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CLINICAL STUDY: CONGESTIVE HEART FAILURE

Comparative beneficial effects of simvastatin and pravastatin on cardiac allograft rejection and survival

^* Ochsner Clinic Foundation, New Orleans, Louisiana, USA

Manuscript received April 21, 2002; revised manuscript received May 27, 2002, accepted June 24, 2002.

^* Reprint requests and correspondence: Dr. Mandeep R. Mehra, Ochsner Clinic Foundation, 1514 Jefferson Highway, New Orleans, Louisiana 70121-2483, USA.
mmehra{at}ochsner.org

OBJECTIVES: We sought to evaluate the relative effects of low doses of pravastatin (20 mg/day) and simvastatin (10 mg/day) on indices of cardiac allograft rejection. We further examined the relative efficacy and safety of these two drugs on lipid-lowering in heart transplantation.

BACKGROUND: The immunomodulatory effects of hydroxy methyl glutaryl-coenzyme A reductase inhibitors have been increasingly recognized. Previous studies have demonstrated an ameliorative influence of pravastatin on hemodynamically compromising rejection after heart transplantation. A recent observational trial suggested that simvastatin 20 mg/day was associated with trends to lower survival and more adverse effects than pravastatin 40 mg/day.

METHODS: In a 12-month prospective, open-label study, 50 heart transplant recipients received either open-label pravastatin 20 mg daily (n = 24) or simvastatin 10 mg daily (n = 26) within four weeks of transplantation. Indices of allograft rejection including treated rejection, rejection with hemodynamic compromise, noncellular rejection, and mean one-year biopsy score were compared between the two cohorts, as well as with a statin-naive control population (n = 37). Lipid levels, safety, and post-transplant outcomes were also assessed as secondary end points.

RESULTS: We found no significant differences in any allograft rejection parameter between the two groups. However, total low-density lipoprotein (LDL), but not high-density lipoprotein cholesterol or triglycerides, were lower in the simvastatin arm (–23% vs. –11%, p = 0.02). No cases of rhabdomyolysis or myositis occurred in either group. Survival at one year was similar in both treatment groups (91% for patients on pravastatin and 92% for patients on simvastatin). Both groups had better survival compared with the statin-naive control group (80%, p = 0.04).

CONCLUSIONS: Simvastatin (10 mg/day) and pravastatin (20 mg/day) are associated with similar beneficial effects on cardiac allograft rejection and one-year survival. At these doses, simvastatin decreases LDL cholesterol more so than pravastatin with no increase in adverse effects in heart transplantation.

Abbreviations and Acronyms   HDL   high-density lipoprotein   HMG-CoA   hydroxy methyl glutaryl-coenzyme A   LDL   low-density lipoprotein   MHC   major histocompatability complex   NO   nitric oxide

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