FDA cardiovascular indication for semaglutide led to short-term uptake but persistent treatment gaps among high-risk patients, new Truveta study finds

BELLEVUE, Wash., Feb. 10, 2026 (GLOBE NEWSWIRE) -- A new peer-reviewed study led by Truveta Research and collaborators finds that the US Food and Drug Administration’s (FDA) March 2024 expansion of semaglutide’s cardiovascular indication was followed by a rapid but short-lived increase in real-world initiation, while overall rates among eligible patients with cardiovascular disease (CVD) and overweight or obesity remained strikingly low.

The study, published in JACC: Advances, analyzed first-time dispensing of semaglutide and tirzepatide among more than 2 million US adults with established CVD and overweight or obesity between January 2021 and May 2025. The study used Truveta Data, which provides de-identified electronic health record and linked pharmacy dispensing data from leading US health systems.

Following FDA approval, first-time dispensing of semaglutide increased immediately by 23%, indicating rapid translation of regulatory and clinical trial evidence into practice. However, this initial surge was followed by a gradual decline in subsequent months. At the same time, tirzepatide did not demonstrate an immediate change after the FDA decision but showed a steady and sustained rise in first-time dispensing over time. Despite these trends, fewer than 1% of eligible adults ultimately initiated either therapy during the study period.

“The FDA’s cardiovascular indication for semaglutide clearly influenced clinical practice, and the immediacy of the response was striking,” said Duy Do, PhD, Principal Applied Research Scientist at Truveta and lead author of the study. “But the more important finding is what didn’t happen. Even after approval, the vast majority of patients who could benefit—those at the highest cardiovascular risk—did not initiate these therapies. That gap represents a missed opportunity for cardiovascular risk reduction.”

The findings suggest that regulatory approval alone may be insufficient to drive immediate and sustained adoption of evidence-based cardiometabolic therapies, particularly for high-cost medications. By focusing on dispensing rather than prescribing, the study captures real-world medication use and highlights barriers such as affordability, access, and workflow challenges that may prevent eligible patients from initiating treatment.

“Real-world data allow us to see how clinical evidence and policy decisions translate—or fail to translate—into everyday care,” said Mitsuaki Sawano, MD, PhD, Senior Assistant Professor at the Teikyo Academic Research Center (TARC), Adjunct Assistant Professor at the Yale/YNHH Center for Outcomes Research and Evaluation (CORE), and Executive Associate Editor of the Journal of the American College of Cardiology (JACC) and collaborator on the study. “Despite strong trial evidence and FDA support, implementation remains limited. Addressing payer policies, access barriers, and clinician and patient awareness will be critical to ensuring these therapies reach the patients most likely to benefit.”

The study also observed diverging post-approval trends between the two medications. While semaglutide dispensing declined after its initial post-approval rise, tirzepatide use continued to grow, potentially reflecting differences in perceived weight-loss efficacy, patient preferences, or evolving prescribing behavior—despite tirzepatide not yet having a definitive cardiovascular indication.

“Our findings underscore the need for policies and care pathways that prioritize equitable access to evidence-based cardiometabolic therapies for patients with established cardiovascular disease,” Do added. “As evidence and regulatory landscapes continue to evolve, health systems and policymakers must focus on closing the gap between what is known to work and what patients actually receive.”

About the study

The full study, “FDA Cardiovascular Indication Expansion and Dispensing of Semaglutide/Tirzepatide in CVD Patients With Overweight/Obesity,” is available online in JACC: Advances.

About Truveta

Saving Lives with Data starts with better evidence. Truveta is a real-world intelligence company unlocking breakthrough discoveries and transforming medicine with unprecedented data and predictive AI. Built with and owned by U.S. health systems, we deliver regulatory-grade evidence and real-time insights used across clinical care, research, and public health.

Truveta membership includes Providence, Advocate Health, Trinity Health, Tenet Healthcare, Northwell Health, AdventHealth, Baptist Health of Northeast Florida, Baylor Scott & White Health, Bon Secours Mercy Health, CommonSpirit Health, Hawaii Pacific Health, HealthPartners, Henry Ford Health System, HonorHealth, Inova, Lehigh Valley Health Network, MedStar Health, Memorial Hermann Health System, MetroHealth, Novant Health, Ochsner Health, Premier Health, Saint Luke’s Health System, Sanford Health, Sentara Healthcare, Texas Health Resources, TriHealth, UnityPoint Health, Virtua Health, and WellSpan Health.

Ellie Lampton
Truveta
2064092192
ellief@truveta.com

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