Philips announces achievement of major milestone in largest ever sleep apnea clinical trial

Andover, MA. – Royal Philips (NYSE: PHG, AEX: PHIA), a major sponsor of the Sleep Apnea cardioVascular Endpoints (SAVE) study, today announced that the study has reached its enrollment goal of 2,500 patients, spread across seven countries and 84 hospitals and  medical institutions. Launched in 2008, the multi-center, randomized, controlled trial examines the effects of CPAP treatment over a two to seven year period, comparing the treatment of CPAP plus standard care with standard care alone. SAVE, the largest study of its kind, takes a global view of how Obstructive Sleep Apnea (OSA) and cardiovascular disease affect patients worldwide. CPAP or Continuous Positive Airway Pressure is a treatment that uses mild air pressure to keep the airways open and is the leading treatment for OSA.

OSA is a condition currently estimated to affect  100 million people worldwide. It is commonly associated with an increased risk for cardiovascular disease. While it is known that treatment is needed for cardiovascular patients with sleep apnea, studies are just now being conducted to examine the preventative effects of treatment on the progression or development of cardiovascular disease. The Philips-sponsored SAVE study aims to determine the effects of CPAP treatment in preventing heart attack, stroke or heart failure in high-risk patients with moderate to severe OSA.

"Philips’ support is crucial to ensuring our results are conclusive," said Dr. Doug McEvoy, senior director, Adelaide Institute for Sleep Health, and principal investigator for the SAVE study.  "As we look toward our next milestone and the completion of the study, we will continue to focus on how best to engage our patients so they are active participants in their own health and treatment. We are looking forward to what the results could mean to the millions affected with these diseases around the globe."

"The results of this study could radically change clinical practices and approaches to both sleep apnea and cardiovascular health," said Mark Aloia, PhD., 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."

In addition to acting as the lead sponsor of this study, Philips has had an active role in training the various SAVE sites in in CPAP adherence techniques to ensure strong patient engagement. Focused on treatment adherence, Philips’ global clinical research team has educated site physicians on driving patient motivation, effective communication, and active participation. 

The SAVE study builds on Philips’ commitment to innovation and clinical advancement. With Philips celebrating its 100 years of research, the global clinical research team will continue its efforts to support clinical trials and research that advance global health.

For more information on the SAVE study, please visit: http://www.savetrial.org/