Randomized Placebo-Controlled Trial of Long-Term Treatment with Sibutramine in Mild to Moderate Obesity

Journal of Family Practice, June, 2001 by Ian G. Smith, Michael A. Goulder

CONCLUSIONS

Dosages of sibutramine 10 mg or 15 mg administered once daily in a primary care general practice setting to patients with mild to moderate uncomplicated obesity produced statistically and clinically significant weight reduction that was maintained over a 12-month treatment period. Sibutramine was safe and well tolerated at both 10-mg and 15-mg once-daily doses. Further studies in patients with medical complications of obesity are under way to evaluate the efficacy of sibutramine-induced weight loss on the comorbidities and risk factors associated with obesity.

KEY POINTS

* In the primary care setting, sibutramine (10 mg or 15 mg once daily) given with dietary advice for 12 months was significantly superior in all weight loss efficacy assessments to dietary advice alone.

* Differences in mean changes in blood pressure were generally not significantly different for sibutramine treatment than placebo treatment.

ACKNOWLEDGMENTS

The author would like to thank the Sibutramine Clinical Study 1047 Team for their contributions, especially J Hosie, I James, and SP Jones.

Competing interests: This study was funded by Knoll Pharmaceuticals, the manufacturer of sibutramine.

REFERENCES

[1.] Kuczmarski RJ, Flegal KM, Campbell SM, Johnson CL. Increasing prevalence of overweight among US adults: the National Health and Nutrition Examination Surveys, 1960 to 1991. JAMA 1994; 272:205-11.

[2.] Mokdad AH, Serdula MK, Dietz WH, Bowman BA, Marks JS, Koplan JP. The spread of the obesity epidemic in the United States, 1991-1998. JAMA 1999; 282:1519-22.

[3.] WHO Expert Committee on Physical Status. Physical status: the use of and interpretation of anthropometry report of a WHO expert committee. Geneva, Switzerland: Geneva World Health Organization; 1995. WHO technical report series 854.

[4.] Her Majesty's Stationery Office. Health Survey for England 1994. London, England: HMSO; 1996.

[5.] Hubert HB, Feinleib M, McNamara PM, Castelli WP. Obesity as an independent risk factor for cardiovascular disease: a 26-year follow-up of participants in the Framingham Heart Study. Circulation 1983; 67:968-77.

[6.] Chan JM, Rimm EB, Colditz GA, Stampfer MJ, Willett WC. Obesity, fat distribution, and weight gain as risk factors for clinical diabetes in men. Diabetes Care 1994; 17:961-69.

[7.] Lew EA, Garfinkel L. Variations in mortality by weight among 750,000 men and women. J Chron Dis 1979; 32:563-76.

[8.] Friedman CD, Kannel WB, Dawber TR. The epidemiology of gallbladder disease: observations in the Framingham Study. J Chron Dis 1966; 19:273-92.

[9.] Spector TD, Hart DJ, Doyle DV. Incidence and progression of osteoarthritis in women with unilateral knee disease in the general population: the effect of obesity. Ann Rheum Dis 1994; 53:565-68.

[10.] Kopelman PG. Sleep-apnea and hypoventilation in obesity. Int J Obes 1992; 16:S37-42.

[11.] Fontaine KR, Cheskin LJ, Barofsky I. Health-related quality of life in obese persons seeking treatment. J Fam Pract 1996; 43:265-70.

[12.] Enzi G. Socioeconomic consequences of obesity-the effect of obesity on the individual. PharmacoEconomics 1994; 5:54-57.