Paper
International Journal of Obesity (2005) 29, 509–516. doi:10.1038/sj.ijo.0802887 Published online 1 February 2005
Influence of Sibutramine on blood pressure: evidence from placebo-controlled trials
This work has not been previously published.
J Jordan1, J Scholze2, B Matiba3, A Wirth4, H Hauner5 and A M Sharma6
- 1Franz-Volhard Clinical Research Center and Helios Klinikum, Medical Faculty of the Charité, Humboldt-University, Berlin, Germany
- 2Outpatient Department, Medical Faculty of the Charité, Humboldt-University, Berlin, Germany
- 3Abbott GmbH & C. KG, Knollstrasse Ludwigshafen, Germany
- 4Teutoburger-Wald-Klinik, Bad Rothenfelde, Germany
- 5Else-Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Klinikum Rechts der Isar, München, Germany
- 6Department of Medicine, McMaster University, Hamilton General Hospital, Hamilton, Ontario, Canada
Correspondence: Dr J Jordan, Franz Volhard Clinical Research Center, Haus 129, Humboldt University, Wiltbergstr. 50, 13125 Berlin, Germany. E-mail: jordan@fvk.charite-buch.de
Received 4 February 2004; Revised 22 September 2004; Accepted 4 November 2004; Published online 1 February 2005.
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, -0.215.2 mmHg with placebo, P=0.9). The change in diastolic blood pressure over the 48 week period was 0.39.5 mmHg with sibutramine and -0.89.2 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.
Keywords:
autonomic, baroreflex, norepinephrine transporter, sympathetic nervous system, catecholamines
