Journal of Clinical Outcomes Management

A third of patients with COVID-19 and thoracic malignancies die, according to updated results from the TERAVOLT registry.

The risk of death was similar across racial and ethnic groups. Factors associated with an increased risk of death were male sex, older age, worse performance scores, and four or more metastatic sites.

“Death rates remain high at 33%, underscoring the importance of COVID-19 vaccination in patients with thoracic cancers, when available,” said Umit Tapan, MD, of Boston University.

Dr. Tapan presented the TERAVOLT update at the 2020 World Congress on Lung Cancer (Abstract P09.18), which was rescheduled for January 2021.

The TERAVOLT registry is a multicenter, observational study with a cross-sectional component and a longitudinal cohort component.

The registry includes patients who have thoracic cancers – non–small cell lung cancer (NSCLC), small cell lung cancer, mesothelioma, thymic epithelial tumors, and other pulmonary neuroendocrine neoplasms – and a COVID-19 diagnosis, either laboratory confirmed with RT-PCR, suspected with symptoms and contacts, or radiologically suspected cases with lung imaging features consistent with COVID-19 pneumonia and symptoms.

Clinical data were extracted from medical records of consecutive patients from Jan. 1, 2020, and will be collected until the end of pandemic, as declared by the World Health Organization. Data collected include demographics, oncologic history and comorbidities, COVID-19 diagnosis, and course of illness and clinical outcomes.

“The overarching goals of this consortium are to provide data for guidance to oncology professionals on managing patients with thoracic malignancies while understanding the risk factors for morbidity and mortality from this novel virus,” Dr. Tapan said.

Data from TERAVOLT were previously presented at AACR, ASCO, and ESMO last year, as well as published in The Lancet Oncology.

Updated results

Dr. Tapan presented data on 1,011 patients from 120 centers in 19 countries. The patients’ median age was 68 years (range, 28-95 years), and more than half were male (58%). Most patients (72%) were White, 20% were Hispanic/Latino, and 8% were Black/African American.

Most patients had NSCLC (82%), and most had stage IV disease (68%). Patients had received a median of one prior line of therapy.

As in earlier reports of TERAVOLT data, the mortality rate was 33%.

In a multivariate analysis, the following characteristics were associated with an increased risk of death:

• Male sex (odds ratio, 1.4).
• Older age (per 10 years; OR, 1.21).
• Performance score of 1 (OR, 1.73), 2 (OR, 4.74), and 3/4 (OR, 10.7).
• Four or more metastatic sites (OR, 3.05).

The following characteristics were associated with an increased risk of hospitalization in a multivariate analysis:

• Male sex (OR, 1.67).
• Older age (per 10 years; OR, 1.24).
• Performance score of 2 (OR, 4.47) and 3/4 (OR, 9.63).
• Four or more metastatic sites (OR, 4.0).
• Thymic carcinoma (OR, 3.58).
• Receiving radiation (OR, 2.1).

Race and ethnicity did not seem to affect the risk of death or hospitalization, “but we plan to conduct further analysis,” Dr. Tapan said.

Roxana Reyes, MD, of Hospital Clínic de Barcelona, said her hospital sees patients with lung cancer at high risk for COVID-19, but there is no screening program in place.

“We use medical consultations to focus on early diagnosis. We treat COVID-19 complications but lose a lot of patients. There is an opportunity to be found to find these patients sooner,” Dr. Reyes said.

She noted that COVID-19 will likely last a long time, and therefore “we have to protect against it and continue to diagnose lung cancer at earlier stages.”

Dr. Reyes disclosed relationships with Roche, Bristol-Myers Squibb, and Merck Sharp & Dohme. Dr. Tapan has no relevant disclosures. The TERAVOLT registry is funded, in part, by the International Association for the Study of Lung Cancer.

A third of patients with COVID-19 and thoracic malignancies die, according to updated results from the TERAVOLT registry.

The risk of death was similar across racial and ethnic groups. Factors associated with an increased risk of death were male sex, older age, worse performance scores, and four or more metastatic sites.

“Death rates remain high at 33%, underscoring the importance of COVID-19 vaccination in patients with thoracic cancers, when available,” said Umit Tapan, MD, of Boston University.

Dr. Tapan presented the TERAVOLT update at the 2020 World Congress on Lung Cancer (Abstract P09.18), which was rescheduled for January 2021.

The TERAVOLT registry is a multicenter, observational study with a cross-sectional component and a longitudinal cohort component.

The registry includes patients who have thoracic cancers – non–small cell lung cancer (NSCLC), small cell lung cancer, mesothelioma, thymic epithelial tumors, and other pulmonary neuroendocrine neoplasms – and a COVID-19 diagnosis, either laboratory confirmed with RT-PCR, suspected with symptoms and contacts, or radiologically suspected cases with lung imaging features consistent with COVID-19 pneumonia and symptoms.

Clinical data were extracted from medical records of consecutive patients from Jan. 1, 2020, and will be collected until the end of pandemic, as declared by the World Health Organization. Data collected include demographics, oncologic history and comorbidities, COVID-19 diagnosis, and course of illness and clinical outcomes.

“The overarching goals of this consortium are to provide data for guidance to oncology professionals on managing patients with thoracic malignancies while understanding the risk factors for morbidity and mortality from this novel virus,” Dr. Tapan said.

Data from TERAVOLT were previously presented at AACR, ASCO, and ESMO last year, as well as published in The Lancet Oncology.

Updated results

Dr. Tapan presented data on 1,011 patients from 120 centers in 19 countries. The patients’ median age was 68 years (range, 28-95 years), and more than half were male (58%). Most patients (72%) were White, 20% were Hispanic/Latino, and 8% were Black/African American.

Most patients had NSCLC (82%), and most had stage IV disease (68%). Patients had received a median of one prior line of therapy.

As in earlier reports of TERAVOLT data, the mortality rate was 33%.

In a multivariate analysis, the following characteristics were associated with an increased risk of death:

• Male sex (odds ratio, 1.4).
• Older age (per 10 years; OR, 1.21).
• Performance score of 1 (OR, 1.73), 2 (OR, 4.74), and 3/4 (OR, 10.7).
• Four or more metastatic sites (OR, 3.05).

The following characteristics were associated with an increased risk of hospitalization in a multivariate analysis:

• Male sex (OR, 1.67).
• Older age (per 10 years; OR, 1.24).
• Performance score of 2 (OR, 4.47) and 3/4 (OR, 9.63).
• Four or more metastatic sites (OR, 4.0).
• Thymic carcinoma (OR, 3.58).
• Receiving radiation (OR, 2.1).

Race and ethnicity did not seem to affect the risk of death or hospitalization, “but we plan to conduct further analysis,” Dr. Tapan said.

Roxana Reyes, MD, of Hospital Clínic de Barcelona, said her hospital sees patients with lung cancer at high risk for COVID-19, but there is no screening program in place.

“We use medical consultations to focus on early diagnosis. We treat COVID-19 complications but lose a lot of patients. There is an opportunity to be found to find these patients sooner,” Dr. Reyes said.

She noted that COVID-19 will likely last a long time, and therefore “we have to protect against it and continue to diagnose lung cancer at earlier stages.”

Dr. Reyes disclosed relationships with Roche, Bristol-Myers Squibb, and Merck Sharp & Dohme. Dr. Tapan has no relevant disclosures. The TERAVOLT registry is funded, in part, by the International Association for the Study of Lung Cancer.

A third of patients with COVID-19 and thoracic malignancies die, according to updated results from the TERAVOLT registry.

The risk of death was similar across racial and ethnic groups. Factors associated with an increased risk of death were male sex, older age, worse performance scores, and four or more metastatic sites.

“Death rates remain high at 33%, underscoring the importance of COVID-19 vaccination in patients with thoracic cancers, when available,” said Umit Tapan, MD, of Boston University.

Dr. Tapan presented the TERAVOLT update at the 2020 World Congress on Lung Cancer (Abstract P09.18), which was rescheduled for January 2021.

The TERAVOLT registry is a multicenter, observational study with a cross-sectional component and a longitudinal cohort component.

The registry includes patients who have thoracic cancers – non–small cell lung cancer (NSCLC), small cell lung cancer, mesothelioma, thymic epithelial tumors, and other pulmonary neuroendocrine neoplasms – and a COVID-19 diagnosis, either laboratory confirmed with RT-PCR, suspected with symptoms and contacts, or radiologically suspected cases with lung imaging features consistent with COVID-19 pneumonia and symptoms.

Clinical data were extracted from medical records of consecutive patients from Jan. 1, 2020, and will be collected until the end of pandemic, as declared by the World Health Organization. Data collected include demographics, oncologic history and comorbidities, COVID-19 diagnosis, and course of illness and clinical outcomes.

“The overarching goals of this consortium are to provide data for guidance to oncology professionals on managing patients with thoracic malignancies while understanding the risk factors for morbidity and mortality from this novel virus,” Dr. Tapan said.

Data from TERAVOLT were previously presented at AACR, ASCO, and ESMO last year, as well as published in The Lancet Oncology.

Updated results

Dr. Tapan presented data on 1,011 patients from 120 centers in 19 countries. The patients’ median age was 68 years (range, 28-95 years), and more than half were male (58%). Most patients (72%) were White, 20% were Hispanic/Latino, and 8% were Black/African American.

Most patients had NSCLC (82%), and most had stage IV disease (68%). Patients had received a median of one prior line of therapy.

As in earlier reports of TERAVOLT data, the mortality rate was 33%.

In a multivariate analysis, the following characteristics were associated with an increased risk of death:

• Male sex (odds ratio, 1.4).
• Older age (per 10 years; OR, 1.21).
• Performance score of 1 (OR, 1.73), 2 (OR, 4.74), and 3/4 (OR, 10.7).
• Four or more metastatic sites (OR, 3.05).

The following characteristics were associated with an increased risk of hospitalization in a multivariate analysis:

• Male sex (OR, 1.67).
• Older age (per 10 years; OR, 1.24).
• Performance score of 2 (OR, 4.47) and 3/4 (OR, 9.63).
• Four or more metastatic sites (OR, 4.0).
• Thymic carcinoma (OR, 3.58).
• Receiving radiation (OR, 2.1).

Race and ethnicity did not seem to affect the risk of death or hospitalization, “but we plan to conduct further analysis,” Dr. Tapan said.

Roxana Reyes, MD, of Hospital Clínic de Barcelona, said her hospital sees patients with lung cancer at high risk for COVID-19, but there is no screening program in place.

“We use medical consultations to focus on early diagnosis. We treat COVID-19 complications but lose a lot of patients. There is an opportunity to be found to find these patients sooner,” Dr. Reyes said.

She noted that COVID-19 will likely last a long time, and therefore “we have to protect against it and continue to diagnose lung cancer at earlier stages.”

Dr. Reyes disclosed relationships with Roche, Bristol-Myers Squibb, and Merck Sharp & Dohme. Dr. Tapan has no relevant disclosures. The TERAVOLT registry is funded, in part, by the International Association for the Study of Lung Cancer.

Adults who eat three slices of white bread daily have a significantly increased risk for dying from cardiovascular causes.

MikeyGen73/Getty Images

That’s one finding from an assessment of a more than 137,000 people in 21 countries that documented a clear link between a high level of consumption of refined grains and a significantly increased risk for death from any cause or major cardiovascular disease (CVD) event during a median follow-up of 9.5 years.

The results showed that people who reported eating at least 350 g (seven servings) of refined grain daily had a significant 29% increased risk of either death or a major CVD event (MI, stroke, or heart failure), compared with those who consumed less than one serving per day (fewer than 50 g) of refined grain after adjustment for multiple potential confounders, according to a report from the Prospective Urban Rural Epidemiology (PURE) study published in the BMJ on Feb. 3, 2021.

The analysis also showed no significant association between levels of whole grains or white rice in the diet and CVD events. Rice was considered a separate grain in the analysis because nearly two-thirds of the PURE study population reside in Asia, where rice is a staple food.

The findings show that “reduction in the quantity of refined grains and sugar, and improvement in the quality of carbohydrates is essential for better health outcomes, although we do not suggest complete elimination of refined grains,” said Mahshid Dehghan, PhD, lead investigator for this report and a researcher in nutrition epidemiology at the Population Health Research Institute of McMaster University, Hamilton, Ont.
 

‘Widely applicable’ results from large, diverse study

Although prior evidence had already shown the CVD risk from eating larger amounts of refined grains, “our findings are robust and more widely applicable because our large study recorded over 9,000 deaths and 3,500 major CVD events across a broad range of refined grain intake, and in a variety of different settings and cultures with varying dietary patterns,” Dr. Dehghan said in an interview.

“This is an important paper, with the strength of data from diverse countries. The associations are robust,” commented Dariush Mozaffarian, MD, DrPH, professor and dean of the Friedman School of Nutrition Science and Policy at Tufts University, Boston, who was not involved in the new report.

“The public and the public health community think about added sugar in food as harmful, but starch has gotten a free pass,” he said in an interview. Recently revised U.S. dietary guidelines recommend that refined grains constitute less than half of a person’s carbohydrate consumption, but that limitation remains set too high, Dr. Mozaffarian cautioned. A much safer daily consumption limit would cap refined grains to no more than one serving a day.

The data for the current PURE analysis came from more than 148,000 people aged 35-70 years at entry in 21 geographically and economically diverse countries. Excluding patients with known CVD at baseline left a cohort of 137,130 people.

The results showed no significant association between the quantity of whole grains consumed and the main outcome, nor a link between higher amounts of white rice consumption and the main outcome.

“Our findings suggest that intake of up to 350 g of cooked rice daily may not pose a significant health risk,” said Dr. Dehghan.

Refined grains produce a glucose surge

Dr. Dehghan and associates speculated that possible explanations for their findings are that “varieties of rice such as long-grain rice and especially parboiled white rice may have both a definite glycemic advantage and an overall nutritional advantage over refined wheat products. Also, depending on the culture and the nature of the rice eaten, rice may be displacing less desirable foods.”

In contrast, refined grains undergo “rapid action by digestive enzymes and quick absorption from the small intestines [that] could lead to an increase in postprandial blood glucose concentrations. The rise in glucose concentrations increases the insulin concentrations, which leads to hypoglycemia, lipolysis, and the stimulation of hunger and food intake,” the authors wrote.

“It’s similar to eating sugar, or candy,” noted Dr. Mozaffarian, as refined grain “is 100% glucose.” Whole grains differ by entering the gut packaged in cell structures that slow digestion and avoid delivering sugar in an unnaturally rapid way.

“We are providing new evidence, and we hope that dietary guidelines in North America encourage individuals to lower their refined grain and sugar intake,” Dr. Dehghan said.

PURE has received partial funding with unrestricted grants from several drug companies. Dr. Dehghan had no disclosures. Dr. Mozaffarian has been an adviser to or has received personal fees from several food companies, but had no relevant disclosures.

