 |
 |
 |
 |
 |
 |
 |
|
|
|
|||||||||
|
|||||||||||
RESEARCH REPORTS |
1 Professor of Medicine & Clinical Nutrition, Endocrine Division, University of Kentucky, Lexington, KY
2 Director, Weight Control, GlaxoSmithKline Consumer Healthcare, Parsippany, NJ
3 Director, Clinical Research and Metabolic Diseases, Hoffmann-La Roche Ltd., Nutley, NJ
4 Statistical Leader, Hoffmann-La Roche Ltd.
5 Drug Safety Surveillance Team Leader, Hoffmann-La Roche Ltd.
6 Director, Medical Affairs, GlaxoSmithKline Consumer Healthcare
7 Senior Statistician, GlaxoSmithKline Consumer Healthcare
* To whom correspondence should be addressed. E-mail: jwandersmd{at}aol.com.
 |
Abstract |
|---|
BACKGROUND: Lifestyle measures are considered the first line of therapy for treating overweight individuals, but many are unable to achieve a meaningful weight loss.
OBJECTIVE: To determine the efficacy and safety of orlistat 60 mg, given 3 times daily, for weight loss in mildly to moderately overweight individuals.
METHODS: A multicenter, 16 week, randomized, double-blind, placebo-controlled study was conducted in 391 overweight subjects at 20 US centers. The main outcome measure was change in weight from baseline to week 16; secondary measures included changes in body mass index, waist circumference, blood pressure, and fasting lipoprotein and glucose levels.
RESULTS: Subjects in both groups lost weight over the treatment period; however, orlistat-treated subjects lost significantly more weight than placebo-treated subjects beyond 2 weeks of treatment. Weight loss from baseline to week 16 was significantly greater in participants receiving orlistat versus those receiving placebo (3.05 vs 1.90 kg; p < 0.001, intent-to-treat analysis). Orlistat-treated subjects who completed 16 weeks of treatment lost 4.8 ± 0.35% (mean ± SE) of baseline weight compared with 3.1 ± 0.38% for the placebo group (p < 0.001). Orlistat-treated subjects, compared with those receiving placebo, also demonstrated a greater relative reduction in total (-4.4% vs 0.0%; p = 0.004) and low-density lipoprotein cholesterol (-7.2% vs -0.6%; p = 0.005) and both diastolic (-3.9% vs -0.5%; p = 0.001) and systolic blood pressure (-4.7% vs -1.8%; p = 0.004). Both groups showed a similar safety profile; gastrointestinal events were significantly more common in the orlistat-treated subjects.
CONCLUSIONS: The use of orlistat 60 mg by mildly to moderately overweight individuals produced significant weight loss in conjunction with a reduced calorie diet and self-instructional materials. This amount of weight loss was associated with improvements in several weight-related risk factors. Orlistat 60 mg may be a useful adjunct to lifestyle measures and has the potential to contribute significantly to weight and risk factor improvement for overweight individuals.
Key Words: orlistat, overweight, weight loss.
Reprints: Dr. Anderson, University of Kentucky, Rm. MN520 Medical Science Bldg., Lexington, KY 40506-0298, fax 859/323-5707, jwandersmd@aol.com.
This article has been cited by other articles:
|
|
 |
|
  K. C. Dunican, A. R. Desilets, and R. J. DeBellis State of the Art Review: Long-term Pharmacotherapy for Overweight and Obesity: A Review of Sibutramine, Orlistat, and Rimonabant American Journal of Lifestyle Medicine, October 1, 2007; 1(5): 367 - 388. [Abstract] [PDF]
|
|
|
|
 |
|
 C. E Rowell and N. Amarshi Comment: Low-Dose Orlistat Effects on Body Weight of Mildly to Moderately Overweight Individuals: A 16 Week, Double-Blind, Placebo-Controlled Trial Ann. Pharmacother., March 1, 2007; 41(3): 529 - 530. [Full Text] [PDF]
|
|
 |
 |
 |
 |
 |
 |
 |
