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



      S. Karger AG

      Blood pressure, Hypertension, Sibutramine, Weight loss

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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/m<sup>2</sup> 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/m<sup>2</sup>, 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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          Most cited references 2

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          Weight and blood pressure. Findings in hypertension screening of 1 million Americans.

          In the nationwide Community Hypertension Evaluation Clinic screening of more than 1 million people, the group classifying itself as overweight had prevalence rates of hypertension 50% to 300% higher than other screenees. Frequency of hypertension in overweight persons aged 20 to 39 years was double that of normal weight and triple that of underweight persons. Among those aged 40 to 64 years, the overweight group had a 50% higher hypertension prevalence rate than the normal-weight group and 100% higher than the underweight group. With each higher degree of blood pressure elevation, relative frequency of hypertension with overweight was larger. Thus this study confirms, in the largest group surveyed to date, similar findings in previous cross-sectional surveys. It is also consistent with data from longitudinal and intervention studies on the importance of overweight in relation to hypertension.
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            The effects of weight reduction on blood pressure in 301 obese patients.

             David Schotte (1990)
            The effects of weight reduction on blood pressure were assessed in 301 obese patients. Weight reduction was achieved by behavior modification, medication, or their combination and was associated with significant reductions in systolic and diastolic blood pressure. The weight reduction method was less important than the amount of weight lost in determining reductions in blood pressure. The greatest reductions in weight and blood pressure occurred during the first half of weight loss, suggesting that even brief treatment (ie, 8 to 10 weeks) may benefit obese, hypertensive patients. Despite repeated measurements, 36 patients who failed to lose weight showed no decrease in blood pressure. Although blood pressure rose during follow-up in patients who regained weight, it remained below baseline levels. These findings provide further support for weight reduction in the control of hypertension.

              Author and article information

              S. Karger AG
              February 2001
              02 March 2001
              : 94
              : 3
              : 152-158
              Albert Schweitzer Ziekenhuis, Lokatie Amstelwijk, Dordrecht, The Netherlands
              47310 Cardiology 2000;94:152–158
              © 2001 S. Karger AG, Basel

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              Page count
              Figures: 1, Tables: 6, References: 23, Pages: 7
              General Cardiology


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