fluvastatin prevents cardiac death and myocardial infarction in renal transplant recipients: post-hoc subgroup analyses of the ALERT Study.

Abstract

Renal transplant recipients have a greatly increased risk of premature cardiovascular disease. The ALERT study was a multicenter, randomized, double-blind, placebo-controlled trial of fluvastatin (40-80 mg/day) in 2102 renal transplant recipients followed for 5-6 years. The main study used a composite cardiac end-point including myocardial infarction, cardiac death and cardiac interventions. Although reduced by fluvastatin, this primary end-point failed to achieve statistical significance thus precluding analysis of predefined subgroups. Therefore, in the present survival analysis, we used an alternative primary end-point of cardiac death or definite nonfatal myocardial infarction (as used in other cardiac outcome trials) which was significantly reduced by Fluvastatin therapy and permits subgroup analysis. Fluvastatin reduced LDL-cholesterol by 1 mmol/L compared with placebo, and the incidence of cardiac death or definite myocardial infarction was reduced from 104 to 70 events (RR 0.65; 95% CI 0.48, 0.88; p = 0.005). Fluvastatin use was associated with reduction in cardiac death or nonfatal myocardial infarction, which achieved statistical significance in many subgroups. The subgroups included patients at lower cardiovascular risk, who were younger, nondiabetic, nonsmokers and without pre-existing CVD. These data support the early introduction of statins following renal transplantation.

• Authors: Alan G Jardine, Hallvard Holdaas, Bengt Fellström, Edward Cole, Gudrun Nyberg, Carola Grönhagen-Riska, Søren Madsen, Hans-Hellmut Neumayer, Bart Maes, Patrice Ambühl, Anders G Olsson, Ingar Holme, Per Fauchald, Claudio Gimpelwicz, Terje R Pedersen, ALERT Study Investigators
• Journal: American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons (Am J Transplant) Vol. 4 Issue 6 Pg. 988-95 (Jun 2004) ISSN: 1600-6135 [Print] United States
• PMID: 15147434 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anticholesteremic Agents
• Cholesterol, LDL
• Fatty Acids, Monounsaturated
• Indoles
• Placebos
• Fluvastatin

Topics

• Adult
• Aged
• Anticholesteremic Agents (therapeutic use)
• Cholesterol, LDL (blood, drug effects)
• Death
• Double-Blind Method
• Fatty Acids, Monounsaturated (therapeutic use)
• Female
• Fluvastatin
• Follow-Up Studies
• Humans
• Indoles (therapeutic use)
• Kidney Transplantation (mortality)
• Male
• Middle Aged
• Myocardial Infarction (prevention & control)
• Placebos
• Risk Factors
• Treatment Outcome