The Respironics division at Philips (NYSE:PHG) said it’s evaluating negative data from a ResMed (NYSE:RMD) clinical trial to determine if it will affect patients who use its BiPAP sleep apnea devices.
Philips said it would evaluate post-market surveillance data and public adverse event data to identify and assess other safety concerns.
Last week, ResMed said a Phase III trial failed to meet its primary endpoints and actually increased the risk of death. The trial was testing 1 of ResMed’s sleep apnea devices on patients with symptomatic chronic heart failure.
Until the company completes its investigation, clinicians should adhere to ResMed’s previously published recommendations "cautioning against the use of ASV therapy in patients with symptomatic chronic heart failure (NYHA 2-4) and reduced LVEF</=45%, AND moderate to severe predominant central sleep apnea," Philips Respironics said.
San Diego-based ResMed’s Serve-HF study showed a 2.5% increased risk of cardiovascular mortality in patients who used its adaptive servo-ventillation therapy versus the control group, who received regular medical care.