ResMed (NYSE:RMD) disclosed that a Phase III trial testing 1 of its sleep apnea devices on patients with symptomatic chronic heart failure didn’t meet primary endpoints and actually increased the risk of death.
ResMed chief medical officer Glenn Richards said the company has alerted regulators and is "working with appropriate global regulatory authorities about the safety signal observed in this study."
"We are further analyzing the data to understand why this unexpected result was observed in this trial," Richards said in prepared remarks.
Investors reacted strongly, driving ResMed’s stock price down 15.5% today to $55.39 apiece in late-morning trading.
Researchers running the San Diego company’s Serve-HF study determined that there was an annual 2.5% increased risk of cardiovascular mortality in patients who received ResMed’s Adaptive Servo-Ventilation Therapy versus the control group, which received regular medical care. The cardiovascular mortality rate in the ASV group hit 10% per year, compared to 7.5% in the control group (although the ASV device itself performed well, the company said).
More broadly, the multinational, multicenter, randomized controlled trial found that there was no statistically significant difference between patients randomized to ResMed’s Adaptive Servo-Ventilation therapy and the control group, the company said.
ResMed said it’s taking quick action with regulators to revise labeling for the ASV devices in response to the study results. New instructions will warn against using the devices with people with symptomatic heart failure with left ventricular ejection fraction less than or equal to 45%. ResMed said it is also notifying providers, physicians and patients about the cardiovascular data that came out of Serve-HF.
The company also noted that the bad results only came from patients with central sleep apnea who had symptomatic chronic heart failure with reduced ejection fraction. Serve-HF never included patients with obstructive sleep apnea without heart failure, ResMed said.
Co-principal investigator Dr. Martin Cowie of London’s Imperial College said the data, though unexpected, still gives researchers valuable insights.
"This study provides valuable, practice-changing guidance on how to best care for people with chronic heart failure," Cowie said in prepared remarks.