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21 January 2003 | Volume 138 Issue 2 | Pages 98-104
Background: Cardiovascular disease is a common cause of morbidity and death in persons with renal insufficiency. Although 3-hydroxy-3methylglutaryl coenzyme A reductase inhibitors (statins) are effective for secondary prevention of cardiovascular events in the general population, they have not been specifically studied in chronic renal insufficiency.
Objective: To determine whether pravastatin is effective and safe for secondary prevention of cardiovascular events in persons with chronic renal insufficiency.
Design: Post hoc subgroup analysis of a randomized, double-blind, placebo-controlled trial.
Setting: The Cholesterol and Recurrent Events (CARE) study, a randomized trial of pravastatin versus placebo in 4159 participants with previous myocardial infarction and total plasma cholesterol levels less than 6.21 mmol/L (<240 mg/dL).
Participants: 1711 participants with chronic renal insufficiency defined by creatinine clearance less than or equal to 75 mL/min, using the Cockcroft–Gault equation.
Measurements: The primary outcome was death from coronary disease or symptomatic nonfatal myocardial infarction.
Results: After a median follow-up of 58.9 months, the incidence of the primary end point was lower in participants receiving pravastatin than in those receiving placebo (adjusted hazard ratio, 0.72 [95% CI, 0.55 to 0.95]; P = 0.02). Pravastatin was associated with lower adjusted hazard ratios for major coronary events (0.72 [CI, 0.59 to 0.88]; P = 0.001) and coronary revascularization (0.65 [CI, 0.50 to 0.83]; P = 0.001), but not total mortality (0.81 [CI, 0.61 to 1.08]; P = 0.14) or stroke (0.62 [CI, 0.39 to 1.00]; P = 0.051). Tests for interaction suggested that the observed benefit was independent of the presence and severity of renal insufficiency. Incidence of side effects was similar in persons receiving pravastatin and those receiving placebo.
Conclusions: These data suggest that pravastatin is effective and appears safe for secondary prevention of cardiovascular events in persons with mild chronic renal insufficiency. Since statins may be underused in this setting, physicians should consider prescribing them for patients with chronic renal insufficiency and known coronary disease.
Editors' Notes
Context
Contribution
Implications
–The Editors
Author and Article Information
From University of Alberta, Edmonton, Alberta, Canada; University of Texas School of Public Health, Houston, Texas; Harvard School of Public Health, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts; and Dalhousie University, Halifax, Nova Scotia, Canada.
Grant Support: By Bristol-Myers Squibb. Dr. Tonelli was a recipient of the Kidney Foundation of Canada/Baxter Corporation Biomedical Research Fellowship. Data analysis for this project was supported by a grant from Bristol-Myers Squibb to University of Texas School of Public Health.
Potential Financial Conflicts of Interest:Consultancies: F.M. Sacks; Honoraria: F.M. Sacks; Grants received: L. Moyé, F.M. Sacks; Other: L. Moyé.
Requests for Single Reprints: Marcello Tonelli, MD, SM, Division of Nephrology and Immunology, University of Alberta, Clinical Sciences Building, Suite 11-108C, 8440 112 Street, Edmonton, Alberta T6B 2B7, Canada.
Current Author Addresses: Dr. Tonelli: Division of Nephrology and Immunology, University of Alberta, Clinical Sciences Building, Suite 11-108C, 8440 112 Street, Edmonton, Alberta T6B 2B7, Canada.
Dr. Moyé: University of Texas School of Public Health, 1200 Herman Pressler E815, Houston, TX 77030.
Dr. Sacks: Nutrition Department, Harvard School of Public Health, 6655 Huntington Avenue, Boston, MA 02115.
Dr. Kiberd: Suite 5078, Dickson Building, 5820 University Avenue, Halifax, Nova Scotia, B3H 1V8, Canada.
Dr. Curhan: Channing Laboratory, 181 Longwood Avenue, Boston, MA 02115.
Author Contributions: Conception and design: M. Tonelli, L. Moyé, F.M. Sacks, B. Kiberd, G. Curhan.
Analysis and interpretation of the data: M. Tonelli, L. Moyé, F.M. Sacks, B. Kiberd, G. Curhan.
Drafting of the article: M. Tonelli, L. Moyé, G. Curhan.
Critical revision of the article for important intellectual content: M. Tonelli, L. Moyé, F.M. Sacks, B. Kiberd, G. Curhan.
Final approval of the article: M. Tonelli, F.M. Sacks, B. Kiberd, G. Curhan.
Statistical expertise: L. Moyé, G. Curhan.
Administrative, technical, or logistic support: F.M. Sacks, G. Curhan. ARTICLE
Pravastatin for Secondary Prevention of Cardiovascular Events in Persons with Mild Chronic Renal Insufficiency
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