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CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea
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2016
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The study aimed to determine whether continuous positive airway pressure (CPAP) reduces major cardiovascular events in adults with moderate‑to‑severe obstructive sleep apnea and established coronary or cerebrovascular disease. In a randomized controlled trial of 2,717 adults aged 45–75, participants received either CPAP plus usual care or usual care alone after a 1‑week sham run‑in, with the primary composite endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack. After a mean follow‑up of 3.7 years, the primary endpoint occurred in 17.0 % of the CPAP group versus 15.4 % of the usual‑care group (hazard ratio 1.10, 95 % CI 0.91–1.32, P = 0.34), and no significant benefit was observed on any individual or other composite cardiovascular outcome, although CPAP markedly reduced snoring, daytime sleepiness, and improved quality of life and mood. The trial was funded by the National Health and Medical Research Council of Australia and others and registered as SAVE ClinicalTrials.gov NCT00738179 and ACTRN12608000409370.
Obstructive sleep apnea is associated with an increased risk of cardiovascular events; whether treatment with continuous positive airway pressure (CPAP) prevents major cardiovascular events is uncertain.After a 1-week run-in period during which the participants used sham CPAP, we randomly assigned 2717 eligible adults between 45 and 75 years of age who had moderate-to-severe obstructive sleep apnea and coronary or cerebrovascular disease to receive CPAP treatment plus usual care (CPAP group) or usual care alone (usual-care group). The primary composite end point was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack. Secondary end points included other cardiovascular outcomes, health-related quality of life, snoring symptoms, daytime sleepiness, and mood.Most of the participants were men who had moderate-to-severe obstructive sleep apnea and minimal sleepiness. In the CPAP group, the mean duration of adherence to CPAP therapy was 3.3 hours per night, and the mean apnea-hypopnea index (the number of apnea or hypopnea events per hour of recording) decreased from 29.0 events per hour at baseline to 3.7 events per hour during follow-up. After a mean follow-up of 3.7 years, a primary end-point event had occurred in 229 participants in the CPAP group (17.0%) and in 207 participants in the usual-care group (15.4%) (hazard ratio with CPAP, 1.10; 95% confidence interval, 0.91 to 1.32; P=0.34). No significant effect on any individual or other composite cardiovascular end point was observed. CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood.Therapy with CPAP plus usual care, as compared with usual care alone, did not prevent cardiovascular events in patients with moderate-to-severe obstructive sleep apnea and established cardiovascular disease. (Funded by the National Health and Medical Research Council of Australia and others; SAVE ClinicalTrials.gov number, NCT00738179 ; Australian New Zealand Clinical Trials Registry number, ACTRN12608000409370 . .)
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