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| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Artículo Open Access |
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Wiley
2026
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| Online Access: | https://onlinelibrary.wiley.com/doi/10.1002/oby.70108 |
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- Addition of Phentermine‐Topiramate to a Digitally Enhanced Lifestyle Intervention: A Double‐Blind Randomized Clinical Trial Alejandro Campos Wissam Ghusn Lizeth Cifuentes Daniel Sacoto Sima Fansa Diego Anazco Maria L. Ricardo‐Silgado Anas Hashem Megan Schaefer William S. Harmsen Heather J. Gunn Craig Peterson Deborah Larsen Santosh T. Varghese Maria D. Hurtado Andres Acosta Obesity ABSTRACT Objective This study compared the effects of phentermine‐topiramate‐ER (mid‐dose 7.5/46 mg) versus placebo on weight loss and cardiovascular disease (CVD) risk outcomes when used as an adjunct to a digitally enhanced lifestyle intervention (DELI). Methods We conducted a 12‐month, randomized, double‐blind, placebo‐controlled trial at a single tertiary academic center in the United States (June 2020–June 2022). Eighty participants with obesity (BMI ≥ 30 kg/m 2 ) were enrolled in the DELI program, consisting of in‐person and telehealth modalities, dietary and physical activity goals, and use of a smartphone application integrated with digital devices (Apple Watch and Bluetooth‐enabled weight scale and blood pressure monitor). Participants were randomized 1:1 to receive either phentermine‐topiramate‐ER ( n = 42) or placebo ( n = 38) in addition to the DELI. Results At 3 months, the phentermine‐topiramate group lost a mean of 10.82 kg versus 4.04 kg in the placebo group (mean difference −6.78 kg; p = 0.002). At 12 months, weight loss was 15.32 kg versus 5.85 kg, respectively (mean difference −9.48 kg; p < 0.001). Participants receiving phentermine‐topiramate‐ER experienced a 3.35% reduction in the estimated atherosclerotic CVD risk compared to baseline ( p = 0.004). Conclusions Phentermine‐topiramate‐ER, when combined with a DELI, produced significant and sustained weight loss and reduced CVD risk in adults with obesity. Trial Registration ClinicalTrials.gov : NCT04408586 10.1002/oby.70108 http://creativecommons.org/licenses/by/4.0/