Key result
Phentermine/topiramate extended-release reduced mean 24-hour systolic blood pressure compared to placebo (difference -3.2 mmHg; 95% CI -5.48 to -0.93; p=0.0059) in adults with overweight or obesity.
Why the study?
PHEN/TPM demonstrates in-clinic BP reduction, but ambulatory BP monitoring may better predict cardiovascular disease risk.
Does phentermine/topiramate extended-release reduce mean 24-h systolic blood pressure in adults with overweight or obesity?
RCT (n=565)
double-blind
randomized
Yes
Does phentermine/topiramate extended-release reduce mean 24-h systolic blood pressure in adults with overweight or obesity?
Mean Difference: -3.2 (95% CI -5.48–-0.93)
Absolute Event Rate: -3.3% vs -0.1%
p-value: p=0.0059
In adults with overweight or obesity, a fixed-dose combination of phentermine and extended-release topiramate significantly reduced 24-hour ambulatory systolic blood pressure compared to placebo or phentermine alone.
PHEN/TPM lowers 24-h SBP versus placebo or phentermine; confirms ambulatory BP benefit in overweight/obesity.
Background: A fixed-dose combination of phentermine and extended-release topiramate (PHEN/TPM - approved for weight management) has demonstrated in-clinic reduction of blood pressure (BP). Ambulatory BP monitoring (ABPM) may be a better predictor of cardiovascular disease risk than in-clinic BP. Methods: This randomized, multicenter, double-blind study enrolled 565 adults with overweight/obesity. Inclusion criteria included participants willing to wear ABPM device for 24 h. Exclusion criteria included screening blood pressure >140/90 mmHg and antihypertensive medications not stable for 3 months prior to randomization. Participants received placebo (n = 184), phentermine 30 mg; (n = 191), or PHEN 15 mg/TPM 92 mg; (n = 190). 24-hour ABPM was performed at baseline and at week 8. The primary endpoint was mean 24-h systolic BP (SBP) as measured by ABPM, in the per protocol population. Results: Participants were mostly female (73.5 %) and White (81.6 %), with a mean age of 53.4 years; 32.4 % had no hypertension diagnosis or treatment, 62.5 % had hypertension using 0 to 2 antihypertensive medications, and 5.1 % had hypertension using ≥ 3 antihypertensive medications. Baseline mean SBP/diastolic BP (DBP) was 123.9/77.6 mmHg. At week 8, mean SBP change was -0.1 mmHg (placebo), +1.4 mmHg (phentermine 30 mg), and -3.3 mmHg (PHEN/TPM). Between-group difference for PHEN/TPM versus placebo was -3.2 mmHg (95 % CI: -5.48, -0.93 mmHg; p = 0.0059). The between-group difference for PHEN/TPM versus phentermine 30 mg was -4.7 mmHg (95 % CI: -6.96, -2.45 mmHg; p < 0.0001). Common (>2 % in any treatment group) adverse events (i.e., dry mouth, constipation, nausea, dizziness, paresthesia, dysgeusia, headache, COVID-19, urinary tract infection, insomnia, and anxiety) were mostly mild or moderate. Conclusions: In this randomized, multicenter, double-blind ABPM study, PHEN/ TPM reduced SBP compared to either placebo or phentermine 30 mg (Funding: Vivus LLC; ClinicalTrials.gov: NCT05215418).
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Bays et al. (2024) conducted an RCT in overweight or obesity (n=565). phentermine/topiramate extended-release vs. placebo and phentermine 30 mg was evaluated on mean 24-h systolic BP (SBP) as measured by ABPM (MD -3.2, 95% CI -5.48, -0.93, p=0.0059). Phentermine/topiramate extended-release reduced mean 24-hour systolic blood pressure compared to placebo (difference -3.2 mmHg; 95% CI -5.48 to -0.93; p=0.0059) in adults with overweight or obesity.
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