ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Friday, September 27, 1996 TAG: 9609270062
SECTION: NATIONAL/INTERNATIONAL PAGE: A-12 EDITION: METRO
DATELINE: BETHESDA, MD.
SOURCE: Associated Press
The first in a new class of obesity drugs works, but there are too many questions about its safety to give it to the thousands of Americans clamoring for it, the government's scientific advisers decided Thursday.
The rejection of Knoll Pharmaceutical's sibutramine disappointed obese patients who had hoped for an alternative to another drug now available, but which on rare occasions produces a potentially fatal side effect.
The two drugs are the only ones that can be taken long-term to help suppress appetite.
Sibutramine ``is mildly effective'' at helping Americans shed pounds, said Dr. Robert Kreisberg of the Baptist Health System in Birmingham, Ala., a member of the Food and Drug Administration's scientific advisory panel.
The panel, nevertheless, voted 5-4 against allowing Knoll to sell sibutramine because the company didn't prove that the weight loss outweighed a side effect - a small but worrisome rise in blood pressure.
A study of 480 patients found 39 percent who took the optimum dose of sibutramine for a year lost 5 percent of their body weight. Only 20 percent of patients could lose that much weight with diet alone.
But the patients averaged a rise in blood pressure of 2 or 3 points, and some patients saw a jump of as many as 10 points. For people whose blood pressure already is too high or with certain other illnesses, even 2 or 3 points could hurt, said Dr. John Flack, a hypertension expert at Wake Forest University.
LENGTH: Short : 38 linesby CNB