The recent approval of the first oral fecal-derived microbiota therapy to prevent the recurrence of Clostridioides difficile (C. diff) infection in patients was welcome news for physicians who’ve struggled under the weight of having too few treatment options for the prevention of C. diff recurrence.

The product, developed by Massachusetts-based Seres Therepeutics and marketed as Vowst, was approved by the U.S. Food and Drug Administration on April 26. It is approved for use in adults who have already been treated with antibiotics for a recurrent infection with C. diff bacteria.

This is the first oral treatment for the prevention of C. diff recurrence and is designed to be delivered in four capsules taken daily for 3 days.

Gastroenterologist Phillip I. Tarr, MD, division chief of gastroenterology at Washington University, St. Louis, and chair of the American Gastroenterological Association Center for Gut Microbiome Research and Education, said that prevention of recurrent C. diff infection “remains challenging,” and that Vowst “provides the first FDA-approved, orally administered microbiome therapeutic with which to achieve this goal. This advance also makes us optimistic we might soon be able to prevent other disorders by managing gut microbial communities.”

Vowst is the second therapy derived from human stool to be approved for the indication in less than 6 months. In December, the FDA approved Rebyota (Ferring), a rectally delivered treatment that also uses microbes from donor feces. Both products were given priority review, orphan drug, and breakthrough therapy designations by the agency.

C. diff infection can be aggravated by an alteration of normal gut flora associated with antibiotics treatment, leading to cycles of repeated infections. Infection can produce diarrhea, abdominal pain, fever, and severe morbidity. In the United States, an estimated 15,000 to 30,000 deaths per year are linked to C. diff. Risk factors for recurrent infection include being 65 or older, hospitalization, being in a nursing home, a weakened immune system, and previous infection with C. diff.

Therapies transplanting fecal microbiota from donors have been used since the 1950s as treatments for recurrent C. diff infection, and in the past decade, as stool banks recruiting screened donors have made fecal microbiota transplants, or FMT, standard of care. However, only in recent years have fecal-derived therapies become subject to standardized safety and efficacy testing.

Both the current FDA-approved products, Rebyota and Vowst, were shown in randomized controlled trials to reduce recurrence of C. diff infection, compared with placebo. In a phase 3 clinical trial of Rebyota (n = 262) in antibiotic-treated patients, one rectally administered dose reduced recurrence of C. diff infection by 70.6% at 8 weeks, compared with 57.5% for placebo. A phase 3 study of Vowst (n = 281) showed recurrence in treated subjects to be 12.4% at 8 weeks, compared with nearly 40% of those receiving placebo (relative risk, 0.32; 95% confidence interval, 0.18-0.58; P less than .001).

Despite screening protocols that have become increasingly homogenized and rigorous, FMT is associated with the risk of introducing pathogens. Vowst is manufactured with purified bacterial spores derived from donor feces, not whole stool. Nonetheless, FDA noted in its statement that Vowst could still potentially introduce infectious agents or allergens.
 

Antibiotics are still first-line treatment

In an interview, Jessica Allegretti, MD, MPH, AGAF, medical director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital, Boston, said that having two FDA-approved therapies with different means of administration “is great for the field and great for patients. These are both meant to be used after a course of antibiotics, so antibiotics are still the mainstay of treatment for C. diff and recurrent C. diff, but we now have more options to prevent recurrence.”

The convenience of an oral therapy that can be taken at home is “very attractive,” Dr. Allegretti added, noting that there will also be patients “who either don’t want to or can’t take capsules, for whom a rectal administration [in a health care setting] may be preferred.”

Dr. Allegretti, who has used FMT to treat recurrent C. difficile for more than a decade, said that she expected traditional FMT using screened donor stool to remain available even as the new products are adopted by clinicians. FMT centers like OpenBiome “will continue to provide access for patients who either don’t have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them,” she said. “I do think there will always be a need for the traditional option. The more options that we have available the better.”

TD Cowen analyst Joseph Thome told Reuters that the drug could be priced close to $20,000 per course, expecting peak sales of $750 million in the U.S. in 2033.

Dr. Allegretti disclosed consulting work for Seres Therapeutics, Ferring, and other manufacturers. She is a member of OpenBiome’s clinical advisory board.

The recent approval of the first oral fecal-derived microbiota therapy to prevent the recurrence of Clostridioides difficile (C. diff) infection in patients was welcome news for physicians who’ve struggled under the weight of having too few treatment options for the prevention of C. diff recurrence.

The product, developed by Massachusetts-based Seres Therepeutics and marketed as Vowst, was approved by the U.S. Food and Drug Administration on April 26. It is approved for use in adults who have already been treated with antibiotics for a recurrent infection with C. diff bacteria.

This is the first oral treatment for the prevention of C. diff recurrence and is designed to be delivered in four capsules taken daily for 3 days.

Gastroenterologist Phillip I. Tarr, MD, division chief of gastroenterology at Washington University, St. Louis, and chair of the American Gastroenterological Association Center for Gut Microbiome Research and Education, said that prevention of recurrent C. diff infection “remains challenging,” and that Vowst “provides the first FDA-approved, orally administered microbiome therapeutic with which to achieve this goal. This advance also makes us optimistic we might soon be able to prevent other disorders by managing gut microbial communities.”

Vowst is the second therapy derived from human stool to be approved for the indication in less than 6 months. In December, the FDA approved Rebyota (Ferring), a rectally delivered treatment that also uses microbes from donor feces. Both products were given priority review, orphan drug, and breakthrough therapy designations by the agency.

C. diff infection can be aggravated by an alteration of normal gut flora associated with antibiotics treatment, leading to cycles of repeated infections. Infection can produce diarrhea, abdominal pain, fever, and severe morbidity. In the United States, an estimated 15,000 to 30,000 deaths per year are linked to C. diff. Risk factors for recurrent infection include being 65 or older, hospitalization, being in a nursing home, a weakened immune system, and previous infection with C. diff.

Therapies transplanting fecal microbiota from donors have been used since the 1950s as treatments for recurrent C. diff infection, and in the past decade, as stool banks recruiting screened donors have made fecal microbiota transplants, or FMT, standard of care. However, only in recent years have fecal-derived therapies become subject to standardized safety and efficacy testing.

Both the current FDA-approved products, Rebyota and Vowst, were shown in randomized controlled trials to reduce recurrence of C. diff infection, compared with placebo. In a phase 3 clinical trial of Rebyota (n = 262) in antibiotic-treated patients, one rectally administered dose reduced recurrence of C. diff infection by 70.6% at 8 weeks, compared with 57.5% for placebo. A phase 3 study of Vowst (n = 281) showed recurrence in treated subjects to be 12.4% at 8 weeks, compared with nearly 40% of those receiving placebo (relative risk, 0.32; 95% confidence interval, 0.18-0.58; P less than .001).

Despite screening protocols that have become increasingly homogenized and rigorous, FMT is associated with the risk of introducing pathogens. Vowst is manufactured with purified bacterial spores derived from donor feces, not whole stool. Nonetheless, FDA noted in its statement that Vowst could still potentially introduce infectious agents or allergens.
 

Antibiotics are still first-line treatment

In an interview, Jessica Allegretti, MD, MPH, AGAF, medical director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital, Boston, said that having two FDA-approved therapies with different means of administration “is great for the field and great for patients. These are both meant to be used after a course of antibiotics, so antibiotics are still the mainstay of treatment for C. diff and recurrent C. diff, but we now have more options to prevent recurrence.”

The convenience of an oral therapy that can be taken at home is “very attractive,” Dr. Allegretti added, noting that there will also be patients “who either don’t want to or can’t take capsules, for whom a rectal administration [in a health care setting] may be preferred.”

Dr. Allegretti, who has used FMT to treat recurrent C. difficile for more than a decade, said that she expected traditional FMT using screened donor stool to remain available even as the new products are adopted by clinicians. FMT centers like OpenBiome “will continue to provide access for patients who either don’t have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them,” she said. “I do think there will always be a need for the traditional option. The more options that we have available the better.”

TD Cowen analyst Joseph Thome told Reuters that the drug could be priced close to $20,000 per course, expecting peak sales of $750 million in the U.S. in 2033.

Dr. Allegretti disclosed consulting work for Seres Therapeutics, Ferring, and other manufacturers. She is a member of OpenBiome’s clinical advisory board.

The recent approval of the first oral fecal-derived microbiota therapy to prevent the recurrence of Clostridioides difficile (C. diff) infection in patients was welcome news for physicians who’ve struggled under the weight of having too few treatment options for the prevention of C. diff recurrence.

The product, developed by Massachusetts-based Seres Therepeutics and marketed as Vowst, was approved by the U.S. Food and Drug Administration on April 26. It is approved for use in adults who have already been treated with antibiotics for a recurrent infection with C. diff bacteria.

This is the first oral treatment for the prevention of C. diff recurrence and is designed to be delivered in four capsules taken daily for 3 days.

Gastroenterologist Phillip I. Tarr, MD, division chief of gastroenterology at Washington University, St. Louis, and chair of the American Gastroenterological Association Center for Gut Microbiome Research and Education, said that prevention of recurrent C. diff infection “remains challenging,” and that Vowst “provides the first FDA-approved, orally administered microbiome therapeutic with which to achieve this goal. This advance also makes us optimistic we might soon be able to prevent other disorders by managing gut microbial communities.”

Vowst is the second therapy derived from human stool to be approved for the indication in less than 6 months. In December, the FDA approved Rebyota (Ferring), a rectally delivered treatment that also uses microbes from donor feces. Both products were given priority review, orphan drug, and breakthrough therapy designations by the agency.

C. diff infection can be aggravated by an alteration of normal gut flora associated with antibiotics treatment, leading to cycles of repeated infections. Infection can produce diarrhea, abdominal pain, fever, and severe morbidity. In the United States, an estimated 15,000 to 30,000 deaths per year are linked to C. diff. Risk factors for recurrent infection include being 65 or older, hospitalization, being in a nursing home, a weakened immune system, and previous infection with C. diff.

Therapies transplanting fecal microbiota from donors have been used since the 1950s as treatments for recurrent C. diff infection, and in the past decade, as stool banks recruiting screened donors have made fecal microbiota transplants, or FMT, standard of care. However, only in recent years have fecal-derived therapies become subject to standardized safety and efficacy testing.

Both the current FDA-approved products, Rebyota and Vowst, were shown in randomized controlled trials to reduce recurrence of C. diff infection, compared with placebo. In a phase 3 clinical trial of Rebyota (n = 262) in antibiotic-treated patients, one rectally administered dose reduced recurrence of C. diff infection by 70.6% at 8 weeks, compared with 57.5% for placebo. A phase 3 study of Vowst (n = 281) showed recurrence in treated subjects to be 12.4% at 8 weeks, compared with nearly 40% of those receiving placebo (relative risk, 0.32; 95% confidence interval, 0.18-0.58; P less than .001).

Despite screening protocols that have become increasingly homogenized and rigorous, FMT is associated with the risk of introducing pathogens. Vowst is manufactured with purified bacterial spores derived from donor feces, not whole stool. Nonetheless, FDA noted in its statement that Vowst could still potentially introduce infectious agents or allergens.
 

Antibiotics are still first-line treatment

In an interview, Jessica Allegretti, MD, MPH, AGAF, medical director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital, Boston, said that having two FDA-approved therapies with different means of administration “is great for the field and great for patients. These are both meant to be used after a course of antibiotics, so antibiotics are still the mainstay of treatment for C. diff and recurrent C. diff, but we now have more options to prevent recurrence.”

