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EXAMINE: CV events raise mortality risk for patients with diabetes
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NEW ORLEANS — In patients with type 2 diabetes and a recent acute coronary syndrome in the EXAMINE trial, those who experienced nonfatal cardiovascular events had an increased risk for cardiovascular-related death, particularly those previously hospitalized for heart failure.
Risk for CV death after a nonfatal CV event was similar regardless of treatment with Nesina (alogliptin, Takeda) or placebo, according to new data presented at the American Diabetes Association Scientific Sessions.
William B. White, MD, professor, Calhoun Cardiology Center, University of Connecticut School of Medicine, and colleagues evaluated risk for CV death in all participants of the EXAMINE trial (n = 5,380) and also in those who experienced an additional on-study major nonfatal CV event, including HF hospitalization, myocardial infarction, stroke and unstable angina. Patients enrolled had type 2 diabetes and were randomly assigned once-daily alogliptin 25 mg or placebo, in addition to standard of care, within 15 to 90 days of an acute coronary syndrome (ACS). Median follow-up was 18 months.
William B. White
The cumulative incidence of CV death was 4.1% in the alogliptin group vs. 4.9% in the placebo group (HR = 0.85; 95% CI, 0.66-1.1). Sudden cardiac death occurred at a cumulative rate of 2.2% vs. 2.7%, respectively (HR = 0.8; 95% CI, 0.57-1.12). According to the researchers, most of the CV deaths in EXAMINE were in patients without a nonfatal CV event after randomization.
Overall, 13.7% of patients experienced a post-randomization nonfatal CV event. Of those, 5.9% were MI, 3.8% unstable angina, 3% HF hospitalization and 1.1% stroke.
“The startling thing in this study was this effect for those who were hospitalized for HF. They head a really high cumulative incidence of CV death, such that 1 in 10 had died within 3 to 4 months of hospitalization for HF, and around one-third had died after just 20 months,” Simon R. Heller, DM, FRCP, from the University of Sheffield, Sheffield, United Kingdom, said during a press conference.
Among patients who experienced nonfatal CV events, compared with those who did not, the adjusted HR for death was 4.96 (95% CI, 3.29-7.47; P < .0001) after HF hospitalization, 3.12 (95% CI, 2.13-4.58; P < .0001) after MI, 3.08 (95% CI, 1.29-7.27; P = .011) after stroke and 1.66 (95% CI, 0.81-3.37; P = .0164) after unstable angina.
When the researchers analyzed post-randomization mortality rates according to treatment assignment, there was no significant difference among patients who did not experience a nonfatal CV event (4.5% alogliptin vs. 5.8% placebo; HR = 0.81; 95% CI, 0.63-1.05). Mortality rates after a first CV event were increased in patients hospitalized for HF after randomization: 22.7% in the alogliptin group vs. 34.1% of the placebo group (HR = 1.02; 95% CI, 0.51-2.02).
“The post-hoc analysis indicates that mortality, including CV mortality, was not higher with alogliptin vs. placebo when studied for 18 months. These data provide additional important information for the health care professional in evaluating treatments for people living with type 2 diabetes,” White said in a press release. – by Katie Kalvaitis
References:
White WB, et al. 1090-P. Presented at: American Diabetes Association Scientific Sessions; June 10-14, 2016; New Orleans.
White WB, et al. Diabetes Care. 2016;doi:10.2337/dc16-0303.
Disclosure: Heller and White report receiving personal fees from Takeda Development Center.
Perspective
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Robert H. Eckel, MD
[In EXAMINE], we see a high rate of mortality, whether you’re treated with alogliptin or placebo, if you have a history of [a nonfatal CV] event, in particular congestive HF. A third [of the participants] died by the termination of the study. That is point No. 1: Let’s prevent cardiovascular disease in diabetes the best way we can. The second point is that … there is a caution in the label now for alogliptin. Is that caution maybe going to be relaxed a bit now based on the fact that alogliptin did not appear to relate to more hospitalization for HF now with the extended analysis of the EXAMINE trial data?
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