Safety and tolerability of high-intensity statin therapy in heart transplant patients receiving immunosuppression with tacrolimus

Clin Transplant. 2019 Jan;33(1):e13454. doi: 10.1111/ctr.13454. Epub 2018 Dec 18.


Background: Following heart transplantation (HT), HMG CoA reductase inhibitors (statins) have been shown to reduce total and low-density lipoprotein (LDL) cholesterol, development of cardiac allograft vasculopathy (CAV), and mortality. Studies in HT patients have demonstrated the safety of low/moderate intensity statins; however, little data exist using high-intensity (HI) statins. The study aim was to evaluate the safety and efficacy of HI statins in HT recipients receiving tacrolimus.

Methods: This single-center, retrospective analysis included adult HT recipients from January 1, 2005, to December 31, 2015, who received HI statin therapy during posttransplant follow-up. The primary outcome, tolerability, was defined as the absence of myalgias, hepatotoxicity, rhabdomyolysis, or HI statin dose reduction/discontinuation. The secondary end point was the mean reduction in total and LDL cholesterol.

Results: Among the 24 patients included, one experienced myalgias and therapy discontinuation (4%; P > 0.99). No other HI statin dose reduction/discontinuation occurred, and no instances of rhabdomyolysis or hepatotoxicity were observed. The average reduction in total and LDL cholesterol after conversion to HI statin was 35 mg/dL (P = 0.02) and 19 mg/dL (P = 0.10), respectively.

Conclusions: High-intensity statin therapy appears safe and efficacious in HT recipients receiving tacrolimus and is a reasonable option for the treatment of refractory hyperlipidemia.

Keywords: atorvastatin calcium; coronary artery disease; graft rejection; heart transplantation; hydroxymethylglutaryl-CoA reductase inhibitors; rosuvastatin calcium; tacrolimus.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Heart Diseases / surgery*
  • Heart Transplantation / methods*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Hyperlipidemias / prevention & control*
  • Immunosuppressive Agents / therapeutic use*
  • Incidence
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Postoperative Complications / drug therapy*
  • Postoperative Complications / epidemiology
  • Prognosis
  • Retrospective Studies
  • Tacrolimus / therapeutic use*
  • United States / epidemiology


  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Immunosuppressive Agents
  • Tacrolimus