[email protected]
 

Adults who eat three slices of white bread daily have a significantly increased risk for dying from cardiovascular causes.

MikeyGen73/Getty Images

That’s one finding from an assessment of a more than 137,000 people in 21 countries that documented a clear link between a high level of consumption of refined grains and a significantly increased risk for death from any cause or major cardiovascular disease (CVD) event during a median follow-up of 9.5 years.

The results showed that people who reported eating at least 350 g (seven servings) of refined grain daily had a significant 29% increased risk of either death or a major CVD event (MI, stroke, or heart failure), compared with those who consumed less than one serving per day (fewer than 50 g) of refined grain after adjustment for multiple potential confounders, according to a report from the Prospective Urban Rural Epidemiology (PURE) study published in the BMJ on Feb. 3, 2021.

The analysis also showed no significant association between levels of whole grains or white rice in the diet and CVD events. Rice was considered a separate grain in the analysis because nearly two-thirds of the PURE study population reside in Asia, where rice is a staple food.

The findings show that “reduction in the quantity of refined grains and sugar, and improvement in the quality of carbohydrates is essential for better health outcomes, although we do not suggest complete elimination of refined grains,” said Mahshid Dehghan, PhD, lead investigator for this report and a researcher in nutrition epidemiology at the Population Health Research Institute of McMaster University, Hamilton, Ont.
 

‘Widely applicable’ results from large, diverse study

Although prior evidence had already shown the CVD risk from eating larger amounts of refined grains, “our findings are robust and more widely applicable because our large study recorded over 9,000 deaths and 3,500 major CVD events across a broad range of refined grain intake, and in a variety of different settings and cultures with varying dietary patterns,” Dr. Dehghan said in an interview.

“This is an important paper, with the strength of data from diverse countries. The associations are robust,” commented Dariush Mozaffarian, MD, DrPH, professor and dean of the Friedman School of Nutrition Science and Policy at Tufts University, Boston, who was not involved in the new report.

“The public and the public health community think about added sugar in food as harmful, but starch has gotten a free pass,” he said in an interview. Recently revised U.S. dietary guidelines recommend that refined grains constitute less than half of a person’s carbohydrate consumption, but that limitation remains set too high, Dr. Mozaffarian cautioned. A much safer daily consumption limit would cap refined grains to no more than one serving a day.

The data for the current PURE analysis came from more than 148,000 people aged 35-70 years at entry in 21 geographically and economically diverse countries. Excluding patients with known CVD at baseline left a cohort of 137,130 people.

The results showed no significant association between the quantity of whole grains consumed and the main outcome, nor a link between higher amounts of white rice consumption and the main outcome.

“Our findings suggest that intake of up to 350 g of cooked rice daily may not pose a significant health risk,” said Dr. Dehghan.

Refined grains produce a glucose surge

Dr. Dehghan and associates speculated that possible explanations for their findings are that “varieties of rice such as long-grain rice and especially parboiled white rice may have both a definite glycemic advantage and an overall nutritional advantage over refined wheat products. Also, depending on the culture and the nature of the rice eaten, rice may be displacing less desirable foods.”

In contrast, refined grains undergo “rapid action by digestive enzymes and quick absorption from the small intestines [that] could lead to an increase in postprandial blood glucose concentrations. The rise in glucose concentrations increases the insulin concentrations, which leads to hypoglycemia, lipolysis, and the stimulation of hunger and food intake,” the authors wrote.

“It’s similar to eating sugar, or candy,” noted Dr. Mozaffarian, as refined grain “is 100% glucose.” Whole grains differ by entering the gut packaged in cell structures that slow digestion and avoid delivering sugar in an unnaturally rapid way.

“We are providing new evidence, and we hope that dietary guidelines in North America encourage individuals to lower their refined grain and sugar intake,” Dr. Dehghan said.

PURE has received partial funding with unrestricted grants from several drug companies. Dr. Dehghan had no disclosures. Dr. Mozaffarian has been an adviser to or has received personal fees from several food companies, but had no relevant disclosures.

[email protected]
 

Adults who eat three slices of white bread daily have a significantly increased risk for dying from cardiovascular causes.

MikeyGen73/Getty Images

That’s one finding from an assessment of a more than 137,000 people in 21 countries that documented a clear link between a high level of consumption of refined grains and a significantly increased risk for death from any cause or major cardiovascular disease (CVD) event during a median follow-up of 9.5 years.

The results showed that people who reported eating at least 350 g (seven servings) of refined grain daily had a significant 29% increased risk of either death or a major CVD event (MI, stroke, or heart failure), compared with those who consumed less than one serving per day (fewer than 50 g) of refined grain after adjustment for multiple potential confounders, according to a report from the Prospective Urban Rural Epidemiology (PURE) study published in the BMJ on Feb. 3, 2021.

The analysis also showed no significant association between levels of whole grains or white rice in the diet and CVD events. Rice was considered a separate grain in the analysis because nearly two-thirds of the PURE study population reside in Asia, where rice is a staple food.

The findings show that “reduction in the quantity of refined grains and sugar, and improvement in the quality of carbohydrates is essential for better health outcomes, although we do not suggest complete elimination of refined grains,” said Mahshid Dehghan, PhD, lead investigator for this report and a researcher in nutrition epidemiology at the Population Health Research Institute of McMaster University, Hamilton, Ont.
 

‘Widely applicable’ results from large, diverse study

Although prior evidence had already shown the CVD risk from eating larger amounts of refined grains, “our findings are robust and more widely applicable because our large study recorded over 9,000 deaths and 3,500 major CVD events across a broad range of refined grain intake, and in a variety of different settings and cultures with varying dietary patterns,” Dr. Dehghan said in an interview.

“This is an important paper, with the strength of data from diverse countries. The associations are robust,” commented Dariush Mozaffarian, MD, DrPH, professor and dean of the Friedman School of Nutrition Science and Policy at Tufts University, Boston, who was not involved in the new report.

“The public and the public health community think about added sugar in food as harmful, but starch has gotten a free pass,” he said in an interview. Recently revised U.S. dietary guidelines recommend that refined grains constitute less than half of a person’s carbohydrate consumption, but that limitation remains set too high, Dr. Mozaffarian cautioned. A much safer daily consumption limit would cap refined grains to no more than one serving a day.

The data for the current PURE analysis came from more than 148,000 people aged 35-70 years at entry in 21 geographically and economically diverse countries. Excluding patients with known CVD at baseline left a cohort of 137,130 people.

The results showed no significant association between the quantity of whole grains consumed and the main outcome, nor a link between higher amounts of white rice consumption and the main outcome.

“Our findings suggest that intake of up to 350 g of cooked rice daily may not pose a significant health risk,” said Dr. Dehghan.

Refined grains produce a glucose surge

Dr. Dehghan and associates speculated that possible explanations for their findings are that “varieties of rice such as long-grain rice and especially parboiled white rice may have both a definite glycemic advantage and an overall nutritional advantage over refined wheat products. Also, depending on the culture and the nature of the rice eaten, rice may be displacing less desirable foods.”

In contrast, refined grains undergo “rapid action by digestive enzymes and quick absorption from the small intestines [that] could lead to an increase in postprandial blood glucose concentrations. The rise in glucose concentrations increases the insulin concentrations, which leads to hypoglycemia, lipolysis, and the stimulation of hunger and food intake,” the authors wrote.

“It’s similar to eating sugar, or candy,” noted Dr. Mozaffarian, as refined grain “is 100% glucose.” Whole grains differ by entering the gut packaged in cell structures that slow digestion and avoid delivering sugar in an unnaturally rapid way.

“We are providing new evidence, and we hope that dietary guidelines in North America encourage individuals to lower their refined grain and sugar intake,” Dr. Dehghan said.

PURE has received partial funding with unrestricted grants from several drug companies. Dr. Dehghan had no disclosures. Dr. Mozaffarian has been an adviser to or has received personal fees from several food companies, but had no relevant disclosures.

[email protected]
 

The Food and Drug Administration has approved intramuscular (IM) administration of peginterferon beta-1a (Plegridy, Biogen) for patients with relapsing forms of multiple sclerosis (MS).

“The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of Plegridy with the potential for significantly reduced injection site reactions,” Biogen said in a news release announcing the FDA action.

Plegridy is a pegylated version of interferon beta-1a, which prolongs the circulation time of the molecule in the body by increasing its size. The process extends the drug’s half-life, allowing for a less-frequent dosing schedule.

Peginterferon beta-1a administered subcutaneously was first approved by the FDA in 2014 based on data showing it significantly reduces MS relapses, disability progression, and brain lesions.

The FDA approved IM administration for peginterferon beta-1a based on data evaluating bioequivalence and adverse reactions associated with IM administration compared with subcutaneous (SC) administration in healthy volunteers.

Bioequivalence of the IM and SC dosing regimens was confirmed and volunteers receiving the drug through IM administration experienced fewer injection site reactions relative to those receiving SC administration (14.4% vs. 32.1%), the company said.

The overall safety profiles of IM and SC administration were generally similar, with no new safety signals.

The European Commission allowed marketing authorization for IM administration of peginterferon beta-1a in December 2020.

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

The Food and Drug Administration has approved intramuscular (IM) administration of peginterferon beta-1a (Plegridy, Biogen) for patients with relapsing forms of multiple sclerosis (MS).

“The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of Plegridy with the potential for significantly reduced injection site reactions,” Biogen said in a news release announcing the FDA action.

Plegridy is a pegylated version of interferon beta-1a, which prolongs the circulation time of the molecule in the body by increasing its size. The process extends the drug’s half-life, allowing for a less-frequent dosing schedule.

Peginterferon beta-1a administered subcutaneously was first approved by the FDA in 2014 based on data showing it significantly reduces MS relapses, disability progression, and brain lesions.

The FDA approved IM administration for peginterferon beta-1a based on data evaluating bioequivalence and adverse reactions associated with IM administration compared with subcutaneous (SC) administration in healthy volunteers.

Bioequivalence of the IM and SC dosing regimens was confirmed and volunteers receiving the drug through IM administration experienced fewer injection site reactions relative to those receiving SC administration (14.4% vs. 32.1%), the company said.

The overall safety profiles of IM and SC administration were generally similar, with no new safety signals.

The European Commission allowed marketing authorization for IM administration of peginterferon beta-1a in December 2020.

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

The Food and Drug Administration has approved intramuscular (IM) administration of peginterferon beta-1a (Plegridy, Biogen) for patients with relapsing forms of multiple sclerosis (MS).

“The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of Plegridy with the potential for significantly reduced injection site reactions,” Biogen said in a news release announcing the FDA action.

Plegridy is a pegylated version of interferon beta-1a, which prolongs the circulation time of the molecule in the body by increasing its size. The process extends the drug’s half-life, allowing for a less-frequent dosing schedule.

Peginterferon beta-1a administered subcutaneously was first approved by the FDA in 2014 based on data showing it significantly reduces MS relapses, disability progression, and brain lesions.

The FDA approved IM administration for peginterferon beta-1a based on data evaluating bioequivalence and adverse reactions associated with IM administration compared with subcutaneous (SC) administration in healthy volunteers.

Bioequivalence of the IM and SC dosing regimens was confirmed and volunteers receiving the drug through IM administration experienced fewer injection site reactions relative to those receiving SC administration (14.4% vs. 32.1%), the company said.

The overall safety profiles of IM and SC administration were generally similar, with no new safety signals.

The European Commission allowed marketing authorization for IM administration of peginterferon beta-1a in December 2020.

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

A small, single-center randomized trial of patients with obesity and advanced type 2 diabetes, defined as diabetes for ≥ 5 years and A1c ≥ 7%, found that a quarter to a half of patients who had metabolic surgery had diabetes remission (cure) that lasted 5-9 years.

That is, of the 60 randomized patients, 50% who had biliopancreatic diversion and 25% who had Roux-en-Y gastric bypass – but none who had received current medical therapy – still had diabetes remission a decade later.

Until now, there had only been 5-year follow-up data from this and similar trials, Geltrude Mingrone, MD, PhD, and colleagues noted in the study published online Jan. 23 in The Lancet.

These results provide “the most robust scientific evidence yet that full-blown type 2 diabetes is a curable disease, not inevitably progressive, and irreversible,” senior author Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, said in a statement from his institution.

“The results of this trial will make a noticeable difference in the field and convince even the most skeptical of clinicians about the role of metabolic surgery as part of optimal care for their patients with difficult to control type 2 diabetes,” predicted two editorialists.

Alexander D. Miras, PhD, section of metabolism, digestion, and reproduction, Imperial College London, and Carel le Roux, MBChB, PhD, of the Diabetes Complications Research Centre, University College Dublin, penned the accompanying commentary.

Patients who had metabolic surgery also had greater weight loss, reduced medication use, lower cardiovascular risk, better quality of life, and a lower incidence of diabetes-related complications compared with those who received medical therapy.

“Clinicians and policymakers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes,” advised Dr. Mingrone of King’s College London and the Catholic University of Rome, and colleagues.
 

“Reassuring results, will make a difference in the field”

“It is reassuring that we now have 10-year data showing greater efficacy of metabolic surgery than conventional medical therapy,” Dr. Miras and Dr. le Roux wrote in their commentary.

There were no unexpected risks associated with surgery, they noted, and the findings are consistent with those of 12 other randomized controlled trials in the past 12 years.

“New generations of diabetologists are now more open to the use of metabolic surgery for patients with suboptimal responses to medical treatments,” they wrote, rather than endlessly intensifying insulin and blaming poor response on poor compliance.

And Dr. Miras and Dr. le Roux “eagerly await” 10-year data from the 150-patient STAMPEDE trial – which is examining sleeve gastrectomy, currently the most widely performed bariatric procedure, as well as Roux-en-Y gastric bypass and medical therapy – following the 5-year results published in 2017.  
 

Diabetes for at least 5 years, mid 40s, half on insulin

Dr. Mingrone and colleagues previously reported 5-year findings from the 60 patients with obesity and advanced diabetes who were seen in a single center in Rome and randomized to three treatments (20 in each group) in 2009-2011.

Biliopancreatic diversion “remains infrequently performed but is still considered the best operation for glycemic control,” the researchers noted.

The primary endpoint was diabetes remission at 2 years (fasting plasma glucose < 100 mg/dL [5.6 mmol/L] and A1c < 6.5%) without the need for ongoing pharmacological treatment for at least 1 year.

Patients were a mean age of 44 years and had a mean body mass index of 44 kg/m^2. About half were men. They had diabetes for a mean of 5.8 years and an average A1c of 8.6%. About half were taking insulin.

Patient retention rate was high (95%) and trial outcomes were assessed by nonsurgeons.

At 10 years, patients’ mean A1c had dropped to 6.4%, 6.7%, and 7.6%, in the biliopancreatic diversion, Roux-en-Y gastric bypass, and medical therapy groups, respectively; only 2.5% of patients in the surgery groups, versus 53% in the medical therapy group, required insulin.

