Abstract
OBJECTIVE:
Sibutramine, a serotonin and norepinephrine transporter inhibitor, is widely used as an adjunctive obesity treatment. There have been concerns that norepinephrine reuptake inhibition with sibutramine could exacerbate arterial hypertension.
DESIGN:
Combined analysis of two placebo-controlled trials.
SUBJECTS:
The combined data set consisted of 1336 patients. Of these patients, 966 were randomized to sibutramine and 370 were randomized to placebo.
MEASUREMENTS:
Body weight, blood pressure, heart rate (HR).
RESULTS:
Sibutramine reduced body weight regardless of basal blood pressure. In the complete set of patients, systolic blood pressure did not change with either intervention over the 48-week period (−0.1±15.5 mmHg with sibutramine, −0.2±15.2 mmHg with placebo, P=0.9). The change in diastolic blood pressure over the 48 week period was 0.3±9.5 mmHg with sibutramine and −0.8±9.2 mmHg with placebo (P=0.049). The blood pressure response was not exacerbated in patients with grade 1 or 2 hypertension or in patients with isolated systolic hypertension. Sibutramine treatment caused a slight increase in supine HR that was sustained throughout the studies.
CONCLUSIONS:
Sibutramine treatment is unlikely to elicit a critical increase in blood pressure even in hypertensive patients. However, blood pressure and HR should be monitored closely. In patients who experience a clinically significant and sustained increase in blood pressure, the drug should probably be discontinued.
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Acknowledgements
This work was supported by Abbott GmbH Co. KG, Germany. The statistical analysis was conducted by the Institute of Applied Statistics, Dr Jörg Schnitker GmbH, Artur-Ladebeck-Str 155, 33647 Bielefeld, Germany. JJ, JS, AW, HH, and AS received research support and lecturer fees from Abbott GmbH.
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Jordan, J., Scholze, J., Matiba, B. et al. Influence of Sibutramine on blood pressure: evidence from placebo-controlled trials. Int J Obes 29, 509–516 (2005). https://doi.org/10.1038/sj.ijo.0802887
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DOI: https://doi.org/10.1038/sj.ijo.0802887
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