The convenience of an oral therapy that can be taken at home is “very attractive,” Dr. Allegretti added, noting that there will also be patients “who either don’t want to or can’t take capsules, for whom a rectal administration [in a health care setting] may be preferred.”

Dr. Allegretti, who has used FMT to treat recurrent C. difficile for more than a decade, said that she expected traditional FMT using screened donor stool to remain available even as the new products are adopted by clinicians. FMT centers like OpenBiome “will continue to provide access for patients who either don’t have the ability to get the FDA-approved products because of insurance coverage, or for financial reasons, or maybe neither of the new products is appropriate for them,” she said. “I do think there will always be a need for the traditional option. The more options that we have available the better.”

TD Cowen analyst Joseph Thome told Reuters that the drug could be priced close to $20,000 per course, expecting peak sales of $750 million in the U.S. in 2033.

Dr. Allegretti disclosed consulting work for Seres Therapeutics, Ferring, and other manufacturers. She is a member of OpenBiome’s clinical advisory board.

The association between colorectal cancer (CRC) and overweight and obesity may be underestimated because body mass index (BMI) is typically measured too near the time of CRC diagnosis and so would not reflect prediagnostic weight loss linked to the condition, a new analysis suggests.

Obesity, assessed using BMI, was associated with a twofold higher risk of CRC 8-10 years prior to diagnosis, while weight loss of 2 kg or more within 2 years of diagnosis was associated with a “dramatic” 7.52-fold increased risk of CRC, the researchers said.

The results “illustrate the dramatic change of BMI as a risk factor associated with CRC, depending on whether the period of potential prediagnostic weight loss is accounted for or not,” Hermann Brenner, MD, MPH, of the German Cancer Research Center, Heidelberg, and colleagues conclude.

The study was published online in JAMA Network Open.

Recent evidence suggests that obesity is associated with an estimated 30% greater risk of CRC. But the extent to which excess body weight influences CRC risk may be underestimated because prediagnostic weight loss has historically been overlooked.

To understand how prediagnostic weight loss could affect the associations found between excess weight and CRC risk, the researchers examined weight data on almost 6,500 patients newly diagnosed with CRC and more than 5,400 control persons who were matched for age, sex, and country of residence. The median age of the cohort was 69 years, and 60.3% were men.

At the time of recruitment, 62% of case patients and 66% of control patients were overweight or obese. No association was found between current BMI and CRC risk.

However, when using patients’ weight from 8-10 years before CRC diagnosis, the researchers found a significant positive association between overweight or obesity and CRC risk (adjusted odds ratio, 1.27 for overweight and 2.09 for obesity). The risk for CRC increased significantly for every 5-unit increase in BMI (aOR, 1.35). These results were similar when the patients were stratified by sex and CRC subsites.

The researchers also found that weight loss of 2 kg or more within 2 years of CRC diagnosis or interview was associated with a 7.52-fold increased risk for CRC.

“While we demonstrated that prediagnostic weight loss is a major concern for CRC,” such prediagnostic weight loss “may play a similarly important role for other cancers and noncancer diseases associated with overweight and obesity,” the authors note.

“Most importantly, however, our results emphasize the importance of interventions aimed at preventing and managing overweight and obesity ... and which may factor more substantially into CRC risk and other obesity-related diseases than suggested by existing epidemiological evidence,” they write.

The study was supported in part by grants from the German Research Council and the German Federal Ministry of Education and Research. The authors have disclosed no relevant financial relationships.

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

The association between colorectal cancer (CRC) and overweight and obesity may be underestimated because body mass index (BMI) is typically measured too near the time of CRC diagnosis and so would not reflect prediagnostic weight loss linked to the condition, a new analysis suggests.

Obesity, assessed using BMI, was associated with a twofold higher risk of CRC 8-10 years prior to diagnosis, while weight loss of 2 kg or more within 2 years of diagnosis was associated with a “dramatic” 7.52-fold increased risk of CRC, the researchers said.

The results “illustrate the dramatic change of BMI as a risk factor associated with CRC, depending on whether the period of potential prediagnostic weight loss is accounted for or not,” Hermann Brenner, MD, MPH, of the German Cancer Research Center, Heidelberg, and colleagues conclude.

The study was published online in JAMA Network Open.

Recent evidence suggests that obesity is associated with an estimated 30% greater risk of CRC. But the extent to which excess body weight influences CRC risk may be underestimated because prediagnostic weight loss has historically been overlooked.

To understand how prediagnostic weight loss could affect the associations found between excess weight and CRC risk, the researchers examined weight data on almost 6,500 patients newly diagnosed with CRC and more than 5,400 control persons who were matched for age, sex, and country of residence. The median age of the cohort was 69 years, and 60.3% were men.

At the time of recruitment, 62% of case patients and 66% of control patients were overweight or obese. No association was found between current BMI and CRC risk.

However, when using patients’ weight from 8-10 years before CRC diagnosis, the researchers found a significant positive association between overweight or obesity and CRC risk (adjusted odds ratio, 1.27 for overweight and 2.09 for obesity). The risk for CRC increased significantly for every 5-unit increase in BMI (aOR, 1.35). These results were similar when the patients were stratified by sex and CRC subsites.

The researchers also found that weight loss of 2 kg or more within 2 years of CRC diagnosis or interview was associated with a 7.52-fold increased risk for CRC.

“While we demonstrated that prediagnostic weight loss is a major concern for CRC,” such prediagnostic weight loss “may play a similarly important role for other cancers and noncancer diseases associated with overweight and obesity,” the authors note.

“Most importantly, however, our results emphasize the importance of interventions aimed at preventing and managing overweight and obesity ... and which may factor more substantially into CRC risk and other obesity-related diseases than suggested by existing epidemiological evidence,” they write.

The study was supported in part by grants from the German Research Council and the German Federal Ministry of Education and Research. The authors have disclosed no relevant financial relationships.

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

The association between colorectal cancer (CRC) and overweight and obesity may be underestimated because body mass index (BMI) is typically measured too near the time of CRC diagnosis and so would not reflect prediagnostic weight loss linked to the condition, a new analysis suggests.

Obesity, assessed using BMI, was associated with a twofold higher risk of CRC 8-10 years prior to diagnosis, while weight loss of 2 kg or more within 2 years of diagnosis was associated with a “dramatic” 7.52-fold increased risk of CRC, the researchers said.

The results “illustrate the dramatic change of BMI as a risk factor associated with CRC, depending on whether the period of potential prediagnostic weight loss is accounted for or not,” Hermann Brenner, MD, MPH, of the German Cancer Research Center, Heidelberg, and colleagues conclude.

The study was published online in JAMA Network Open.

Recent evidence suggests that obesity is associated with an estimated 30% greater risk of CRC. But the extent to which excess body weight influences CRC risk may be underestimated because prediagnostic weight loss has historically been overlooked.

To understand how prediagnostic weight loss could affect the associations found between excess weight and CRC risk, the researchers examined weight data on almost 6,500 patients newly diagnosed with CRC and more than 5,400 control persons who were matched for age, sex, and country of residence. The median age of the cohort was 69 years, and 60.3% were men.

At the time of recruitment, 62% of case patients and 66% of control patients were overweight or obese. No association was found between current BMI and CRC risk.

However, when using patients’ weight from 8-10 years before CRC diagnosis, the researchers found a significant positive association between overweight or obesity and CRC risk (adjusted odds ratio, 1.27 for overweight and 2.09 for obesity). The risk for CRC increased significantly for every 5-unit increase in BMI (aOR, 1.35). These results were similar when the patients were stratified by sex and CRC subsites.

The researchers also found that weight loss of 2 kg or more within 2 years of CRC diagnosis or interview was associated with a 7.52-fold increased risk for CRC.

“While we demonstrated that prediagnostic weight loss is a major concern for CRC,” such prediagnostic weight loss “may play a similarly important role for other cancers and noncancer diseases associated with overweight and obesity,” the authors note.

“Most importantly, however, our results emphasize the importance of interventions aimed at preventing and managing overweight and obesity ... and which may factor more substantially into CRC risk and other obesity-related diseases than suggested by existing epidemiological evidence,” they write.

The study was supported in part by grants from the German Research Council and the German Federal Ministry of Education and Research. The authors have disclosed no relevant financial relationships.

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

SAN DIEGO – Despite the high prevalence of hypertension in the United States, confusion and gaps about how to diagnose and manage it remain, according to a presenter at the annual meeting of the American College of Physicians.

In a major shift in the definition of hypertension, guidelines published in 2017 reclassified 130/80 mm Hg as high blood pressure, or stage 1 hypertension. Previous guidelines classified 130/80 mm Hg as elevated, and 140/90 mm Hg used to be the threshold for stage 1 hypertension.

“This shift in classification criteria may cause confusion among clinicians caring for patients with hypertension and has a significant impact on how we diagnose and manage hypertension in our practice,” said Shawna D. Nesbitt, MD, professor of internal medicine at the University of Texas Southwestern Medical Center and medical director at Parkland Hypertension Clinic in Dallas. Dr. Nesbitt is an expert in the diagnosis and treatment of hypertension, particularly complex and refractory cases.

Christos Evangelou/MDedge News

Cardiovascular disease (CVD) is the leading cause of death in the United States, accounting for nearly one-quarter of all deaths in men and in women. Hypertension is a key factor contributing to CVD. The hypertension‐related CVD mortality is currently on the rise in many U.S. demographic groups, including younger individuals (35-64 years old), she said.

When asked about the potential causes of this trend, Dr. Nesbitt explained that the epidemics of obesity and overweight are critical contributors to the high prevalence of hypertension.

The new definition means a wider gap in the prevalence of hypertension between men and women, as well as between Black and White people in the United States. The U.S. rates of hypertension and hypertension‐related CVD mortality are much higher in Black than in White people in this country. Hypertension control rates are the lowest in Black, Hispanic, and Asian males, Dr. Nesbitt said.
 

Accurate measurement of blood pressure is crucial

The changes in classification criteria for hypertension have made accurate measurements of blood pressure important. A key challenge in the evaluation of hypertension in the clinic is the difference in the methods used to measure blood pressure between trials and real-world clinical practice.

“We can’t easily translate data collected in clinical trials into real-life scenarios, and this can have important implications in our expectations of treatment outcome,” Dr. Nesbitt cautioned.

Commenting on the best practices in blood pressure measurements in the office, Dr. Nesbitt said that patients need to be seated with their feet on the floor and their backs and arms supported. In addition, patients need to have at least 5 minutes of rest without talking.

“It is very important to help patients understand what triggers their blood pressure to be elevated and teach them how and when to measure their blood pressure at home using their own devices,” she added.

Another critical question is how to translate the new guidelines into changes in clinical care, she said.
 

Current treatment landscape of hypertension

Ensuring a healthy diet, weight, and sleep, participating in physical activity, avoiding nicotine, and managing blood pressure, cholesterol, and sugar levels are the new “Life’s Essential 8” strategies proposed by the American Heart Association (AHA) to reduce CVD risk.

“Sleep has recently been added to the AHA guidelines because it modulates many factors contributing to hypertension,” Dr. Nesbitt pointed out. She advised that clinicians should ask patients about their sleep and educate them on healthy sleeping habits.

Some of the evidence used to develop the new AHA guidelines is derived from the SPRINT trial, which showed that controlling blood pressure reduces the risk of major adverse cardiovascular events. “This is our ultimate goal for our patients with hypertension,” Dr. Nesbitt noted.

Regarding the best practice in hypertension management, Dr. Nesbitt explained that with the new blood pressure thresholds, more patients will be diagnosed with stage 1 hypertension and need the nonpharmacological therapy suggested by the AHA. But patients with stage 1 hypertension and with a high CVD risk (at least  10%) also should receive blood pressure-lowering medications, so an accurate assessment of the risk of clinical atherosclerotic cardiovascular disease (ASCVD) or the estimated 10-year CVD risk is crucial. “If we are not careful, we might miss some patients who need to be treated,” she said.