At study end, patients in the surgery groups had lost about 29% of their initial weight versus a weight loss of 4.2% in the medical therapy group.
 

First 2 years after surgery is key

“We also learnt that patients who do not go into remission after 2 years are very unlikely to ever do so,” Dr. Miras and Dr. le Roux observed, which “might help us to intensify modern and potent glucose-lowering therapies like SGLT2 inhibitors and GLP-1 receptor agonists earlier after metabolic surgery.”

Ten of 19 patients (53%) in the biliopancreatic diversion group and 10 of 15 patients (67%) in the Roux-en-Y gastric bypass group who had diabetes remission at 2 years had a diabetes relapse, but at 10 years, they all had adequate glycemic control (mean A1c 6.7%), despite drastically reduced use of diabetes medications.

The two patients who crossed over to surgery from the medical therapy group had postoperative diabetes remission, which was maintained at 10 years in one patient.
 

Better risk-to-benefit ratio with Roux-en-y gastric bypass

No patient in the medical therapy group had a serious adverse event, but one patient in each surgery group had deep vein thrombosis or pulmonary embolism, and one patient in the biliopancreatic diversion group had an episode of atrial fibrillation. There were no late surgical complications.

Iron deficiency and mild osteopenia occurred in both surgical groups, but were more common in the biliopancreatic diversion group. And osteoporosis, transient nyctalopia (night blindness) due to vitamin A deficiency, and kidney stones were observed only with biliopancreatic diversion.

This suggests that despite the greater antidiabetic potential of biliopancreatic diversion, Roux-en-Y gastric bypass might have a more favorable risk-to-benefit profile as a standard surgical option for the treatment of type 2 diabetes, Dr. Mingrone and colleagues concluded.

The authors and Dr. Miras have reported no relevant financial relationships. Dr. le Roux has reported receiving funding from the Science Foundation Ireland, the Health Research Board, and the Irish Research Council for type 2 diabetes research, and serves on several advisory boards outside of the scope of the current study.

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

A small, single-center randomized trial of patients with obesity and advanced type 2 diabetes, defined as diabetes for ≥ 5 years and A1c ≥ 7%, found that a quarter to a half of patients who had metabolic surgery had diabetes remission (cure) that lasted 5-9 years.

That is, of the 60 randomized patients, 50% who had biliopancreatic diversion and 25% who had Roux-en-Y gastric bypass – but none who had received current medical therapy – still had diabetes remission a decade later.

Until now, there had only been 5-year follow-up data from this and similar trials, Geltrude Mingrone, MD, PhD, and colleagues noted in the study published online Jan. 23 in The Lancet.

These results provide “the most robust scientific evidence yet that full-blown type 2 diabetes is a curable disease, not inevitably progressive, and irreversible,” senior author Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, said in a statement from his institution.

“The results of this trial will make a noticeable difference in the field and convince even the most skeptical of clinicians about the role of metabolic surgery as part of optimal care for their patients with difficult to control type 2 diabetes,” predicted two editorialists.

Alexander D. Miras, PhD, section of metabolism, digestion, and reproduction, Imperial College London, and Carel le Roux, MBChB, PhD, of the Diabetes Complications Research Centre, University College Dublin, penned the accompanying commentary.

Patients who had metabolic surgery also had greater weight loss, reduced medication use, lower cardiovascular risk, better quality of life, and a lower incidence of diabetes-related complications compared with those who received medical therapy.

“Clinicians and policymakers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes,” advised Dr. Mingrone of King’s College London and the Catholic University of Rome, and colleagues.
 

“Reassuring results, will make a difference in the field”

“It is reassuring that we now have 10-year data showing greater efficacy of metabolic surgery than conventional medical therapy,” Dr. Miras and Dr. le Roux wrote in their commentary.

There were no unexpected risks associated with surgery, they noted, and the findings are consistent with those of 12 other randomized controlled trials in the past 12 years.

“New generations of diabetologists are now more open to the use of metabolic surgery for patients with suboptimal responses to medical treatments,” they wrote, rather than endlessly intensifying insulin and blaming poor response on poor compliance.

And Dr. Miras and Dr. le Roux “eagerly await” 10-year data from the 150-patient STAMPEDE trial – which is examining sleeve gastrectomy, currently the most widely performed bariatric procedure, as well as Roux-en-Y gastric bypass and medical therapy – following the 5-year results published in 2017.  
 

Diabetes for at least 5 years, mid 40s, half on insulin

Dr. Mingrone and colleagues previously reported 5-year findings from the 60 patients with obesity and advanced diabetes who were seen in a single center in Rome and randomized to three treatments (20 in each group) in 2009-2011.

Biliopancreatic diversion “remains infrequently performed but is still considered the best operation for glycemic control,” the researchers noted.

The primary endpoint was diabetes remission at 2 years (fasting plasma glucose < 100 mg/dL [5.6 mmol/L] and A1c < 6.5%) without the need for ongoing pharmacological treatment for at least 1 year.

Patients were a mean age of 44 years and had a mean body mass index of 44 kg/m^2. About half were men. They had diabetes for a mean of 5.8 years and an average A1c of 8.6%. About half were taking insulin.

Patient retention rate was high (95%) and trial outcomes were assessed by nonsurgeons.

At 10 years, patients’ mean A1c had dropped to 6.4%, 6.7%, and 7.6%, in the biliopancreatic diversion, Roux-en-Y gastric bypass, and medical therapy groups, respectively; only 2.5% of patients in the surgery groups, versus 53% in the medical therapy group, required insulin.

At study end, patients in the surgery groups had lost about 29% of their initial weight versus a weight loss of 4.2% in the medical therapy group.
 

First 2 years after surgery is key

“We also learnt that patients who do not go into remission after 2 years are very unlikely to ever do so,” Dr. Miras and Dr. le Roux observed, which “might help us to intensify modern and potent glucose-lowering therapies like SGLT2 inhibitors and GLP-1 receptor agonists earlier after metabolic surgery.”

Ten of 19 patients (53%) in the biliopancreatic diversion group and 10 of 15 patients (67%) in the Roux-en-Y gastric bypass group who had diabetes remission at 2 years had a diabetes relapse, but at 10 years, they all had adequate glycemic control (mean A1c 6.7%), despite drastically reduced use of diabetes medications.

The two patients who crossed over to surgery from the medical therapy group had postoperative diabetes remission, which was maintained at 10 years in one patient.
 

Better risk-to-benefit ratio with Roux-en-y gastric bypass

No patient in the medical therapy group had a serious adverse event, but one patient in each surgery group had deep vein thrombosis or pulmonary embolism, and one patient in the biliopancreatic diversion group had an episode of atrial fibrillation. There were no late surgical complications.

Iron deficiency and mild osteopenia occurred in both surgical groups, but were more common in the biliopancreatic diversion group. And osteoporosis, transient nyctalopia (night blindness) due to vitamin A deficiency, and kidney stones were observed only with biliopancreatic diversion.

This suggests that despite the greater antidiabetic potential of biliopancreatic diversion, Roux-en-Y gastric bypass might have a more favorable risk-to-benefit profile as a standard surgical option for the treatment of type 2 diabetes, Dr. Mingrone and colleagues concluded.

The authors and Dr. Miras have reported no relevant financial relationships. Dr. le Roux has reported receiving funding from the Science Foundation Ireland, the Health Research Board, and the Irish Research Council for type 2 diabetes research, and serves on several advisory boards outside of the scope of the current study.

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

A small, single-center randomized trial of patients with obesity and advanced type 2 diabetes, defined as diabetes for ≥ 5 years and A1c ≥ 7%, found that a quarter to a half of patients who had metabolic surgery had diabetes remission (cure) that lasted 5-9 years.

That is, of the 60 randomized patients, 50% who had biliopancreatic diversion and 25% who had Roux-en-Y gastric bypass – but none who had received current medical therapy – still had diabetes remission a decade later.

Until now, there had only been 5-year follow-up data from this and similar trials, Geltrude Mingrone, MD, PhD, and colleagues noted in the study published online Jan. 23 in The Lancet.

These results provide “the most robust scientific evidence yet that full-blown type 2 diabetes is a curable disease, not inevitably progressive, and irreversible,” senior author Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, said in a statement from his institution.

“The results of this trial will make a noticeable difference in the field and convince even the most skeptical of clinicians about the role of metabolic surgery as part of optimal care for their patients with difficult to control type 2 diabetes,” predicted two editorialists.

Alexander D. Miras, PhD, section of metabolism, digestion, and reproduction, Imperial College London, and Carel le Roux, MBChB, PhD, of the Diabetes Complications Research Centre, University College Dublin, penned the accompanying commentary.

Patients who had metabolic surgery also had greater weight loss, reduced medication use, lower cardiovascular risk, better quality of life, and a lower incidence of diabetes-related complications compared with those who received medical therapy.

“Clinicians and policymakers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes,” advised Dr. Mingrone of King’s College London and the Catholic University of Rome, and colleagues.
 

“Reassuring results, will make a difference in the field”

“It is reassuring that we now have 10-year data showing greater efficacy of metabolic surgery than conventional medical therapy,” Dr. Miras and Dr. le Roux wrote in their commentary.

There were no unexpected risks associated with surgery, they noted, and the findings are consistent with those of 12 other randomized controlled trials in the past 12 years.

“New generations of diabetologists are now more open to the use of metabolic surgery for patients with suboptimal responses to medical treatments,” they wrote, rather than endlessly intensifying insulin and blaming poor response on poor compliance.

And Dr. Miras and Dr. le Roux “eagerly await” 10-year data from the 150-patient STAMPEDE trial – which is examining sleeve gastrectomy, currently the most widely performed bariatric procedure, as well as Roux-en-Y gastric bypass and medical therapy – following the 5-year results published in 2017.  
 

Diabetes for at least 5 years, mid 40s, half on insulin

Dr. Mingrone and colleagues previously reported 5-year findings from the 60 patients with obesity and advanced diabetes who were seen in a single center in Rome and randomized to three treatments (20 in each group) in 2009-2011.

Biliopancreatic diversion “remains infrequently performed but is still considered the best operation for glycemic control,” the researchers noted.

The primary endpoint was diabetes remission at 2 years (fasting plasma glucose < 100 mg/dL [5.6 mmol/L] and A1c < 6.5%) without the need for ongoing pharmacological treatment for at least 1 year.

Patients were a mean age of 44 years and had a mean body mass index of 44 kg/m^2. About half were men. They had diabetes for a mean of 5.8 years and an average A1c of 8.6%. About half were taking insulin.

Patient retention rate was high (95%) and trial outcomes were assessed by nonsurgeons.

At 10 years, patients’ mean A1c had dropped to 6.4%, 6.7%, and 7.6%, in the biliopancreatic diversion, Roux-en-Y gastric bypass, and medical therapy groups, respectively; only 2.5% of patients in the surgery groups, versus 53% in the medical therapy group, required insulin.

At study end, patients in the surgery groups had lost about 29% of their initial weight versus a weight loss of 4.2% in the medical therapy group.
 

First 2 years after surgery is key

“We also learnt that patients who do not go into remission after 2 years are very unlikely to ever do so,” Dr. Miras and Dr. le Roux observed, which “might help us to intensify modern and potent glucose-lowering therapies like SGLT2 inhibitors and GLP-1 receptor agonists earlier after metabolic surgery.”

Ten of 19 patients (53%) in the biliopancreatic diversion group and 10 of 15 patients (67%) in the Roux-en-Y gastric bypass group who had diabetes remission at 2 years had a diabetes relapse, but at 10 years, they all had adequate glycemic control (mean A1c 6.7%), despite drastically reduced use of diabetes medications.

The two patients who crossed over to surgery from the medical therapy group had postoperative diabetes remission, which was maintained at 10 years in one patient.
 

Better risk-to-benefit ratio with Roux-en-y gastric bypass

No patient in the medical therapy group had a serious adverse event, but one patient in each surgery group had deep vein thrombosis or pulmonary embolism, and one patient in the biliopancreatic diversion group had an episode of atrial fibrillation. There were no late surgical complications.

Iron deficiency and mild osteopenia occurred in both surgical groups, but were more common in the biliopancreatic diversion group. And osteoporosis, transient nyctalopia (night blindness) due to vitamin A deficiency, and kidney stones were observed only with biliopancreatic diversion.

This suggests that despite the greater antidiabetic potential of biliopancreatic diversion, Roux-en-Y gastric bypass might have a more favorable risk-to-benefit profile as a standard surgical option for the treatment of type 2 diabetes, Dr. Mingrone and colleagues concluded.

The authors and Dr. Miras have reported no relevant financial relationships. Dr. le Roux has reported receiving funding from the Science Foundation Ireland, the Health Research Board, and the Irish Research Council for type 2 diabetes research, and serves on several advisory boards outside of the scope of the current study.

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

Oral contraceptive use is associated with a decreased risk of ovarian and endometrial cancer 3 decades after discontinuation, according to an analysis of data from more than 250,000 women.

At the same time, oral contraceptive use is associated with a short-term increased risk of breast cancer after discontinuation, although the lifetime risk of breast cancer is not significantly different, the researchers found.

The absolute risk of breast cancer after discontinuation is “extremely small” and should be a limited factor when deciding whether to start oral contraceptive pills (OCPs), a doctor said.

The study was conducted by Torgny Karlsson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala (Sweden) University, and colleagues and published online in Cancer Research.


 

Reinforcing and extending knowledge

“These findings are generally consistent with what is known, but extend that knowledge, most notably by the longer-term follow-up for the cohort,” commented Nancy L. Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, both in Boston. “Other studies have also shown that OCPs lower risk of ovarian and endometrial cancer. This study suggests that this protective benefit extends up to 30-35 years after discontinuing OCPs.”

The results “reinforce the message to patients of the protective effect of OCPs on risk of ovarian and endometrial cancer,” Dr. Keating said. “Women concerned about these cancers can be reassured that this protective effect appears to persist for decades after discontinuing use.”

Prior studies have indicated that oral contraceptives may be associated with an increased risk of breast cancer.

In terms of breast cancer risk, the study “again extends follow-up and shows that risk of breast cancer was higher for current and ever users through age 50,” although the lifetime risk was not elevated, Dr. Keating said.

“The counseling regarding the effect on breast cancer is more complex,” she said. “I tell women about the very small increased risk of breast cancer during and immediately after use. Because cancer is very rare among women at the ages when OCPs are typically prescribed, the absolute risk increase is extremely small. This paper adds reassurance that this small increase in risk does not persist.”

For certain patients, the association may be more relevant.

“For most women, this risk is so small that it should be a limited factor in their decision to start OCPs,” Dr. Keating said. “However, for women with a substantially higher risk of breast cancer, or a family history of breast cancer at a young age, the small increased risk of breast cancer during and immediately after OCP use is more relevant, and counseling should include carefully weighing the benefits and harms of OCPs with other forms of contraception (and no contraception).”

