medwireNews: Icosapent ethyl reduces the risk for first and total cardiovascular (CV) events in statin-treated patients with diabetes, suggests a subgroup analysis of the REDUCE-IT trial.
The main findings from this trial indicated that treatment with the highly purified eicosapentaenoic acid ethyl ester at a dose of 2 g twice daily significantly reduced the risk for the primary composite endpoint – comprising CV death, myocardial infarction, stroke, coronary revascularization, and unstable angina – relative to placebo among high-risk patients with elevated triglyceride levels despite statin use, said Deepak Bhatt (Brigham and Women’s Hospital, Boston, Massachusetts, USA) at the virtual ADA 80th Scientific Sessions.
Primary care diabetologist Jay Shubrook comments on the subgroup analysis results
The current subgroup analysis, presented in a late-breaking poster, included 4787 patients with diabetes with a median age of 64.0 years and a median BMI of 32.0 kg/m2. The majority (91%) of participants with diabetes were taking at least one antidiabetes medication at baseline.
In accordance with the main trial findings, patients with diabetes who received icosapent ethyl had a significant 23% lower risk for total primary endpoint events than those given placebo, at rates of 38.9% and 51.6%, respectively.
Similarly, patients in the icosapent ethyl arm had a significant 23% reduced risk for experiencing a first primary endpoint event compared with those in the placebo group (22.2 vs 29.2%). The investigators observed a similar pattern of results for the secondary composite outcome of hard major adverse cardiovascular outcomes (CV death, myocardial infarction, or stroke), with icosapent ethyl conferring a 29% reduction in the risk for total events and a 30% reduction in the risk for first events.
Bhatt said that these risk reductions remained “consistent and robust” among patients with and without established cardiovascular disease.
He added that the safety profile of icosapent ethyl in patients with diabetes was “generally consistent with the full study,” with participants in the active treatment arm experiencing higher rates of atrial fibrillation/flutter (3.5 vs 2.2%) and bleeding (13.1 vs 10.9%) than those given placebo. Rates of serious bleeding were not significantly different in the two groups (3.2 vs 2.5%), and Bhatt remarked that there were “no meaningful between-group differences” in glycated hemoglobin levels or glycemic control.
He acknowledged that the REDUCE-IT trial “was not powered for subgroup analyses” and that the study of patients with diabetes included both prespecified and post-hoc analyses.
Nonetheless, Bhatt concluded that the study highlighted “the substantial impact of icosapent ethyl on the underlying atherothrombotic burden in the at-risk REDUCE-IT population, both in those with but also in those without diabetes.”
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