Calcium channel blockers, thiazide diuretics, and ACE inhibitors or angiotensin receptor blockers (ARBs) are the treatment of choice for patients with newly diagnosed hypertension. Although extensively used in the past, beta-blockers are no longer a first-line treatment for hypertension.

When asked why beta-blockers are no longer suitable for routine initial treatment of hypertension, Dr. Nesbitt said that they are effective in controlling palpitations but “other antihypertensive drugs have proven far better in controlling blood pressure.”

Hypertension is multifactorial and often occurs in combination with other conditions, including diabetes and chronic kidney disease. When developing a treatment plan for patients with hypertension, comorbidities need to be considered, because their management may also help control blood pressure, especially for conditions that may contribute to the development of hypertension.

Common conditions that contribute to and often coexist with hypertension include sleep apnea, obesity, anxiety, and depression. However, convincing people to seek mental health support can be very challenging, Dr. Nesbitt said.

She added that hypertension is a complex disease with a strong social component. Understanding its pathophysiology and social determinants is paramount for successfully managing hypertension at the individual level, as well as at the community level.
 

Identification and management of side effects is key

Dr. Nesbitt also discussed the importance of the identification and management of side effects associated with blood pressure-lowering drugs. She cautioned that, if not managed, side effects can lead to treatment nonadherence and pseudo‐resistance, both of which can jeopardize the successful management of hypertension.

When asked about her approach to managing side effects and convincing patients to continue taking their medications, Dr. Nesbitt noted that “setting realistic expectations and goals is key.”

In an interview after Dr. Nesbitt’s presentation, Jesica Naanous, MD, agreed that having an honest conversation with the patients is the best way to convince them to keep taking their medications. She also explains to patients that the complications of uncontrolled blood pressure are worse than the side effects of the drugs.

“As a last resort, I change a blood pressure-lowering agent to another,” added Dr. Naanous, an internist at the American British Cowdray (ABC) Medical Center in Mexico City. She explained that many antihypertensive drugs have different toxicity profiles, and simply changing to another agent can make treatment more tolerable for the patient.

Dr. Nesbitt reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing health care products used by or on patients.

SAN DIEGO – Despite the high prevalence of hypertension in the United States, confusion and gaps about how to diagnose and manage it remain, according to a presenter at the annual meeting of the American College of Physicians.

In a major shift in the definition of hypertension, guidelines published in 2017 reclassified 130/80 mm Hg as high blood pressure, or stage 1 hypertension. Previous guidelines classified 130/80 mm Hg as elevated, and 140/90 mm Hg used to be the threshold for stage 1 hypertension.

“This shift in classification criteria may cause confusion among clinicians caring for patients with hypertension and has a significant impact on how we diagnose and manage hypertension in our practice,” said Shawna D. Nesbitt, MD, professor of internal medicine at the University of Texas Southwestern Medical Center and medical director at Parkland Hypertension Clinic in Dallas. Dr. Nesbitt is an expert in the diagnosis and treatment of hypertension, particularly complex and refractory cases.

Christos Evangelou/MDedge News

Cardiovascular disease (CVD) is the leading cause of death in the United States, accounting for nearly one-quarter of all deaths in men and in women. Hypertension is a key factor contributing to CVD. The hypertension‐related CVD mortality is currently on the rise in many U.S. demographic groups, including younger individuals (35-64 years old), she said.

When asked about the potential causes of this trend, Dr. Nesbitt explained that the epidemics of obesity and overweight are critical contributors to the high prevalence of hypertension.

The new definition means a wider gap in the prevalence of hypertension between men and women, as well as between Black and White people in the United States. The U.S. rates of hypertension and hypertension‐related CVD mortality are much higher in Black than in White people in this country. Hypertension control rates are the lowest in Black, Hispanic, and Asian males, Dr. Nesbitt said.
 

Accurate measurement of blood pressure is crucial

The changes in classification criteria for hypertension have made accurate measurements of blood pressure important. A key challenge in the evaluation of hypertension in the clinic is the difference in the methods used to measure blood pressure between trials and real-world clinical practice.

“We can’t easily translate data collected in clinical trials into real-life scenarios, and this can have important implications in our expectations of treatment outcome,” Dr. Nesbitt cautioned.

Commenting on the best practices in blood pressure measurements in the office, Dr. Nesbitt said that patients need to be seated with their feet on the floor and their backs and arms supported. In addition, patients need to have at least 5 minutes of rest without talking.

“It is very important to help patients understand what triggers their blood pressure to be elevated and teach them how and when to measure their blood pressure at home using their own devices,” she added.

Another critical question is how to translate the new guidelines into changes in clinical care, she said.
 

Current treatment landscape of hypertension

Ensuring a healthy diet, weight, and sleep, participating in physical activity, avoiding nicotine, and managing blood pressure, cholesterol, and sugar levels are the new “Life’s Essential 8” strategies proposed by the American Heart Association (AHA) to reduce CVD risk.

“Sleep has recently been added to the AHA guidelines because it modulates many factors contributing to hypertension,” Dr. Nesbitt pointed out. She advised that clinicians should ask patients about their sleep and educate them on healthy sleeping habits.

Some of the evidence used to develop the new AHA guidelines is derived from the SPRINT trial, which showed that controlling blood pressure reduces the risk of major adverse cardiovascular events. “This is our ultimate goal for our patients with hypertension,” Dr. Nesbitt noted.

Regarding the best practice in hypertension management, Dr. Nesbitt explained that with the new blood pressure thresholds, more patients will be diagnosed with stage 1 hypertension and need the nonpharmacological therapy suggested by the AHA. But patients with stage 1 hypertension and with a high CVD risk (at least  10%) also should receive blood pressure-lowering medications, so an accurate assessment of the risk of clinical atherosclerotic cardiovascular disease (ASCVD) or the estimated 10-year CVD risk is crucial. “If we are not careful, we might miss some patients who need to be treated,” she said.

Calcium channel blockers, thiazide diuretics, and ACE inhibitors or angiotensin receptor blockers (ARBs) are the treatment of choice for patients with newly diagnosed hypertension. Although extensively used in the past, beta-blockers are no longer a first-line treatment for hypertension.

When asked why beta-blockers are no longer suitable for routine initial treatment of hypertension, Dr. Nesbitt said that they are effective in controlling palpitations but “other antihypertensive drugs have proven far better in controlling blood pressure.”

Hypertension is multifactorial and often occurs in combination with other conditions, including diabetes and chronic kidney disease. When developing a treatment plan for patients with hypertension, comorbidities need to be considered, because their management may also help control blood pressure, especially for conditions that may contribute to the development of hypertension.

Common conditions that contribute to and often coexist with hypertension include sleep apnea, obesity, anxiety, and depression. However, convincing people to seek mental health support can be very challenging, Dr. Nesbitt said.

She added that hypertension is a complex disease with a strong social component. Understanding its pathophysiology and social determinants is paramount for successfully managing hypertension at the individual level, as well as at the community level.
 

Identification and management of side effects is key

Dr. Nesbitt also discussed the importance of the identification and management of side effects associated with blood pressure-lowering drugs. She cautioned that, if not managed, side effects can lead to treatment nonadherence and pseudo‐resistance, both of which can jeopardize the successful management of hypertension.

When asked about her approach to managing side effects and convincing patients to continue taking their medications, Dr. Nesbitt noted that “setting realistic expectations and goals is key.”

In an interview after Dr. Nesbitt’s presentation, Jesica Naanous, MD, agreed that having an honest conversation with the patients is the best way to convince them to keep taking their medications. She also explains to patients that the complications of uncontrolled blood pressure are worse than the side effects of the drugs.

“As a last resort, I change a blood pressure-lowering agent to another,” added Dr. Naanous, an internist at the American British Cowdray (ABC) Medical Center in Mexico City. She explained that many antihypertensive drugs have different toxicity profiles, and simply changing to another agent can make treatment more tolerable for the patient.

Dr. Nesbitt reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing health care products used by or on patients.

SAN DIEGO – Despite the high prevalence of hypertension in the United States, confusion and gaps about how to diagnose and manage it remain, according to a presenter at the annual meeting of the American College of Physicians.

In a major shift in the definition of hypertension, guidelines published in 2017 reclassified 130/80 mm Hg as high blood pressure, or stage 1 hypertension. Previous guidelines classified 130/80 mm Hg as elevated, and 140/90 mm Hg used to be the threshold for stage 1 hypertension.

“This shift in classification criteria may cause confusion among clinicians caring for patients with hypertension and has a significant impact on how we diagnose and manage hypertension in our practice,” said Shawna D. Nesbitt, MD, professor of internal medicine at the University of Texas Southwestern Medical Center and medical director at Parkland Hypertension Clinic in Dallas. Dr. Nesbitt is an expert in the diagnosis and treatment of hypertension, particularly complex and refractory cases.

Christos Evangelou/MDedge News

Cardiovascular disease (CVD) is the leading cause of death in the United States, accounting for nearly one-quarter of all deaths in men and in women. Hypertension is a key factor contributing to CVD. The hypertension‐related CVD mortality is currently on the rise in many U.S. demographic groups, including younger individuals (35-64 years old), she said.

When asked about the potential causes of this trend, Dr. Nesbitt explained that the epidemics of obesity and overweight are critical contributors to the high prevalence of hypertension.

The new definition means a wider gap in the prevalence of hypertension between men and women, as well as between Black and White people in the United States. The U.S. rates of hypertension and hypertension‐related CVD mortality are much higher in Black than in White people in this country. Hypertension control rates are the lowest in Black, Hispanic, and Asian males, Dr. Nesbitt said.
 

Accurate measurement of blood pressure is crucial

The changes in classification criteria for hypertension have made accurate measurements of blood pressure important. A key challenge in the evaluation of hypertension in the clinic is the difference in the methods used to measure blood pressure between trials and real-world clinical practice.

“We can’t easily translate data collected in clinical trials into real-life scenarios, and this can have important implications in our expectations of treatment outcome,” Dr. Nesbitt cautioned.

Commenting on the best practices in blood pressure measurements in the office, Dr. Nesbitt said that patients need to be seated with their feet on the floor and their backs and arms supported. In addition, patients need to have at least 5 minutes of rest without talking.

“It is very important to help patients understand what triggers their blood pressure to be elevated and teach them how and when to measure their blood pressure at home using their own devices,” she added.

Another critical question is how to translate the new guidelines into changes in clinical care, she said.
 

Current treatment landscape of hypertension

Ensuring a healthy diet, weight, and sleep, participating in physical activity, avoiding nicotine, and managing blood pressure, cholesterol, and sugar levels are the new “Life’s Essential 8” strategies proposed by the American Heart Association (AHA) to reduce CVD risk.

“Sleep has recently been added to the AHA guidelines because it modulates many factors contributing to hypertension,” Dr. Nesbitt pointed out. She advised that clinicians should ask patients about their sleep and educate them on healthy sleeping habits.

Some of the evidence used to develop the new AHA guidelines is derived from the SPRINT trial, which showed that controlling blood pressure reduces the risk of major adverse cardiovascular events. “This is our ultimate goal for our patients with hypertension,” Dr. Nesbitt noted.

Regarding the best practice in hypertension management, Dr. Nesbitt explained that with the new blood pressure thresholds, more patients will be diagnosed with stage 1 hypertension and need the nonpharmacological therapy suggested by the AHA. But patients with stage 1 hypertension and with a high CVD risk (at least  10%) also should receive blood pressure-lowering medications, so an accurate assessment of the risk of clinical atherosclerotic cardiovascular disease (ASCVD) or the estimated 10-year CVD risk is crucial. “If we are not careful, we might miss some patients who need to be treated,” she said.