Although the protective effects of oral contraceptives on ovarian and endometrial cancer were well known, the study describes long-term outcomes that can further inform patient counseling, said Samuel S. Badalian, MD, PhD, chief of the department of obstetrics and gynecology at Bassett Medical Center in Cooperstown, N.Y., and clinical professor of obstetrics and gynecology at the State University of New York, Syracuse.

“Women with individual or family risk factors of ovarian or endometrial cancers will need to know about the protective effects of oral contraceptives and long-term benefits related with their use (30-35 years after discontinuation),” Dr. Badalian said. “Women with family history of breast cancer need to know that lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
 

Data from the U.K. Biobank

To examine the time-dependent effects between long-term oral contraceptive use and cancer risk, the researchers examined data from 256,661 women from the U.K. Biobank who were born between 1939 and 1970. The researchers identified cancer diagnoses using information from national registers and self-reported data until March 2019.

Of the women included in the study, 82% had used or still were using oral contraceptives, whereas 18% had never used oral contraceptives. Overall, ever users were younger, more frequently smokers, and had a lower body mass index, compared with never users. Most women started using oral contraceptives between 1969 and 1978. Last use of oral contraceptives occurred on average 10.7 years after starting.

The researchers adjusted for covariates and used logistic regression analyses to measure the cumulative risk of cancer. They used Cox regression analysis to examine instantaneous risk, measured using hazard ratios.

In all, there were 17,739 cases of breast cancer (6.9%), 1,966 cases of ovarian cancer (0.76%), and 2,462 cases of endometrial cancer (0.96%).

Among ever users, the likelihood of ovarian cancer (OR, 0.72) and endometrial cancer (OR, 0.68) was lower, compared with never users. “However, we did not see a significant association between oral contraceptive use and breast cancer” for the study period as a whole, the researchers reported. When the researchers limited follow-up to age 50 years, however, the odds ratio for breast cancer was increased (OR, 1.09).

“Surprisingly, we only found a small increased risk of breast cancer among oral contraceptive users, and the increased risk disappeared within a few years after discontinuation,” Åsa Johansson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala University and one of the study authors, said in a news release. “Our results suggest that the lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”

Oral contraceptives today typically use lower doses of estrogen and other types of progesterone, compared with formulas commonly used when participants in the study started taking them, so the results may not directly apply to patients currently taking oral contraceptives, the researchers noted.

The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Kjell and Märta Beijers, the Marcus Borgström, the Åke Wiberg, and the A and M Rudbergs foundations. The authors, Dr. Keating, and Dr. Badalian had no conflicts of interest.
 

[email protected]

Oral contraceptive use is associated with a decreased risk of ovarian and endometrial cancer 3 decades after discontinuation, according to an analysis of data from more than 250,000 women.

At the same time, oral contraceptive use is associated with a short-term increased risk of breast cancer after discontinuation, although the lifetime risk of breast cancer is not significantly different, the researchers found.

The absolute risk of breast cancer after discontinuation is “extremely small” and should be a limited factor when deciding whether to start oral contraceptive pills (OCPs), a doctor said.

The study was conducted by Torgny Karlsson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala (Sweden) University, and colleagues and published online in Cancer Research.


 

Reinforcing and extending knowledge

“These findings are generally consistent with what is known, but extend that knowledge, most notably by the longer-term follow-up for the cohort,” commented Nancy L. Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, both in Boston. “Other studies have also shown that OCPs lower risk of ovarian and endometrial cancer. This study suggests that this protective benefit extends up to 30-35 years after discontinuing OCPs.”

The results “reinforce the message to patients of the protective effect of OCPs on risk of ovarian and endometrial cancer,” Dr. Keating said. “Women concerned about these cancers can be reassured that this protective effect appears to persist for decades after discontinuing use.”

Prior studies have indicated that oral contraceptives may be associated with an increased risk of breast cancer.

In terms of breast cancer risk, the study “again extends follow-up and shows that risk of breast cancer was higher for current and ever users through age 50,” although the lifetime risk was not elevated, Dr. Keating said.

“The counseling regarding the effect on breast cancer is more complex,” she said. “I tell women about the very small increased risk of breast cancer during and immediately after use. Because cancer is very rare among women at the ages when OCPs are typically prescribed, the absolute risk increase is extremely small. This paper adds reassurance that this small increase in risk does not persist.”

For certain patients, the association may be more relevant.

“For most women, this risk is so small that it should be a limited factor in their decision to start OCPs,” Dr. Keating said. “However, for women with a substantially higher risk of breast cancer, or a family history of breast cancer at a young age, the small increased risk of breast cancer during and immediately after OCP use is more relevant, and counseling should include carefully weighing the benefits and harms of OCPs with other forms of contraception (and no contraception).”

Although the protective effects of oral contraceptives on ovarian and endometrial cancer were well known, the study describes long-term outcomes that can further inform patient counseling, said Samuel S. Badalian, MD, PhD, chief of the department of obstetrics and gynecology at Bassett Medical Center in Cooperstown, N.Y., and clinical professor of obstetrics and gynecology at the State University of New York, Syracuse.

“Women with individual or family risk factors of ovarian or endometrial cancers will need to know about the protective effects of oral contraceptives and long-term benefits related with their use (30-35 years after discontinuation),” Dr. Badalian said. “Women with family history of breast cancer need to know that lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
 

Data from the U.K. Biobank

To examine the time-dependent effects between long-term oral contraceptive use and cancer risk, the researchers examined data from 256,661 women from the U.K. Biobank who were born between 1939 and 1970. The researchers identified cancer diagnoses using information from national registers and self-reported data until March 2019.

Of the women included in the study, 82% had used or still were using oral contraceptives, whereas 18% had never used oral contraceptives. Overall, ever users were younger, more frequently smokers, and had a lower body mass index, compared with never users. Most women started using oral contraceptives between 1969 and 1978. Last use of oral contraceptives occurred on average 10.7 years after starting.

The researchers adjusted for covariates and used logistic regression analyses to measure the cumulative risk of cancer. They used Cox regression analysis to examine instantaneous risk, measured using hazard ratios.

In all, there were 17,739 cases of breast cancer (6.9%), 1,966 cases of ovarian cancer (0.76%), and 2,462 cases of endometrial cancer (0.96%).

Among ever users, the likelihood of ovarian cancer (OR, 0.72) and endometrial cancer (OR, 0.68) was lower, compared with never users. “However, we did not see a significant association between oral contraceptive use and breast cancer” for the study period as a whole, the researchers reported. When the researchers limited follow-up to age 50 years, however, the odds ratio for breast cancer was increased (OR, 1.09).

“Surprisingly, we only found a small increased risk of breast cancer among oral contraceptive users, and the increased risk disappeared within a few years after discontinuation,” Åsa Johansson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala University and one of the study authors, said in a news release. “Our results suggest that the lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”

Oral contraceptives today typically use lower doses of estrogen and other types of progesterone, compared with formulas commonly used when participants in the study started taking them, so the results may not directly apply to patients currently taking oral contraceptives, the researchers noted.

The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Kjell and Märta Beijers, the Marcus Borgström, the Åke Wiberg, and the A and M Rudbergs foundations. The authors, Dr. Keating, and Dr. Badalian had no conflicts of interest.
 

[email protected]

Oral contraceptive use is associated with a decreased risk of ovarian and endometrial cancer 3 decades after discontinuation, according to an analysis of data from more than 250,000 women.

At the same time, oral contraceptive use is associated with a short-term increased risk of breast cancer after discontinuation, although the lifetime risk of breast cancer is not significantly different, the researchers found.

The absolute risk of breast cancer after discontinuation is “extremely small” and should be a limited factor when deciding whether to start oral contraceptive pills (OCPs), a doctor said.

The study was conducted by Torgny Karlsson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala (Sweden) University, and colleagues and published online in Cancer Research.


 

Reinforcing and extending knowledge

“These findings are generally consistent with what is known, but extend that knowledge, most notably by the longer-term follow-up for the cohort,” commented Nancy L. Keating, MD, MPH, professor of health care policy and medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital, both in Boston. “Other studies have also shown that OCPs lower risk of ovarian and endometrial cancer. This study suggests that this protective benefit extends up to 30-35 years after discontinuing OCPs.”

The results “reinforce the message to patients of the protective effect of OCPs on risk of ovarian and endometrial cancer,” Dr. Keating said. “Women concerned about these cancers can be reassured that this protective effect appears to persist for decades after discontinuing use.”

Prior studies have indicated that oral contraceptives may be associated with an increased risk of breast cancer.

In terms of breast cancer risk, the study “again extends follow-up and shows that risk of breast cancer was higher for current and ever users through age 50,” although the lifetime risk was not elevated, Dr. Keating said.

“The counseling regarding the effect on breast cancer is more complex,” she said. “I tell women about the very small increased risk of breast cancer during and immediately after use. Because cancer is very rare among women at the ages when OCPs are typically prescribed, the absolute risk increase is extremely small. This paper adds reassurance that this small increase in risk does not persist.”

For certain patients, the association may be more relevant.

“For most women, this risk is so small that it should be a limited factor in their decision to start OCPs,” Dr. Keating said. “However, for women with a substantially higher risk of breast cancer, or a family history of breast cancer at a young age, the small increased risk of breast cancer during and immediately after OCP use is more relevant, and counseling should include carefully weighing the benefits and harms of OCPs with other forms of contraception (and no contraception).”

Although the protective effects of oral contraceptives on ovarian and endometrial cancer were well known, the study describes long-term outcomes that can further inform patient counseling, said Samuel S. Badalian, MD, PhD, chief of the department of obstetrics and gynecology at Bassett Medical Center in Cooperstown, N.Y., and clinical professor of obstetrics and gynecology at the State University of New York, Syracuse.

“Women with individual or family risk factors of ovarian or endometrial cancers will need to know about the protective effects of oral contraceptives and long-term benefits related with their use (30-35 years after discontinuation),” Dr. Badalian said. “Women with family history of breast cancer need to know that lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”
 

Data from the U.K. Biobank

To examine the time-dependent effects between long-term oral contraceptive use and cancer risk, the researchers examined data from 256,661 women from the U.K. Biobank who were born between 1939 and 1970. The researchers identified cancer diagnoses using information from national registers and self-reported data until March 2019.

Of the women included in the study, 82% had used or still were using oral contraceptives, whereas 18% had never used oral contraceptives. Overall, ever users were younger, more frequently smokers, and had a lower body mass index, compared with never users. Most women started using oral contraceptives between 1969 and 1978. Last use of oral contraceptives occurred on average 10.7 years after starting.

The researchers adjusted for covariates and used logistic regression analyses to measure the cumulative risk of cancer. They used Cox regression analysis to examine instantaneous risk, measured using hazard ratios.

In all, there were 17,739 cases of breast cancer (6.9%), 1,966 cases of ovarian cancer (0.76%), and 2,462 cases of endometrial cancer (0.96%).

Among ever users, the likelihood of ovarian cancer (OR, 0.72) and endometrial cancer (OR, 0.68) was lower, compared with never users. “However, we did not see a significant association between oral contraceptive use and breast cancer” for the study period as a whole, the researchers reported. When the researchers limited follow-up to age 50 years, however, the odds ratio for breast cancer was increased (OR, 1.09).

“Surprisingly, we only found a small increased risk of breast cancer among oral contraceptive users, and the increased risk disappeared within a few years after discontinuation,” Åsa Johansson, PhD, a researcher in the department of immunology, genetics, and pathology at Uppsala University and one of the study authors, said in a news release. “Our results suggest that the lifetime risk of breast cancer might not differ between ever and never users, even if there is an increased short-term risk.”

Oral contraceptives today typically use lower doses of estrogen and other types of progesterone, compared with formulas commonly used when participants in the study started taking them, so the results may not directly apply to patients currently taking oral contraceptives, the researchers noted.

The study was supported by the Swedish Research Council, the Swedish Cancer Society, and the Kjell and Märta Beijers, the Marcus Borgström, the Åke Wiberg, and the A and M Rudbergs foundations. The authors, Dr. Keating, and Dr. Badalian had no conflicts of interest.
 

[email protected]

The Biden administration has halted a Trump administration initiative that would have allowed more physicians to prescribe buprenorphine for opioid use disorder (OUD).

Under the Trump administration’s plan, many doctors would be exempt from taking a day’s training before they could prescribe buprenorphine for OUD.

On Jan. 25, 2021, citing anonymous sources, the Washington Post reported that this action by the Biden administration was likely. At the time, there were concerns about whether the Department of Health & Human Services had the legal authority to make this policy change, the Post reported. The Substance Abuse and Mental Health Services Administration subsequently announced the derailment of the buprenorphine proposal on its website.

The plan was unveiled Jan. 14 in the final days of the Trump administration. In SAMHSA’s view, the proposal was made “prematurely.” The SAMHSA statement did not detail the reasons for abandoning the Jan. 14 proposal. It had been scheduled to take effect upon publication in the Federal Register.

Instead of finalizing it in this way, the HHS said it would work with other federal agencies to “increase access to buprenorphine, reduce overdose rates and save lives.”

The HHS decision to scupper the proposal disappointed many physician groups. In a letter dated Jan. 27, several physician groups called on the Biden administration to proceed with the Trump proposal.

Under current federal law, physicians who wish to prescribe buprenorphine outside of opioid treatment programs must take an 8-hour course and receive a waiver from the Drug Enforcement Administration, the letter noted. It was signed by the American College of Emergency Physicians, the American Medical Association, and other organizations.
 

Treatment barrier

After taking the training course, it can take 60-90 days for physicians to receive the waiver. The license application can then be submitted. Physician groups argue that this so-called X-waiver requirement creates a barrier to providing medication-assisted treatment.

“Due to the stigma, some clinicians are not willing to pursue this DEA license or even engage in treatment of patients with [OUD],” the letter said.

The Trump administration’s proposal would have limited most physicians to treating no more than 30 patients with buprenorphine for OUD at any one time. This cap would not have applied to hospital-based physicians, such as those practicing emergency medicine, the HHS noted in a statement. The policy would have applied to only physicians who already have registered with the DEA.

Patrice A. Harris, MD, the immediate past president of the AMA and chair of the organization’s Opioid Task Force, was among the many physicians who supported the Trump administration proposal.

“It is estimated that more than 2 million Americans need treatment for opioid use disorder, but only a small percentage actually receive treatment,” Dr. Harris said in statement. Dr. Harris also noted that overdose deaths have reportedly accelerated during the COVID-19 pandemic.

Centers for Disease Control and Prevention data show there were more than 83,000 drug overdose deaths in the United States in the 12 months ending in June 2020. That is the highest number of overdose deaths ever recorded in a 12-month period and is an increase of more than 21%, compared with the previous year.
 

A ‘disappointment’

On Jan. 28, Dr. Harris said the decision to drop the plan was a disappointment.

