About One-Third Eligible for Weight Loss Drugs Meet Trial Exclusion Criteria

Follow Drugslib on

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 3, 2024.

By Elana Gotkine HealthDay Reporter

MONDAY, Dec. 2, 2024 -- About one-third of U.S. adults without diabetes who are eligible for weight loss treatment with glucagon-like peptide 1 (GLP-1) receptor agonists and GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists meet exclusion criteria for clinical trials, according to a research letter published online Nov. 25 in JAMA Internal Medicine.

Lily G. Bessette and Timothy S. Anderson, M.D., from the University of Pittsburgh, estimated the extent to which individuals meeting U.S. Food and Drug Administration label criteria for GLP-1 and GLP-1/GIP for weight loss may have met trial eligibility criteria in a cross-sectional study using pooled data from the National Health and Nutrition Examination Survey. For each medication, the proportion of individuals meeting the FDA label indication who also met trial exclusion criteria was calculated.

The cohort included 8,767 participants, weighted to represent 110.3 million U.S. adults with overweight or obesity. The researchers found that 88.9, 89.0, and 90.6 percent of the participants met the FDA label criteria for weight loss treatment with liraglutide, semaglutide, and tirzepatide, respectively. Of those eligible for treatment, 28.1, 26.2, and 33.1 percent, respectively, met exclusion criteria. More adults aged 60 years or older met at least one exclusion criteria compared with younger age groups. The most common exclusion criteria were major depressive disorder, malignant neoplasms, liver disease (tirzepatide only), and uncontrolled hypertension.

"Until there is evidence from high-quality postmarketing studies, the FDA should consider updating labeling to advise caution on generalizing the safety and effectiveness of GLP-1 and GLP-1/GIP to populations excluded from pivotal trials," the authors write.

Abstract/Full Text (subscription or payment may be required)

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2024-12-04 00:00

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords