If you are overweight and your doctor has told you that you are at risk for type-2 diabetes, you might avoid getting the disease with the help of a new drug, and of course diet and exercise, or at least, you might have a better chance of avoiding the disease than if you do nothing.
Qsymia (KYOO-see-me-a) was the drug used in an extension of the CONQUER trial that had already shown that the drug was better than placebo for weight-reduction. Qsymia is a combination drug that includes phentermine and topiramate, and was developed by VIVUS a biopharmaceutical company in Mountain View, Calif.
In the CONQUER trial of 2,487 people, those who took a low-dose of the drug lost an average of almost 18 pounds in a little more than a year, while those in the higher dose group lost and average of 22 pounds compared to an average weight-loss of almost 2.5 pounds for the placebo group.
To see if the amount of weight reduction might also reduce the number of those patients who go on to actually be diagnosed with type 2 diabetes, the researchers, led by Tim Garvey, MD of the University of Alabama, Birmingham, AL, conducted an second trial using a subgroup of those in the CONQUER trial.
Called the SEQUEL trial, the researchers continued to follow those participants from centers that had shown high enrollment and retained their participants. In other words they only included those who were highly motivated and likely to stick with the study to the end.
That turned out to be 475 people with prediabetes, metabolic syndrome, or both. Metabolic syndrome is a combination of disorders that puts a person at risk of heart disease and diabetes. They followed these folks for another two years and published the results online Oct. 8, 2013, in Diabetes Care.
In addition to maintaining its weight-loss advantage over placebo, Qsymia reduced the risk of being diagnosed with type 2. A total of 6.1 percent of the placebo group went on to be diagnosed with type 2 diabetes, while 1.8 percent of the low-dose and 1.3 percent of the high-dose group were diagnosed with type 2 by the end of the two years. That works out to a 70.5 percent reduction in risk in the low-dose group, and a nearly 79 percent reduction in risk for the high-dose group compared to the placebo group.
The only problem with Qsymia, however, is that motivation factor, not just on the part of patients being willing to stick with the regimen, but on the part of their doctors in prescribing it.
As reported by MedPage Today, the FDA requires the doctor to perform a risk evaluation and mitigation strategy (REMS) before prescribing the drug. That means the doctor must complete an online training module and maintain more paperwork, all of which takes time.
On top of that some doctors may hesitate to prescribe a drug that contains phentermine, one of the ingredients in the infamous FEN-PHEN weight-loss drug linked to heart valve problems years ago. That is despite studies showing that the harmful effects were caused by the FEN (fenfluramine) half of the drug, not the phentermine half.
If you can overcome the obstacles, the researchers are optimistic that Qsymia might be useful for overweight people at risk for type 2 diabetes who want to avoid progressing to diabetes.