Sibutramine does not worsen sleep apnea syndrome: a randomized double-blind placebo-controlled study.
BACKGROUND
As any drug acting on the central nervous system, sibutramine might worsen obstructive sleep apnea-hypopnea syndrome (OSAHS). This study aims to assess the risk of administering sibutramine to patients with OSAHS.


METHODS
We screened male, symptomatic OSAHS patients who presented consecutively at the sleep clinic. Twenty-one subjects were included, aged between 30 and 60 years, body mass index between 25 and 35kg/m(2) and apnea-hypopnea index (AHI) greater than 10AH/h. Intervention was administration of 15mg sibutramine (SB) or placebo (PL), at bedtime, for 1 month. Each patient underwent overnight polysomnograms both before entering the study and after 1 month. Outcome measures were AHI and sleep efficiency (SE).


RESULTS
Two patients withdrew prematurely, one due to headache, a possible side effect. Results are from 10 patients in the SB group and nine in the PL group. No significant differences were seen in any of the groups before or after treatment in measures of SE, respiratory disturbance, body weight, blood pressure, cardiac or respiratory frequency. Significant reduction occurred in the amount of REM sleep, from 19 to 13% (P=0.04) in SB group and in Epworth sleepiness score in PL and SB groups.


CONCLUSIONS
The results indicate that sibutramine does not worsen sleep or breathing during sleep in patients with OSAHS.
Martinez
Denis
D
Sleep Laboratory, Federal University of Rio Grande do Sul (UFRGS), Santa Casa Hospital Complex, Porto Alegre, RS, Brazil. denis@sono.com.br
Basile
Bibiana Ribeiro
BR
D000328:Adult; D001067:Appetite Depressants / Q000009:adverse effects*; D001794:Blood Pressure / Q000187:drug effects; D003503:Cyclobutanes / Q000009:adverse effects*; D004311:Double-Blind Method; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D017286:Polysomnography; D020181:Sleep Apnea, Obstructive / Q000139:chemically induced* / Q000503:physiopathology; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced* / Q000503:physiopathology
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine