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I: Introduction
- Clofibrate and Niacin in Coronary Heart Disease
- JAMA, 1975
- investigators: Coronary Drug Project Research Group
- sponsers: National Heart Lung and Blood Institute (NHLBI)
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O: Objective
to test the efficacy and safety of several lipid-lowering drugs in the long-term therapy of CHD in men with previous MI
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D: Design (inclusion)
- 8,341 men; aged 30-64
- at least 3 months past MI and no worsening of coronary disease
- Risk Group 1: 1 MI, no complications
- Risk Group 2: 1+ MI, with complications
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D: Design
- clofibrate: 1.8 g/day
- niacin: 3.0 g/day
- placebo
- 74 months in length
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E: Endpoint
- Primary: total mortality
- Other major: coronary mortality, sudden death, non-fatal cardio event: recurrent MI, angina, CHF, stroke, pulmonary embolism
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Z-values
- used instead of p-values
- statistically significant (.01 p-value) with z>2.58 or z<-2.58
- statistically significant (.005 p-value) with z>2.81 or z<-2.81
- negative z-values denotes event rate lower in drug arm v. placebo
- further z-value from 0; more statistically significant
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R: Results (niacin endpoints)
- Death: clo (25.5%), nia (24.4%), placebo(25.4%) statistically insignificant
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R: Results (lipids)
- clofibrate: TC (-6.5%), TGs (-22.3%)
- niacin: TC (-9.9%), TGs (-26.1%)
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R: Results (safety/side effects)
Dropout Rates: clofibrate (77.1%), niacin (66.2%), palcebo (77.8%)
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