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Clinical Review Report: Icosapent Ethyl (Vascepa): (HLS Therapeutics Inc.): Indication: Prevention of cardiovascular events in statin-treated patients [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2020 Aug.

Cover of Clinical Review Report: Icosapent Ethyl (Vascepa)

Clinical Review Report: Icosapent Ethyl (Vascepa): (HLS Therapeutics Inc.): Indication: Prevention of cardiovascular events in statin-treated patients [Internet].

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Conclusions

Icosapent ethyl reduced the occurrence of events included in the composite outcome of CV death, non-fatal MI, non-fatal stroke, coronary revascularization, and hospitalization for unstable angina in patients treated with statins and with residual CV risk (i.e., those with increased TG levels despite treatment and with established CVD or at high risk of CV events). The key secondary end points — a composite of CV death, MI, or stroke — were also fewer in those treated with icosapent ethyl than in the placebo group. Icosapent ethyl also had a beneficial effect when the components of the composite outcome CV mortality, non-fatal CV events, and coronary revascularization were evaluated individually, although there was no difference in all-cause mortality or hospitalizations due to heart failure and arrhythmia. The effects of icosapent ethyl, however, might include an increase in the number of adverse events such as serious bleeding, peripheral edema, and hospitalization due to atrial fibrillation. The results may not be generalizable; they may be restricted to the specific population enrolled in the REDUCE-IT study.

Copyright © 2020 Canadian Agency for Drugs and Technologies in Health.

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Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK565999

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