Influence of Sibutramine on blood pressure: evidence from placebo-controlled trials.
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.


METHODS
Combined analysis of two placebo-controlled trials.


METHODS
The combined data set consisted of 1336 patients. Of these patients, 966 were randomized to sibutramine and 370 were randomized to placebo.


METHODS
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.
Jordan
J
J
Franz-Volhard Clinical Research Center and Helios Klinikum, Medical Faculty of the Charité, Humboldt-University, Berlin, Germany. jordan@fvk.charite-buch.de
Scholze
J
J
Matiba
B
B
Wirth
A
A
Hauner
H
H
Sharma
A M
AM
D000293:Adolescent; D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000009:adverse effects*; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects*; D015992:Body Mass Index; D001835:Body Weight / Q000187:drug effects; D003503:Cyclobutanes / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000139:chemically induced / Q000188:drug therapy / Q000503:physiopathology; D008297:Male; D008562:Membrane Glycoproteins / Q000037:antagonists & inhibitors; D049990:Membrane Transport Modulators; D026901:Membrane Transport Proteins / Q000037:antagonists & inhibitors; D008875:Middle Aged; D009419:Nerve Tissue Proteins / Q000037:antagonists & inhibitors; D050484:Norepinephrine Plasma Membrane Transport Proteins; D009765:Obesity / Q000097:blood / Q000188:drug therapy / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic; D050486:Serotonin Plasma Membrane Transport Proteins; D027981:Symporters / Q000037:antagonists & inhibitors
D019440:Anti-Obesity Agents; D000959:Antihypertensive Agents; D003503:Cyclobutanes; D008562:Membrane Glycoproteins; D049990:Membrane Transport Modulators; D026901:Membrane Transport Proteins; D009419:Nerve Tissue Proteins; D050484:Norepinephrine Plasma Membrane Transport Proteins; C493227:SLC6A2 protein, human; C493230:SLC6A4 protein, human; D050486:Serotonin Plasma Membrane Transport Proteins; D027981:Symporters; C058254:sibutramine