Safety and efficacy of atorvastatin in heart transplant recipients

Patel, Devang N; Pagani, Francis D; Koelling, Todd M; Dyke, David B; Baliga, Ragavendra R; Cody, Robert J; Lake, Kathleen D; Aaronson, Keith D

« Previous Next »The Journal of Heart and Lung Transplantation
Volume 21, Issue 2 , Pages 204-210, February 2002

Safety and efficacy of atorvastatin in heart transplant recipients

Devang N Patel, MD
- Cardiac Transplant Program, Department of Internal Medicine, Ann Arbor, Michigan, USA
Francis D Pagani, MD
- Department of Surgery, University of Michigan Health System, Ann Arbor, Michigan, USA
Todd M Koelling, MD
- Cardiac Transplant Program, Department of Internal Medicine, Ann Arbor, Michigan, USA
David B Dyke, MD
- Cardiac Transplant Program, Department of Internal Medicine, Ann Arbor, Michigan, USA
Ragavendra R Baliga, MD
- Cardiac Transplant Program, Department of Internal Medicine, Ann Arbor, Michigan, USA
Robert J Cody, MD
- Cardiac Transplant Program, Department of Internal Medicine, Ann Arbor, Michigan, USA
Kathleen D Lake, PharmD
- Cardiac Transplant Program, Department of Internal Medicine, Ann Arbor, Michigan, USA
Keith D Aaronson, MD, MS
- Reprint requests: Keith Aaronson, University of Michigan Medical Center, Division of Cardiology, Room L3623, Ann Arbor, MI 48109-0271 USA Telephone: (734) 764-7440. Fax: (734) 615-3326
- Cardiac Transplant Program, Department of Internal Medicine, Ann Arbor, Michigan, USA

Received 19 January 2001; accepted 27 June 2001.

Abstract

Background: Pravastatin and simvastatin prolong survival and reduce transplant-related coronary vasculopathy, although low-density lipoprotein (LDL) lowering with these agents is only modest. The objective of this study was to assess the safety of moderate dose atorvastatin and its efficacy when prior treatment with another statin had failed to lower LDL to < 100 mg/dl.

Methods: Data from 185 patients were retrospectively evaluated for adverse events, duration of exposure (person-days), and the mean atorvastatin dose exposure. Changes in lipid parameters, and prednisone and cyclosporine doses were determined.

Results: Safety: 48 patients received atorvastatin for 24,240 person-days at a mean dose exposure of 21 ± 10 mg. Rhabdomyolysis, myositis, myalgias, and hepatotoxicity occurred in 0, 2, 2, and 0 patients, respectively. All events occurred at the 10-mg dose, within the first 3 months, and were rapidly reversible with atorvastatin discontinuation. Efficacy: Thirty-four patients evaluable for efficacy analyses had a pre-atorvastatin LDL of 145 ± 38 mg/dl on the following statins: pravastatin (n = 30, 40 ± 0mg), fluvastatin (n = 3, 33 ± 12 mg), simvastatin (n = 1, 40 mg). After atorvastatin (21 ± 9 mg/day) for 133 ± 67 days, LDL was reduced to 97 ± 24 mg/dl (relative reduction 31 ± 20%, p < 0.0001). At the end of the observation period (418 ± 229 days, atorvastatin final dose 24 ± 14 mg/day), LDL was further decreased to 88 ± 23 mg (relative reduction 37 ± 17%, p < 0.0001).

Conclusion: Atorvastatin, when used at moderate doses and with close biochemical and clinical monitoring, appears to be safe and is effective in aggressively lowering LDL in heart transplant recipients when treatment with other statins has failed to achieve LDL goals.