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.
Not Another Fen-Phen
Phentermine was once widely prescribed as the “phen” part of the fen-phen weight loss combo that shot to fame in the mid-1990s, and then fell from grace after its use was linked to pulmonary hypertension (high blood pressure in the lungs) and heart valve disease. The problems were found to be related to the “fen” or fenfluramine part of the combination, not the phentermine.
Louis Aronne, MD, founder and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York, believes that combination drugs such as Qnexa hold promise in the battle of the bulge.
“Instead of using single agents, we need to use combination drugs to break through the [weight loss] plateaus,” says Aronne, who was not involved in the trials but has been an adviser to Vivus and other companies developing weight loss drugs.
“This is a breakthrough in that we have something that we know is effective and we can use it at lower doses,” which improves the safety profile, he says.
Although both pills are independently FDA-approved, the new combination pill can’t be used simply by combining the two drugs, as the dosages in Qnexa are unique and lower than what is commercially available, he says.
If approved, candidates for Qnexa may include people with a BMI of 27 to 30 and other conditions related to being overweight, and people with a BMI of 30 or higher. A BMI takes height and weight into account to measure body fat. If your BMI is greater than 25, you are considered overweight. If it is over 30, you are considered obese.