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CONQUER study

Qsymia significantly improves heart disease risk factors

Improvements were significantly greater among patients who lost 10% or more of their starting weight
Company defends slow sales as part of a strategic marketing plan

Data from the CONQUER trial has concluded that weight loss resulting from treatment with Qsymia capsules led to significant improvements in cholesterol, blood pressure and triglycerides in obese and overweight patients experiencing one or more of these associated conditions. Improvements were significantly greater among patients who lost 10% or more of their starting weight.

"This provides clear evidence that patients with hypertension or high cholesterol treated with Qsymia for one year experienced significant weight loss and clinically meaningful improvements in their underlying cardiovascular risk factors," said Dr Suzanne Oparil, director of the Vascular Biology and Hypertension Program, University of Alabama at Birmingham, and an investigator in the study. "The ability to improve underlying risk factors is another reason physicians should proactively discuss the medical treatment of obesity with their patients who have failed lifestyle modification alone."

The study was published online in The American Journal of Cardiology.

Qsymia (also known as Qsiva) is a combination of the drugs phentermine and topiramate, intended for the treatment of obesity and related conditions such as type 2 diabetes. Phentermine is an appetite suppressant and stimulant of the amphetamine and phenethylamine class. Topiramate is an anticonvulsant that has weight loss side effects.

Primary end points of the trial were percentage weight loss and the proportion of participants achieving ≥5% weight loss. Additional end points were changes in lipid variables in the dyslipidemia population and blood pressure in the hypertensive population, determined by treatment and weight loss.

The outcomes showed that Qsymia roduced significantly greater dose-related mean percentage weight loss compared with placebo in the subgroups of participants with dyslipidemia and those with hypertension.

Regardless of treatment group assignment, participants with dyslipidemia who lost ≥5% of their baseline weight experienced significantly greater reductions in triglycerides (−14.5% to −39.8%), and in non–high-density lipoprotein cholesterol (−9.4% to −14.8%) than those losing <5% of their weight (p<0.05).  Patients with hypertension at baseline showed reduced systolic blood pressure by −7.5 to −11.8mmHg (p<0.001 vs. those with <5% weight loss).

Study

The aim of the 56-week, randomised, double-blind, placebo-controlled, multi-centre trial was to evaluate changes in cardiovascular risk factors in obese patients with dyslipidemia and/or hypertension receiving Qsymia.

Participants with BMI 27-45 were randomised to placebo, PHEN 7.5mg/TPM ER 46mg, or PHEN 15mg/TPM ER 92mg. Patients also received standardised diet and lifestyle modification counselling at each study visit, including a 500 kcal/day reduction in caloric intake, on the basis of the LEARN (Lifestyle, Exercise, Attitudes, Relationships, Nutrition) programme.

The authors concluded that facilitating weight loss by augmenting lifestyle changes with pharmacotherapies may decrease the risk for cardiovascular disease in obese and overweight patients with co-morbidities.

Developed by Vivus, the drug received FDA approval in July 2012, only the second weight loss drug approved in the US in 13 years (Belviq (Arena Pharmaceuticals) was also approved in July 2012). Qsymia is approved for use in adults with a BMI>30 or adults with a BMI>27 who have at least one weight-related condition such as hypertension, type 2 diabetes or dyslipidemia.

Slow sales

The publication of these positive results comes at the same time as Vivus announced slow sales of Qsymia, since its launch in the third quarter of 2012. The company has defended the sales, claiming that they are taking a cautious approach in an attempt to overcome the scepticism, safety concerns, and in some cases lawsuits, that have beleaguered previous weight loss drugs in the US.  

Reuters report that Vivus has lost nearly half of its market value since September and two of the company’s largest shareholders have questioned the company's strategy.

However, Vivua defended their strategy a slow but steady marketing of Qsymia, to gain their customer’s confidence in the product.

"A slower launch that allows people some time to try and use the drug, and make sure the effects they are seeing are good and any risks are more modest, makes more sense both in the medical and financial sense," Kurt Kessler, ZS Associates, told Reuters.

Thomson Reuters Pharma estimates sales of Qsymia will reach US$1.2 billion by 2017, sales in 2013 are expected to be around US$128 million.

Arena is currently waiting for regulatory classification for Belviq from US authorities to determine the risk of abuse before launch.

 

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