“We encourage the current administration to quickly develop a path forward that removes the burdensome waiver requirement, thus allowing more physicians to prescribe this lifesaving medication,” she said in a statement sent to this news organization.

In a Jan. 26 statement, the American Society of Addiction Medicine urged Congress to eliminate the X-waiver and called for more education and training in the treatment of patients who struggle with opioids.

In the 116th session of Congress, which ended on Jan. 3, there was bipartisan support for proposed legislation to ease requirements for buprenorphine prescribing. A House bill had more than 90 Democratic and 21 Republican sponsors. A companion Senate bill had three Democratic and three Republican Sponsors, including Sen. Maggie Hassan (D-N.H.). On Jan. 25, Dr. Hassan tweeted that she would be seeking an explanation from the Biden administration if it halted the plan to ease the waiver restriction.

“Medication-assisted treatment can save lives, and the buprenorphine waiver requirement should be eliminated so that physicians can more easily prescribe it to those who need it,” she said.

Many clinicians and policy experts turned to Twitter to urge an easing of buprenorphine prescribing, using the hashtag “Xthexwaiver.”

Among them was the official who put forward the Jan. 14 proposal, Brett Giroir, MD. He served as assistant secretary for health during the Trump administration.

 

Objections

In its Jan. 25 article, the Washington Post referred to an article in Alcoholism and Drug Abuse Weekly in which a top federal official in the Trump administration objected to Dr. Giroir’s plan.

Elinore F. McCance-Katz, MD, PhD, who served as the assistant secretary of HHS for SAMHSA, had earlier proposed raising the cap for addiction experts. Alcoholism and Drug Abuse Weekly quotes Dr. McCance-Katz as saying the Trump buprenorphine proposal was “unfair to the incoming administration.”

“The Biden administration has so much work to do to get their programs and policies into place, and to do something like this at the 11th hour that could get doctors into trouble – it’s heinous,” she said in the article.

Dr. McCance-Katz had resigned before the Trump administration proposal was unveiled. On Jan. 7, she issued a public notice announcing she would resign, citing concerns about the previous day’s attack on the U.S. Capitol.

“It had been my plan to stay until the change in administration occurred, but my plans abruptly changed last evening when, on my way back from visiting an excellent residential treatment program in New York, I saw the violent takeover of the Capitol building,” she said.

On Twitter, Roland Flores, MD, an anesthesiologist and pain specialist, urged his colleagues to consider the need for more education among clinicians who treat OUD. He jousted a bit with those favoring a swift drive to “XtheXwaiver” and questioned their arguments about the burden of the current rules.

“I think ‘all this red tape’ is a little bit of an exaggeration – it’s an 8-hour online course, and an application,” Dr. Flores tweeted in one exchange. “But #XtheXwaiver is fine – it’s probably rooted in stigma. It’s unlikely to make much difference tho. The waiver wasn’t the thing keeping docs from prescribing.”

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

The Biden administration has halted a Trump administration initiative that would have allowed more physicians to prescribe buprenorphine for opioid use disorder (OUD).

Under the Trump administration’s plan, many doctors would be exempt from taking a day’s training before they could prescribe buprenorphine for OUD.

On Jan. 25, 2021, citing anonymous sources, the Washington Post reported that this action by the Biden administration was likely. At the time, there were concerns about whether the Department of Health & Human Services had the legal authority to make this policy change, the Post reported. The Substance Abuse and Mental Health Services Administration subsequently announced the derailment of the buprenorphine proposal on its website.

The plan was unveiled Jan. 14 in the final days of the Trump administration. In SAMHSA’s view, the proposal was made “prematurely.” The SAMHSA statement did not detail the reasons for abandoning the Jan. 14 proposal. It had been scheduled to take effect upon publication in the Federal Register.

Instead of finalizing it in this way, the HHS said it would work with other federal agencies to “increase access to buprenorphine, reduce overdose rates and save lives.”

The HHS decision to scupper the proposal disappointed many physician groups. In a letter dated Jan. 27, several physician groups called on the Biden administration to proceed with the Trump proposal.

Under current federal law, physicians who wish to prescribe buprenorphine outside of opioid treatment programs must take an 8-hour course and receive a waiver from the Drug Enforcement Administration, the letter noted. It was signed by the American College of Emergency Physicians, the American Medical Association, and other organizations.
 

Treatment barrier

After taking the training course, it can take 60-90 days for physicians to receive the waiver. The license application can then be submitted. Physician groups argue that this so-called X-waiver requirement creates a barrier to providing medication-assisted treatment.

“Due to the stigma, some clinicians are not willing to pursue this DEA license or even engage in treatment of patients with [OUD],” the letter said.

The Trump administration’s proposal would have limited most physicians to treating no more than 30 patients with buprenorphine for OUD at any one time. This cap would not have applied to hospital-based physicians, such as those practicing emergency medicine, the HHS noted in a statement. The policy would have applied to only physicians who already have registered with the DEA.

Patrice A. Harris, MD, the immediate past president of the AMA and chair of the organization’s Opioid Task Force, was among the many physicians who supported the Trump administration proposal.

“It is estimated that more than 2 million Americans need treatment for opioid use disorder, but only a small percentage actually receive treatment,” Dr. Harris said in statement. Dr. Harris also noted that overdose deaths have reportedly accelerated during the COVID-19 pandemic.

Centers for Disease Control and Prevention data show there were more than 83,000 drug overdose deaths in the United States in the 12 months ending in June 2020. That is the highest number of overdose deaths ever recorded in a 12-month period and is an increase of more than 21%, compared with the previous year.
 

A ‘disappointment’

On Jan. 28, Dr. Harris said the decision to drop the plan was a disappointment.

“We encourage the current administration to quickly develop a path forward that removes the burdensome waiver requirement, thus allowing more physicians to prescribe this lifesaving medication,” she said in a statement sent to this news organization.

In a Jan. 26 statement, the American Society of Addiction Medicine urged Congress to eliminate the X-waiver and called for more education and training in the treatment of patients who struggle with opioids.

In the 116th session of Congress, which ended on Jan. 3, there was bipartisan support for proposed legislation to ease requirements for buprenorphine prescribing. A House bill had more than 90 Democratic and 21 Republican sponsors. A companion Senate bill had three Democratic and three Republican Sponsors, including Sen. Maggie Hassan (D-N.H.). On Jan. 25, Dr. Hassan tweeted that she would be seeking an explanation from the Biden administration if it halted the plan to ease the waiver restriction.

“Medication-assisted treatment can save lives, and the buprenorphine waiver requirement should be eliminated so that physicians can more easily prescribe it to those who need it,” she said.

Many clinicians and policy experts turned to Twitter to urge an easing of buprenorphine prescribing, using the hashtag “Xthexwaiver.”

Among them was the official who put forward the Jan. 14 proposal, Brett Giroir, MD. He served as assistant secretary for health during the Trump administration.

 

Objections

In its Jan. 25 article, the Washington Post referred to an article in Alcoholism and Drug Abuse Weekly in which a top federal official in the Trump administration objected to Dr. Giroir’s plan.

Elinore F. McCance-Katz, MD, PhD, who served as the assistant secretary of HHS for SAMHSA, had earlier proposed raising the cap for addiction experts. Alcoholism and Drug Abuse Weekly quotes Dr. McCance-Katz as saying the Trump buprenorphine proposal was “unfair to the incoming administration.”

“The Biden administration has so much work to do to get their programs and policies into place, and to do something like this at the 11th hour that could get doctors into trouble – it’s heinous,” she said in the article.

Dr. McCance-Katz had resigned before the Trump administration proposal was unveiled. On Jan. 7, she issued a public notice announcing she would resign, citing concerns about the previous day’s attack on the U.S. Capitol.

“It had been my plan to stay until the change in administration occurred, but my plans abruptly changed last evening when, on my way back from visiting an excellent residential treatment program in New York, I saw the violent takeover of the Capitol building,” she said.

On Twitter, Roland Flores, MD, an anesthesiologist and pain specialist, urged his colleagues to consider the need for more education among clinicians who treat OUD. He jousted a bit with those favoring a swift drive to “XtheXwaiver” and questioned their arguments about the burden of the current rules.

“I think ‘all this red tape’ is a little bit of an exaggeration – it’s an 8-hour online course, and an application,” Dr. Flores tweeted in one exchange. “But #XtheXwaiver is fine – it’s probably rooted in stigma. It’s unlikely to make much difference tho. The waiver wasn’t the thing keeping docs from prescribing.”

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

The Biden administration has halted a Trump administration initiative that would have allowed more physicians to prescribe buprenorphine for opioid use disorder (OUD).

Under the Trump administration’s plan, many doctors would be exempt from taking a day’s training before they could prescribe buprenorphine for OUD.

On Jan. 25, 2021, citing anonymous sources, the Washington Post reported that this action by the Biden administration was likely. At the time, there were concerns about whether the Department of Health & Human Services had the legal authority to make this policy change, the Post reported. The Substance Abuse and Mental Health Services Administration subsequently announced the derailment of the buprenorphine proposal on its website.

The plan was unveiled Jan. 14 in the final days of the Trump administration. In SAMHSA’s view, the proposal was made “prematurely.” The SAMHSA statement did not detail the reasons for abandoning the Jan. 14 proposal. It had been scheduled to take effect upon publication in the Federal Register.

Instead of finalizing it in this way, the HHS said it would work with other federal agencies to “increase access to buprenorphine, reduce overdose rates and save lives.”

The HHS decision to scupper the proposal disappointed many physician groups. In a letter dated Jan. 27, several physician groups called on the Biden administration to proceed with the Trump proposal.

Under current federal law, physicians who wish to prescribe buprenorphine outside of opioid treatment programs must take an 8-hour course and receive a waiver from the Drug Enforcement Administration, the letter noted. It was signed by the American College of Emergency Physicians, the American Medical Association, and other organizations.
 

Treatment barrier

After taking the training course, it can take 60-90 days for physicians to receive the waiver. The license application can then be submitted. Physician groups argue that this so-called X-waiver requirement creates a barrier to providing medication-assisted treatment.

“Due to the stigma, some clinicians are not willing to pursue this DEA license or even engage in treatment of patients with [OUD],” the letter said.

The Trump administration’s proposal would have limited most physicians to treating no more than 30 patients with buprenorphine for OUD at any one time. This cap would not have applied to hospital-based physicians, such as those practicing emergency medicine, the HHS noted in a statement. The policy would have applied to only physicians who already have registered with the DEA.

Patrice A. Harris, MD, the immediate past president of the AMA and chair of the organization’s Opioid Task Force, was among the many physicians who supported the Trump administration proposal.

“It is estimated that more than 2 million Americans need treatment for opioid use disorder, but only a small percentage actually receive treatment,” Dr. Harris said in statement. Dr. Harris also noted that overdose deaths have reportedly accelerated during the COVID-19 pandemic.

Centers for Disease Control and Prevention data show there were more than 83,000 drug overdose deaths in the United States in the 12 months ending in June 2020. That is the highest number of overdose deaths ever recorded in a 12-month period and is an increase of more than 21%, compared with the previous year.
 

A ‘disappointment’

On Jan. 28, Dr. Harris said the decision to drop the plan was a disappointment.

“We encourage the current administration to quickly develop a path forward that removes the burdensome waiver requirement, thus allowing more physicians to prescribe this lifesaving medication,” she said in a statement sent to this news organization.

In a Jan. 26 statement, the American Society of Addiction Medicine urged Congress to eliminate the X-waiver and called for more education and training in the treatment of patients who struggle with opioids.

In the 116th session of Congress, which ended on Jan. 3, there was bipartisan support for proposed legislation to ease requirements for buprenorphine prescribing. A House bill had more than 90 Democratic and 21 Republican sponsors. A companion Senate bill had three Democratic and three Republican Sponsors, including Sen. Maggie Hassan (D-N.H.). On Jan. 25, Dr. Hassan tweeted that she would be seeking an explanation from the Biden administration if it halted the plan to ease the waiver restriction.

“Medication-assisted treatment can save lives, and the buprenorphine waiver requirement should be eliminated so that physicians can more easily prescribe it to those who need it,” she said.

Many clinicians and policy experts turned to Twitter to urge an easing of buprenorphine prescribing, using the hashtag “Xthexwaiver.”

Among them was the official who put forward the Jan. 14 proposal, Brett Giroir, MD. He served as assistant secretary for health during the Trump administration.

 

Objections

In its Jan. 25 article, the Washington Post referred to an article in Alcoholism and Drug Abuse Weekly in which a top federal official in the Trump administration objected to Dr. Giroir’s plan.

Elinore F. McCance-Katz, MD, PhD, who served as the assistant secretary of HHS for SAMHSA, had earlier proposed raising the cap for addiction experts. Alcoholism and Drug Abuse Weekly quotes Dr. McCance-Katz as saying the Trump buprenorphine proposal was “unfair to the incoming administration.”

“The Biden administration has so much work to do to get their programs and policies into place, and to do something like this at the 11th hour that could get doctors into trouble – it’s heinous,” she said in the article.

Dr. McCance-Katz had resigned before the Trump administration proposal was unveiled. On Jan. 7, she issued a public notice announcing she would resign, citing concerns about the previous day’s attack on the U.S. Capitol.

“It had been my plan to stay until the change in administration occurred, but my plans abruptly changed last evening when, on my way back from visiting an excellent residential treatment program in New York, I saw the violent takeover of the Capitol building,” she said.

On Twitter, Roland Flores, MD, an anesthesiologist and pain specialist, urged his colleagues to consider the need for more education among clinicians who treat OUD. He jousted a bit with those favoring a swift drive to “XtheXwaiver” and questioned their arguments about the burden of the current rules.

“I think ‘all this red tape’ is a little bit of an exaggeration – it’s an 8-hour online course, and an application,” Dr. Flores tweeted in one exchange. “But #XtheXwaiver is fine – it’s probably rooted in stigma. It’s unlikely to make much difference tho. The waiver wasn’t the thing keeping docs from prescribing.”

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

The National Institutes of Health has launched a database to track COVID-19–related neurologic symptoms, complications, and outcomes as well as the effects of the virus on preexisting neurologic conditions.

“We know COVID-19 can disrupt multiple body systems, but the effects of the virus and the body’s response to COVID-19 infection on the brain, spinal cord, nerves, and muscle can be particularly devastating and contribute to persistence of disability even after the virus is cleared,” said Barbara Karp, MD, program director at the National Institute of Neurological Disorders and Stroke.

“There is an urgent need to understand COVID-19–related neurological problems, which not uncommonly include headaches, fatigue, cognitive difficulties, stroke, pain, and sleep disorders as well as some very rare complications of serious infections,” said Dr. Karp.

The COVID-19 NeuroDatabank/BioBank (NeuroCOVID) is funded by the NINDS. It was created and will be maintained by researchers at NYU Langone Health in New York.

The project is led by Andrea Troxel, ScD, professor of population health, and Eva Petkova, PhD, professor of population health and child and adolescent psychiatry, both at New York University.

