki stressed that statins should still be the first choice as they are effective, taken orally, and inexpensive.

“Other medications do not have all these advantages. For example, PCSK9 inhibitors are very effective but they are expensive and injectable,” he noted. “And while ezetimibe [Zetia] is now generic so inexpensive, it has a more modest effect on LDL-lowering compared to statins, so by itself it is not normally enough for most patients to get to their target LDL, but it is an option for use in combination with a statin.”

He added that the NLA message is to do everything possible to keep patients on a statin, especially patients with preexisting ASCVD.

“We would like these patients to be on high-intensity statins. If they really can’t tolerate this, then they could be on a low-intensity statin plus an additional agent.”

Commenting on the NLA statement, SAMSON study coauthor James Howard, MB BChir, PhD, Imperial College London, said he had reservations about some of the recommendations.

“Whilst I think it is great news that the existence and importance of the nocebo effect is increasingly recognized in international guidelines and statements, I think we need to be very careful about recommending reduced doses and frequencies of statins,” Dr. Howard said.

“Studies such as SAMSON and StatinWISE indicate the vast majority of side effects reported by patients taking statins are not caused by the statin molecule, but instead are caused by either the nocebo effect, or ever-present background symptoms that are wrongly attributed to the statins,” he commented. “Therefore, to recommend that the correct approach in a patient with a history of MI suffering symptoms on 80 mg of atorvastatin is to reduce the dose or try alternate daily dosing. This reinforces the view that these drugs are side-effect prone and need to be carefully titrated.”

Dr. Howard suggested that patients should be educated on the possibility of the nocebo effect or background symptoms and encouraged to retrial statins at the same dose. “If that doesn’t work, then formal recording with a symptom diary might help patients recognize background symptoms,” he added.

Dr. Howard noted that, if symptoms still persist, an “n-of-1” trial could be conducted, in which the patient rotates between multiple periods of taking a statin and a placebo, but he acknowledged that this is expensive and time consuming. 

Also commenting, Steve Nissen, MD, Cleveland Clinic, said he thought the NLA statement was “reasonable and thoughtful.”

“Regardless of whether the symptoms are due to the nocebo effect or not, some patients will just not take a statin no matter how hard you try to convince them to persevere, so we do need alternatives,” Dr. Nissen said.

He noted that current alternatives would include the PCSK9 inhibitors and ezetimibe, but a future candidate could be the oral bempedoic acid (Nexletol), which is currently being evaluated in a large outcomes trial (CLEAR Outcomes).

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

The U.S. National Lipid Association has issued a new scientific statement on the management of patients with statin intolerance, which recommends different strategies to help patients stay on statin medications, and also suggests alternatives that can be used in patients who really cannot tolerate statin drugs.

The statement was published online in the Journal of Clinical Lipidology.  

It notes that, although statins are generally well tolerated, statin intolerance is reported in 5%-30% of patients and contributes to reduced statin adherence and persistence, as well as higher risk for adverse cardiovascular outcomes.

RogerAshford/Thinkstock

The statement acknowledges the importance of identifying modifiable risk factors for statin intolerance and recognizes the possibility of a “nocebo” effect, basically the patient expectation of harm resulting in perceived side effects.

To identify a tolerable statin regimen, it recommends that clinicians consider using several different strategies (different statin, dose, and/or dosing frequency), and to classify a patient as having statin intolerance, a minimum of two statins should have been attempted, including at least one at the lowest-approved daily dosage.

The statement says that nonstatin therapy may be required for patients who cannot reach therapeutic objectives with lifestyle and maximal tolerated statin therapy, and in these cases, therapies with outcomes data from randomized trials showing reduced cardiovascular events are favored.

In high and very high-risk patients who are statin intolerant, clinicians should consider initiating nonstatin therapy while additional attempts are made to identify a tolerable statin in order to limit the time of exposure to elevated levels of atherogenic lipoproteins, it suggests.

“There is strong evidence that statins reduce risk of cardiovascular events particularly in patients with atherosclerotic cardiovascular disease, but recent research shows that only about half of patients with ASCVD are on a statin,” Kevin C. Maki, PhD, coauthor of the statement and current president of the National Lipid Association, said in an interview.

“There is an urgent problem with underutilization of statins and undertreatment of ASCVD. And we know that perceived side effects associated with statins are a common reason for discontinuation of these drugs and the consequent failure to manage ASCVD adequately,” he said.  

