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Focused atorvastatin therapy in managed-care patients with coronary heart disease and CKD.
Am J Kidney Dis. 2009 May; 53(5):741-50.AJ

Abstract

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.

Authors+Show Affiliations

Jacksonville Center for Clinical Research, Jacksonville, FL 32216, USA. michaelkoren@jaxresearch.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19216014

Citation

Koren, Michael J., et al. "Focused Atorvastatin Therapy in Managed-care Patients With Coronary Heart Disease and CKD." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 53, no. 5, 2009, pp. 741-50.
Koren MJ, Davidson MH, Wilson DJ, et al. Focused atorvastatin therapy in managed-care patients with coronary heart disease and CKD. Am J Kidney Dis. 2009;53(5):741-50.
Koren, M. J., Davidson, M. H., Wilson, D. J., Fayyad, R. S., Zuckerman, A., & Reed, D. P. (2009). Focused atorvastatin therapy in managed-care patients with coronary heart disease and CKD. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 53(5), 741-50. https://doi.org/10.1053/j.ajkd.2008.11.025
Koren MJ, et al. Focused Atorvastatin Therapy in Managed-care Patients With Coronary Heart Disease and CKD. Am J Kidney Dis. 2009;53(5):741-50. PubMed PMID: 19216014.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Focused atorvastatin therapy in managed-care patients with coronary heart disease and CKD. AU - Koren,Michael J, AU - Davidson,Michael H, AU - Wilson,Daniel J, AU - Fayyad,Rana S, AU - Zuckerman,Andrea, AU - Reed,David P, AU - ,, Y1 - 2009/02/11/ PY - 2008/07/10/received PY - 2008/11/11/accepted PY - 2009/2/14/entrez PY - 2009/2/14/pubmed PY - 2009/5/15/medline SP - 741 EP - 50 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 53 IS - 5 N2 - 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. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/19216014/Focused_atorvastatin_therapy_in_managed_care_patients_with_coronary_heart_disease_and_CKD_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0272-6386(08)01760-5 DB - PRIME DP - Unbound Medicine ER -