title: 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.affiliation: Western Infirmary, Glasgow, Scotland, UK. a.g.jardine@clinmed.gla.ac.uk
authors.forename: Alan G
authors.initials: AG
authors.lastname: Jardine
authors.forename: Hallvard
authors.initials: H
authors.lastname: Holdaas
authors.forename: Bengt
authors.initials: B
authors.lastname: Fellström
authors.forename: Edward
authors.initials: E
authors.lastname: Cole
authors.forename: Gudrun
authors.initials: G
authors.lastname: Nyberg
authors.forename: Carola
authors.initials: C
authors.lastname: Grönhagen-Riska
authors.forename: Søren
authors.initials: S
authors.lastname: Madsen
authors.forename: Hans-Hellmut
authors.initials: HH
authors.lastname: Neumayer
authors.forename: Bart
authors.initials: B
authors.lastname: Maes
authors.forename: Patrice
authors.initials: P
authors.lastname: Ambühl
authors.forename: Anders G
authors.initials: AG
authors.lastname: Olsson
authors.forename: Ingar
authors.initials: I
authors.lastname: Holme
authors.forename: Per
authors.initials: P
authors.lastname: Fauchald
authors.forename: Claudio
authors.initials: C
authors.lastname: Gimpelwicz
authors.forename: Terje R
authors.initials: TR
authors.lastname: Pedersen
mesh_terms: D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D008078:Cholesterol, LDL / Q000097:blood / Q000187:drug effects; D003643:Death; D004311:Double-Blind Method; D005229:Fatty Acids, Monounsaturated / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D005500:Follow-Up Studies; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control*; D010919:Placebos; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D010919:Placebos; D000077340:Fluvastatin