Dr. Maki noted that the NLA’s first message is that, when experiencing symptoms taking statins, a large majority of patients can still tolerate a statin. “They can try a different agent or a different dose. But for those who still can’t tolerate a statin, we then recommend nonstatin therapies and we favor those therapies with evidence from randomized trials.”

He pointed out that many patients who believe they are experiencing side effects from taking statins still experience the same effects on a placebo, a condition known as the nocebo effect.

“Several studies have shown that the nocebo effect is very common and accounts for more than half of perceived statin side effects. It is therefore estimated that many of the complaints of statin intolerance are probably not directly related to the pharmacodynamic actions of the drugs,” Dr. Maki said.

One recent study on the nocebo effect, the SAMSON study, suggested that 90% of symptoms attributed to statins were elicited by placebo tablets too.

But Dr. Maki added that it can be a losing battle for the clinician if patients think their symptoms are related to taking a statin.

“We suggest that clinicians inform patients that most people can tolerate a statin – maybe with a different agent or an alternative dose – and it is really important to lower LDL cholesterol as that will lower the risk of MI and stroke, so we need to find a regimen that works for each individual,” he said. “Most people can find a regimen that works. If this means taking a lower dose of a statin, they can take some additional therapy as well. This is a better situation than stopping taking statins altogether and allowing ASCVD to progress.”

Dr. Maki stressed that statins should still be the first choice as they are effective, taken orally, and inexpensive.

“Other medications do not have all these advantages. For example, PCSK9 inhibitors are very effective but they are expensive and injectable,” he noted. “And while ezetimibe [Zetia] is now generic so inexpensive, it has a more modest effect on LDL-lowering compared to statins, so by itself it is not normally enough for most patients to get to their target LDL, but it is an option for use in combination with a statin.”

He added that the NLA message is to do everything possible to keep patients on a statin, especially patients with preexisting ASCVD.

“We would like these patients to be on high-intensity statins. If they really can’t tolerate this, then they could be on a low-intensity statin plus an additional agent.”

Commenting on the NLA statement, SAMSON study coauthor James Howard, MB BChir, PhD, Imperial College London, said he had reservations about some of the recommendations.

“Whilst I think it is great news that the existence and importance of the nocebo effect is increasingly recognized in international guidelines and statements, I think we need to be very careful about recommending reduced doses and frequencies of statins,” Dr. Howard said.

“Studies such as SAMSON and StatinWISE indicate the vast majority of side effects reported by patients taking statins are not caused by the statin molecule, but instead are caused by either the nocebo effect, or ever-present background symptoms that are wrongly attributed to the statins,” he commented. “Therefore, to recommend that the correct approach in a patient with a history of MI suffering symptoms on 80 mg of atorvastatin is to reduce the dose or try alternate daily dosing. This reinforces the view that these drugs are side-effect prone and need to be carefully titrated.”

Dr. Howard suggested that patients should be educated on the possibility of the nocebo effect or background symptoms and encouraged to retrial statins at the same dose. “If that doesn’t work, then formal recording with a symptom diary might help patients recognize background symptoms,” he added.

Dr. Howard noted that, if symptoms still persist, an “n-of-1” trial could be conducted, in which the patient rotates between multiple periods of taking a statin and a placebo, but he acknowledged that this is expensive and time consuming. 

Also commenting, Steve Nissen, MD, Cleveland Clinic, said he thought the NLA statement was “reasonable and thoughtful.”

“Regardless of whether the symptoms are due to the nocebo effect or not, some patients will just not take a statin no matter how hard you try to convince them to persevere, so we do need alternatives,” Dr. Nissen said.

He noted that current alternatives would include the PCSK9 inhibitors and ezetimibe, but a future candidate could be the oral bempedoic acid (Nexletol), which is currently being evaluated in a large outcomes trial (CLEAR Outcomes).

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

The number of pediatric hepatitis cases has remained steady since 2017, new research from the Centers for Disease Control and Prevention suggests, despite the recent investigation into children with hepatitis of unknown cause. The study also found that there was no indication of elevated rates of adenovirus type 40/41 infection in children.

But Rohit Kohli, MBBS, MS, chief of the Division of Gastroenterology, Hepatology, and Nutrition at the Children’s Hospital Los Angeles, California, says that although the study is “well-designed and robust,” that does not mean that these hepatitis cases of unknown origin are no longer a concern. He was not involved with the CDC research. “As a clinician, I’m still worried,” he said. “Why I feel like this is not conclusive is that there are other data from entities like the United Kingdom Health Security Agency that are incongruent with [these findings],” he said.

