Effect of fluvastatin on cardiac outcomes in kidney transplant patients with systemic lupus erythematosus: A randomized placebo‐controlled study

• Published in: Arthritis and rheumatism Vol. 60; no. 4; pp. 1060 - 1064
• Main Authors: Norby, Gudrun E., Holme, Ingar, Fellström, Bengt, Jardine, Alan, Cole, Edward, Abedini, Sadollah, Holdaas, Hallvard
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01-04-2009; Wiley
• Subjects: Adult; Anticholesteremic Agents - administration & dosage; Anticholesteremic Agents - adverse effects; Biological and medical sciences; Cholesterol, LDL - blood; Coronary Artery Disease - mortality; Death, Sudden, Cardiac - prevention & control; Dermatologi och venerologi, klinisk genetik, invärtesmedicin; Dermatology and venerology,clinical genetics, internal medicine; Diseases of the osteoarticular system; Fatty Acids, Monounsaturated - administration & dosage; Fatty Acids, Monounsaturated - adverse effects; Follow-Up Studies; Humans; Indoles - administration & dosage; Indoles - adverse effects; Internal medicine; Invärtesmedicin; Kaplan-Meier Estimate; Kidney diseases; Kidney Transplantation; Lupus Erythematosus, Systemic - mortality; Lupus Nephritis - mortality; Lupus Nephritis - surgery; Medical sciences; MEDICIN; MEDICINE; Middle Aged; Morbidity; Myocardial Infarction - mortality; Myocardial Infarction - prevention & control; Njursjukdomar; Placebos; Postoperative Complications - mortality; Postoperative Complications - prevention & control; Proportional Hazards Models; Risk Factors; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Immunopathology; Connective tissue disease; Skin disease; Prognosis; Rheumatology; Autoimmune disease; Cardiovascular disease; Hypocholesterolemic agent; Kidney; Fluvastatin; Systemic lupus erythematosus; Systemic disease; Antilipemic agent
• ISSN: 0004-3591; 1529-0131; 1529-0131
• DOI: 10.1002/art.24379

Objective
Patients with systemic lupus erythematosus (SLE), with or without end‐stage renal failure, are at increased risk of premature cardiovascular disease. Although statin therapy has been found to reduce cardiovascular risk in the general population, its effectiveness in kidney transplant recipients with SLE has not been examined. This study was undertaken to investigate the effect of fluvastatin on cardiac end points in a randomized controlled trial of renal transplant patients with SLE.
Methods
Patients with SLE were identified from among participants in the Assessment of Lescol in Renal Transplantation trial, a randomized, double‐blind, placebo‐controlled study of the effect of fluvastatin (40–80 mg/day) on cardiovascular outcomes in renal transplant recipients. Patients were randomized to either a group receiving fluvastatin or a placebo group for the duration of the 5–6‐year trial, and then invited to continue in a 2‐year open‐label extension during which all participants, regardless of original group, received fluvastatin. Patients were followed up for a total of 7–8 years for assessment of the primary end point of major cardiac events, comprising nonfatal myocardial infarction, cardiac death, and coronary intervention procedures.
Results
Fluvastatin reduced low‐density lipoprotein cholesterol levels by 29.2% (95% confidence interval [95% CI] 18.3–40%), from a mean ± SD of 4.0 ± 0.9 mmoles/liter to 2.8 ± 1.1 mmoles/liter, and total cholesterol by 19.6% (95% CI 11.7–27.5%), from 6.4 ± 0.9 mmoles/liter to 5.1 ± 1.1 mmoles/liter. Compared with placebo‐treated patients, patients randomized to receive fluvastatin exhibited a 73.4% reduction in the risk of major cardiac events (relative risk 26.6 [95% CI 5.9–119.4], P = 0.064).
Conclusion
Our results indicate that the effect of fluvastatin on cardiac events in renal transplant recipients with SLE is similar to that observed with statin therapy in the renal transplant population as a whole.