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Vol. 94, No. 3, 2000
Issue release date: February 2001
Cardiology 2000;94:152–158

Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Sibutramine in Obese Hypertensive Patients

Hazenberg B.P.
Albert Schweitzer Ziekenhuis, Lokatie Amstelwijk, Dordrecht, The Netherlands

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Objectives: To compare weight loss efficacy, safety and tolerability of sibutramine and placebo in mildly to moderately obese hypertensive subjects; to assess the effect of weight loss on blood pressure. Design: Randomized, double-blind, parallel-group; 3-week placebo run-in and 12-week treatment phase. Setting: Nine hospital outpatient clinics and general practices in the Netherlands. Participants: 127 men and women, 18–65 years old, with body mass indices (BMI) ranging from 27 to 40 kg/m2 and stabilized hypertension – mean resting diastolic blood pressure of 90–120 mm Hg – with or without antihypertensive medication. Interventions: Sibutramine 10 mg once daily; placebo. Main outcome measures: Body weight, blood pressure, routine laboratory and clinical safety monitoring. Results: Of 113 evaluable patients, 54 received sibutramine and 59 placebo. Weight reduction was significantly greater with sibutramine from week 2 onwards (last observation carried forward): mean, 4.4 kg with sibutramine and 2.2 kg with placebo (p = 0.002); mean percentage weight reduction, 4.7 and 2.3%, respectively (p < 0.001); mean BMI reduction, 1.6 and 0.8 kg/m2, respectively (p < 0.01). Reduction in excessive body weight was associated with a reduction in blood pressure in both groups, although the mean reduction in supine diastolic blood pressure was numerically, but not statistically significantly, greater in the placebo group (5.7 mm Hg) compared with the sibutramine group (4.0 mm Hg; p = 0.21). Similar reductions were seen in supine systolic blood pressure. Both treatments were well tolerated. Conclusions: Sibutramine 10 mg once daily is a useful, effective therapy for obesity in the presence of stable hypertension.

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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