The research was published in the CDC’s Morbidity and Mortality Weekly Report.

In November 2021, the Alabama Department of Public Health began an investigation with the CDC after a cluster of children were admitted to a children’s hospital in the state with severe hepatitis, who all tested positive for adenovirus. When the United Kingdom’s Health Security Agency announced an investigation into similar cases in early April 2022, the CDC decided to expand their search nationally.

Now, as of June 15, the agency is investigating 290 cases in 41 states and U.S. territories. Worldwide, 650 cases in 33 countries have been reported, according to the most recent update by the World Health Organization on May 27, 2022. At least 38 patients have needed liver transplants, and nine deaths have been reported to WHO.

In its most recent press call on the topic, the CDC announced that it’s aware of six deaths in the United States through May 20, 2022. The COVID-19 vaccine has been ruled out as a potential cause because the majority of affected children are unvaccinated or are too young to receive the vaccine. Adenovirus infection remains a leading suspect in these sick children because the virus has been detected in 60.8% of tested cases, WHO reports.

Investigators have detected an increase in reported pediatric hepatitis cases, compared with prior years in the United Kingdom, but it was not clear whether that same pattern would be found in the United States. Neither pediatric hepatitis nor adenovirus type 40/41 are reportable conditions in the United States. In the May 20 CDC press call, Umesh Parashar, MD, chief of the CDC’s Viral Gastroenteritis Branch, said that an estimated 1,500-2,000 children aged younger than 10 are hospitalized in the United States for hepatitis every year. “That’s a fairly large number,” he said, and it might make it difficult to detect a small increase in cases.

To better estimate trends in pediatric hepatitis and adenovirus infection in the United States, investigators collected available data on emergency department (ED) visits, hospitalizations, and liver transplants associated with hepatitis in children as well as adenovirus stool testing results. Researchers used four large databases: the National Syndromic Surveillance Program; the Premier Healthcare Database Special Release; the Organ Procurement and Transplant Network; and Labcorp, which is a large commercial lab network.

To account for changes in health care utilization in the first year of the COVID-19 pandemic, the team compared hepatitis-associated ED visits, hospitalizations, and liver transplants from October 2021 to March 2022 versus the same months (January to March and October to December) in 2017, 2018, and 2019. For adenovirus stool testing, results from October 2021 to March 2022 were compared with the same calendar months (October to March) from 2017-2018, 2018-2019, and 2019-2020, to help control for seasonality.

• Weekly ED visits with hepatitis-associated discharge codes
• Hepatitis-associated monthly hospitalizations in children aged 0-4 years (22 vs. 19.5; P = .26)
• Hepatitis-associated monthly hospitalization in children aged 5-11 years (12 vs. 10.5; P = .42)
• Monthly liver transplants (5 vs. 4; P = .19)
• Percentage of stool specimens positive for adenovirus types 40/41, though the number of specimens tested was highest in March 2022

The authors acknowledged that pediatric hepatitis is rare, so it may be difficult tease out small changes in the number of cases. Also, data on hospitalizations and liver transplants have a 2- to 3-month reporting delay, so the case counts for March 2022 “might be underreported,” they wrote. Mr. Kohli noted that because hepatitis and adenovirus are not reportable conditions, the analysis relied on retrospective data from insurance companies and electronic medical records. Retrospective data are inherently limited, compared with prospective analyses, he said, and it’s possible that certain cases could be included in more than one database and thus be double-counted, whereas other cases could be missed entirely.

These findings also conflict with data from the United Kingdom, which in May reported that the average number of hepatitis cases had increased, compared with previous years, he said. More data are needed, he said, and he is involved with a study with the North American Society for Pediatric Gastroenterology and the American Association for the Study of Liver Diseases that is also collecting data to try to understand whether there has been an uptick in pediatric hepatitis cases. The study will collect patient data directly from hospitals as well as include additional pathology data, such as biopsy results.

“We should not be inhibited to look further academically – and public health–wise – while we take into cognizance this very good, robust attempt from the CDC,” he said.

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

The number of pediatric hepatitis cases has remained steady since 2017, new research from the Centers for Disease Control and Prevention suggests, despite the recent investigation into children with hepatitis of unknown cause. The study also found that there was no indication of elevated rates of adenovirus type 40/41 infection in children.

But Rohit Kohli, MBBS, MS, chief of the Division of Gastroenterology, Hepatology, and Nutrition at the Children’s Hospital Los Angeles, California, says that although the study is “well-designed and robust,” that does not mean that these hepatitis cases of unknown origin are no longer a concern. He was not involved with the CDC research. “As a clinician, I’m still worried,” he said. “Why I feel like this is not conclusive is that there are other data from entities like the United Kingdom Health Security Agency that are incongruent with [these findings],” he said.

