Icosapent ethyl reduces both first and total CV events in diabetes patients
Icosapent ethyl 4 g/day resulted in substantial CV benefits in diabetes patients on background therapy of statin. Both first and total (first and recurrent) CV events were reduced with icosapent ethyl compared to placebo (HR for first events was 0.77, 95%CI: -0.66-0.88, P=0.0003; HR for total events 0.77, 95%CI: 0.68-0.87, P=0.00005).
Efficacy and safety with icosapent ethyl in the diabetes subgroup were consistent with that observed in the total trial population, including reductions in secondary and tertiary outcomes and non-significant increase in AF/flutter (3.5% in the icosapent ethyl group vs. 2.2% in the placebo group, P=0.13) and an increase in bleeding (13.1% in those with icosapent ethyl vs. 10.9% in those with placebo, P=0.02) (serious bleeding was not significantly increased). Fasting glucose and HbA1c were stable during the trial.
In the REDUCE-IT trial, use of icosapent ethyl, 4 g/day, resulted in a reduction of CV risk compared to placebo in statin-treated patients with either diabetes plus risk factors or established CVD. Primary endpoint was a composite of CV death, myocardial infarction, stroke, coronary revascularization, or unstable angina. Key secondary endpoint was CV death, MI or stroke. 58.5% of patients in REDUCE-iT had diabetes, of whom 91.% were on ≥1 diabetes medication, and 49.5% on ≥2.
- Our reporting is based on the information provided at the ADA congress -