A possible explanation for the contrasting results of REDUCE-IT vs. STRENGTH: cohort study mimicking trial designs
Authors' conclusion
The contrasting results of REDUCE-IT vs. STRENGTH can partly be explained by a difference in the effect of comparator oils (mineral vs. corn), but not of active oils [eicosapentaenoic acid (EPA) vs. EPA + docosahexaenoic acid], on lipid traits and C-reactive protein.
Study context
- Population
- Copenhagen General Population Study participants meeting key inclusion criteria of REDUCE-IT or STRENGTHCopenhagen General Population Study (CGPS)
- Participants
- 106,088 participants
- Exposure
- CGPS mimicking REDUCE-IT vs CGPS mimicking STRENGTH
- CGPS mimicking REDUCE-ITn = 5,684
- CGPS mimicking STRENGTHn = 6,862
- Outcome
- Estimated HR for ASCVD from combined changes in plasma TG, LDL-C and C-reactive protein
- Follow-up
- Median trial durations (4.9 and 3.5 years)
Methodological detailsgeneral population cohort (CGPS)
- General population cohort (CGPS)
Main finding
As reported in the abstract
ASCVD, active oil vs comparator oil
Active oil vs Comparator oilHazard ratio (CI)
CGPS mimicking REDUCE-IT; REDUCE-IT trial HR 0.75 (0.68-0.83)
0.88(0.84–0.93)
CGPS mimicking STRENGTH; STRENGTH trial HR 0.99 (0.90-1.09)
0.96(0.93–0.99)
Observational data: associations, not effects.
Further findings
Estimated atherosclerotic cardiovascular disease (ASCVD) risk in CGPS, active oil (from changes in TG, LDL-C and C-reactive protein in original trials)
| Comparison | HR (95% CI) | |
|---|---|---|
| Active oilMimicking REDUCE-IT | 0.96 (0.93–0.99) | |
| Active oilMimicking STRENGTH | 0.94 (0.91–0.98) | |
| 0.512Hazard ratio (log scale) |
Estimated ASCVD risk in CGPS, comparator oil
| Comparison | HR (CI) | |
|---|---|---|
| Comparator oilMimicking REDUCE-IT | 1.07 (1.04–1.10) | |
| Comparator oilMimicking STRENGTH | 0.99 (0.98–0.99) | |
| 0.512Hazard ratio (log scale) |
Original publication
A possible explanation for the contrasting results of REDUCE-IT vs. STRENGTH: cohort study mimicking trial designs. Eur Heart J. Published 29 August 2021. doi:10. 1093/ eurheartj/ ehab555
Summarised from the published abstract; every number is checked against it