title: Simvastatin initiated early after heart transplantation: 8-year prospective experience.
abstract: BACKGROUND
  Randomized clinical trials have demonstrated that the use of statins in heart transplant patients lowers cholesterol levels and significantly reduces mortality and the development of transplant vasculopathy. The aim of the present study was to test these effects and the safety of statin therapy over an 8-year period.
  
  
  RESULTS
  In 1991, a prospective, randomized, unmasked study was initiated to compare the efficacy of simvastatin, started on the fourth postoperative day (n=35), with that of dietary therapy alone (n=37). Because of significantly improved survival and a lower incidence of transplant vasculopathy, most patients in both groups received statins as open-label prescriptions after 4 years. After 8 years, the Kaplan-Meier survival rate was 88.6% in the simvastatin group versus 59.5% in the control group (P<0.006 by log rank; hazard ratio, 0.24; 95% CI, 0.08 to 0.71). Deaths in the simvastatin and control groups were due to transplant vasculopathy (1 versus 4; P<0.2), severe transplant rejection (1 versus 5; P<0.1), malignancies (0 versus 3; P<0.1), and other causes (2 versus 3; P<0.7). The incidence of transplant vasculopathy confirmed by angiography was 24.4% in the simvastatin group versus 54.7% in the control group (P<0.02 by log rank). There was no difference in organ function between the 2 groups. No severe adverse effects of the therapy were observed up to the end of the 8-year observation period.
  
  
  CONCLUSIONS
  Simvastatin therapy initiated early after heart transplantation leads to significantly better 8-year survival rates and a significantly lower incidence of transplant vasculopathy without impairment of organ function or severe adverse effects.
authors.affiliation: Division of Cardiac Surgery, Munich-Bogenhausen, Germany. klaus.wenke@extern.lrz-muenchen.de
authors.forename: Klaus
authors.initials: K
authors.lastname: Wenke
authors.forename: Bruno
authors.initials: B
authors.lastname: Meiser
authors.forename: Joachim
authors.initials: J
authors.lastname: Thiery
authors.forename: Dorothea
authors.initials: D
authors.lastname: Nagel
authors.forename: Wolfgang
authors.initials: W
authors.lastname: von Scheidt
authors.forename: Karl
authors.initials: K
authors.lastname: Krobot
authors.forename: Gerhard
authors.initials: G
authors.lastname: Steinbeck
authors.forename: Dietrich
authors.initials: D
authors.lastname: Seidel
authors.forename: Bruno
authors.initials: B
authors.lastname: Reichart
mesh_terms: D000328:Adult; D008078:Cholesterol, LDL / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000453:epidemiology; D016027:Heart Transplantation / Q000009:adverse effects / Q000401:mortality / Q000473:pathology; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D019821:Simvastatin / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate; D013997:Time Factors
chemical_list: D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D019821:Simvastatin