Calcium channel blockers, thiazide diuretics, and ACE inhibitors or angiotensin receptor blockers (ARBs) are the treatment of choice for patients with newly diagnosed hypertension. Although extensively used in the past, beta-blockers are no longer a first-line treatment for hypertension.

When asked why beta-blockers are no longer suitable for routine initial treatment of hypertension, Dr. Nesbitt said that they are effective in controlling palpitations but “other antihypertensive drugs have proven far better in controlling blood pressure.”

Hypertension is multifactorial and often occurs in combination with other conditions, including diabetes and chronic kidney disease. When developing a treatment plan for patients with hypertension, comorbidities need to be considered, because their management may also help control blood pressure, especially for conditions that may contribute to the development of hypertension.

Common conditions that contribute to and often coexist with hypertension include sleep apnea, obesity, anxiety, and depression. However, convincing people to seek mental health support can be very challenging, Dr. Nesbitt said.

She added that hypertension is a complex disease with a strong social component. Understanding its pathophysiology and social determinants is paramount for successfully managing hypertension at the individual level, as well as at the community level.
 

Identification and management of side effects is key

Dr. Nesbitt also discussed the importance of the identification and management of side effects associated with blood pressure-lowering drugs. She cautioned that, if not managed, side effects can lead to treatment nonadherence and pseudo‐resistance, both of which can jeopardize the successful management of hypertension.

When asked about her approach to managing side effects and convincing patients to continue taking their medications, Dr. Nesbitt noted that “setting realistic expectations and goals is key.”

In an interview after Dr. Nesbitt’s presentation, Jesica Naanous, MD, agreed that having an honest conversation with the patients is the best way to convince them to keep taking their medications. She also explains to patients that the complications of uncontrolled blood pressure are worse than the side effects of the drugs.

“As a last resort, I change a blood pressure-lowering agent to another,” added Dr. Naanous, an internist at the American British Cowdray (ABC) Medical Center in Mexico City. She explained that many antihypertensive drugs have different toxicity profiles, and simply changing to another agent can make treatment more tolerable for the patient.

Dr. Nesbitt reported no relationships with entities whose primary business is producing, marketing, selling, reselling, or distributing health care products used by or on patients.

WASHINGTON, D.C. – Remote monitoring of infant weight reduced the number of office visits among newborns, according to a new study presented at the Pediatric Academic Societies annual meeting.

The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.

Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.

The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers. 

“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”

Keeping infants at home can also protect babies from infections they might catch in the clinic.

“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”

Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary. 

The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration. 

Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.

Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.

Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.

“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.

Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group. 

The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.

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

WASHINGTON, D.C. – Remote monitoring of infant weight reduced the number of office visits among newborns, according to a new study presented at the Pediatric Academic Societies annual meeting.

The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.

Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.

The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers. 

“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”

Keeping infants at home can also protect babies from infections they might catch in the clinic.

“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”

Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary. 

The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration. 

Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.

Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.

Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.

“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.

Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group. 

The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.

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

WASHINGTON, D.C. – Remote monitoring of infant weight reduced the number of office visits among newborns, according to a new study presented at the Pediatric Academic Societies annual meeting.

The pilot trial compared the frequency of office visits for healthy babies born at 37 weeks’ gestation or later. One group of 20 infants had their weight monitored at home by parents, and another group of 20 infants received usual care, which included two in-person office visits over the first 6 weeks of life.

Researchers found that visits for infants in the intervention group decreased by 25% after the first week of life and by 23% after the second week.

The remote method can help alert physicians earlier to insufficient weight because parents report gains or losses three times a week over the 6 weeks, resulting in more data for providers. 

“You’re going to see fewer visits with people who have scales because the docs are getting the information they need, which is: ‘Is this baby doing okay or not?’ ” said Diane DiTomasso, PhD, RN, a professor at the University of Rhode Island, South Kingstown, who was not involved with the study. “I think it’s a very necessary study because, to my knowledge, nobody has done a randomized controlled trial on this topic.”

Keeping infants at home can also protect babies from infections they might catch in the clinic.

“There are a lot of other kids in an office setting, and kids like touching things,” said Anirudha Das, MD, MPH, a neonatologist at Cleveland Clinic Children’s and the lead author of the study. “When there are a lot of other kids, there are a lot of viruses. It’s a very dangerous environment.”

Parents in the intervention group were given scales and asked to enter their infant’s weight into a patient portal app three times per week for 6 weeks. Physicians then determined if in-office visits were necessary. 

The benefits of home weight checks can include helping to allow for breastfeeding for a longer duration. 

Weight is more closely monitored for breastfed infants. Waiting weeks for office checks can heighten parental anxiety and lead to prematurely stopping breastfeeding. With regular at-home checks, parents receive up-to-date information from physicians that can alleviate concerns and empower them with more control over the process, according to Dr. DiTomasso.

Breastfeeding is associated with a lower risk for cardiovascular disease, diabetes, obesity, cancer in later life, and a lower risk of breast cancer for breastfeeding parents.

Office weight checks can also alleviate a significant and unnecessary burden for parents, Dr. Das said.

“You shouldn’t have to put your baby in a car, possibly in freezing temperatures, hire someone to take care of your other kids, drive to the hospital, pay for parking, and walk to the office for a weight check,” Dr. Das said.

Dr. Das noted that, because of technical errors, parents weren’t able to use remote monitoring and had in-person visits during the first 5 days of life. The intervention group had more visits during that period than the usual-care group. 

The study was funded by the American Academy of Pediatrics. The authors and Dr. Das reported no relevant financial relationships.

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

MANCHESTER, ENGLAND – The use of NSAIDs may mask the true level of inflammation of the sacroiliac joint (SIJ), as seen on MRI, among people with axial spondyloarthritis (axSpA), according to results of the DyNAMISM study.

“We’ve found that in about one in four patients, NSAIDs make a difference to the scan results,” Gareth T. Jones, PhD, said at the annual meeting of the British Society for Rheumatology.

Sara Freeman/MDedge News

A total of 23% of patients whose MRI results were positive for sacroiliitis when no NSAIDs had been used for a couple of weeks received negative MRI results 6 weeks after the NSAIDs were reinstated.

“This is important in terms of diagnosis, in terms of disease classification, and may be important in terms of future treatment decisions,” added Dr. Jones, professor of epidemiology at the Aberdeen Centre for Arthritis and Musculoskeletal Health at the University of Aberdeen, (Scotland).

“Our recommendation from these results is that if a patient is willing to attempt to wash out [NSAIDs] prior to an MRI, we would recommend that they do so,” Dr. Jones said.
 

NSAIDs and AxSpA inflammation

“NSAIDs are often used as the first-line treatment for axial spondyloarthritis due to their ability to effectively reduce pain and stiffness associated with the condition,” Denis Poddubnyy, MD, who was not involved in the research, told this news organization.

“However, there is still a question as to whether NSAIDs have a true anti-inflammatory effect on the axial inflammation, as detected by MRI,” added Dr. Poddubnyy, head of rheumatology at Charité–Universitätsmedizin Berlin in Germany.

With an absence of randomized, controlled trials, it remains “uncertain how much of the observed reduction in inflammation is attributable to the natural course of the disease and spontaneous resolution of inflammation rather than the effect of NSAIDs,” Dr. Poddubnyy said.
 

The DyNAMISM Study

“Sacroiliitis is a painful inflammatory condition. This is investigated looking for the evidence of inflammation on MRI, but many patients are taking anti-inflammatory medication,” Dr. Jones said at the meeting.

“So perhaps patients are taking drugs [that are] hiding the very thing that we’re looking for,” he added. Hence, the DyNAMISM study (Do Nonsteroidal Anti-inflammatory Drugs Mask Inflammation in Spondyloarthritis on MRI) was conceived.

The researchers recruited 311 adults with suspected or established axSpA who were taking daily NSAIDs such as ibuprofen or diclofenac across 34 centers in England and Scotland. Patients taking other anti-inflammatory medications that could not be stopped were excluded, as were patients who were currently taking or had recently taken tumor necrosis factor inhibitors.

The study used a standardized MRI protocol. Two independent readers experienced in scoring SIJ scans were employed; a third was used when the two disagreed. The primary outcome was meeting the Assessment of Spondyloarthritis international Society criteria for a positive result on MRI.

The average age of the study subjects was 42 years, 62% were men, and 87% were White. The median duration of symptoms was 9 years, and the median time since diagnosis was 1 year.

The study design required that patients stop NSAID use over a period of 1-2 weeks before undergoing an MRI scan, which 286 did. Of these, 146 received MRI results that were positive for SIJ inflammation; those patients continued in the study. The 140 patients with negative scans were excluded. Patients could then resume taking NSAIDs before being scanned again around 6 weeks later. In all, 129 patients underwent both MRI scans.
 

How much might fluctuating inflammation matter?

‘It’s a shame you didn’t scan the negative people, because the natural history is a fluctuating inflammation,” Fraser Birrell, MBChB, PhD, of Newcastle University, Newcastle upon Tyne, England, pointed out in discussion.

“Nonsteroidals are modestly effective and probably made no difference,” he argued. “I would have expected a certain proportion of the negatives are positive.”

The study had a pragmatic design, Dr. Jones countered. “We had enormous debate before the study; it would have been nice to do a sort of a randomized, crossover design, but it would have resulted in a lot of inefficiency.”

Regarding the duration of the NSAID washout period, Dr. Jones noted that they saw little difference between shorter or longer washout periods and that the data showed that “a 2-week washout is a reasonable target.”

Performing the second scan 6 weeks after NSAIDs were reinstated “exceeds the period where clinical benefits should be expected. It may be that if we’d waited longer, the proportion would have gone up. So, we would argue that actually, if anything, that 23% may be an underestimate of the real effect.”

Although some patients may have declined to participate in the study because they did not want to stop taking NSAIDs, Dr. Jones noted that a good proportion did stop taking them, and so the study shows that patients can tolerate washout. Around 45% of patients reported experiencing disease flares during this time, but this did not have any significant effect on validated disease activity or pain measures, Dr. Jones reported.

So, if patients are willing to stop NSAIDs before a scan, “they should be counseled that they may experience a small increase in disease activity and spinal pain, but also to be counseled that the majority of patients can tolerate this,” Dr. Jones suggested.

Trials are needed, Dr. Poddubnyy said: “Future randomized, controlled studies are needed to conclusively determine the efficacy of NSAIDs in reducing inflammation in the axial skeleton of axSpA patients.”

Dr. Poddubnyy added: “It would also be valuable to assess in a randomized setting whether the use of NSAIDs impacts the diagnostic performance of MRI, which takes into account not only inflammatory but also structural changes, which are not influenced by NSAIDs.”

The DyNAMISM study was funded by Arthritis Research UK and was run by the University of Aberdeen in conjunction with NHS Grampian, Scotland. Dr. Jones has disclosed no relevant financial relationships. Dr. Poddubnyy disclosed ties with AbbVie, Biocad, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Medscape, Merck Sharp & Dohme, Moonlake, Novartis, PeerVoice, Pfizer, Samsung Bioepis, and UCB.

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

MANCHESTER, ENGLAND – The use of NSAIDs may mask the true level of inflammation of the sacroiliac joint (SIJ), as seen on MRI, among people with axial spondyloarthritis (axSpA), according to results of the DyNAMISM study.

“We’ve found that in about one in four patients, NSAIDs make a difference to the scan results,” Gareth T. Jones, PhD, said at the annual meeting of the British Society for Rheumatology.

