FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Philips’ Sleep Apnea Trial Reaches Critical Enrollment Milestone

Feb. 19, 2014
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Royal Philips said Tuesday it had reached an enrollment goal of 2,500 patients in its Sleep Apnea cardioVascular Endpoints (SAVE) trial. Preliminary results are expected in 2016.

The Phase III randomized, controlled, prospective, parallel and open-label trial — spread across 84 hospitals in seven countries including Australia, New Zealand, Spain, China and Brazil — evaluates the results of continuous positive airway pressure (CPAP) plus standard care in preventing heart attack, stroke or heart failure in adults with established coronary or cerebrovascular disease and moderate-to-severe obstructive sleep apnea versus standard care alone.

“The results of this study could radically change clinical practices and approaches to sleep apnea and cardiovascular health,” said Mark Aloia, senior director of global clinical research at Philips Healthcare. “If the results prove positive, it will be a major advancement in determining whether PAP therapy has a role in preventing cardiovascular disease and its progression in people with sleep disorder breathing.”

Moderate to severe obstructive sleep apnea affects 100 million people worldwide, according to Philips. — Lena Freund

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