Cor Vasa 2008, 50(10):368-372 | DOI: 10.33678/cor.2008.134

The efficacy and safety of combination therapy with atorvastatin and tacrolimus in heart transplant recipients

Blanka Skalická^*, Ivan Málek, Yevheniya Vymětalová, Lenka Hošková, Mariana Podzimková, Josef Kautzner

Klinika kardiologie, Institut klinické a experimentální medicíny, Praha, Česká republika

Background: HMG-CoA inhibitors are a common part of standard drug regimen after orthotopic heart transplantation (OHTx). On the other hand, they are potentially dangerous as they could interact with cyclosporin A (CsA). The aim of this study was to evaluate the efficacy and safety of combination therapy with atorvastatin and tacrolimus (TAC) in heart transplant recipients.

Methods: We followed a group of 31 OHTx patients with repeatedly documented plasma levels of total cholesterol above 5.5 mmol/L while on fluvastatin therapy. CsA was the main immunosuppressive drug. The patients were subsequently switched to a combination of TAC and atorvastatin at a starting dose of 20 mg. Four patients had to discontinue this therapy due to adverse events. The remaining 27 OHTx patients remained on follow-up. Clinical assessment with blood tests was performed one month and four months after changing the drug regimen. A subgroup of 19 patients had additional follow-up assessment after seven months of therapy.

Results: Neither myalgia nor an increase in plasma creatine kinase levels were observed. Total cholesterol levels decreased significantly after the first month of treatment (6.06 ± 0.89 mmol/L vs. 4.74 ± 0.70 mmol/L; p < 0.0001). A similar trend was observed for LDL-cholesterol and apolipoprotein-B. The therapeutic effect remained stable throughout follow-up.

Conclusions: In patients after OHTx, switching to a combination of TAC and atorvastatin resulted in a significant decrease in cholesterol, LDL-cholesterol and apolipoprotein-B levels.

Keywords: Atorvastatin; Dyslipidemia; Heart transplantation; Statins; Tacrolimus

Published: October 1, 2008  Show citation