Prevention & lipidsSecondary analysis
REDUCE-IT USA
- Prespecified subgroup analysis of the REDUCE-IT randomised trial
- placebo-controlled
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
Primary result
Primary composite end point (US subgroup)
Hazard ratio
0.69
95% CI 0.59–0.80
P = 0.000001
By group
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 | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Key secondary composite: CV death, nonfatal MI or nonfatal stroke | 12.1% | 16.6% | 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. Circulation. Published 11 November 2019. doi:10.1161/circulationaha.119.044440
Summarised from the published abstract; every number is checked against it