Sara Freeman/MDedge News

A total of 23% of patients whose MRI results were positive for sacroiliitis when no NSAIDs had been used for a couple of weeks received negative MRI results 6 weeks after the NSAIDs were reinstated.

“This is important in terms of diagnosis, in terms of disease classification, and may be important in terms of future treatment decisions,” added Dr. Jones, professor of epidemiology at the Aberdeen Centre for Arthritis and Musculoskeletal Health at the University of Aberdeen, (Scotland).

“Our recommendation from these results is that if a patient is willing to attempt to wash out [NSAIDs] prior to an MRI, we would recommend that they do so,” Dr. Jones said.
 

NSAIDs and AxSpA inflammation

“NSAIDs are often used as the first-line treatment for axial spondyloarthritis due to their ability to effectively reduce pain and stiffness associated with the condition,” Denis Poddubnyy, MD, who was not involved in the research, told this news organization.

“However, there is still a question as to whether NSAIDs have a true anti-inflammatory effect on the axial inflammation, as detected by MRI,” added Dr. Poddubnyy, head of rheumatology at Charité–Universitätsmedizin Berlin in Germany.

With an absence of randomized, controlled trials, it remains “uncertain how much of the observed reduction in inflammation is attributable to the natural course of the disease and spontaneous resolution of inflammation rather than the effect of NSAIDs,” Dr. Poddubnyy said.
 

The DyNAMISM Study

“Sacroiliitis is a painful inflammatory condition. This is investigated looking for the evidence of inflammation on MRI, but many patients are taking anti-inflammatory medication,” Dr. Jones said at the meeting.

“So perhaps patients are taking drugs [that are] hiding the very thing that we’re looking for,” he added. Hence, the DyNAMISM study (Do Nonsteroidal Anti-inflammatory Drugs Mask Inflammation in Spondyloarthritis on MRI) was conceived.

The researchers recruited 311 adults with suspected or established axSpA who were taking daily NSAIDs such as ibuprofen or diclofenac across 34 centers in England and Scotland. Patients taking other anti-inflammatory medications that could not be stopped were excluded, as were patients who were currently taking or had recently taken tumor necrosis factor inhibitors.

The study used a standardized MRI protocol. Two independent readers experienced in scoring SIJ scans were employed; a third was used when the two disagreed. The primary outcome was meeting the Assessment of Spondyloarthritis international Society criteria for a positive result on MRI.

The average age of the study subjects was 42 years, 62% were men, and 87% were White. The median duration of symptoms was 9 years, and the median time since diagnosis was 1 year.

The study design required that patients stop NSAID use over a period of 1-2 weeks before undergoing an MRI scan, which 286 did. Of these, 146 received MRI results that were positive for SIJ inflammation; those patients continued in the study. The 140 patients with negative scans were excluded. Patients could then resume taking NSAIDs before being scanned again around 6 weeks later. In all, 129 patients underwent both MRI scans.
 

How much might fluctuating inflammation matter?

‘It’s a shame you didn’t scan the negative people, because the natural history is a fluctuating inflammation,” Fraser Birrell, MBChB, PhD, of Newcastle University, Newcastle upon Tyne, England, pointed out in discussion.

“Nonsteroidals are modestly effective and probably made no difference,” he argued. “I would have expected a certain proportion of the negatives are positive.”

The study had a pragmatic design, Dr. Jones countered. “We had enormous debate before the study; it would have been nice to do a sort of a randomized, crossover design, but it would have resulted in a lot of inefficiency.”

Regarding the duration of the NSAID washout period, Dr. Jones noted that they saw little difference between shorter or longer washout periods and that the data showed that “a 2-week washout is a reasonable target.”

Performing the second scan 6 weeks after NSAIDs were reinstated “exceeds the period where clinical benefits should be expected. It may be that if we’d waited longer, the proportion would have gone up. So, we would argue that actually, if anything, that 23% may be an underestimate of the real effect.”

Although some patients may have declined to participate in the study because they did not want to stop taking NSAIDs, Dr. Jones noted that a good proportion did stop taking them, and so the study shows that patients can tolerate washout. Around 45% of patients reported experiencing disease flares during this time, but this did not have any significant effect on validated disease activity or pain measures, Dr. Jones reported.

So, if patients are willing to stop NSAIDs before a scan, “they should be counseled that they may experience a small increase in disease activity and spinal pain, but also to be counseled that the majority of patients can tolerate this,” Dr. Jones suggested.

Trials are needed, Dr. Poddubnyy said: “Future randomized, controlled studies are needed to conclusively determine the efficacy of NSAIDs in reducing inflammation in the axial skeleton of axSpA patients.”

Dr. Poddubnyy added: “It would also be valuable to assess in a randomized setting whether the use of NSAIDs impacts the diagnostic performance of MRI, which takes into account not only inflammatory but also structural changes, which are not influenced by NSAIDs.”

The DyNAMISM study was funded by Arthritis Research UK and was run by the University of Aberdeen in conjunction with NHS Grampian, Scotland. Dr. Jones has disclosed no relevant financial relationships. Dr. Poddubnyy disclosed ties with AbbVie, Biocad, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Medscape, Merck Sharp & Dohme, Moonlake, Novartis, PeerVoice, Pfizer, Samsung Bioepis, and UCB.

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

MANCHESTER, ENGLAND – The use of NSAIDs may mask the true level of inflammation of the sacroiliac joint (SIJ), as seen on MRI, among people with axial spondyloarthritis (axSpA), according to results of the DyNAMISM study.

“We’ve found that in about one in four patients, NSAIDs make a difference to the scan results,” Gareth T. Jones, PhD, said at the annual meeting of the British Society for Rheumatology.

Sara Freeman/MDedge News

A total of 23% of patients whose MRI results were positive for sacroiliitis when no NSAIDs had been used for a couple of weeks received negative MRI results 6 weeks after the NSAIDs were reinstated.

“This is important in terms of diagnosis, in terms of disease classification, and may be important in terms of future treatment decisions,” added Dr. Jones, professor of epidemiology at the Aberdeen Centre for Arthritis and Musculoskeletal Health at the University of Aberdeen, (Scotland).

“Our recommendation from these results is that if a patient is willing to attempt to wash out [NSAIDs] prior to an MRI, we would recommend that they do so,” Dr. Jones said.
 

NSAIDs and AxSpA inflammation

“NSAIDs are often used as the first-line treatment for axial spondyloarthritis due to their ability to effectively reduce pain and stiffness associated with the condition,” Denis Poddubnyy, MD, who was not involved in the research, told this news organization.

“However, there is still a question as to whether NSAIDs have a true anti-inflammatory effect on the axial inflammation, as detected by MRI,” added Dr. Poddubnyy, head of rheumatology at Charité–Universitätsmedizin Berlin in Germany.

With an absence of randomized, controlled trials, it remains “uncertain how much of the observed reduction in inflammation is attributable to the natural course of the disease and spontaneous resolution of inflammation rather than the effect of NSAIDs,” Dr. Poddubnyy said.
 

The DyNAMISM Study

“Sacroiliitis is a painful inflammatory condition. This is investigated looking for the evidence of inflammation on MRI, but many patients are taking anti-inflammatory medication,” Dr. Jones said at the meeting.

“So perhaps patients are taking drugs [that are] hiding the very thing that we’re looking for,” he added. Hence, the DyNAMISM study (Do Nonsteroidal Anti-inflammatory Drugs Mask Inflammation in Spondyloarthritis on MRI) was conceived.

The researchers recruited 311 adults with suspected or established axSpA who were taking daily NSAIDs such as ibuprofen or diclofenac across 34 centers in England and Scotland. Patients taking other anti-inflammatory medications that could not be stopped were excluded, as were patients who were currently taking or had recently taken tumor necrosis factor inhibitors.

The study used a standardized MRI protocol. Two independent readers experienced in scoring SIJ scans were employed; a third was used when the two disagreed. The primary outcome was meeting the Assessment of Spondyloarthritis international Society criteria for a positive result on MRI.

The average age of the study subjects was 42 years, 62% were men, and 87% were White. The median duration of symptoms was 9 years, and the median time since diagnosis was 1 year.

The study design required that patients stop NSAID use over a period of 1-2 weeks before undergoing an MRI scan, which 286 did. Of these, 146 received MRI results that were positive for SIJ inflammation; those patients continued in the study. The 140 patients with negative scans were excluded. Patients could then resume taking NSAIDs before being scanned again around 6 weeks later. In all, 129 patients underwent both MRI scans.
 

How much might fluctuating inflammation matter?

‘It’s a shame you didn’t scan the negative people, because the natural history is a fluctuating inflammation,” Fraser Birrell, MBChB, PhD, of Newcastle University, Newcastle upon Tyne, England, pointed out in discussion.

“Nonsteroidals are modestly effective and probably made no difference,” he argued. “I would have expected a certain proportion of the negatives are positive.”

The study had a pragmatic design, Dr. Jones countered. “We had enormous debate before the study; it would have been nice to do a sort of a randomized, crossover design, but it would have resulted in a lot of inefficiency.”

Regarding the duration of the NSAID washout period, Dr. Jones noted that they saw little difference between shorter or longer washout periods and that the data showed that “a 2-week washout is a reasonable target.”

Performing the second scan 6 weeks after NSAIDs were reinstated “exceeds the period where clinical benefits should be expected. It may be that if we’d waited longer, the proportion would have gone up. So, we would argue that actually, if anything, that 23% may be an underestimate of the real effect.”

Although some patients may have declined to participate in the study because they did not want to stop taking NSAIDs, Dr. Jones noted that a good proportion did stop taking them, and so the study shows that patients can tolerate washout. Around 45% of patients reported experiencing disease flares during this time, but this did not have any significant effect on validated disease activity or pain measures, Dr. Jones reported.

So, if patients are willing to stop NSAIDs before a scan, “they should be counseled that they may experience a small increase in disease activity and spinal pain, but also to be counseled that the majority of patients can tolerate this,” Dr. Jones suggested.

Trials are needed, Dr. Poddubnyy said: “Future randomized, controlled studies are needed to conclusively determine the efficacy of NSAIDs in reducing inflammation in the axial skeleton of axSpA patients.”

Dr. Poddubnyy added: “It would also be valuable to assess in a randomized setting whether the use of NSAIDs impacts the diagnostic performance of MRI, which takes into account not only inflammatory but also structural changes, which are not influenced by NSAIDs.”

The DyNAMISM study was funded by Arthritis Research UK and was run by the University of Aberdeen in conjunction with NHS Grampian, Scotland. Dr. Jones has disclosed no relevant financial relationships. Dr. Poddubnyy disclosed ties with AbbVie, Biocad, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Medscape, Merck Sharp & Dohme, Moonlake, Novartis, PeerVoice, Pfizer, Samsung Bioepis, and UCB.

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

An investigational outpatient endoscopic procedure may help eliminate the need for insulin in people with type 2 diabetes, early research suggests.

Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.

In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.

“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.

Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”

ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
 

Is semaglutide muddying the findings?

Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.

“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”

However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”

Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.

Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.

Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”

But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
 

All patients stopped insulin, most for a year

The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.

Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.

Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”

Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

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

An investigational outpatient endoscopic procedure may help eliminate the need for insulin in people with type 2 diabetes, early research suggests.

Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.

In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.

“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.

Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”

ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
 

Is semaglutide muddying the findings?

Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.

“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”

However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”

Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.

Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.

Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”

But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
 

All patients stopped insulin, most for a year

The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.

Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.

Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”

Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

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

An investigational outpatient endoscopic procedure may help eliminate the need for insulin in people with type 2 diabetes, early research suggests.

Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.

