Icosapent ethyl did not reduce the risk of hospitalisation in COVID-19

Icosapent ethyl did not significantly influence hospital outcomes in an outpatient COVID-19 population. However, all clinical outcome measures trended towards a benefit of icosapent ethyl in the PREPARE-IT 2 trial. The agent was well tolerated and did not inflict notable safety issues [1].

Icosapent ethyl is an oral form of eicosapentaenoic acid (EPA) that has been associated with a risk reduction of cardiovascular events in the phase 3 REDUCE-IT trial (NCT01492361 [2]. Moreover, the phase 2 Cardiolink-9 trial (NCT04412018) displayed symptom-reducing and inflammation-reducing qualities of icosapent ethyl in patients with COVID-19 [3]. The current PREPARE IT-2 trial, presented by Dr Rafael Díaz (Estudios Clínicos Latinoamérica, Argentina), investigated the efficacy and safety of icosapent ethyl in non-hospitalised patients with COVID-19. Enrolled were 2,052 patients with recently diagnosed COVID-19, who were older than 40 years, and without a clear indication for hospitalisation. They were randomised 1:1 to oral icosapent ethyl (8 g daily for the first 3 days, then 4 g daily) or placebo. The primary outcome was COVID-19- related hospitalisation (indication or actual) or death. Dr Díaz presented the 4-week outcomes of the study.

The proportion of COVID-19 related hospitalisations or death was not significantly different for patients receiving icosapent ethyl (11.2%) compared with patients receiving placebo (13.7%; HR 084; P=0.17). Similarly, secondary outcomes did not display significant differences between the active arm and the placebo arm of the study. Dr Díaz explained that all outcome measures trended towards a benefit of icosapent ethyl. “If we conduct an even larger trial, we could establish whether icosapent ethyl has a role in the outpatient management of patients with COVID-19,” argued Dr Díaz. Adverse events were equally divided across the study groups. However, more discontinuations were observed in the icosapent ethyl group (7.1%) than in the placebo group (3.8%).

 

1. 
   
   1. Díaz R, et al. PREPARE IT-2: a pragmatic trial evaluating icosapent ethyl (IPE) in non-hospitalized patients with a positive diagnosis of COVID-19 to reduce hospitalization rates and complications. LBS06, AHA Scientific Sessions 2021, 13–15 November.
   2. Bhatt DL, et al. N Engl J Med 2019;380:11–22.
   3. Kosmopoulos A, et al. iScience 2021;24(9):103040.

 

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Posted on 14 January 202227 March 2024