6/28/23, 11:35 PM IMPROVE-IT Pathway Feedback Search Clinical Topics Home Studies IMPROVE IT IMPROVE IT Disease Disease Disease Dyslipidemia Non-ST-elevation myocardial inf ST-elev Trial question What is the effect of the addition of ezetimibe to statin therapy in patients who have been hospitalized for an acute coronary syndrome? Study design Multi-center Double blinded RCT Population Characteristics of study participants 24.0% female N = 18144 76.0% male 18144 patients (4416 female, 13728 male) Inclusion criteria: patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg/dL Key exclusion criteria: planned CABG for the acute coronary syndrome event, CrCl of < 30 mL/min, active liver disease, or use of statin therapy that had LDL cholesterol-lowering potency > 40 mg of simvastatin Interventions N=9067 simvastatin-ezetimibe (simvastatin at a dose of 40 mg plus ezetimibe at a dose of 10 mg, once daily) N=9077 simvastatin monotherapy once daily (simvastatin at a dose of 40 mg plus placebo) Primary outcome https://web.pathway.md/studies/rec5r6HSU3d2QP2kO 1/2 6/28/23, 11:35 PM IMPROVE-IT Pathway Death from cardiovascular causes, major coronary event, or nonfatal stroke, Kaplan-Meier event rate at 7 years 34.7 % 34.7 32.7 26.0 % 17.4 % Significant decrease 8.7 % NNT = 50 0.0 % Simvastatin-ezetimibe Simvastatin monotherapy once daily Significant decrease in death from cardiovascular causes, major coronary event, or nonfatal stroke, Kaplan-Meier event rate at 7 years (32.7% vs. 34.7%; HR 0.936, 95% CI 0.89 to 0.99) Secondary outcomes Significant increase in median time-weighted average LDL cholesterol level (53.2 vs. 69.9; difference 16.7, 95% CI -17.49 to -16.02) Safety outcomes No significant differences in rates of prespecified muscle, gallbladder, and hepatic adverse events and cancer. Conclusion In patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg/dL, simvastatin-ezetimibe was superior to simvastatin monotherapy once daily with respect to death from cardiovascular causes, major coronary event, or nonfatal stroke, Kaplan-Meier event rate at 7 years. Reference Cannon CP, Blazing MA, Giugliano RP et al. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387-97. Open reference URL https://web.pathway.md/studies/rec5r6HSU3d2QP2kO 2/2