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May 4, 2010 (New York) -- An experimental weight loss/blood pressure pill may pack a one-two punch against hunger and high blood pressure, one of the main health consequences of obesity, according to new research presented at the American Society of Hypertension’s 25th annual meeting in New York.
Taken once a day, Qnexa combines the appetite suppressant phentermine with the anti-seizure drug topiramate in a unique formulation. Data on this drug are slated to be reviewed this summer by an FDA advisory panel. The FDA is not obligated to follow the advice of its expert panels, but it usually does.
Phentermine quickly suppresses appetite, while the controlled-release topiramate decreases appetite and increases satiety throughout the day. “When the hunger comes back, the topiramate kicks in,” says study author Suzanne Oparil, MD, a professor of medicine, physiology, and biophysics and director of the vascular biology and hypertension program at the University of Alabama at Birmingham. Topiramate also has blood pressure-lowering effects, she says. Oparil is a consultant for Qnexa manufacturer Vivus.
The new analysis of three separate studies included more than 4,500 people. Researchers compared several doses of the new pill with placebo among severely obese adults, as well as overweight, nonobese people who had other health problems related to their weight, such as high blood pressure or metabolic syndrome, a cluster of risk factors that increase risk for diabetes and heart disease.
Overall, people who took the combination pill lost more weight than their counterparts who were given a placebo. The higher the dose, the more substantial the weight loss, and the more likely it was to be maintained over time, the study shows.
At six months, people who took the full dose of Qnexa once daily lost nearly 10% of their body weight; by one year, it was up to 10.4%. Those who took the medium dose of the pill lost 8% of their body weight at six months and 8.2% by one year. The people who took the lowest dose of the drug dropped about 5.1% of body weight at six months, and, on average, gained some back by one year.
The new drug also resulted in drops in systolic blood pressure -- the upper number in a blood pressure reading -- at one year.
A sub-analysis of people with high blood pressure showed that the new pill also helped reduce blood pressure in this group and allowed them to reduce the number of other blood pressure medications they were taking.
The new pill did have some side effects, including altered taste, constipation, dizziness, dry mouth, and headache. But “there were no surprises,” Oparil says.
“It was safe and efficacious across a broad patient population -- some who were very obese and some who were less obese, but had metabolic syndrome or high blood pressure,” she says.