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Volume 89, Issue 5, Pages 1221-1228 (May 2008)


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Effect of sibutramine on weight reduction in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial

Åsa Lindholm, M.D.aCorresponding Author Informationemail address, Marie Bixo, M.D., Ph.D.b, Inger Björn, M.D., Ph.D.bc, Pål Wölner-Hanssen, M.D., Ph.D.d, Mats Eliasson, M.D., Ph.D.e, Anders Larsson, M.D., Ph.D.f, Owe Johnson, M.D., Ph.D.g, Inger Sundström Poromaa, M.D., Ph.D.h

Received 18 January 2007; received in revised form 28 March 2007; accepted 1 May 2007. published online 05 July 2007.

Objective

To examine the efficacy of sibutramine together with brief lifestyle modification for weight reduction in obese women with polycystic ovary syndrome (PCOS).

Design

Investigator-initiated, multicenter, double-blind, randomized, parallel-group clinical trial.

Setting

Departments of Obstetrics and Gynecology in primary care, referral centers, and private practice.

Patient(s)

Forty-two patients with confirmed PCOS were included in the study, and 34 patients completed the study.

Intervention

Sibutramine 15 mg once daily together with brief lifestyle modification was compare with placebo together with brief lifestyle modification.

Main Outcome Measure(s)

The primary endpoint was to assess weight loss. Secondary endpoints included the efficacy of sibutramine for treatment of menstrual pattern and cardiovascular risk factors.

Result(s)

After 6 months the sibutramine group had lost 7.8 ± 5.1 kg compared with a weight loss of 2.8 ± 6.2 kg in the placebo group. Sibutramine treatment resulted in significant decreases in apolipoprotein B, apolipoprotein B/apolipoprotein A ratio, triglycerides, and cystatin C levels.

Conclusion(s)

Sibutramine in combination with lifestyle intervention results in significant weight reduction in obese patients with PCOS. In addition to the weight loss, sibutramine seems to have beneficial effects on metabolic and cardiovascular risk factors.

a Department of Obstetrics and Gynecology, Sunderby Hospital, Luleå, Sweden

b Department of Clinical Science, Obstetrics and Gynecology, University Hospital, Umeå, Sweden

c Läkarhuset Björnen, Piteå, Sweden

d Department of Obstetrics and Gynecology, Lund University Hospital, Lund, Sweden

e Department of Internal Medicine, Sunderby Hospital, Luleå, Sweden

f Department of Clinical Chemistry, University Hospital, Uppsala, Sweden

g Department of Internal Medicine, University Hospital, Umeå, Sweden

h Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden

Corresponding Author InformationReprint requests: Åsa Lindholm, M.D., Department of Obstetrics and Gynecology, Sunderby Hospital, 971 80 Luleå, Sweden (Fax: +46 920 211801).

 Supported by grants from the Family Planning Foundation, Utvecklingsfonden Uppsala University Hospital, Visare Norr, and by a small grant (20000 SEK) from Abbott Scandinavia AB. Abbott Scandinavia AB had no influence on the planning or completing the study, nor any influence on how data were analyzed or presented. Abbott Scandinavia AB had no access to the data.

PII: S0015-0282(07)01029-1

doi:10.1016/j.fertnstert.2007.05.002


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