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EXAMINE: Alogliptin showed no effect on CV mortality, HF hospitalization
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WASHINGTON — Alogliptin, a dipeptidyl-peptidase IV inhibitor, was not associated with increased risk for CV mortality or hospitalization for HF in patients with type 2 diabetes and recent ACS, according to new findings from the EXAMINE trial.
Researchers presented two subanalyses from the EXAMINE study assessing CV safety of alogliptin (Nesina, Takeda Pharmaceuticals) for the treatment of patients at elevated risk for CVD at the American College of Cardiology Scientific Sessions.
The trial was designed for noninferiority to satisfy FDA requirements that new diabetes drugs be subjected to studies to rule out CV risk.
No difference in CV mortality
William B. White
In one subanalysis, presented by William B. White, MD, researchers reported no difference in rates of CV mortality among patients assigned alogliptin vs. those assigned placebo (4.1% vs. 4.9%; HR=0.85; 95% CI, 0.66-1.1). Researchers also found that alogliptin did not increase sudden cardiac death (alogliptin group, 2.2%; placebo group, 2.7%; HR=0.8; 95% CI, 0.57-1.12).
“We’ve been looking at a few interesting analyses from EXAMINE, and one of the things that is a little striking … is that, at least numerically, we have a lower CV death rate on alogliptin compared to placebo,” White, of the University of Connecticut, told Cardiology Today. “It is not statistically significant, but the time to the first death of a CV nature turned out to be 21% lower on alogliptin than on placebo.”
No differences related to HF
In the other subanalysis, presented by Faiez Zannad, MD, PhD, of Henri Poincaré University of Nancy, France, there was no difference between the groups in the prespecified composite CV outcome of first occurrence of all-cause mortality, nonfatal MI and stroke, urgent revascularization due to unstable angina and hospitalization for HF (HR=0.98; 95% CI, 0.86-1.12).
Within that composite endpoint, hospitalization for HF occurred in 3.1% of patients assigned alogliptin vs. 2.9% of those assigned placebo (HR=1.07; 95% CI, 0.79-1.46).
In addition, researchers also found that alogliptin did not induce new-onset HF or worsen HF outcomes in patients with a history of HF and/or markers for HF. “The people who were the sickest people coming into the study, those with an ACS and a history of HF, while having a much larger event rate compared with those without a history of HF, there was no difference [for them] between alogliptin and placebo,” White said.
“We believe that this is an important finding because over the last few months … a lot of individuals in the endocrinology world in particular… have been saying that this class of drugs should not be used in patients with a history of HF,” White said in an interview. “This absolutely disproves that. We have very tight evidence that mortality and HF are not increased on this particular dipeptidyl-peptidase IV inhibitor.” – by Erik Swain
For more information:
White WB. Abstract 1152-248.
Zannad F. Abstract 1152-249. Both presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, D.C.
Disclosure: White reports consulting for Takeda as chair of the steering committee of the EXAMINE trial.