The research was published in the CDC’s Morbidity and Mortality Weekly Report.

In November 2021, the Alabama Department of Public Health began an investigation with the CDC after a cluster of children were admitted to a children’s hospital in the state with severe hepatitis, who all tested positive for adenovirus. When the United Kingdom’s Health Security Agency announced an investigation into similar cases in early April 2022, the CDC decided to expand their search nationally.

Now, as of June 15, the agency is investigating 290 cases in 41 states and U.S. territories. Worldwide, 650 cases in 33 countries have been reported, according to the most recent update by the World Health Organization on May 27, 2022. At least 38 patients have needed liver transplants, and nine deaths have been reported to WHO.

In its most recent press call on the topic, the CDC announced that it’s aware of six deaths in the United States through May 20, 2022. The COVID-19 vaccine has been ruled out as a potential cause because the majority of affected children are unvaccinated or are too young to receive the vaccine. Adenovirus infection remains a leading suspect in these sick children because the virus has been detected in 60.8% of tested cases, WHO reports.

Investigators have detected an increase in reported pediatric hepatitis cases, compared with prior years in the United Kingdom, but it was not clear whether that same pattern would be found in the United States. Neither pediatric hepatitis nor adenovirus type 40/41 are reportable conditions in the United States. In the May 20 CDC press call, Umesh Parashar, MD, chief of the CDC’s Viral Gastroenteritis Branch, said that an estimated 1,500-2,000 children aged younger than 10 are hospitalized in the United States for hepatitis every year. “That’s a fairly large number,” he said, and it might make it difficult to detect a small increase in cases.

To better estimate trends in pediatric hepatitis and adenovirus infection in the United States, investigators collected available data on emergency department (ED) visits, hospitalizations, and liver transplants associated with hepatitis in children as well as adenovirus stool testing results. Researchers used four large databases: the National Syndromic Surveillance Program; the Premier Healthcare Database Special Release; the Organ Procurement and Transplant Network; and Labcorp, which is a large commercial lab network.

To account for changes in health care utilization in the first year of the COVID-19 pandemic, the team compared hepatitis-associated ED visits, hospitalizations, and liver transplants from October 2021 to March 2022 versus the same months (January to March and October to December) in 2017, 2018, and 2019. For adenovirus stool testing, results from October 2021 to March 2022 were compared with the same calendar months (October to March) from 2017-2018, 2018-2019, and 2019-2020, to help control for seasonality.

• Weekly ED visits with hepatitis-associated discharge codes
• Hepatitis-associated monthly hospitalizations in children aged 0-4 years (22 vs. 19.5; P = .26)
• Hepatitis-associated monthly hospitalization in children aged 5-11 years (12 vs. 10.5; P = .42)
• Monthly liver transplants (5 vs. 4; P = .19)
• Percentage of stool specimens positive for adenovirus types 40/41, though the number of specimens tested was highest in March 2022

The authors acknowledged that pediatric hepatitis is rare, so it may be difficult tease out small changes in the number of cases. Also, data on hospitalizations and liver transplants have a 2- to 3-month reporting delay, so the case counts for March 2022 “might be underreported,” they wrote. Mr. Kohli noted that because hepatitis and adenovirus are not reportable conditions, the analysis relied on retrospective data from insurance companies and electronic medical records. Retrospective data are inherently limited, compared with prospective analyses, he said, and it’s possible that certain cases could be included in more than one database and thus be double-counted, whereas other cases could be missed entirely.

These findings also conflict with data from the United Kingdom, which in May reported that the average number of hepatitis cases had increased, compared with previous years, he said. More data are needed, he said, and he is involved with a study with the North American Society for Pediatric Gastroenterology and the American Association for the Study of Liver Diseases that is also collecting data to try to understand whether there has been an uptick in pediatric hepatitis cases. The study will collect patient data directly from hospitals as well as include additional pathology data, such as biopsy results.

“We should not be inhibited to look further academically – and public health–wise – while we take into cognizance this very good, robust attempt from the CDC,” he said.

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

The number of pediatric hepatitis cases has remained steady since 2017, new research from the Centers for Disease Control and Prevention suggests, despite the recent investigation into children with hepatitis of unknown cause. The study also found that there was no indication of elevated rates of adenovirus type 40/41 infection in children.

