Sleep medicine · 2005
Sibutramine does not worsen sleep apnea syndrome: a randomized double-blind placebo-controlled study.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Martinez Denis, Basile Bibiana Ribeiro
Аннотация
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.
CONCLUSION: The results indicate that sibutramine does not worsen sleep or breathing during sleep in 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.
CONCLUSION: The results indicate that sibutramine does not worsen sleep or breathing during sleep in patients with OSAHS.