title: An observational study of ezetimibe in cardiac transplant recipients receiving calcineurin inhibitors.
abstract: BACKGROUND
  Cardiac transplant patients are at risk for developing cardiac allograft vasculopathy, and dyslipidemia in this patient population has been associated with increased risk. Data evaluating the efficacy and safety of ezetimibe in this population are minimal.
  
  
  OBJECTIVE
  The purpose of this study was to assess the effects of ezetimibe, alone or in combination with other lipid-lowering agents, in cardiac transplant recipients receiving calcineurin inhibitors (CNIs).
  
  
  METHODS
  This study was a single-center retrospective chart review. Data on demographics, medications prescribed for dyslipidemia and prevention of transplant rejection, results of lipid panels, CNI blood concentrations, and adverse effects were extracted from medical records of cardiac transplant recipients who were prescribed ezetimibe, either alone or in combination with other lipid-lowering agents, and seen at least once in a 12-month period at a cardiac transplantation clinic of an 800-bed teaching hospital.
  
  
  RESULTS
  There were 71 patients prescribed ezetimibe in whom a safety analysis was performed. Approximately 49% (n = 35) were included in the analysis for lipid lowering. Ezetimibe significantly decreased low-density lipoprotein cholesterol (LDL-C; 129 mg/dL vs 94 mg/dL, P < .0001), non-high-density lipoprotein cholesterol (non-HDL-C; 170 mg/dL vs 127.5 mg/dL, P = .0058), and total cholesterol (236 mg/dL vs 200 mg/dL, P < .0001). There was no significant change in HDL-C and triglycerides as compared with baseline. The proportion of patients achieving goal LDL-C < 100 mg/dL significantly increased from 11.5% at baseline to 60.5% after the addition of ezetimibe (P < .0001). Ezetimibe had no measurable effect on blood CNI concentrations or doses. Adverse effects were reported by 15.5% of patients (n = 11), with 4% (n = 3) of patients discontinuing therapy. The most common complaints were gastrointestinal intolerance and myalgia.
  
  
  CONCLUSIONS
  Ezetimibe was associated with lower LDL-C in cardiac transplant recipients either as combination therapy in patients with elevated LDL-C or as monotherapy, with a low frequency of adverse effects.
authors.affiliation: Lancaster General Health, Lancaster, PA, USA.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Makkar
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Sanoski
authors.forename: Lee R
authors.initials: LR
authors.lastname: Goldberg
authors.forename: Sarah A
authors.initials: SA
authors.lastname: Spinler
mesh_terms: D000328:Adult; D000368:Aged; D064591:Allografts / Q000098:blood supply; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001384:Azetidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D065095:Calcineurin Inhibitors; D008078:Cholesterol, LDL / Q000097:blood*; D003327:Coronary Disease / Q000097:blood / Q000517:prevention & control; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000097:blood / Q000188:drug therapy*; D000069438:Ezetimibe; D005260:Female; D016027:Heart Transplantation; D006746:Hospital Bed Capacity, 500 and over; D006784:Hospitals, Teaching; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D000924:Anticholesteremic Agents; D001384:Azetidines; D065095:Calcineurin Inhibitors; D008078:Cholesterol, LDL; D007166:Immunosuppressive Agents; D000069438:Ezetimibe
keywords: cardiac transplant; dyslipidemia; ezetimibe; hyperlipidemia; safety; statin