Weight Loss Drug Reported to Help Prediabetes and Diabetes
Use of a certain weight loss drug seems to help some people who have prediabetes or diabetes lose weight and better manage their blood glucose levels. Although this sounds like great news, there are several important things you should know about this study and the drug.
Before we discuss those factors and the study, let me identify the drug in question. It is Qsymia (extended release combination of phentermine and topiramate), which was approved in July 2012 and released to the market in September 2012. However, at that time until April 2013, Qsymia was distributed solely to certified pharmacies and available only by mail.
The new study
The study was conducted by Tim Garvey, MD, and his colleagues at the University of Alabama at Birmingham who evaluated data from the phase III CONQUER trial (866 patients) and the follow-up SEQUEL trial (675 who continued). The total length of both trials was 108 weeks.
At the start of the study, the participants were classified as having either prediabetes or metabolic syndrome. Two-thirds of the individuals were women, the mean age was 50 years, and the average weight was 220 pounds.
Here is a breakdown of their findings based on 108 weeks of treatment with Qsymia or placebo:
- Average weight loss was 10.9 percent of body weight among individuals who took the low dose (7.5mg/46mg) of the drug and 12.1 percent among those who took the high dose (15mg/92mg)
- Average weight loss among participants who took a placebo was 2.5 percent
- The annualized incidence rate of type 2 diabetes was 6.1 among those in the placebo group, 1.8 among those taking a low dose of Qsymia, and 1.3 among those in the high-dose group
- The authors reported that compared with placebo, a low dose of the drug reduced the risk of diabetes by 70.5 percent and a high dose by 78.7 percent
- Individuals who lost the least amount of weight (less than 5 percent of their body weight) had an annualized diabetes incidence rate of 6.3 while those who lost the most (at least 15%) had an annualized rate of only 0.9
According to Garvey and his team, use of Qsymia, along with lifestyle changes, the drug might represent a “new and effective therapeutic approach” for people to lose weight and reduce their risk of type 2 diabetes.
Some things to consider
It is critical for everyone to remember that Qsymia and other weight loss drugs are always accompanied by instructions to consume a low-fat, reduced-calorie diet and participate in regular exercise. These lifestyle recommendations alone can control blood glucose for most patients if they follow them.
So why take Qsymia or other weight loss drugs? The results of this study suggest the drug was helpful for weight loss and reducing the risk of developing diabetes, but could these individuals have done just as well or better if they had received closely managed help with diet and exercise and thus avoided the risk of side effects and expense associated with Qsymia?
Side effects of Qsymia can be serious and include the following. (This is not a complete list.)
- Elevated heart rate at rest.
- Suicidal thoughts or actions, which are associated with the topiramate in the drug
- Cognitive impairment
- Depression and anxiety
- Upper respiratory tract infections
- Paraesthesia, characterized by tingling in the feet, hands, or face
- Kidney stone formation
Note also that the drug should never be taken by women who are pregnant or even before they become pregnant, as it can cause significant birth defects (e.g., cleft palate and cleft lip).
It also should be emphasized that the study was supported by the maker of Qsymia (Vivus) and that Dr. Garvey reported financial links with Vivus as well as with several other pharmaceutical companies. In addition, several of the study’s authors work for Vivus.
Losing weight can be a significant challenge but it is considered a critical factor in preventing and controlling prediabetes and type 2 diabetes. Qsymia may be an option, but if you do consider this drug, be sure to explore nondrug weight loss alternatives as well. If Qsymia is still on the table after you have exhausted other choices, become familiar with studies of the drug (including who has sponsored them) and discuss the potential dangers with a knowledgeable healthcare professional.
Garvey WT et al. Prevention of type 2 diabetes in subjects with prediabetes and metabolic syndrome treated with phentermine and topiramate extended-release. Diabetes Care 2013; DOI:10.2337/dc13-1518
Qsymia prescribing information