Source: Placenta  |  Posted 9 years ago

By Jill Stein
Special to DG News

SAN FRANCISCO, CA -- June 18, 2002 -- A weight management program in combination with the drug sibutramine (Meridia) is more effective in achieving weight loss than a weight management program alone, according to data presented at the 62nd Scientific Sessions of the American Diabetes Association (ADA).

Dr. Marsha A. Raebel, with Kaiser Permanente of Colorado and the University of Colorado in Denver, United States, presented the results of a prospective, randomized study that examined the impact of sibutramine in combination with a weight management program in the naturalistic setting of Kaiser Permanente of Colorado.

Five hundred and seventy one patients were randomized to drug or non-drug treatment; 339 patients completed the 12 month study.

Results of the intent-to-treaty analysis demonstrated that 49.8 percent of the drug group (versus 19.1 percent of the non-drug group) lost more than 5 percent body weight.

Over the study period, a statistically significant increase in high-density lipoprotein in the drug therapy group was observed. Blood pressure did not change in either study group and a statistically significant increase in pulse rate was observed only in females in the drug therapy group.

The clinical effectiveness of sibutramine seen in clinical trials was observed.

Preliminary safety data indicate that sibutramine was well tolerated. Serious adverse events were reported in 26 (10 percent) of 265 patients in the drug group and 17 (8 percent) of 214 patients in the non-drug group. There were no significant differences in serious adverse events between the two groups.

Non serious adverse events did not differ from those reported in the Meridia product labeling (ie. dry mouth, constipation, insomnia, and headache). Co-morbidities did not change significantly from baseline to 12 months.

Dr. Raebel said the study is the largest thus far to assess the efficacy of sibutramine in the naturalistic setting of a health maintenance organization.

Funding for the study was obtained from Abbott Laboratories (formerly Knoll Pharmaceuticals).