In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.

“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.

Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”

ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
 

Is semaglutide muddying the findings?

Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.

“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”

However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”

Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.

Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.

Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”

But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
 

All patients stopped insulin, most for a year

The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.

Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.

Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”

Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

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

In September 2021, a community in Virginia experienced an outbreak of hepatitis A virus (HAV) that was ultimately linked to an infected food handler.¹ A total of 149 cases were reported over the next 12 months; 51 were directly related to the food handler and the remainder were the result of sustained community transmission. Of the 51 people who were directly infected by the food handler, 31 were hospitalized and 3 died. This incident offers important reminders about public health surveillance and the role that family physicians can play.

Hepatitis A virus is transmitted through food and drinks that have been contaminated by small amounts of stool that contains the virus or through close contact (including sexual contact) with a person who is infected. The incubation period can range from 15 to 59 days.

HAV generally resolves in a few days to weeks, with no long-term effects. However, recent outbreaks have been associated with high hospitalization and mortality rates because of the underlying comorbidities of those infected.

An increase in incidence. The national rate of HAV infection reached a low of less than 1/100,000 in 2015 but has since increased to almost 6/100,000 in 2019. This increase is mostly due to outbreaks linked to spread among people without a fixed residence, those who use illicit drugs, and men who have sex with men.²

In the Virginia outbreak, the food handler had a risk factor for HAV and was unvaccinated. He worked at 3 different locations of a restaurant chain for a total of 16 days while infectious, preparing ready-to-eat food without using gloves. Furthermore, he delayed seeking medical care for more than 2 weeks—at which time, the nature of his employment was not disclosed.

Prevention is straightforward. HAV infection can be prevented by administration of either HAV vaccine or immune globulin within 2 weeks of exposure.³ During an HAV outbreak, vaccination is recommended for people considered to be at risk, including those without a fixed residence, those who use illicit drugs, those who travel internationally, and men who have sex with men.³

There are 3 HAV vaccines available in the United States: 2 single-antigen vaccines, Havrix and Vaqta, both approved for children and adults, and a combination vaccine (containing both HAV and hepatitis B antigens), Twinrix, which is approved for those ages 18 years and older. All are inactivated vaccines.

What you can do. The Virginia outbreak illustrates the important role that family physicians can and do play in public health. We should:

• Encourage adults with risk factors for HAV to be vaccinated.
• Ask those with an HAV diagnosis about the people they may have exposed through personal contact or occupational exposure.
• Promptly report infectious diseases that are designated “reportable” to the public health department.
• Immediately report (by telephone) when HAV and other enteric infections involve a food handler.

In September 2021, a community in Virginia experienced an outbreak of hepatitis A virus (HAV) that was ultimately linked to an infected food handler.¹ A total of 149 cases were reported over the next 12 months; 51 were directly related to the food handler and the remainder were the result of sustained community transmission. Of the 51 people who were directly infected by the food handler, 31 were hospitalized and 3 died. This incident offers important reminders about public health surveillance and the role that family physicians can play.

Hepatitis A virus is transmitted through food and drinks that have been contaminated by small amounts of stool that contains the virus or through close contact (including sexual contact) with a person who is infected. The incubation period can range from 15 to 59 days.

HAV generally resolves in a few days to weeks, with no long-term effects. However, recent outbreaks have been associated with high hospitalization and mortality rates because of the underlying comorbidities of those infected.

An increase in incidence. The national rate of HAV infection reached a low of less than 1/100,000 in 2015 but has since increased to almost 6/100,000 in 2019. This increase is mostly due to outbreaks linked to spread among people without a fixed residence, those who use illicit drugs, and men who have sex with men.²

In the Virginia outbreak, the food handler had a risk factor for HAV and was unvaccinated. He worked at 3 different locations of a restaurant chain for a total of 16 days while infectious, preparing ready-to-eat food without using gloves. Furthermore, he delayed seeking medical care for more than 2 weeks—at which time, the nature of his employment was not disclosed.

Prevention is straightforward. HAV infection can be prevented by administration of either HAV vaccine or immune globulin within 2 weeks of exposure.³ During an HAV outbreak, vaccination is recommended for people considered to be at risk, including those without a fixed residence, those who use illicit drugs, those who travel internationally, and men who have sex with men.³

There are 3 HAV vaccines available in the United States: 2 single-antigen vaccines, Havrix and Vaqta, both approved for children and adults, and a combination vaccine (containing both HAV and hepatitis B antigens), Twinrix, which is approved for those ages 18 years and older. All are inactivated vaccines.

What you can do. The Virginia outbreak illustrates the important role that family physicians can and do play in public health. We should:

• Encourage adults with risk factors for HAV to be vaccinated.
• Ask those with an HAV diagnosis about the people they may have exposed through personal contact or occupational exposure.
• Promptly report infectious diseases that are designated “reportable” to the public health department.
• Immediately report (by telephone) when HAV and other enteric infections involve a food handler.

In September 2021, a community in Virginia experienced an outbreak of hepatitis A virus (HAV) that was ultimately linked to an infected food handler.¹ A total of 149 cases were reported over the next 12 months; 51 were directly related to the food handler and the remainder were the result of sustained community transmission. Of the 51 people who were directly infected by the food handler, 31 were hospitalized and 3 died. This incident offers important reminders about public health surveillance and the role that family physicians can play.

Hepatitis A virus is transmitted through food and drinks that have been contaminated by small amounts of stool that contains the virus or through close contact (including sexual contact) with a person who is infected. The incubation period can range from 15 to 59 days.

HAV generally resolves in a few days to weeks, with no long-term effects. However, recent outbreaks have been associated with high hospitalization and mortality rates because of the underlying comorbidities of those infected.

An increase in incidence. The national rate of HAV infection reached a low of less than 1/100,000 in 2015 but has since increased to almost 6/100,000 in 2019. This increase is mostly due to outbreaks linked to spread among people without a fixed residence, those who use illicit drugs, and men who have sex with men.²

In the Virginia outbreak, the food handler had a risk factor for HAV and was unvaccinated. He worked at 3 different locations of a restaurant chain for a total of 16 days while infectious, preparing ready-to-eat food without using gloves. Furthermore, he delayed seeking medical care for more than 2 weeks—at which time, the nature of his employment was not disclosed.

Prevention is straightforward. HAV infection can be prevented by administration of either HAV vaccine or immune globulin within 2 weeks of exposure.³ During an HAV outbreak, vaccination is recommended for people considered to be at risk, including those without a fixed residence, those who use illicit drugs, those who travel internationally, and men who have sex with men.³

There are 3 HAV vaccines available in the United States: 2 single-antigen vaccines, Havrix and Vaqta, both approved for children and adults, and a combination vaccine (containing both HAV and hepatitis B antigens), Twinrix, which is approved for those ages 18 years and older. All are inactivated vaccines.

What you can do. The Virginia outbreak illustrates the important role that family physicians can and do play in public health. We should:

• Encourage adults with risk factors for HAV to be vaccinated.
• Ask those with an HAV diagnosis about the people they may have exposed through personal contact or occupational exposure.
• Promptly report infectious diseases that are designated “reportable” to the public health department.
• Immediately report (by telephone) when HAV and other enteric infections involve a food handler.

The first guideline for definitive local therapy options in the treatment of oligometastatic non–small cell lung cancer (NSCLC) has now been released.

The result of a joint effort by the American Society for Radiation Oncology and European Society for Radiotherapy and Oncology, the guidelines emphasizes the need for a multidisciplinary team approach to guide treatment decisions for oligometastatic disease.

Historically, treatment for oligometastatic NSCLC has involved systemic therapy including chemotherapy or immunotherapy, and local therapy was given only for palliation and symptom relief. But increasing evidence has demonstrated that definitive local therapy may have an additional role in controlling tumor growth and improving survival outcomes, and an increasing number of radiation oncologists and multidisciplinary teams are now using local therapy beyond palliative care for these patients, the authors noted.

“Oligometastatic NSCLC is a phase in lung cancer development that may offer us new opportunities to improve patient outcomes, because it typically is more treatable than widely metastatic cancer,” said Puneeth Iyengar, MD, PhD, cochair of the guideline task force and an associate professor of radiation oncology at UT Southwestern Medical Center, Dallas.

“The research on local therapy for oligometastatic cancer is still at a relatively early stage, but we already see indicators of potential benefits for patients. Adding local therapy to systemic therapy may lead to more durable cancer control, potentially improving progression-free survival, overall survival and quality of life,” he said in a statement.

The new guideline is published in Practical Radiation Oncology.

The purpose of this joint guideline was to provide recommendations on local therapy use for oligometastatic NSCLC, along with a summary of the evidence justifying its incorporation into standard treatment paradigms.
 

Key recommendations

Owing to the lack of significant randomized phase 3 trials, the guideline task force strongly recommended a patient-centered, multidisciplinary approach for all decision-making regarding potential treatment. In addition, algorithms were also created for the optimal clinical scenarios for local therapy and the different types of local therapy that are available for these patients.

Key recommendations include:

• The integration of definitive local therapy is recommended only for patients who have five or fewer distant extracranial metastases, and only when technically feasible and clinically safe for all disease sites. Definitive local therapy is also conditionally recommended for carefully selected patients with synchronous oligometastatic, metachronous oligorecurrent, induced oligopersistent, or induced oligoprogressive conditions for extracranial NSCLC.
• Radiation and surgery are the only recommended modalities for definitive local treatment of oligometastatic NSCLC. Radiation is favored when multiple organ systems are being treated or when the clinical priority is to minimize breaks from systemic therapy, whereas surgery is favored when large tissue sampling is needed for molecular testing to guide systemic therapy.
• For sequencing and timing, there is an emphasis on upfront, definitive local treatment for symptomatic metastases. For asymptomatic patients with synchronous disease, at least 3 months of standard-of-care systemic therapy is recommended before starting definitive local therapy.
• For optimal staging, radiation dosing, treatment planning, and delivery techniques, there is a preference for hypofractionated radiation therapy or stereotactic body radiation therapy when appropriate. The task force also emphasizes the importance of appropriate imaging and comments that it “cannot be overstated” to diagnose oligometastatic disease; they recommend that care teams consult guidelines from groups such as the National Comprehensive Cancer Network and the European Organisation for Research and Treatment of Cancer.
• Patients who develop disease progression at a limited number of sites, so-called oligoprogression at previously treated sites, and/or de novo recurrences at new sites may benefit from repeat local definitive therapy performed with the aim of prolonging progression-free survival or delaying a switch in systemic therapies.

Matthias Guckenberger, MD, cochair of the guideline task force and a professor and chairman of radiation oncology at the University Hospital Zürich, cautioned that “despite the widespread enthusiasm in the field of oligometastatic disease, the quality of evidence supporting the integration of definitive local therapy into a multimodality treatment strategy is still lower as compared to indications such as locally advanced NSCLC.”

“To compensate for this lack of highest-quality evidence, recommendations of this guideline were established by a broad consensus involving experts from ASTRO and ESTRO, colleagues from the fields of thoracic surgery and medical oncology and a patient representative,” Dr. Guckenberger said in a statement.

The guideline task force also emphasized the need for equitable use of these techniques, noting that “a significant effort must be taken to ensure that the decisions regarding the use of local therapies for oligometastatic NSCLC be applied equally across all patients to avoid any health disparities.”

This work was funded by ASTRO. Dr. Iyengar reported no disclosures. Dr. Guckenberger reports relationships with the European Thoracic Oncology Platform, Varian, ViewRay, and ESTRO. Several of the coauthors disclosed relationships with industry.

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

The first guideline for definitive local therapy options in the treatment of oligometastatic non–small cell lung cancer (NSCLC) has now been released.