But Rohit Kohli, MBBS, MS, chief of the Division of Gastroenterology, Hepatology, and Nutrition at the Children’s Hospital Los Angeles, California, says that although the study is “well-designed and robust,” that does not mean that these hepatitis cases of unknown origin are no longer a concern. He was not involved with the CDC research. “As a clinician, I’m still worried,” he said. “Why I feel like this is not conclusive is that there are other data from entities like the United Kingdom Health Security Agency that are incongruent with [these findings],” he said.

The research was published in the CDC’s Morbidity and Mortality Weekly Report.

In November 2021, the Alabama Department of Public Health began an investigation with the CDC after a cluster of children were admitted to a children’s hospital in the state with severe hepatitis, who all tested positive for adenovirus. When the United Kingdom’s Health Security Agency announced an investigation into similar cases in early April 2022, the CDC decided to expand their search nationally.

Now, as of June 15, the agency is investigating 290 cases in 41 states and U.S. territories. Worldwide, 650 cases in 33 countries have been reported, according to the most recent update by the World Health Organization on May 27, 2022. At least 38 patients have needed liver transplants, and nine deaths have been reported to WHO.

In its most recent press call on the topic, the CDC announced that it’s aware of six deaths in the United States through May 20, 2022. The COVID-19 vaccine has been ruled out as a potential cause because the majority of affected children are unvaccinated or are too young to receive the vaccine. Adenovirus infection remains a leading suspect in these sick children because the virus has been detected in 60.8% of tested cases, WHO reports.

Investigators have detected an increase in reported pediatric hepatitis cases, compared with prior years in the United Kingdom, but it was not clear whether that same pattern would be found in the United States. Neither pediatric hepatitis nor adenovirus type 40/41 are reportable conditions in the United States. In the May 20 CDC press call, Umesh Parashar, MD, chief of the CDC’s Viral Gastroenteritis Branch, said that an estimated 1,500-2,000 children aged younger than 10 are hospitalized in the United States for hepatitis every year. “That’s a fairly large number,” he said, and it might make it difficult to detect a small increase in cases.

To better estimate trends in pediatric hepatitis and adenovirus infection in the United States, investigators collected available data on emergency department (ED) visits, hospitalizations, and liver transplants associated with hepatitis in children as well as adenovirus stool testing results. Researchers used four large databases: the National Syndromic Surveillance Program; the Premier Healthcare Database Special Release; the Organ Procurement and Transplant Network; and Labcorp, which is a large commercial lab network.

To account for changes in health care utilization in the first year of the COVID-19 pandemic, the team compared hepatitis-associated ED visits, hospitalizations, and liver transplants from October 2021 to March 2022 versus the same months (January to March and October to December) in 2017, 2018, and 2019. For adenovirus stool testing, results from October 2021 to March 2022 were compared with the same calendar months (October to March) from 2017-2018, 2018-2019, and 2019-2020, to help control for seasonality.

• Weekly ED visits with hepatitis-associated discharge codes
• Hepatitis-associated monthly hospitalizations in children aged 0-4 years (22 vs. 19.5; P = .26)
• Hepatitis-associated monthly hospitalization in children aged 5-11 years (12 vs. 10.5; P = .42)
• Monthly liver transplants (5 vs. 4; P = .19)
• Percentage of stool specimens positive for adenovirus types 40/41, though the number of specimens tested was highest in March 2022

The authors acknowledged that pediatric hepatitis is rare, so it may be difficult tease out small changes in the number of cases. Also, data on hospitalizations and liver transplants have a 2- to 3-month reporting delay, so the case counts for March 2022 “might be underreported,” they wrote. Mr. Kohli noted that because hepatitis and adenovirus are not reportable conditions, the analysis relied on retrospective data from insurance companies and electronic medical records. Retrospective data are inherently limited, compared with prospective analyses, he said, and it’s possible that certain cases could be included in more than one database and thus be double-counted, whereas other cases could be missed entirely.

These findings also conflict with data from the United Kingdom, which in May reported that the average number of hepatitis cases had increased, compared with previous years, he said. More data are needed, he said, and he is involved with a study with the North American Society for Pediatric Gastroenterology and the American Association for the Study of Liver Diseases that is also collecting data to try to understand whether there has been an uptick in pediatric hepatitis cases. The study will collect patient data directly from hospitals as well as include additional pathology data, such as biopsy results.

“We should not be inhibited to look further academically – and public health–wise – while we take into cognizance this very good, robust attempt from the CDC,” he said.

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