REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States

Bhatt, DL; Miller, M; Brinton, EA; Jacobson, TA; Steg, PG; Ketchum, SB; Doyle, RT; Juliano, RA; Jiao, L; Granowitz, C; Tardif, JC; Olshansky, B; Chung, MK; Gibson, CM; Giugliano, RP; Budoff, MJ; Ballantyne, CM; REDUCE-IT Investigators

doi:10.1161/circulationaha.119.044440

Prevention & lipids

REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States

CirculationPublished 11 Nov 2019Prespecified subgroup analysis of the REDUCE-IT randomised trial

Primary result · Primary composite end point (US subgroup)ResultHazard ratio 0.69 95% CI 0.59–0.80

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Authors' conclusion

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.

Study context

Population: US statin-treated patients with TG ≥135 and <500 mg/dL, LDL-C >40 and ≤100 mg/dL and history of atherosclerosis or DM38.5% of the trial
Participants: 3,146 patients

Comparison: Icosapent ethyl vs placebo in US patients
Primary endpoint: CV death, nonfatal MI, nonfatal stroke, coronary revascularization or hospitalization for unstable angina
Follow-up: Median 4.9 years

Methodological detailsplacebo-controlled

Placebo-controlled

Primary result

Primary composite end point (US subgroup)

Hazard ratio

0.69

95% CI 0.59–0.80

P = 0.000001

By group

Placebo24.7%

Icosapent ethyl18.2%

Icosapent ethyl vs Placebo

HR 0.69 (95% CI 0.59–0.80); P = 0.000001

As reported in the abstract

Secondary outcomes

Outcome	Icosapent ethyl	Placebo	← Lower risk with icosapent ethyl ←→ Higher risk with icosapent ethyl →	HR (95% CI)	P value
Key secondary composite: CV death, nonfatal MI or nonfatal stroke	12.1%	16.6%	0.512	0.69 (0.57–0.83)	P = 0.00008
			0.512Hazard ratio (log scale)

CV death

CV death 6.7% to 4.7%; HR 0.66 (95% CI 0.49-0.90): P = 0.007

MI

MI 8.8% to 6.7%; HR 0.72 (95% CI 0.56-0.93): P = 0.01

Stroke

Stroke 4.1% to 2.6%; HR 0.63 (95% CI 0.43-0.93): P = 0.02

All-cause mortality

All-cause mortality 9.8% to 7.2%; HR 0.70 (95% CI 0.55-0.90): P = 0.004

US vs non-US interaction P=0.02

Safety

Safety and tolerability

Consistent with the full study cohort

Original publication

REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States. Circulation. Published 11 November 2019. doi:10.1161/circulationaha.119.044440

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