“We’ve built a pretty comprehensive database that will accept deidentified patient information about new neurological issues that coincide with their COVID disease or worsening of preexisting neurological problems,” said Dr. Troxel. “In addition, we have a bio repository that will accept almost any kind of biological sample, such as blood, plasma, cerebrospinal fluid, and tissue,” she said.

“Neuroimages are very difficult to store because the files are so enormous, but we’ve had some questions about that, and we’re looking into whether we can accommodate neuroimages,” Dr. Troxel noted.

Dr. Troxel said a “blast of information and invitations” has gone out in an effort to acquire data and biospecimens. “We’ve been really pleased with the amount of interest already, interest not only from large academic medical centers, as you might expect, but also from some smaller stand-alone clinics and even some individuals who have either experienced some of these neurological problems of COVID or know those who have and are really eager to try to provide information,” she added.

Researchers interested in using data and biosamples from the database may submit requests to the NeuroCOVID Steering Committee. More information is available online on the NeuroCOVID website.

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

The National Institutes of Health has launched a database to track COVID-19–related neurologic symptoms, complications, and outcomes as well as the effects of the virus on preexisting neurologic conditions.

“We know COVID-19 can disrupt multiple body systems, but the effects of the virus and the body’s response to COVID-19 infection on the brain, spinal cord, nerves, and muscle can be particularly devastating and contribute to persistence of disability even after the virus is cleared,” said Barbara Karp, MD, program director at the National Institute of Neurological Disorders and Stroke.

“There is an urgent need to understand COVID-19–related neurological problems, which not uncommonly include headaches, fatigue, cognitive difficulties, stroke, pain, and sleep disorders as well as some very rare complications of serious infections,” said Dr. Karp.

The COVID-19 NeuroDatabank/BioBank (NeuroCOVID) is funded by the NINDS. It was created and will be maintained by researchers at NYU Langone Health in New York.

The project is led by Andrea Troxel, ScD, professor of population health, and Eva Petkova, PhD, professor of population health and child and adolescent psychiatry, both at New York University.

“We’ve built a pretty comprehensive database that will accept deidentified patient information about new neurological issues that coincide with their COVID disease or worsening of preexisting neurological problems,” said Dr. Troxel. “In addition, we have a bio repository that will accept almost any kind of biological sample, such as blood, plasma, cerebrospinal fluid, and tissue,” she said.

“Neuroimages are very difficult to store because the files are so enormous, but we’ve had some questions about that, and we’re looking into whether we can accommodate neuroimages,” Dr. Troxel noted.

Dr. Troxel said a “blast of information and invitations” has gone out in an effort to acquire data and biospecimens. “We’ve been really pleased with the amount of interest already, interest not only from large academic medical centers, as you might expect, but also from some smaller stand-alone clinics and even some individuals who have either experienced some of these neurological problems of COVID or know those who have and are really eager to try to provide information,” she added.

Researchers interested in using data and biosamples from the database may submit requests to the NeuroCOVID Steering Committee. More information is available online on the NeuroCOVID website.

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

The National Institutes of Health has launched a database to track COVID-19–related neurologic symptoms, complications, and outcomes as well as the effects of the virus on preexisting neurologic conditions.

“We know COVID-19 can disrupt multiple body systems, but the effects of the virus and the body’s response to COVID-19 infection on the brain, spinal cord, nerves, and muscle can be particularly devastating and contribute to persistence of disability even after the virus is cleared,” said Barbara Karp, MD, program director at the National Institute of Neurological Disorders and Stroke.

“There is an urgent need to understand COVID-19–related neurological problems, which not uncommonly include headaches, fatigue, cognitive difficulties, stroke, pain, and sleep disorders as well as some very rare complications of serious infections,” said Dr. Karp.

The COVID-19 NeuroDatabank/BioBank (NeuroCOVID) is funded by the NINDS. It was created and will be maintained by researchers at NYU Langone Health in New York.

The project is led by Andrea Troxel, ScD, professor of population health, and Eva Petkova, PhD, professor of population health and child and adolescent psychiatry, both at New York University.

“We’ve built a pretty comprehensive database that will accept deidentified patient information about new neurological issues that coincide with their COVID disease or worsening of preexisting neurological problems,” said Dr. Troxel. “In addition, we have a bio repository that will accept almost any kind of biological sample, such as blood, plasma, cerebrospinal fluid, and tissue,” she said.

“Neuroimages are very difficult to store because the files are so enormous, but we’ve had some questions about that, and we’re looking into whether we can accommodate neuroimages,” Dr. Troxel noted.

Dr. Troxel said a “blast of information and invitations” has gone out in an effort to acquire data and biospecimens. “We’ve been really pleased with the amount of interest already, interest not only from large academic medical centers, as you might expect, but also from some smaller stand-alone clinics and even some individuals who have either experienced some of these neurological problems of COVID or know those who have and are really eager to try to provide information,” she added.

Researchers interested in using data and biosamples from the database may submit requests to the NeuroCOVID Steering Committee. More information is available online on the NeuroCOVID website.

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

For appetite control, a low-fat, plant-based diet has advantages over a low-carbohydrate, animal-based ketogenic diet, although the keto diet wins when it comes to keeping post-meal glucose and insulin levels in check, new research suggests.

In a highly controlled crossover study conducted at the National Institutes of Health, people consumed fewer daily calories when on a low-fat, plant-based diet, but their insulin and blood glucose levels were higher than when they followed a low-carbohydrate, animal-based diet.

“There is this somewhat-outdated idea now that higher-fat diets, because they have more calories per gram, tend to make people overeat – something called the passive overconsumption model,” senior investigator Kevin Hall, PhD, National Institute of Diabetes and Digestive and Kidney Diseases, said in an interview.

The other more popular model these days, he explained, is the carbohydrate-insulin model, which holds that following a diet high in carbohydrates and sugar that causes insulin levels to spike will increase hunger and cause a person to overeat.

In this study, Dr. Hall and colleagues tested these two hypotheses head to head.

“The short answer is that we got exactly the opposite predictions from the carbohydrate-insulin model of obesity. In other words, instead of making people eat more and gaining weight and body fat, they actually ended up eating less on that diet and losing body fat compared to the higher-fat diet,” Dr. Hall said.

“Yet, the passive overconsumption model also failed, because despite them eating a very energy-dense diet and high fat, they didn’t gain weight and gain body fat. And so both of these models of why people overeat and gain weight seem to be inadequate in our study,” he said. “This suggests that things are a little bit more complicated.”

The study was published online Jan. 21, 2021 in Nature Medicine.
 

Pros and cons to both diets

For the study, the researchers housed 20 healthy adults who did not have diabetes for 4 continuous weeks at the NIH Clinical Center. The mean age of the participants was 29.9 years, and the mean body mass index was 27.8 kg/m².

The participants were randomly allocated to consume ad libitum either a plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with low-energy density (about 1 kcal/g⁻¹), or an animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with high energy density (about 2 kcal/g⁻¹) for 2 weeks. They then crossed over to the alternate diet for 2 weeks.

Both diets contained about 14% protein and were matched for total calories, although the low-carb diet had twice as many calories per gram of food than the low-fat diet. Participants could eat what and however much they chose of the meals they were given.

One participant withdrew, owing to hypoglycemia during the low-carbohydrate diet phase. For the primary outcome, the researchers compared mean daily ad libitum energy intake between each 2-week diet period.

They found that energy intake from the low-fat diet was reduced by approximately 550-700 kcal/d⁻¹, compared with the low-carbohydrate keto diet. Yet, despite the large differences in calorie intake, participants reported no differences in hunger, enjoyment of meals, or fullness between the two diets.

Participants lost weight on both diets (about 1-2 kg on average), but only the low-fat diet led to a significant loss of body fat.

“Interestingly, our findings suggest benefits to both diets, at least in the short term,” Dr. Hall said in a news release.

“While the low-fat, plant-based diet helps curb appetite, the animal-based, low-carb diet resulted in lower and more steady insulin and glucose levels. We don’t yet know if these differences would be sustained over the long term,” he said.

Dr. Hall added that it’s important to note that the study was not designed to make diet recommendations for weight loss, and the results might have been different had the participants been actively trying to lose weight.

“In fact, they didn’t even know what the study was about; we just said we want you to eat the two diets, and we’re going to see what happens in your body either as you eat as much or as little as you want,” he said.

“It’s a bit of a mixed bag in terms of which diet might be better for an individual. I think you can interpret this study as that there are positives and negatives for both diets,” Dr. Hall said.
 

Diet ‘tribes’

In a comment, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said it’s important to note that “a ‘low-carb diet’ has yet to be defined, and many definitions exist.

“We really need a standard definition of what constitutes ‘low-carb’ so that studies can be designed and evaluated in a consistent manner. It’s problematic because, without a standard definition, the ‘diet tribe’ researchers (keto versus plant-based) always seem to find the answer that is in their own favor,” Dr. Wallace said. “This study does seem to use less than 20 grams of carbs per day, which in my mind is pretty low carb.”

Perhaps the most important caveat, he added, is that, in the real world, “most people don’t adhere to these very strict diets – not even for 2 weeks.”

The study was supported by the NIDDK Intramural Research Program, with additional NIH support from a National Institute of Nursing Research grant. One author has received reimbursement for speaking at conferences sponsored by companies selling nutritional products, serves on the scientific advisory council for Kerry Taste and Nutrition, and is part of an academic consortium that has received research funding from Abbott Nutrition, Nestec, and Danone. Dr. Hall and the other authors disclosed no relevant financial relationships. Dr. Wallace is principal and CEO of the Think Healthy Group, editor of the Journal of Dietary Supplements, and deputy editor of the Journal of the American College of Nutrition.

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

For appetite control, a low-fat, plant-based diet has advantages over a low-carbohydrate, animal-based ketogenic diet, although the keto diet wins when it comes to keeping post-meal glucose and insulin levels in check, new research suggests.

In a highly controlled crossover study conducted at the National Institutes of Health, people consumed fewer daily calories when on a low-fat, plant-based diet, but their insulin and blood glucose levels were higher than when they followed a low-carbohydrate, animal-based diet.

“There is this somewhat-outdated idea now that higher-fat diets, because they have more calories per gram, tend to make people overeat – something called the passive overconsumption model,” senior investigator Kevin Hall, PhD, National Institute of Diabetes and Digestive and Kidney Diseases, said in an interview.

The other more popular model these days, he explained, is the carbohydrate-insulin model, which holds that following a diet high in carbohydrates and sugar that causes insulin levels to spike will increase hunger and cause a person to overeat.

In this study, Dr. Hall and colleagues tested these two hypotheses head to head.

“The short answer is that we got exactly the opposite predictions from the carbohydrate-insulin model of obesity. In other words, instead of making people eat more and gaining weight and body fat, they actually ended up eating less on that diet and losing body fat compared to the higher-fat diet,” Dr. Hall said.

“Yet, the passive overconsumption model also failed, because despite them eating a very energy-dense diet and high fat, they didn’t gain weight and gain body fat. And so both of these models of why people overeat and gain weight seem to be inadequate in our study,” he said. “This suggests that things are a little bit more complicated.”

The study was published online Jan. 21, 2021 in Nature Medicine.
 

Pros and cons to both diets

For the study, the researchers housed 20 healthy adults who did not have diabetes for 4 continuous weeks at the NIH Clinical Center. The mean age of the participants was 29.9 years, and the mean body mass index was 27.8 kg/m².

The participants were randomly allocated to consume ad libitum either a plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with low-energy density (about 1 kcal/g⁻¹), or an animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with high energy density (about 2 kcal/g⁻¹) for 2 weeks. They then crossed over to the alternate diet for 2 weeks.

Both diets contained about 14% protein and were matched for total calories, although the low-carb diet had twice as many calories per gram of food than the low-fat diet. Participants could eat what and however much they chose of the meals they were given.

One participant withdrew, owing to hypoglycemia during the low-carbohydrate diet phase. For the primary outcome, the researchers compared mean daily ad libitum energy intake between each 2-week diet period.

They found that energy intake from the low-fat diet was reduced by approximately 550-700 kcal/d⁻¹, compared with the low-carbohydrate keto diet. Yet, despite the large differences in calorie intake, participants reported no differences in hunger, enjoyment of meals, or fullness between the two diets.

Participants lost weight on both diets (about 1-2 kg on average), but only the low-fat diet led to a significant loss of body fat.

“Interestingly, our findings suggest benefits to both diets, at least in the short term,” Dr. Hall said in a news release.

“While the low-fat, plant-based diet helps curb appetite, the animal-based, low-carb diet resulted in lower and more steady insulin and glucose levels. We don’t yet know if these differences would be sustained over the long term,” he said.

Dr. Hall added that it’s important to note that the study was not designed to make diet recommendations for weight loss, and the results might have been different had the participants been actively trying to lose weight.

“In fact, they didn’t even know what the study was about; we just said we want you to eat the two diets, and we’re going to see what happens in your body either as you eat as much or as little as you want,” he said.

“It’s a bit of a mixed bag in terms of which diet might be better for an individual. I think you can interpret this study as that there are positives and negatives for both diets,” Dr. Hall said.
 

Diet ‘tribes’

In a comment, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said it’s important to note that “a ‘low-carb diet’ has yet to be defined, and many definitions exist.

“We really need a standard definition of what constitutes ‘low-carb’ so that studies can be designed and evaluated in a consistent manner. It’s problematic because, without a standard definition, the ‘diet tribe’ researchers (keto versus plant-based) always seem to find the answer that is in their own favor,” Dr. Wallace said. “This study does seem to use less than 20 grams of carbs per day, which in my mind is pretty low carb.”

Perhaps the most important caveat, he added, is that, in the real world, “most people don’t adhere to these very strict diets – not even for 2 weeks.”

The study was supported by the NIDDK Intramural Research Program, with additional NIH support from a National Institute of Nursing Research grant. One author has received reimbursement for speaking at conferences sponsored by companies selling nutritional products, serves on the scientific advisory council for Kerry Taste and Nutrition, and is part of an academic consortium that has received research funding from Abbott Nutrition, Nestec, and Danone. Dr. Hall and the other authors disclosed no relevant financial relationships. Dr. Wallace is principal and CEO of the Think Healthy Group, editor of the Journal of Dietary Supplements, and deputy editor of the Journal of the American College of Nutrition.

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

For appetite control, a low-fat, plant-based diet has advantages over a low-carbohydrate, animal-based ketogenic diet, although the keto diet wins when it comes to keeping post-meal glucose and insulin levels in check, new research suggests.

In a highly controlled crossover study conducted at the National Institutes of Health, people consumed fewer daily calories when on a low-fat, plant-based diet, but their insulin and blood glucose levels were higher than when they followed a low-carbohydrate, animal-based diet.

“There is this somewhat-outdated idea now that higher-fat diets, because they have more calories per gram, tend to make people overeat – something called the passive overconsumption model,” senior investigator Kevin Hall, PhD, National Institute of Diabetes and Digestive and Kidney Diseases, said in an interview.

