Positive topline data were announced from a phase 4 study evaluating the effect of Qsymia (phentermine and topiramate extended-release capsules) on 24-hour ambulatory blood pressure (ABPM).
Qsymia is approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: adults with an initial body mass index (BMI) of at least 30kg/m2 (obese), or at least 27kg/m2 (overweight) in the presence of at least 1 weight related comorbidity (eg, hypertension, type 2 diabetes, or dyslipidemia). It is also indicated for pediatric patients 12 years of age and older with BMI in the 95th percentile or greater standardized for age and sex.
The double-blind study (ClinicalTrials.gov Identifier: NCT05215418) included 565 overweight/obese adults who were randomly assigned 1:1:1 to receive either Qsymia (titrated to phentermine 15mg/topiramate 92mg), placebo, or phentermine 30mg once daily for 8 weeks.
The primary endpoint was the change from baseline to week 8 in mean systolic blood pressure as measured by 24-hour ABPM. Findings demonstrated that treatment with Qsymia was associated with reductions in systolic blood pressure when compared with placebo or phentermine.
“A challenge for patients and clinicians is that anti-obesity medications have variable effects on blood pressure; this is a clinically relevant consideration given that high blood pressure is a major cardiovascular disease risk factor,” said Dr Harold Bays, Medical Director and President of the Louisville Metabolic and Atherosclerosis Research Center, and a principal investigator for this trial. “This data supports that beyond beneficial effects of reducing body weight, Qsymia also favorably affects blood pressure – a common and important health metric.”
Full study results are expected to be published or presented in a peer-reviewed forum, according to Vivus.
Qsymia is a Schedule IV controlled substance. The product is supplied as an extended-release capsule containing phentermine/topiramate in the following strengths: 3.75mg/23mg, 7.5mg/46mg, 11.25mg/69mg, and 15mg/92mg.
References:
New clinical data demonstrate that Qsymia®, the leading once-daily oral weight-management medication, reduces blood pressure. News release. Vivus LLC. November 28, 2023. https://www.globenewswire.com/news-release/2023/11/28/2787056/0/en/New-Clinical-Data-Demonstrate-that-QSYMIA-the-Leading-Once-Daily-Oral-Weight-Management-Medication-Reduces-Blood-Pressure.html.