Effects of Icosapent Ethyl on Risk and Duration of Hospitalizations and Death in REDUCE-IT

Aims Among statin-treated participants with elevated triglycerides and known cardiovascular disease or with diabetes and other risk factors, icosapent ethyl reduced the risk of cardiovascular events in the REDUCE-IT study. In this post hoc analysis of REDUCE-IT, we quantified the effects of icosapent ethyl on total hospitalizations and days lost to hospitalization and death. Methods Randomization to treatment with 2 g twice daily of icosapent ethyl or matching placebo was performed among 8179 participants receiving statin therapy with established cardiovascular disease or age ≥50 years with diabetes and ≥1 additional risk factor, fasting triglyceride 1.69–5.63 mmol/L, and low-density lipoprotein cholesterol 1.06–2.59 mmol/L. Total hospitalizations were analyzed with a competing risks marginal model for total events. The likelihood of no days lost to hospitalization and death and the rate of days lost among those who were hospitalized or died during the study were analyzed with a zero-inflated Poisson regression model. Results During a median 5.0 years of follow-up, icosapent ethyl treatment was associated with fewer total hospitalizations (HR (95% CI) = 0.91 (0.84, 0.98), P=0.017). Participants randomized to icosapent ethyl were more likely to survive until the end of the study without hospitalization (OR (95% CI) = 1.12 (1.02, 1.22), p=0.016) and had fewer days lost among those who were hospitalized or died (RR (95% CI) = 0.93 (0.93, 0.94), p<0.001). Conclusion Icosapent ethyl was associated with fewer total hospitalizations and fewer days lost due to hospitalization and death, providing additional insights on the effects of icosapent ethyl on patient-centered measures of total disease burden.