Background: Lipid-lowering therapy with statins has been associated with decreased mortality and morbidity in heart transplant recipients. Among the available drugs, pravastatin, fluvastatin or low-dose simvastatin have been recommended due to the low risk of pharmacokinetic interaction. However, these first-line statins possess a rather modest lipid-lowering effect and selection of alternative statins is limited due to interactions with cyclosporine (CsA). The aim of this prospective study was to evaluate the safety and efficacy of conversion to tacrolimus and atorvastatin in CsA-treated heart transplant recipients and dyslipidemia refractory to fluvastatin.
Methods: Thirty heart transplant recipients taking CsA and fluvastatin 40 to 80 mg/day, with total cholesterol levels of >211 mg/dl, were recruited. After baseline assessment, they were converted to tacrolimus and atorvastatin at a starting dose of 20 mg/day and underwent clinical and laboratory follow-up at 1, 4, 7, 10 and 13 months.
Results: During 13 months of follow-up, treatment with tacrolimus and atorvastatin was tolerated in 24 patients (80%). No case of myotoxicity, liver toxicity or new-onset diabetes was observed. After conversion, the mean cholesterol level (as averaged from levels at 1, 4, 7, 10 and 13 months) was lower than before conversion (183 +/- 24 vs 231 +/- 33 mg/dl, p < 0.0001). When compared with baseline values, conversion also resulted in lower mean LDL-cholesterol levels (92 +/- 25 vs 130 +/- 38 mg/dl, p < 0.0001) and lower mean triglyceride levels (166 +/- 60 vs 220 +/- 101 mg/dl, p < 0.0001).
Conclusions: Conversion to tacrolimus and atorvastatin appears to be a safe and effective lipid-lowering therapy in CsA-treated heart transplant recipients with dyslipidemia refractory to fluvastatin.