BACKGROUND: Although recent evidence suggests that OSA treatment may cause weight gain, the long-term effects of CPAP on weight are not well established. METHODS: This study was a post hoc analysis of the Sleep Apnea Cardiovascular Endpoints (SAVE) study, a multicenter, randomized trial of CPAP plus standard care versus standard care alone in adults with a history of cardiac or cerebrovascular events and moderate to severe OSA. Participants with weight, BMI, and neck and waist circumferences measured at baseline and during follow-up were included. Linear mixed models were used to examine sex-specific temporal differences, and a sensitivity analysis compared high CPAP adherers (>= 4 h per night) with propensity-matched control participants. RESULTS: A total of 2,483 adults (1,248 in the CPAP group and 1,235 in the control group) were included (mean 6.1 +/- 1.5 measures of weight available). After a mean follow-up of 3.78 years, there was no difference in weight change between the CPAP and control groups, for male subjects (mean (95% CI) between-group difference 0.07 kg (-0.40 to 0.54); p = 0.773) or female subjects (mean (95% CI) between-group difference -0.14 kg (-0.37 to 0.09); p = 0.233). Similarly, there were no significant differences in BMI or other anthropometric measures. Although male participants who used CPAP >= 4 h per night gained slightly more weight than matched male control subjects without CPAP (mean difference 0.38 kg (95% CI 0.04 to 0.73); p = 0.031), there were no between-group differences in other anthropometric variables, nor were there any differences between female high CPAP adherers and matched control subjects. CONCLUSIONS: Long-term CPAP use in patients with comorbid OSA and cardiovascular disease does not result in clinically significant weight change. TRIAL REGISTRY: ClinicalTrials.gov number NCT00738179; URL www.ClinicalTrials.gov.

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