BACKGROUND: This post hoc analysis of the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) Study investigates the effect of focused atorvastatin therapy versus usual care on cardiovascular outcomes in patients with coronary heart disease (CHD) with and without chronic kidney disease (CKD). STUDY DESIGN: Prospective randomized open-label; median follow-up, 54.3 months. SETTING & PARTICIPANTS: Managed care or Veterans Affairs facilities; 2,442 patients with CHD with dyslipidemia; mean age, 61.6 years. INTERVENTION: Focused atorvastatin therapy to a low-density lipoprotein cholesterol goal of less than 80 mg/dL or maximum dose of 80 mg/d versus usual care as deemed appropriate by patients' regular physicians. PREDICTOR: Baseline estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease Study equation of less than 60 mL/min/1.73 m(2) (patients with CKD) and 60 mL/min/1.73 m(2) or greater (patients without CKD). OUTCOMES & MEASUREMENTS: The primary end point was time to first cardiovascular event. Change from baseline eGFR was assessed in 1,768 patients with follow-up renal data. RESULTS: At baseline, 579 patients (23.7%) had CKD: 31.6% of these patients experienced a primary cardiovascular event during the study versus 23.6% of patients without CKD (hazard ratio [HR], 1.41; 95% confidence interval [CI], 1.18 to 1.68; P < 0.001). Compared with usual care, atorvastatin therapy reduced the relative risk of a primary outcome by 28% in patients with CKD (HR, 0.72; 95% CI, 0.54 to 0.97; P = 0.02) and 11% in patients without CKD (HR, 0.89; 95% CI, 0.74 to 1.07; P = 0.3) (P for treatment by CKD interaction = 0.2). There was no decrease in eGFR in atorvastatin-treated patients during the course of the study. LIMITATIONS: Follow-up of atorvastatin patients was restricted to every 6 months; interim data were unavailable for usual-care patients. CONCLUSIONS: Patients with CHD and CKD are at increased risk of cardiovascular events. Compared with usual care, focused atorvastatin treatment decreased cardiovascular risk for established patients in real-world settings, with no significant difference in treatment effects observed between patients with and without CKD.
RCT Entities:
BACKGROUND: This post hoc analysis of the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) Study investigates the effect of focused atorvastatin therapy versus usual care on cardiovascular outcomes in patients with coronary heart disease (CHD) with and without chronic kidney disease (CKD). STUDY DESIGN: Prospective randomized open-label; median follow-up, 54.3 months. SETTING & PARTICIPANTS: Managed care or Veterans Affairs facilities; 2,442 patients with CHD with dyslipidemia; mean age, 61.6 years. INTERVENTION: Focused atorvastatin therapy to a low-density lipoprotein cholesterol goal of less than 80 mg/dL or maximum dose of 80 mg/d versus usual care as deemed appropriate by patients' regular physicians. PREDICTOR: Baseline estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease Study equation of less than 60 mL/min/1.73 m(2) (patients with CKD) and 60 mL/min/1.73 m(2) or greater (patients without CKD). OUTCOMES & MEASUREMENTS: The primary end point was time to first cardiovascular event. Change from baseline eGFR was assessed in 1,768 patients with follow-up renal data. RESULTS: At baseline, 579 patients (23.7%) had CKD: 31.6% of these patients experienced a primary cardiovascular event during the study versus 23.6% of patients without CKD (hazard ratio [HR], 1.41; 95% confidence interval [CI], 1.18 to 1.68; P < 0.001). Compared with usual care, atorvastatin therapy reduced the relative risk of a primary outcome by 28% in patients with CKD (HR, 0.72; 95% CI, 0.54 to 0.97; P = 0.02) and 11% in patients without CKD (HR, 0.89; 95% CI, 0.74 to 1.07; P = 0.3) (P for treatment by CKD interaction = 0.2). There was no decrease in eGFR in atorvastatin-treated patients during the course of the study. LIMITATIONS: Follow-up of atorvastatinpatients was restricted to every 6 months; interim data were unavailable for usual-care patients. CONCLUSIONS:Patients with CHD and CKD are at increased risk of cardiovascular events. Compared with usual care, focused atorvastatin treatment decreased cardiovascular risk for established patients in real-world settings, with no significant difference in treatment effects observed between patients with and without CKD.
Authors: Jennifer E Ho; David D Waters; Allison Kean; Daniel J Wilson; David A Demicco; Andrei Breazna; Chuan-Chuan Wun; Prakash C Deedwania; Kiran K Khush Journal: Am J Cardiol Date: 2012-03-28 Impact factor: 2.778
Authors: Suetonia C Palmer; Jonathan C Craig; Sankar D Navaneethan; Marcello Tonelli; Fabio Pellegrini; Giovanni F M Strippoli Journal: Ann Intern Med Date: 2012-08-21 Impact factor: 25.391