After the hypertension drug aliskiren was shown to increase side effects in heart failure patients with diabetes, the European Medicines Agency asked researchers to remove similar patients from an ongoing study. Photo by Johan Swanepoel/Shutterstock
FLORENCE, Italy, May 23 (UPI) -- A hypertension drug thought to benefit heart failure patients with diabetes did not reduce the rate of patient death during a clinical trial, researchers reported at a conference.
Heart failure patients with diabetes were removed from the ATMOSPHERE trial when the drug aliskiren, marketed as Tekturna, was found to be no better than two other drugs and in some cases caused excess risk of cardiovascular and renal events, researchers said in a presentation at Heart Failure 2016.
Aliskiren is a renin inhibitor, which blocks an enzyme involved with blood pressure regulation. After the ALTITUDE and ASTRONAUT studies suggested the drug could cause harm in patients, the European Medicines Agency told researchers to remove heart failure patients from the third study.
In 2012, the U.S. Food and Drug Administration issued a warning after results from ALTITUDE were published not to use the drug when treating hypertension in patients with type 2 diabetes.
The ATMOSPHERE study did not show a danger to patients, instead appearing to have no greater effect on preventing death from heart failure than the drug enalapril, an angiotensin-converting enzyme, or ACE, inhibitor.
"We did a rigorous trial which should have shown that aliskiren is as good as an ACE inhibitor," Dr. Lars Kober, a professor at the University of Copenhagen, said in a press release. "The drug was never given the chance to demonstrate how good it is because of regulatory interference. That will never be tested now."
For the study, early results for which were published in The New England Journal of Medicine, researchers recruited more than 7,000 patients, randomly treating 2,336 with enalapril, 2,340 with aliskiren and 2,340 with both. Of the patients, 27.7 percent had diabetes.
During a median follow-up of 36.6 months, 29.5 percent of diabetic patients taking both drugs died, 33.1 percent given enalapril died and 27.4 percent of those treated with aliskiren died -- showing the drug was no better overall than the ACE inhibitor.
"This was a subgroup analysis with the inherent limitations of this type of study," Kober said. "It failed to show superiority or non-inferiority of aliskiren over the ACE inhibitor enalapril in heart failure patients with diabetes. The result may have been positive had the European Medicines Agency not asked us to withdraw patients with diabetes from the trial. We will never know, as the angiotensin receptor neprilysin inhibitor LCZ696 has since emerged and bypassed the need for aliskiren."
