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Volume 53, Issue 5, Pages 741-750 (May 2009)


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Focused Atorvastatin Therapy in Managed-Care Patients With Coronary Heart Disease and CKD

ALLIANCE InvestigatorsMichael J. Koren, MD1Corresponding Author Informationemail address, Michael H. Davidson, MD2, Daniel J. Wilson, MD3, Rana S. Fayyad, PhD3, Andrea Zuckerman, MD3, David P. Reed, MD3

Received 10 July 2008; accepted 11 November 2008. published online 12 February 2009.

Refers to article:
Statin Effects in CKD: Is There a “Point of No Return”?
Christoph Wanner
American Journal of Kidney Diseases
May 2009 (Vol. 53, Issue 5, Pages 723-725)
Full Text | Full-Text PDF (132 KB)
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 m2 (patients with CKD) and 60 mL/min/1.73 m2 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.

1 Jacksonville Center for Clinical Research, Jacksonville, FL

2 Section of Cardiology, Pritzker School of Medicine, University of Chicago, Chicago, IL

3 Pfizer Inc, New York, NY

Corresponding Author InformationAddress correspondence to Michael J. Koren, MD, Jacksonville Center for Clinical Research, 4085 University Blvd S, Ste 1, Jacksonville, FL 32216

 Originally published online as doi:10.1053/j.ajkd.2008.11.025 on February 12, 2009.

 For a list of ALLIANCE Investigators, please see reference 18.

PII: S0272-6386(08)01760-5

doi:10.1053/j.ajkd.2008.11.025


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