The other more popular model these days, he explained, is the carbohydrate-insulin model, which holds that following a diet high in carbohydrates and sugar that causes insulin levels to spike will increase hunger and cause a person to overeat.

In this study, Dr. Hall and colleagues tested these two hypotheses head to head.

“The short answer is that we got exactly the opposite predictions from the carbohydrate-insulin model of obesity. In other words, instead of making people eat more and gaining weight and body fat, they actually ended up eating less on that diet and losing body fat compared to the higher-fat diet,” Dr. Hall said.

“Yet, the passive overconsumption model also failed, because despite them eating a very energy-dense diet and high fat, they didn’t gain weight and gain body fat. And so both of these models of why people overeat and gain weight seem to be inadequate in our study,” he said. “This suggests that things are a little bit more complicated.”

The study was published online Jan. 21, 2021 in Nature Medicine.
 

Pros and cons to both diets

For the study, the researchers housed 20 healthy adults who did not have diabetes for 4 continuous weeks at the NIH Clinical Center. The mean age of the participants was 29.9 years, and the mean body mass index was 27.8 kg/m².

The participants were randomly allocated to consume ad libitum either a plant-based, low-fat diet (10.3% fat, 75.2% carbohydrate) with low-energy density (about 1 kcal/g⁻¹), or an animal-based, ketogenic, low-carbohydrate diet (75.8% fat, 10.0% carbohydrate) with high energy density (about 2 kcal/g⁻¹) for 2 weeks. They then crossed over to the alternate diet for 2 weeks.

Both diets contained about 14% protein and were matched for total calories, although the low-carb diet had twice as many calories per gram of food than the low-fat diet. Participants could eat what and however much they chose of the meals they were given.

One participant withdrew, owing to hypoglycemia during the low-carbohydrate diet phase. For the primary outcome, the researchers compared mean daily ad libitum energy intake between each 2-week diet period.

They found that energy intake from the low-fat diet was reduced by approximately 550-700 kcal/d⁻¹, compared with the low-carbohydrate keto diet. Yet, despite the large differences in calorie intake, participants reported no differences in hunger, enjoyment of meals, or fullness between the two diets.

Participants lost weight on both diets (about 1-2 kg on average), but only the low-fat diet led to a significant loss of body fat.

“Interestingly, our findings suggest benefits to both diets, at least in the short term,” Dr. Hall said in a news release.

“While the low-fat, plant-based diet helps curb appetite, the animal-based, low-carb diet resulted in lower and more steady insulin and glucose levels. We don’t yet know if these differences would be sustained over the long term,” he said.

Dr. Hall added that it’s important to note that the study was not designed to make diet recommendations for weight loss, and the results might have been different had the participants been actively trying to lose weight.

“In fact, they didn’t even know what the study was about; we just said we want you to eat the two diets, and we’re going to see what happens in your body either as you eat as much or as little as you want,” he said.

“It’s a bit of a mixed bag in terms of which diet might be better for an individual. I think you can interpret this study as that there are positives and negatives for both diets,” Dr. Hall said.
 

Diet ‘tribes’

In a comment, Taylor Wallace, PhD, adjunct professor, department of nutrition and food studies, George Mason University, Fairfax, Va., said it’s important to note that “a ‘low-carb diet’ has yet to be defined, and many definitions exist.

“We really need a standard definition of what constitutes ‘low-carb’ so that studies can be designed and evaluated in a consistent manner. It’s problematic because, without a standard definition, the ‘diet tribe’ researchers (keto versus plant-based) always seem to find the answer that is in their own favor,” Dr. Wallace said. “This study does seem to use less than 20 grams of carbs per day, which in my mind is pretty low carb.”

Perhaps the most important caveat, he added, is that, in the real world, “most people don’t adhere to these very strict diets – not even for 2 weeks.”

The study was supported by the NIDDK Intramural Research Program, with additional NIH support from a National Institute of Nursing Research grant. One author has received reimbursement for speaking at conferences sponsored by companies selling nutritional products, serves on the scientific advisory council for Kerry Taste and Nutrition, and is part of an academic consortium that has received research funding from Abbott Nutrition, Nestec, and Danone. Dr. Hall and the other authors disclosed no relevant financial relationships. Dr. Wallace is principal and CEO of the Think Healthy Group, editor of the Journal of Dietary Supplements, and deputy editor of the Journal of the American College of Nutrition.

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

Patients with early, undifferentiated arthritis may benefit from milder or stronger treatments, depending on the number of their risk factors for developing rheumatoid arthritis, researchers say.

Thinkstock/ LarsNeumann

If the finding is borne out by further research, clinicians could consider treating some of these patients with hydroxychloroquine, steroids, or nonsteroidal anti-inflammatory drugs (NSAIDs) rather than methotrexate, said Pascal de Jong, MD, PhD, a rheumatologist at Erasmus Medical Center in Rotterdam, the Netherlands.

“Maybe those patients with fewer risk factors should get less intensive treatment,” he said in an interview. The study by de Jong and colleagues was published online Jan. 23 in Rheumatology.

The European Alliance of Associations for Rheumatology recommends starting treatment with methotrexate for patients who are at risk for persistent arthritis, which it says is “factually synonymous” with rheumatoid arthritis.

But these recommendations are based on studies involving patients with established rheumatoid arthritis, Dr. de Jong said.

In an earlier study, he and his colleagues found that hydroxychloroquine can be just as effective as methotrexate for patients newly diagnosed with rheumatoid arthritis who don’t have autoantibodies. This led them to wonder whether their findings might apply to some subgroups of patients with early arthritis.

As an initial test of this idea, they identified 130 patients from the Rotterdam Early Arthritis Cohort (tREACH) trial who had at least one swollen joint but who did meet the diagnostic criteria for rheumatoid arthritis.

They sorted the patients into groups on the basis of the number of risk factors for persistent arthritis. The risk factors were autoantibody positivity (rheumatoid factor and/or anticitrullinated protein antibody), polyarthritis (more than four swollen joints), erosive disease, and elevations in levels of acute-phase reactants.

Thirty-one patients had none of these risk factors, 66 patients had one risk factor, and the remaining 33 patients had at least two risk factors.

After 2 years of follow-up, 74% of the patients who had had no risk factors had recovered from their arthritis and had not taken disease-modifying antirheumatic drugs (DMARDs) for at least 6 months (DMARD-free remission). Among the patients who had had one risk factor, 48% achieved DMARD-free remission. Among those who had had two risk factors, 45% achieved DMARD-free remission. The differences between the group that had had no risk factors and the other two groups were statistically significant (P < .05).

The researchers found that those patients who had been experiencing their symptoms for fewer than 6 months were more likely to achieve disease-free remission.

They also sorted patients into different groups on the basis of the treatments they received. One group of 30 comprised all patients who had been initially treated with methotrexate and included patients who had also received other drugs. One group of 40 received hydroxychloroquine initially, and one group of 60 comprised patients who had received no DMARDs initially and included those who had received NSAIDs or glucocorticoids.

There was no statistically significant difference in DMARD-free remission rates among the treatment groups. However, among those patients who were not treated initially with DMARDs, the chance of sustaining DMARD-free remission for more than a year was lower in comparison with the patients who received methotrexate initially (odds ratio, 4.28; 95% confidence interval, 1.34-13.72; P < .05).

Those patients who had fewer baseline risk factors were more likely to have their medication dosages tapered, and they were at lower risk for flares. Patients with more risk factors were more likely to require an intensificiation of treatment, such as with the use of biologicals.

Methotrexate is more likely to cause side effects such as nausea, fatigue, and hair loss than hydroxychloroquine, Dr. de Jong said. “If the medication is better tolerated, it also influences the compliance of the patient,” he said.

The study could help rheumatologists determine which patients need the most aggressive treatment, agreed Kevin Deane, MD, PhD, associate professor of medicine, division of rheumatology, the University of Colorado, Aurora.

“That’s a common clinical problem,” he said. “Somebody comes in with sort of mild arthritis, and you don’t quite know what it is yet.”

But he added that more research is needed to understand what treatment works best for those patients whose arthritis has not yet been differentiated. Primary care physicians who suspect inflammatory arthritis should refer their patients to rheumatologists and should test for rheumatoid factors and anticyclic citrullinated peptide, Dr. Deane said.

The authors and Dr. Deane have disclosed no relevant financial relationships.

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

Patients with early, undifferentiated arthritis may benefit from milder or stronger treatments, depending on the number of their risk factors for developing rheumatoid arthritis, researchers say.

Thinkstock/ LarsNeumann

If the finding is borne out by further research, clinicians could consider treating some of these patients with hydroxychloroquine, steroids, or nonsteroidal anti-inflammatory drugs (NSAIDs) rather than methotrexate, said Pascal de Jong, MD, PhD, a rheumatologist at Erasmus Medical Center in Rotterdam, the Netherlands.

“Maybe those patients with fewer risk factors should get less intensive treatment,” he said in an interview. The study by de Jong and colleagues was published online Jan. 23 in Rheumatology.

The European Alliance of Associations for Rheumatology recommends starting treatment with methotrexate for patients who are at risk for persistent arthritis, which it says is “factually synonymous” with rheumatoid arthritis.

But these recommendations are based on studies involving patients with established rheumatoid arthritis, Dr. de Jong said.

In an earlier study, he and his colleagues found that hydroxychloroquine can be just as effective as methotrexate for patients newly diagnosed with rheumatoid arthritis who don’t have autoantibodies. This led them to wonder whether their findings might apply to some subgroups of patients with early arthritis.

As an initial test of this idea, they identified 130 patients from the Rotterdam Early Arthritis Cohort (tREACH) trial who had at least one swollen joint but who did meet the diagnostic criteria for rheumatoid arthritis.

They sorted the patients into groups on the basis of the number of risk factors for persistent arthritis. The risk factors were autoantibody positivity (rheumatoid factor and/or anticitrullinated protein antibody), polyarthritis (more than four swollen joints), erosive disease, and elevations in levels of acute-phase reactants.

Thirty-one patients had none of these risk factors, 66 patients had one risk factor, and the remaining 33 patients had at least two risk factors.

After 2 years of follow-up, 74% of the patients who had had no risk factors had recovered from their arthritis and had not taken disease-modifying antirheumatic drugs (DMARDs) for at least 6 months (DMARD-free remission). Among the patients who had had one risk factor, 48% achieved DMARD-free remission. Among those who had had two risk factors, 45% achieved DMARD-free remission. The differences between the group that had had no risk factors and the other two groups were statistically significant (P < .05).

The researchers found that those patients who had been experiencing their symptoms for fewer than 6 months were more likely to achieve disease-free remission.

They also sorted patients into different groups on the basis of the treatments they received. One group of 30 comprised all patients who had been initially treated with methotrexate and included patients who had also received other drugs. One group of 40 received hydroxychloroquine initially, and one group of 60 comprised patients who had received no DMARDs initially and included those who had received NSAIDs or glucocorticoids.

There was no statistically significant difference in DMARD-free remission rates among the treatment groups. However, among those patients who were not treated initially with DMARDs, the chance of sustaining DMARD-free remission for more than a year was lower in comparison with the patients who received methotrexate initially (odds ratio, 4.28; 95% confidence interval, 1.34-13.72; P < .05).

Those patients who had fewer baseline risk factors were more likely to have their medication dosages tapered, and they were at lower risk for flares. Patients with more risk factors were more likely to require an intensificiation of treatment, such as with the use of biologicals.

Methotrexate is more likely to cause side effects such as nausea, fatigue, and hair loss than hydroxychloroquine, Dr. de Jong said. “If the medication is better tolerated, it also influences the compliance of the patient,” he said.

The study could help rheumatologists determine which patients need the most aggressive treatment, agreed Kevin Deane, MD, PhD, associate professor of medicine, division of rheumatology, the University of Colorado, Aurora.

“That’s a common clinical problem,” he said. “Somebody comes in with sort of mild arthritis, and you don’t quite know what it is yet.”

But he added that more research is needed to understand what treatment works best for those patients whose arthritis has not yet been differentiated. Primary care physicians who suspect inflammatory arthritis should refer their patients to rheumatologists and should test for rheumatoid factors and anticyclic citrullinated peptide, Dr. Deane said.

The authors and Dr. Deane have disclosed no relevant financial relationships.

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

Patients with early, undifferentiated arthritis may benefit from milder or stronger treatments, depending on the number of their risk factors for developing rheumatoid arthritis, researchers say.

Thinkstock/ LarsNeumann

If the finding is borne out by further research, clinicians could consider treating some of these patients with hydroxychloroquine, steroids, or nonsteroidal anti-inflammatory drugs (NSAIDs) rather than methotrexate, said Pascal de Jong, MD, PhD, a rheumatologist at Erasmus Medical Center in Rotterdam, the Netherlands.

“Maybe those patients with fewer risk factors should get less intensive treatment,” he said in an interview. The study by de Jong and colleagues was published online Jan. 23 in Rheumatology.

The European Alliance of Associations for Rheumatology recommends starting treatment with methotrexate for patients who are at risk for persistent arthritis, which it says is “factually synonymous” with rheumatoid arthritis.

But these recommendations are based on studies involving patients with established rheumatoid arthritis, Dr. de Jong said.

In an earlier study, he and his colleagues found that hydroxychloroquine can be just as effective as methotrexate for patients newly diagnosed with rheumatoid arthritis who don’t have autoantibodies. This led them to wonder whether their findings might apply to some subgroups of patients with early arthritis.

As an initial test of this idea, they identified 130 patients from the Rotterdam Early Arthritis Cohort (tREACH) trial who had at least one swollen joint but who did meet the diagnostic criteria for rheumatoid arthritis.

They sorted the patients into groups on the basis of the number of risk factors for persistent arthritis. The risk factors were autoantibody positivity (rheumatoid factor and/or anticitrullinated protein antibody), polyarthritis (more than four swollen joints), erosive disease, and elevations in levels of acute-phase reactants.

Thirty-one patients had none of these risk factors, 66 patients had one risk factor, and the remaining 33 patients had at least two risk factors.

After 2 years of follow-up, 74% of the patients who had had no risk factors had recovered from their arthritis and had not taken disease-modifying antirheumatic drugs (DMARDs) for at least 6 months (DMARD-free remission). Among the patients who had had one risk factor, 48% achieved DMARD-free remission. Among those who had had two risk factors, 45% achieved DMARD-free remission. The differences between the group that had had no risk factors and the other two groups were statistically significant (P < .05).

The researchers found that those patients who had been experiencing their symptoms for fewer than 6 months were more likely to achieve disease-free remission.

They also sorted patients into different groups on the basis of the treatments they received. One group of 30 comprised all patients who had been initially treated with methotrexate and included patients who had also received other drugs. One group of 40 received hydroxychloroquine initially, and one group of 60 comprised patients who had received no DMARDs initially and included those who had received NSAIDs or glucocorticoids.

