6/29/23, 1:45 AM PROVE IT-TIMI 22 Pathway Feedback Search Clinical Topics Home Studies PROVE IT TIMI 22 PROVE IT TIMI 22 Disease Disease Non-ST-elevation myocardial inf ST-elevation myocardial infarction 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 N = 4162 78.0% male 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) https://web.pathway.md/studies/reccpjTP6VQ2ixy9K 1/2 6/29/23, 1:45 AM PROVE IT-TIMI 22 Pathway Primary outcome Death or major cardiovascular events at 2 years 26.3 % 26.3 22.4 19.7 % 13.2 % Significant increase 6.6 % NNH = 26 0.0 % Intensive statin therapy Standard statin therapy Significant increase in death or major cardiovascular events at 2 years (22.4% vs. 26.3%; RR 16, 95% CI 0.05 to 0.26) Secondary outcomes Significant increase in death due to coronary heart disease, myocardial infarction, or revascularization at 2 years (19.7% vs. 22.3%; RR 14, 95% CI 1.34 to 26.66) No significant difference in death from any cause (2.2% vs. 3.2%; RR 28, 95% CI -2.33 to 58.33) 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 cardiovascular 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. Open reference URL https://web.pathway.md/studies/reccpjTP6VQ2ixy9K 2/2