REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States.
Abstract | BACKGROUND: Some trials have found that patients from the United States derive less benefit than patients enrolled outside the United States. This prespecified REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl - Intervention Trial) subgroup analysis was conducted to determine the degree of benefit of icosapent ethyl in the United States. METHODS: RESULTS: A total of 3146 US patients (38.5% of the trial) were randomized and followed for a median of 4.9 years; 32.3% were women and 9.7% were Hispanic. The primary composite end point occurred in 24.7% of placebo-treated patients versus 18.2% of icosapent ethyl-treated patients (hazard ratio [HR], 0.69 [95% CI, 0.59-0.80]; P=0.000001); the key secondary composite end point occurred in 16.6% versus 12.1% (HR, 0.69 [95% CI, 0.57-0.83]; P=0.00008). All prespecified hierarchical end points were meaningfully and significantly reduced, including cardiovascular death (6.7% to 4.7%; HR, 0.66 [95% CI, 0.49-0.90]; P=0.007), myocardial infarction (8.8% to 6.7%; HR, 0.72 [95% CI, 0.56-0.93]; P=0.01), stroke (4.1% to 2.6%; HR, 0.63 [95% CI, 0.43-0.93]; P=0.02), and all-cause mortality (9.8% to 7.2%; HR, 0.70 [95% CI, 0.55-0.90]; P=0.004); for all-cause mortality in the US versus non-US patients, Pinteraction=0.02. Safety and tolerability findings were consistent with the full study cohort. CONCLUSIONS: Whereas the non-US subgroup showed significant reductions in the primary and key secondary end points, the US subgroup demonstrated particularly robust risk reductions across a variety of individual and composite end points, including all-cause mortality. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01492361.
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Authors | Deepak L Bhatt, Michael Miller, Eliot A Brinton, Terry A Jacobson, Ph Gabriel Steg, Steven B Ketchum, Ralph T Doyle Jr, Rebecca A Juliano, Lixia Jiao, Craig Granowitz, Jean-Claude Tardif, Brian Olshansky, Mina K Chung, C Michael Gibson, Robert P Giugliano, Matthew J Budoff, Christie M Ballantyne, REDUCE-IT Investigators |
Journal | Circulation
(Circulation)
Vol. 141
Issue 5
Pg. 367-375
(02 04 2020)
ISSN: 1524-4539 [Electronic] United States |
PMID | 31707829
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Cholesterol, LDL
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- eicosapentaenoic acid ethyl ester
- Eicosapentaenoic Acid
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Topics |
- Aged
- Cholesterol, LDL
(drug effects)
- Double-Blind Method
- Eicosapentaenoic Acid
(analogs & derivatives, pharmacology)
- Female
- Humans
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
(therapeutic use)
- Male
- Middle Aged
- Myocardial Infarction
(drug therapy, mortality)
- Risk Factors
- Stroke
(drug therapy, mortality)
- United States
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