The efficacy and safety of ezetimibe for treatment of dyslipidemia after heart transplantation.
BACKGROUND
Statins, although the treatment of choice for dyslipidemia after heart transplantation (HT), are not always well tolerated or effective. In such cases, administration of ezetimibe may be useful.


OBJECTIVE
The aim of this study was to assess the efficacy and safety of ezetimibe, with or without statins, after HT.


METHODS
Thirty-six HT patients, 97% of whom were males of overall mean age of 57 +/- 13 years, were all unable to reach target lipid levels with statins alone and/or were intolerant of statins. They were prescribed ezetimibe, with or without a statin. Efficacy and safety were evaluated after 1, 3, 6, and 12 months.


RESULTS
Thirty-four patients were evaluated at 1 month and 12 months. Ezetimibe was prescribed to 27 patients (75%) because of statin inefficacy, and to 9 patients (25%) because of statin intolerance, manifested by myalgia in 4 cases (11%), hepatotoxicity in 2 cases (6%), and rhabdomyolysis in 3 cases (8%). Lipid levels (mg/dL; baseline vs 1 year) were as follows: cholesterol, 235 +/- 49 versus 167 +/- 32 (P = .013); LDL cholesterol, 137 +/- 47 versus 89 +/- 29 (P = .001); HDL cholesterol, 54 +/- 13 versus 51 +/- 10 (P = .235); and triglycerides, 243 +/- 187 versus 143 +/- 72 (P = .022). There were no cases of liver toxicity, renal dysfunction, or significant alteration of immunosuppressive pharmacokinetics. Ezetimibe was withdrawn from 2 patients because of hand edema or asymptomatic recurrence of rhabdomyolysis first caused by statins.


CONCLUSIONS
With or without a statin, ezetimibe was generally well tolerated, reducing total cholesterol, LDL cholesterol, and triglyceride levels with no long-term alteration of HDL cholesterol levels. CPK surveillance is recommended because of a slight continued risk of adverse effects. Further studies should evaluate the benefit for survival.
Crespo-Leiro
M G
MG
Heart Transplant Unit, Cardiology Service, Complejo Hospitalario Universitario Juan Canalejo, La Coruña, Spain. Marisa_Crespo@canalejo.org
Paniagua
M J
MJ
Marzoa
R
R
Grille
Z
Z
Naya
C
C
Flores
X
X
Rodriguez
J A
JA
Mosquera
V
V
Franco
R
R
Castro-Beiras
A
A
D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D000069059:Atorvastatin; D001384:Azetidines / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D050171:Dyslipidemias / Q000188:drug therapy*; D000069438:Ezetimibe; D005260:Female; D016027:Heart Transplantation / Q000276:immunology / Q000502:physiology*; D006538:Heptanoic Acids / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000188:drug therapy*; D017035:Pravastatin / Q000627:therapeutic use; D011758:Pyrroles / Q000627:therapeutic use; D055815:Young Adult
D000924:Anticholesteremic Agents; D001384:Azetidines; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007166:Immunosuppressive Agents; D008055:Lipids; D011758:Pyrroles; D000069059:Atorvastatin; D000069438:Ezetimibe; D017035:Pravastatin