We will soon be able to take the first new diet drug since 1999 when the U.S. Food and Drug Administration approved Xenical, known generically as orlistat. The FDA approved the new drug, Belviq, known generically as lorcaserin hydrochloride, on June 27. The manufacturer, Switzerland’s Arena Pharmaceuticals, hopes to have it on the market here early next year.
But those of us lucky enough to have type 2 diabetes already had our choice of three diabetes drugs that help us manage our blood sugar and happen to help us lose some weight. While people who used these drugs in clinical trials typically didn’t lose quite as much weight as those who used Belviq, the unwanted side effects of the three diabetes drugs tend to be much less serious.
Taking Belviq won’t be a free ride. The FDA approved it for people willing to eat less and exercise more.
Generally, only people who are obese, meaning that they have a body-mass index of 30 or more, will be able to get it. But if you have diabetes or another weight-related condition and a BMI of 27 or more, your doctor will be able to prescribe it.
Belviq, which Arena Pharmaceuticals says we should pronounce as BEL-VEEK, will work to suppress our appetites. It will trigger receptors in our brains that make us feel full.
Almost half of the people without type 2 diabetes, 47 percent, lost at least 5 percent of their body weight after one year on Belviq in clinical trials. By comparison, only about one-fourth of the people in the trials who got a placebo lost as much.
But people with type 2 diabetes didn’t do as well weight-wise on Belviq. About 38 percent of them lost at least 5 percent of their body weight. Still, Belviq typically reduced their A1C from 8.1 to 7.2.
This might sound pretty good so far. But what concerns me are the side effects. The FDA says that for those of us who have diabetes they “are low blood sugar (hypoglycemia), headache, back pain, cough, and fatigue.”
They haven’t studied the combined use of Belviq and insulin, according to the official prescribing information for Belviq. They also don’t know if taking Belviq along with an antidepressant is safe. They also don’t know yet how much risk of “cardiovascular morbidity and mortality” people taking Belviq might have.
About 2.3 percent of the people in the clinical trials suffered difficulty with concentration, attention, and memory, and got confused. Depression was one of the most common reasons why some people dropped out of the clinical trials.
These possible side effects are enough to give anyone pause. But next week another weight loss drug, Qnexa, a combination of phentermine and topiramate, from Vivus in Mountain View, California, will go before the FDA. Some experts expect that the FDA will approve it and that Vivus will launch it before Arena is able to launch Belviq. Preliminary reports from Vivus seem to show that it could lead to more weight loss and fewer side effects than from taking Belviq. Update July 18: The FDA did approve the new Vivus drug for weight loss yesterday, and its new name is Qsymia.
But those of us who have type 2 diabetes already have three other weight-loss choices not available to anyone else. These are medications that our doctors can prescribe for blood sugar control. Only incidentally can they help us lose weight.
The first of these three was Amylin Pharmaceuticals’ Byetta, generically known as exenatide. In clinical trials of 24 weeks people averaged a weight loss of just 3.1 pounds, compared with 10.4 pounds from Belviq in a year.
But some people lost a lot more, myself included. I got so excited about it that I wrote a book, Losing Weight with Your Diabetes Medication: How Byetta and Other Drugs Can Help You Lose More Weight than You Ever Thought Possible. Byetta kick-started my ability to control my weight. I got so excited about Byetta’s prospects that years ago I bought Amylin stock, which I just tendered after Bristol-Myers Squibb bought Amylin.
Since then, Amylin introduced and the FDA approved a once-a-week version of Byetta called Bydureon. In its clinical trials of 24 weeks people typically lost more weight, 5.1 pounds.
You hear a lot about these drugs for blood sugar management and not much about them for weight loss. That’s because Amylin and Novo Nordisk have to tread carefully with the FDA about promoting them that way. I know from my experience of writing about the wonders of Byetta for me and others who I interviewed that Amylin took a hands-off approach.
If you need to lose weight as well as manage your type 2 diabetes, you may want to consider adding Belviq or Qnexa to the arsenal of drugs that you are taking, when they become available. Or right now you can choose one of these diabetes drugs that will help you manage your blood glucose as well as your weight.
Published On: July 12, 2012