This article is more than 5 years old. Information may no longer be current.
Phentermine-topiramate improved CV risk factors through weight loss
Click Here to Manage Email Alerts
PHOENIX — After 2 years of treatment with phentermine-topiramate extended-release, weight loss of at least 5% resulted in positive effects on obese patients’ cardiovascular risk factors, notably hypertension and dyslipidemia, according to data presented here.
Results of a post-hoc analysis of the CONQUER and SEQUEL trials demonstrate that more than half of patients assigned to a mid- or top-doses of phentermine-topiramate extended release (Qsymia, Vivus) achieved weight loss ≥10%. Additionally, about 15% of patients assigned to the top-dose and 10% to the mid-dose achieved at least 20% weight loss.
“This association (AACE) is the first to recognize obesity as a chronic medical condition and the algorithm released by this association last week provides a step-wise approach in a complication-centric model of treatment of obesity and associated risk factors. We believe these data showing continued improvement in CV risk factors with greater weight loss fit nicely into that treatment scheme,” Charles Bowden, MD, employee at Vivus, said during his presentation.
108-week data
The post-hoc analysis aimed to determine the effects of weight loss with phentermine-topiramate on CVD risk factors over the course of 108 weeks.
In the CONQUER and 52-week extension SEQUEL trials, patients were randomly assigned phentermine 7.5 mg/ topiramate 46 mg extended-release (mid-dose), phentermine 15 mg/topiramate 92 mg extended-release (top-dose) or placebo. All patients, regardless of dosage, were provided with a lifestyle management program.
Bowden and colleagues collected data on randomization dose and weight loss, and then constructed four categories of weight loss: <5%, 5% to 10%, 10% to 15% and >15%. They examined the effects on CV risk factors, namely hypertension and dyslipidemia.
At 108 weeks, weight loss was as follows: 2.1 kg in the placebo plus lifestyle modification group, 9.1 kg in the mid-dose group and 10.9 kg in the top-dose group (P<.0001 vs. placebo).
Improved CVD comorbidity
Researchers observed significant improvements in CVD risk factors in all four weight-loss categories, the extent of which increased with greater weight loss. Mean change in systolic BP with <5%, 5% to 10%, 10% to 15% and >15% weight loss was: –1.6 mm Hg, –4.0 mm Hg, –6.1 mm Hg and –8.7 mm Hg. Similarly, mean change in diastolic BP was: –2.0 mm Hg, –3.6 mm Hg, –3.6 mm Hg and –5.9 mm Hg. Mean percent change in lipid parameters for each weight loss category (<5%, 5% to 10%, 10% to 15% and >15%) was: 1.9%, 7.8%, 10.7% and 24.3% for HDL; –7.1%, –7.7%, –9.3% and –13.1% for non-HDL; and 4.6%, –8.7%, –17.1% and –28.9% for triglycerides.
Based on this, the researchers developed a composite of medication intensity for both antihypertensive and lipid-lowering medications. According to Bowden, the composite was a net number of medications, the net change in number of medications and the net change in dosage of medications.
“For example, if a patient went from two antihypertensives to one, that would be scored as a 50% reduction. Similarly, if a patient went from 100 mg to 50 mg, that would also be scored as a 50% reduction.”
They determined the net result in each of the four weight-loss categories. For antihypertensive medications, a loss of at least 10% is needed to see a significant reduction in intensity of antihypertensive medications. For lipid-lowering medications, a loss of about 15% or more is required for a significant reduction in medication intensity.
Overall, the drug was well-tolerated. Constipation, paresthesia, sinusitis, dry mouth and change in sense of taste, particularly with regard to carbonated beverages, were most common. – by Stacey L. Adams
For more information:
Cheskin L. Abstract #600. Presented at: the AACE Annual Scientific and Clinical Congress; May 1-5, 2013; Phoenix.
Disclosures: Cheskin is a stock holder and member of the national advisory board of Vivus, and Bowden is an employee of Vivus.