PROVE IT-TIMI 22
Trial question
What is the role of intensive therapy in patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
22.0% female
78.0% male
N = 4162
4162 patients (911 female, 3251 male).
Inclusion criteria: patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days.
Key exclusion criteria: current statin therapy at a dose of 80 mg/day, or current lipid lowering therapy with fibric acid derivatives or niacin, obstructive hepatobiliary disease or other serious hepatic disease.
Interventions
N=2099 intensive statin therapy (80 mg of atorvastatin daily).
N=2063 standard statin therapy (40 mg of pravastatin daily).
Primary outcome
Death or major CV events at 2 years
22.4%
26.3%
26.3 %
19.7 %
13.2 %
6.6 %
0.0 %
Intensive statin
therapy
Standard statin
therapy
Significant
decrease ▼
NNT = 25
Significant decrease in death or major CV events at 2 years (22.4% vs. 26.3%; RR 0.16, 95% CI 0.05 to 0.26).
Secondary outcomes
Significant decrease in death due to coronary artery disease, MI, or revascularization at 2 years (19.7% vs. 22.3%; RR 0.14, 95% CI 0.01 to 0.27).
Borderline significant decrease in death from any cause (2.2% vs. 3.2%; RR 0.28, 95% CI -0.02 to 0.58).
Safety outcomes
No significant differences in discontinuation of treatment because of adverse events (22.8% vs. 21.4%, p=0.30).
Significant differences in liver enzyme elevation (3.3% vs. 1.1%, p < 0.001).
Conclusion
In patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days, intensive statin therapy was superior to standard statin therapy with respect to death or major CV events at 2 years.
Reference
Cannon CP, Braunwald E, McCabe CH et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504.
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