There was no statistically significant difference in DMARD-free remission rates among the treatment groups. However, among those patients who were not treated initially with DMARDs, the chance of sustaining DMARD-free remission for more than a year was lower in comparison with the patients who received methotrexate initially (odds ratio, 4.28; 95% confidence interval, 1.34-13.72; P < .05).

Those patients who had fewer baseline risk factors were more likely to have their medication dosages tapered, and they were at lower risk for flares. Patients with more risk factors were more likely to require an intensificiation of treatment, such as with the use of biologicals.

Methotrexate is more likely to cause side effects such as nausea, fatigue, and hair loss than hydroxychloroquine, Dr. de Jong said. “If the medication is better tolerated, it also influences the compliance of the patient,” he said.

The study could help rheumatologists determine which patients need the most aggressive treatment, agreed Kevin Deane, MD, PhD, associate professor of medicine, division of rheumatology, the University of Colorado, Aurora.

“That’s a common clinical problem,” he said. “Somebody comes in with sort of mild arthritis, and you don’t quite know what it is yet.”

But he added that more research is needed to understand what treatment works best for those patients whose arthritis has not yet been differentiated. Primary care physicians who suspect inflammatory arthritis should refer their patients to rheumatologists and should test for rheumatoid factors and anticyclic citrullinated peptide, Dr. Deane said.

The authors and Dr. Deane have disclosed no relevant financial relationships.

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

The use of low-dose aspirin among older people shows no effect in reducing the incidence of certain cancer types. However, the treatment – particularly with frequency of at least three times a week – is associated with reductions in mortality in bladder cancer and breast cancer, new observational research shows.

“The results presented here add to the accumulating evidence that aspirin may improve survival for some cancers,” the authors write in their cohort study that uses data from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. The new research was published online Jan. 15 in JAMA Network Open. 

“Although prior research has been most heavily concentrated in gastrointestinal cancers, our analysis extends the advantages associated with aspirin use to other cancers, such as bladder and breast cancers,” they explained.

In commenting on the study, John J. McNeil, MBBS, PhD, head of the department of epidemiology and preventive medicine at Monash University in Melbourne, said the findings, though intriguing, are not necessarily conclusive.

“The data was derived from a very large and well-conducted study,” Dr. McNeil, who has led other research on aspirin use and the elderly, said in an interview.

“But these conclusions were drawn from the observational component of the study and therefore potentially confounded by other characteristics that differentiate aspirin users from nonusers.”
 

Aspirin/cancer research in older people lacking

With well-known reports of decreased risks of heart disease, stroke, cancer – particularly gastrointestinal cancers – and all-cause mortality, as many as 25%-50% of adults in the U.S. report taking aspirin daily or every other day.

However, evidence of the benefits relating to cancer, specifically in older people, has been inconsistent, with one recent notable study, the randomized, double-blind ASPREE trial, showing no effect of aspirin on cancer incidence, but a higher mortality rate in elderly patients randomly assigned to aspirin for primary prevention.

To further investigate the effects in older patients, first author Holli A. Loomans-Kropp, PhD, and colleagues with the National Cancer Institute evaluated data on patients who were either 65 years or older at baseline or who had reached aged 65 during follow-up in the PLCO Cancer Screening Trial, which had enrollment from 1993 to 2001.

The authors identified 139,896 individuals with a mean age at baseline of 66.4 years; about half were women and 88.5% were non-Hispanic White.

Follow-up took place until the time of death, December 2014 for those who consented to follow-up, or December 2009 for those who refused consent to follow-up. The authors reported that there were 32,580 incident cancers, including 5.4% bladder, 14% breast, 1% esophageal, 1.2% gastric, 2.7% pancreatic, and 2.2% uterine cancers.

The study showed no association between aspirin use and the incidence of any of the cancer types included in the study among those over age 65.

However, further multivariate analysis of survival showed that, with follow-up adjusted to until the time of death, Dec. 31, 2015, or earlier refusal to consent, the use of aspirin at least three times per week was associated with reduced mortality in those with bladder (hazard ratio, 0.67) and breast (HR, 0.75) cancers, whereas no significant associations were observed with esophageal, gastric, pancreatic, or uterine cancer.

A similar association of any aspirin use (less than three times per week) with bladder (HR, 0.75) and breast (HR, 0.79) cancer survival was observed, the authors noted.

“These results may indicate that, for some cancer types, any aspirin use may be advantageous; however, greater benefit may be observed with increased frequency of use,” the authors wrote.
 

Mechanism speculation focuses on COX-2 pathway

Theories of the mechanisms behind a potential benefit of aspirin for those with bladder cancer include that urothelial cancer has increased RNA and protein expression of cyclooxygenase-2 (COX-2) and urinary prostaglandin E2, “suggesting up-regulation of the COX-2 pathway during cancer progression,” the authors wrote.  

In breast cancer, a similar elevated expression of COX-2 has been shown to predict disease outcomes, including progression and decreased survival.

“This may be partly due to the mechanistic interplay between angiogenesis, cell proliferation, apoptosis, and inflammatory processes,” the authors noted.

The study isn’t the first to show a benefit specifically with bladder cancer; other studies include recent research (J Urol. 2018 Nov;200[5]:1014-21) showing that daily aspirin use among patients with bladder cancer was associated with increased 5-year survival following radical cystectomy, the authors noted.

Dr. McNeil noted that the new findings from the U.S. researchers, particularly regarding bladder cancer, are of interest. “The reduction in mortality from breast cancer is modest, but the reduction in mortality from bladder cancer was more impressive,” he said.

“However, given the fact that this finding is observational data and was a sole finding among multiple comparisons, it must be seen as suggestive rather than proven.”

Regarding possible mechanisms, Dr. McNeil added that, like the bulk of the prior research, many questions remain.

“There have been many suggestions about ways that aspirin might work at a molecular and cellular level, but no firm consensus has been reached.”

The study authors and Dr. McNeil disclosed no relevant financial relationships.

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

The use of low-dose aspirin among older people shows no effect in reducing the incidence of certain cancer types. However, the treatment – particularly with frequency of at least three times a week – is associated with reductions in mortality in bladder cancer and breast cancer, new observational research shows.

“The results presented here add to the accumulating evidence that aspirin may improve survival for some cancers,” the authors write in their cohort study that uses data from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. The new research was published online Jan. 15 in JAMA Network Open. 

“Although prior research has been most heavily concentrated in gastrointestinal cancers, our analysis extends the advantages associated with aspirin use to other cancers, such as bladder and breast cancers,” they explained.

In commenting on the study, John J. McNeil, MBBS, PhD, head of the department of epidemiology and preventive medicine at Monash University in Melbourne, said the findings, though intriguing, are not necessarily conclusive.

“The data was derived from a very large and well-conducted study,” Dr. McNeil, who has led other research on aspirin use and the elderly, said in an interview.

“But these conclusions were drawn from the observational component of the study and therefore potentially confounded by other characteristics that differentiate aspirin users from nonusers.”
 

Aspirin/cancer research in older people lacking

With well-known reports of decreased risks of heart disease, stroke, cancer – particularly gastrointestinal cancers – and all-cause mortality, as many as 25%-50% of adults in the U.S. report taking aspirin daily or every other day.

However, evidence of the benefits relating to cancer, specifically in older people, has been inconsistent, with one recent notable study, the randomized, double-blind ASPREE trial, showing no effect of aspirin on cancer incidence, but a higher mortality rate in elderly patients randomly assigned to aspirin for primary prevention.

To further investigate the effects in older patients, first author Holli A. Loomans-Kropp, PhD, and colleagues with the National Cancer Institute evaluated data on patients who were either 65 years or older at baseline or who had reached aged 65 during follow-up in the PLCO Cancer Screening Trial, which had enrollment from 1993 to 2001.

The authors identified 139,896 individuals with a mean age at baseline of 66.4 years; about half were women and 88.5% were non-Hispanic White.

Follow-up took place until the time of death, December 2014 for those who consented to follow-up, or December 2009 for those who refused consent to follow-up. The authors reported that there were 32,580 incident cancers, including 5.4% bladder, 14% breast, 1% esophageal, 1.2% gastric, 2.7% pancreatic, and 2.2% uterine cancers.

The study showed no association between aspirin use and the incidence of any of the cancer types included in the study among those over age 65.

However, further multivariate analysis of survival showed that, with follow-up adjusted to until the time of death, Dec. 31, 2015, or earlier refusal to consent, the use of aspirin at least three times per week was associated with reduced mortality in those with bladder (hazard ratio, 0.67) and breast (HR, 0.75) cancers, whereas no significant associations were observed with esophageal, gastric, pancreatic, or uterine cancer.

A similar association of any aspirin use (less than three times per week) with bladder (HR, 0.75) and breast (HR, 0.79) cancer survival was observed, the authors noted.

“These results may indicate that, for some cancer types, any aspirin use may be advantageous; however, greater benefit may be observed with increased frequency of use,” the authors wrote.
 

Mechanism speculation focuses on COX-2 pathway

Theories of the mechanisms behind a potential benefit of aspirin for those with bladder cancer include that urothelial cancer has increased RNA and protein expression of cyclooxygenase-2 (COX-2) and urinary prostaglandin E2, “suggesting up-regulation of the COX-2 pathway during cancer progression,” the authors wrote.  

In breast cancer, a similar elevated expression of COX-2 has been shown to predict disease outcomes, including progression and decreased survival.

“This may be partly due to the mechanistic interplay between angiogenesis, cell proliferation, apoptosis, and inflammatory processes,” the authors noted.

The study isn’t the first to show a benefit specifically with bladder cancer; other studies include recent research (J Urol. 2018 Nov;200[5]:1014-21) showing that daily aspirin use among patients with bladder cancer was associated with increased 5-year survival following radical cystectomy, the authors noted.

Dr. McNeil noted that the new findings from the U.S. researchers, particularly regarding bladder cancer, are of interest. “The reduction in mortality from breast cancer is modest, but the reduction in mortality from bladder cancer was more impressive,” he said.

“However, given the fact that this finding is observational data and was a sole finding among multiple comparisons, it must be seen as suggestive rather than proven.”

Regarding possible mechanisms, Dr. McNeil added that, like the bulk of the prior research, many questions remain.

“There have been many suggestions about ways that aspirin might work at a molecular and cellular level, but no firm consensus has been reached.”

The study authors and Dr. McNeil disclosed no relevant financial relationships.

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

The use of low-dose aspirin among older people shows no effect in reducing the incidence of certain cancer types. However, the treatment – particularly with frequency of at least three times a week – is associated with reductions in mortality in bladder cancer and breast cancer, new observational research shows.

“The results presented here add to the accumulating evidence that aspirin may improve survival for some cancers,” the authors write in their cohort study that uses data from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. The new research was published online Jan. 15 in JAMA Network Open. 

“Although prior research has been most heavily concentrated in gastrointestinal cancers, our analysis extends the advantages associated with aspirin use to other cancers, such as bladder and breast cancers,” they explained.

In commenting on the study, John J. McNeil, MBBS, PhD, head of the department of epidemiology and preventive medicine at Monash University in Melbourne, said the findings, though intriguing, are not necessarily conclusive.

“The data was derived from a very large and well-conducted study,” Dr. McNeil, who has led other research on aspirin use and the elderly, said in an interview.

“But these conclusions were drawn from the observational component of the study and therefore potentially confounded by other characteristics that differentiate aspirin users from nonusers.”
 

Aspirin/cancer research in older people lacking

With well-known reports of decreased risks of heart disease, stroke, cancer – particularly gastrointestinal cancers – and all-cause mortality, as many as 25%-50% of adults in the U.S. report taking aspirin daily or every other day.

However, evidence of the benefits relating to cancer, specifically in older people, has been inconsistent, with one recent notable study, the randomized, double-blind ASPREE trial, showing no effect of aspirin on cancer incidence, but a higher mortality rate in elderly patients randomly assigned to aspirin for primary prevention.

To further investigate the effects in older patients, first author Holli A. Loomans-Kropp, PhD, and colleagues with the National Cancer Institute evaluated data on patients who were either 65 years or older at baseline or who had reached aged 65 during follow-up in the PLCO Cancer Screening Trial, which had enrollment from 1993 to 2001.

The authors identified 139,896 individuals with a mean age at baseline of 66.4 years; about half were women and 88.5% were non-Hispanic White.

Follow-up took place until the time of death, December 2014 for those who consented to follow-up, or December 2009 for those who refused consent to follow-up. The authors reported that there were 32,580 incident cancers, including 5.4% bladder, 14% breast, 1% esophageal, 1.2% gastric, 2.7% pancreatic, and 2.2% uterine cancers.

The study showed no association between aspirin use and the incidence of any of the cancer types included in the study among those over age 65.

However, further multivariate analysis of survival showed that, with follow-up adjusted to until the time of death, Dec. 31, 2015, or earlier refusal to consent, the use of aspirin at least three times per week was associated with reduced mortality in those with bladder (hazard ratio, 0.67) and breast (HR, 0.75) cancers, whereas no significant associations were observed with esophageal, gastric, pancreatic, or uterine cancer.

A similar association of any aspirin use (less than three times per week) with bladder (HR, 0.75) and breast (HR, 0.79) cancer survival was observed, the authors noted.

“These results may indicate that, for some cancer types, any aspirin use may be advantageous; however, greater benefit may be observed with increased frequency of use,” the authors wrote.
 

Mechanism speculation focuses on COX-2 pathway

Theories of the mechanisms behind a potential benefit of aspirin for those with bladder cancer include that urothelial cancer has increased RNA and protein expression of cyclooxygenase-2 (COX-2) and urinary prostaglandin E2, “suggesting up-regulation of the COX-2 pathway during cancer progression,” the authors wrote.  

In breast cancer, a similar elevated expression of COX-2 has been shown to predict disease outcomes, including progression and decreased survival.

“This may be partly due to the mechanistic interplay between angiogenesis, cell proliferation, apoptosis, and inflammatory processes,” the authors noted.

The study isn’t the first to show a benefit specifically with bladder cancer; other studies include recent research (J Urol. 2018 Nov;200[5]:1014-21) showing that daily aspirin use among patients with bladder cancer was associated with increased 5-year survival following radical cystectomy, the authors noted.

Dr. McNeil noted that the new findings from the U.S. researchers, particularly regarding bladder cancer, are of interest. “The reduction in mortality from breast cancer is modest, but the reduction in mortality from bladder cancer was more impressive,” he said.

“However, given the fact that this finding is observational data and was a sole finding among multiple comparisons, it must be seen as suggestive rather than proven.”

Regarding possible mechanisms, Dr. McNeil added that, like the bulk of the prior research, many questions remain.

“There have been many suggestions about ways that aspirin might work at a molecular and cellular level, but no firm consensus has been reached.”

The study authors and Dr. McNeil disclosed no relevant financial relationships.

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