Daily Fat Calorie Intake in IMPROVE-IT Trial
The IMPROVE-IT trial did not report specific daily fat calorie intake data for participants.
What IMPROVE-IT Actually Measured
The IMPROVE-IT trial focused exclusively on lipid-lowering pharmacotherapy (simvastatin 40 mg with or without ezetimibe 10 mg) in post-acute coronary syndrome patients, without implementing or reporting dietary fat interventions. 1
Trial Design Specifics
- Population: 18,144 participants >50 years of age hospitalized for ACS within the previous 10 days 1
- Intervention: Simvastatin 40 mg + ezetimibe 10 mg versus simvastatin 40 mg + placebo 1
- Primary focus: LDL-C reduction through medication, not dietary modification 1
- Median follow-up: 6 years 1
Key Lipid Outcomes (Not Dietary Data)
- Baseline mean LDL-C: 93.8 mg/dL in both groups 1
- Achieved LDL-C at 1 year: 53.2 mg/dL (ezetimibe group) vs 69.9 mg/dL (placebo group) 1
- This represented a 24% greater reduction with ezetimibe versus placebo 1
Why Dietary Fat Data Was Not Collected
IMPROVE-IT was designed as a pure pharmacologic intervention trial to test whether adding ezetimibe to moderate-intensity statin therapy would reduce cardiovascular events. 1 The trial was not multifactorial and did not include dietary interventions or monitoring of macronutrient intake 1.
Clinical Implications
- The 6.4% relative risk reduction in major cardiovascular events (RR 0.936,95% CI 0.89-0.99) was achieved through medication alone 1
- Number needed to treat was 56 in primary prevention and 32 in secondary prevention over ~4 years 1
- The trial validated that LDL-C lowering reduces cardiovascular risk regardless of the mechanism (statin vs. non-statin) 1, 2