About One-Third Eligible for Weight Loss Drugs Meet Trial Exclusion Criteria
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.
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Posted December 2024
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