The result of a joint effort by the American Society for Radiation Oncology and European Society for Radiotherapy and Oncology, the guidelines emphasizes the need for a multidisciplinary team approach to guide treatment decisions for oligometastatic disease.

Historically, treatment for oligometastatic NSCLC has involved systemic therapy including chemotherapy or immunotherapy, and local therapy was given only for palliation and symptom relief. But increasing evidence has demonstrated that definitive local therapy may have an additional role in controlling tumor growth and improving survival outcomes, and an increasing number of radiation oncologists and multidisciplinary teams are now using local therapy beyond palliative care for these patients, the authors noted.

“Oligometastatic NSCLC is a phase in lung cancer development that may offer us new opportunities to improve patient outcomes, because it typically is more treatable than widely metastatic cancer,” said Puneeth Iyengar, MD, PhD, cochair of the guideline task force and an associate professor of radiation oncology at UT Southwestern Medical Center, Dallas.

“The research on local therapy for oligometastatic cancer is still at a relatively early stage, but we already see indicators of potential benefits for patients. Adding local therapy to systemic therapy may lead to more durable cancer control, potentially improving progression-free survival, overall survival and quality of life,” he said in a statement.

The new guideline is published in Practical Radiation Oncology.

The purpose of this joint guideline was to provide recommendations on local therapy use for oligometastatic NSCLC, along with a summary of the evidence justifying its incorporation into standard treatment paradigms.
 

Key recommendations

Owing to the lack of significant randomized phase 3 trials, the guideline task force strongly recommended a patient-centered, multidisciplinary approach for all decision-making regarding potential treatment. In addition, algorithms were also created for the optimal clinical scenarios for local therapy and the different types of local therapy that are available for these patients.

Key recommendations include:

• The integration of definitive local therapy is recommended only for patients who have five or fewer distant extracranial metastases, and only when technically feasible and clinically safe for all disease sites. Definitive local therapy is also conditionally recommended for carefully selected patients with synchronous oligometastatic, metachronous oligorecurrent, induced oligopersistent, or induced oligoprogressive conditions for extracranial NSCLC.
• Radiation and surgery are the only recommended modalities for definitive local treatment of oligometastatic NSCLC. Radiation is favored when multiple organ systems are being treated or when the clinical priority is to minimize breaks from systemic therapy, whereas surgery is favored when large tissue sampling is needed for molecular testing to guide systemic therapy.
• For sequencing and timing, there is an emphasis on upfront, definitive local treatment for symptomatic metastases. For asymptomatic patients with synchronous disease, at least 3 months of standard-of-care systemic therapy is recommended before starting definitive local therapy.
• For optimal staging, radiation dosing, treatment planning, and delivery techniques, there is a preference for hypofractionated radiation therapy or stereotactic body radiation therapy when appropriate. The task force also emphasizes the importance of appropriate imaging and comments that it “cannot be overstated” to diagnose oligometastatic disease; they recommend that care teams consult guidelines from groups such as the National Comprehensive Cancer Network and the European Organisation for Research and Treatment of Cancer.
• Patients who develop disease progression at a limited number of sites, so-called oligoprogression at previously treated sites, and/or de novo recurrences at new sites may benefit from repeat local definitive therapy performed with the aim of prolonging progression-free survival or delaying a switch in systemic therapies.

Matthias Guckenberger, MD, cochair of the guideline task force and a professor and chairman of radiation oncology at the University Hospital Zürich, cautioned that “despite the widespread enthusiasm in the field of oligometastatic disease, the quality of evidence supporting the integration of definitive local therapy into a multimodality treatment strategy is still lower as compared to indications such as locally advanced NSCLC.”

“To compensate for this lack of highest-quality evidence, recommendations of this guideline were established by a broad consensus involving experts from ASTRO and ESTRO, colleagues from the fields of thoracic surgery and medical oncology and a patient representative,” Dr. Guckenberger said in a statement.

The guideline task force also emphasized the need for equitable use of these techniques, noting that “a significant effort must be taken to ensure that the decisions regarding the use of local therapies for oligometastatic NSCLC be applied equally across all patients to avoid any health disparities.”

This work was funded by ASTRO. Dr. Iyengar reported no disclosures. Dr. Guckenberger reports relationships with the European Thoracic Oncology Platform, Varian, ViewRay, and ESTRO. Several of the coauthors disclosed relationships with industry.

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

The first guideline for definitive local therapy options in the treatment of oligometastatic non–small cell lung cancer (NSCLC) has now been released.

The result of a joint effort by the American Society for Radiation Oncology and European Society for Radiotherapy and Oncology, the guidelines emphasizes the need for a multidisciplinary team approach to guide treatment decisions for oligometastatic disease.

Historically, treatment for oligometastatic NSCLC has involved systemic therapy including chemotherapy or immunotherapy, and local therapy was given only for palliation and symptom relief. But increasing evidence has demonstrated that definitive local therapy may have an additional role in controlling tumor growth and improving survival outcomes, and an increasing number of radiation oncologists and multidisciplinary teams are now using local therapy beyond palliative care for these patients, the authors noted.

“Oligometastatic NSCLC is a phase in lung cancer development that may offer us new opportunities to improve patient outcomes, because it typically is more treatable than widely metastatic cancer,” said Puneeth Iyengar, MD, PhD, cochair of the guideline task force and an associate professor of radiation oncology at UT Southwestern Medical Center, Dallas.

“The research on local therapy for oligometastatic cancer is still at a relatively early stage, but we already see indicators of potential benefits for patients. Adding local therapy to systemic therapy may lead to more durable cancer control, potentially improving progression-free survival, overall survival and quality of life,” he said in a statement.

The new guideline is published in Practical Radiation Oncology.

The purpose of this joint guideline was to provide recommendations on local therapy use for oligometastatic NSCLC, along with a summary of the evidence justifying its incorporation into standard treatment paradigms.
 

Key recommendations

Owing to the lack of significant randomized phase 3 trials, the guideline task force strongly recommended a patient-centered, multidisciplinary approach for all decision-making regarding potential treatment. In addition, algorithms were also created for the optimal clinical scenarios for local therapy and the different types of local therapy that are available for these patients.

Key recommendations include:

• The integration of definitive local therapy is recommended only for patients who have five or fewer distant extracranial metastases, and only when technically feasible and clinically safe for all disease sites. Definitive local therapy is also conditionally recommended for carefully selected patients with synchronous oligometastatic, metachronous oligorecurrent, induced oligopersistent, or induced oligoprogressive conditions for extracranial NSCLC.
• Radiation and surgery are the only recommended modalities for definitive local treatment of oligometastatic NSCLC. Radiation is favored when multiple organ systems are being treated or when the clinical priority is to minimize breaks from systemic therapy, whereas surgery is favored when large tissue sampling is needed for molecular testing to guide systemic therapy.
• For sequencing and timing, there is an emphasis on upfront, definitive local treatment for symptomatic metastases. For asymptomatic patients with synchronous disease, at least 3 months of standard-of-care systemic therapy is recommended before starting definitive local therapy.
• For optimal staging, radiation dosing, treatment planning, and delivery techniques, there is a preference for hypofractionated radiation therapy or stereotactic body radiation therapy when appropriate. The task force also emphasizes the importance of appropriate imaging and comments that it “cannot be overstated” to diagnose oligometastatic disease; they recommend that care teams consult guidelines from groups such as the National Comprehensive Cancer Network and the European Organisation for Research and Treatment of Cancer.
• Patients who develop disease progression at a limited number of sites, so-called oligoprogression at previously treated sites, and/or de novo recurrences at new sites may benefit from repeat local definitive therapy performed with the aim of prolonging progression-free survival or delaying a switch in systemic therapies.

Matthias Guckenberger, MD, cochair of the guideline task force and a professor and chairman of radiation oncology at the University Hospital Zürich, cautioned that “despite the widespread enthusiasm in the field of oligometastatic disease, the quality of evidence supporting the integration of definitive local therapy into a multimodality treatment strategy is still lower as compared to indications such as locally advanced NSCLC.”

“To compensate for this lack of highest-quality evidence, recommendations of this guideline were established by a broad consensus involving experts from ASTRO and ESTRO, colleagues from the fields of thoracic surgery and medical oncology and a patient representative,” Dr. Guckenberger said in a statement.

The guideline task force also emphasized the need for equitable use of these techniques, noting that “a significant effort must be taken to ensure that the decisions regarding the use of local therapies for oligometastatic NSCLC be applied equally across all patients to avoid any health disparities.”

This work was funded by ASTRO. Dr. Iyengar reported no disclosures. Dr. Guckenberger reports relationships with the European Thoracic Oncology Platform, Varian, ViewRay, and ESTRO. Several of the coauthors disclosed relationships with industry.

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

Cisplatin is one of the most commonly used chemotherapeutic agents for treating a variety of cancers, such as lung, bladder, and ovarian cancers. But the therapy comes with a drawback – ototoxicity.

“More than half of adult and pediatric patients with cancer treated with cisplatin developed hearing impairment with major impact on patients’ health-related quality of life,” researchers noted in a clinical review published in JCO Oncology Practice.

It is estimated that 36% of adult patients and 40%-60% of pediatric patients experience cisplatin-induced ototoxicity. It can present as tinnitus (ringing in the ears), loss of hearing in the high-frequency range (4000 – 8000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The incidence of cisplatin-induced ototoxicity is estimated to be 36% of adult patients and 40% to 60% of pediatric patients. Ototoxicity can present as tinnitus, loss of hearing in the high-frequency range (4,000-8,000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The risk of developing cisplatin-induced ototoxicity depends on various factors, including the cumulative dose of cisplatin, the duration of treatment, and individual patient factors, such as age and preexisting hearing problems.

The lack of real-world practice patterns for monitoring ototoxicity makes identifying effective prevention and intervention strategies challenging, say the authors, led by Asmi Chattaraj, MD, of the University of Pittsburgh Medical Center (UPMC), McKeesport, Pa.

The team conducted a survey of oncologists with the UPMC Hillman Cancer Center network regarding patterns for monitoring and reducing the risk of ototoxicity.

Of the 35 responding oncologists, the majority (97%) indicated that they regularly discuss the risk of ototoxicity with all patients before they receive cisplatin. However, only 18% of the respondents said they obtain audiograms for patients before administering cisplatin, 69% order audiograms only if patients complain of hearing loss or tinnitus, and 35% of respondents do not perform regular monitoring for ototoxicity.

“This heterogeneity of practice within a single network highlights the need for high-quality evidence to guide clinical practice and the urgent need to standardize the necessary diagnostic steps to monitor for ototoxicity and its effect on the quality of life in the adult oncology practice, similar to the current practice in the pediatric patient population,” the researchers determined.
 

Proactive rather than reactive

Managing cisplatin-induced ototoxicity “must be viewed as a proactive measure rather than a reactive measure,” Nisha A. Mohindra, MD, wrote in an accompanying editorial.

Dr. Mohindra noted that although it is recommended that audiology assessments be conducted before, during, and after administration of ototoxicity drugs, the monitoring for ototoxicity remains underutilized in clinical practice. The path to better outcomes begins with implementing testing into clinical practice, she suggested.

“The most effective mechanism to manage ototoxicity currently is to identify patients at risk and implement programs to support ongoing monitoring,” Dr. Mohindra wrote.

“Even if ototoxicity cannot be prevented in some patients, providing treating oncologists with a timely opportunity to alter therapy or providing patients with support, guidance, and earlier access to rehabilitation services may mitigate long-term effects of hearing loss,” she concluded.

The researchers have disclosed numerous relationships with industry, a full listing of which is available with the original article.

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

Cisplatin is one of the most commonly used chemotherapeutic agents for treating a variety of cancers, such as lung, bladder, and ovarian cancers. But the therapy comes with a drawback – ototoxicity.

“More than half of adult and pediatric patients with cancer treated with cisplatin developed hearing impairment with major impact on patients’ health-related quality of life,” researchers noted in a clinical review published in JCO Oncology Practice.

It is estimated that 36% of adult patients and 40%-60% of pediatric patients experience cisplatin-induced ototoxicity. It can present as tinnitus (ringing in the ears), loss of hearing in the high-frequency range (4000 – 8000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The incidence of cisplatin-induced ototoxicity is estimated to be 36% of adult patients and 40% to 60% of pediatric patients. Ototoxicity can present as tinnitus, loss of hearing in the high-frequency range (4,000-8,000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The risk of developing cisplatin-induced ototoxicity depends on various factors, including the cumulative dose of cisplatin, the duration of treatment, and individual patient factors, such as age and preexisting hearing problems.

The lack of real-world practice patterns for monitoring ototoxicity makes identifying effective prevention and intervention strategies challenging, say the authors, led by Asmi Chattaraj, MD, of the University of Pittsburgh Medical Center (UPMC), McKeesport, Pa.

The team conducted a survey of oncologists with the UPMC Hillman Cancer Center network regarding patterns for monitoring and reducing the risk of ototoxicity.

Of the 35 responding oncologists, the majority (97%) indicated that they regularly discuss the risk of ototoxicity with all patients before they receive cisplatin. However, only 18% of the respondents said they obtain audiograms for patients before administering cisplatin, 69% order audiograms only if patients complain of hearing loss or tinnitus, and 35% of respondents do not perform regular monitoring for ototoxicity.

“This heterogeneity of practice within a single network highlights the need for high-quality evidence to guide clinical practice and the urgent need to standardize the necessary diagnostic steps to monitor for ototoxicity and its effect on the quality of life in the adult oncology practice, similar to the current practice in the pediatric patient population,” the researchers determined.
 

Proactive rather than reactive

Managing cisplatin-induced ototoxicity “must be viewed as a proactive measure rather than a reactive measure,” Nisha A. Mohindra, MD, wrote in an accompanying editorial.

Dr. Mohindra noted that although it is recommended that audiology assessments be conducted before, during, and after administration of ototoxicity drugs, the monitoring for ototoxicity remains underutilized in clinical practice. The path to better outcomes begins with implementing testing into clinical practice, she suggested.

“The most effective mechanism to manage ototoxicity currently is to identify patients at risk and implement programs to support ongoing monitoring,” Dr. Mohindra wrote.

“Even if ototoxicity cannot be prevented in some patients, providing treating oncologists with a timely opportunity to alter therapy or providing patients with support, guidance, and earlier access to rehabilitation services may mitigate long-term effects of hearing loss,” she concluded.

The researchers have disclosed numerous relationships with industry, a full listing of which is available with the original article.

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

Cisplatin is one of the most commonly used chemotherapeutic agents for treating a variety of cancers, such as lung, bladder, and ovarian cancers. But the therapy comes with a drawback – ototoxicity.

“More than half of adult and pediatric patients with cancer treated with cisplatin developed hearing impairment with major impact on patients’ health-related quality of life,” researchers noted in a clinical review published in JCO Oncology Practice.

It is estimated that 36% of adult patients and 40%-60% of pediatric patients experience cisplatin-induced ototoxicity. It can present as tinnitus (ringing in the ears), loss of hearing in the high-frequency range (4000 – 8000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The incidence of cisplatin-induced ototoxicity is estimated to be 36% of adult patients and 40% to 60% of pediatric patients. Ototoxicity can present as tinnitus, loss of hearing in the high-frequency range (4,000-8,000 Hz), or, at late stages, a decrease in the ability to hear lower frequencies.

The risk of developing cisplatin-induced ototoxicity depends on various factors, including the cumulative dose of cisplatin, the duration of treatment, and individual patient factors, such as age and preexisting hearing problems.

The lack of real-world practice patterns for monitoring ototoxicity makes identifying effective prevention and intervention strategies challenging, say the authors, led by Asmi Chattaraj, MD, of the University of Pittsburgh Medical Center (UPMC), McKeesport, Pa.

The team conducted a survey of oncologists with the UPMC Hillman Cancer Center network regarding patterns for monitoring and reducing the risk of ototoxicity.

Of the 35 responding oncologists, the majority (97%) indicated that they regularly discuss the risk of ototoxicity with all patients before they receive cisplatin. However, only 18% of the respondents said they obtain audiograms for patients before administering cisplatin, 69% order audiograms only if patients complain of hearing loss or tinnitus, and 35% of respondents do not perform regular monitoring for ototoxicity.

“This heterogeneity of practice within a single network highlights the need for high-quality evidence to guide clinical practice and the urgent need to standardize the necessary diagnostic steps to monitor for ototoxicity and its effect on the quality of life in the adult oncology practice, similar to the current practice in the pediatric patient population,” the researchers determined.
 

Proactive rather than reactive

Managing cisplatin-induced ototoxicity “must be viewed as a proactive measure rather than a reactive measure,” Nisha A. Mohindra, MD, wrote in an accompanying editorial.

Dr. Mohindra noted that although it is recommended that audiology assessments be conducted before, during, and after administration of ototoxicity drugs, the monitoring for ototoxicity remains underutilized in clinical practice. The path to better outcomes begins with implementing testing into clinical practice, she suggested.

“The most effective mechanism to manage ototoxicity currently is to identify patients at risk and implement programs to support ongoing monitoring,” Dr. Mohindra wrote.

“Even if ototoxicity cannot be prevented in some patients, providing treating oncologists with a timely opportunity to alter therapy or providing patients with support, guidance, and earlier access to rehabilitation services may mitigate long-term effects of hearing loss,” she concluded.

The researchers have disclosed numerous relationships with industry, a full listing of which is available with the original article.

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

A new study shows that people with long COVID respond differently to COVID vaccines and that the condition may be caused by a dysfunction of the immune system – possibly explaining why some people experience symptoms for months while others recover and resume normal lives. 

The study compared people who already had long COVID with people who had recovered from the virus. Both groups had not yet been vaccinated prior to the study. When researchers analyzed blood samples after people received an initial vaccine dose, they found that people with long COVID and people who had already recovered from the virus had similar immune responses at first. But after 8 weeks, the long-COVID group’s immune response remained elevated, while the other group’s response had declined.

The long-COVID group also showed an extra immune response that tried to fight the virus in a secondary way that researchers didn’t expect. Both groups showed an initial increase in their blood of antibodies that primarily target what’s known as the “spike” protein of the coronavirus, which allows the virus to invade healthy cells. But the long-COVID group also showed a prolonged increased immune response that tried to fight the part of the virus related to how it replicates.

“Theoretically, the production of these antibodies could mean that people are more protected from infection,” said researcher Catherine Le, MD, in a statement. “We also need to investigate if the elevated immune response corresponds with severity or number of long–COVID-19 symptoms.”

Dr. Le is codirector of the COVID-19 Recovery Program at Cedars-Sinai Medical Center in Los Angeles, where the study was conducted.

Study participants agreed in September 2020 to participate in long-term COVID research at Cedars-Sinai. The new analysis was published earlier this year in BMC Infectious Diseases and included 245 people who had long COVID and 86 health care workers who had recovered from COVID but did not have long-term symptoms. 

For the study, long COVID was defined as having symptoms that lasted more than 12 weeks. Common long-COVID symptoms are fatigue, shortness of breath, and brain dysfunction such as confusion and forgetfulness.

The authors said it’s unclear why the two groups had different immune responses and also noted that their study was limited by a small sample size. Their research of blood samples is ongoing, with the goals of identifying a way to diagnose long COVID with a laboratory test and of better understanding what causes the condition.

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

A new study shows that people with long COVID respond differently to COVID vaccines and that the condition may be caused by a dysfunction of the immune system – possibly explaining why some people experience symptoms for months while others recover and resume normal lives. 

The study compared people who already had long COVID with people who had recovered from the virus. Both groups had not yet been vaccinated prior to the study. When researchers analyzed blood samples after people received an initial vaccine dose, they found that people with long COVID and people who had already recovered from the virus had similar immune responses at first. But after 8 weeks, the long-COVID group’s immune response remained elevated, while the other group’s response had declined.

The long-COVID group also showed an extra immune response that tried to fight the virus in a secondary way that researchers didn’t expect. Both groups showed an initial increase in their blood of antibodies that primarily target what’s known as the “spike” protein of the coronavirus, which allows the virus to invade healthy cells. But the long-COVID group also showed a prolonged increased immune response that tried to fight the part of the virus related to how it replicates.

“Theoretically, the production of these antibodies could mean that people are more protected from infection,” said researcher Catherine Le, MD, in a statement. “We also need to investigate if the elevated immune response corresponds with severity or number of long–COVID-19 symptoms.”

Dr. Le is codirector of the COVID-19 Recovery Program at Cedars-Sinai Medical Center in Los Angeles, where the study was conducted.

Study participants agreed in September 2020 to participate in long-term COVID research at Cedars-Sinai. The new analysis was published earlier this year in BMC Infectious Diseases and included 245 people who had long COVID and 86 health care workers who had recovered from COVID but did not have long-term symptoms. 

For the study, long COVID was defined as having symptoms that lasted more than 12 weeks. Common long-COVID symptoms are fatigue, shortness of breath, and brain dysfunction such as confusion and forgetfulness.

The authors said it’s unclear why the two groups had different immune responses and also noted that their study was limited by a small sample size. Their research of blood samples is ongoing, with the goals of identifying a way to diagnose long COVID with a laboratory test and of better understanding what causes the condition.

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

A new study shows that people with long COVID respond differently to COVID vaccines and that the condition may be caused by a dysfunction of the immune system – possibly explaining why some people experience symptoms for months while others recover and resume normal lives. 

The study compared people who already had long COVID with people who had recovered from the virus. Both groups had not yet been vaccinated prior to the study. When researchers analyzed blood samples after people received an initial vaccine dose, they found that people with long COVID and people who had already recovered from the virus had similar immune responses at first. But after 8 weeks, the long-COVID group’s immune response remained elevated, while the other group’s response had declined.

The long-COVID group also showed an extra immune response that tried to fight the virus in a secondary way that researchers didn’t expect. Both groups showed an initial increase in their blood of antibodies that primarily target what’s known as the “spike” protein of the coronavirus, which allows the virus to invade healthy cells. But the long-COVID group also showed a prolonged increased immune response that tried to fight the part of the virus related to how it replicates.

“Theoretically, the production of these antibodies could mean that people are more protected from infection,” said researcher Catherine Le, MD, in a statement. “We also need to investigate if the elevated immune response corresponds with severity or number of long–COVID-19 symptoms.”

Dr. Le is codirector of the COVID-19 Recovery Program at Cedars-Sinai Medical Center in Los Angeles, where the study was conducted.

Study participants agreed in September 2020 to participate in long-term COVID research at Cedars-Sinai. The new analysis was published earlier this year in BMC Infectious Diseases and included 245 people who had long COVID and 86 health care workers who had recovered from COVID but did not have long-term symptoms. 

For the study, long COVID was defined as having symptoms that lasted more than 12 weeks. Common long-COVID symptoms are fatigue, shortness of breath, and brain dysfunction such as confusion and forgetfulness.

The authors said it’s unclear why the two groups had different immune responses and also noted that their study was limited by a small sample size. Their research of blood samples is ongoing, with the goals of identifying a way to diagnose long COVID with a laboratory test and of better understanding what causes the condition.

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