This work was presented, in part, at the First Joint Transplant Meeting of the American Society of Transplant Surgeons and the American Society of Transplantation, May 13–17, 2000, Chicago, IL, USA, and at the 18th International Congress of the Transplantation Society, Rome, Italy, August 27–September 1, 2000.
Effects of Sirolimus on Lipids in Renal Allograft Recipients: An Analysis Using the Framingham Risk Model†
Article first published online: 13 JUN 2002
American Journal of Transplantation
Volume 2, Issue 6, pages 551–559, July 2002
How to Cite
Blum, C. B. (2002), Effects of Sirolimus on Lipids in Renal Allograft Recipients: An Analysis Using the Framingham Risk Model. American Journal of Transplantation, 2: 551–559. doi: 10.1034/j.1600-6143.2002.20610.x
- Issue published online: 13 JUN 2002
- Article first published online: 13 JUN 2002
- Received 9 July 2001, revised and accepted for publication 1 January 2002
- coronary heart disease;
- Framingham risk model;
This report describes the effects of sirolimus on plasma lipids, and uses the Framingham risk model to assess the clinical importance of these effects.
Lipid data from two large controlled studies of 1295 renal transplant patients were analyzed retrospectively. Sirolimus 2 mg/day and 5 mg/day were compared with placebo or azathioprine, and administered concomitantly with steroids and cyclosporine over 12 months.
Hypercholesterolemia and hypertriglyceridemia occurred in all treatment groups and were maximal at 2–3 months. The sirolimus groups evidenced higher lipid levels than the controls, but the elevations diminished over time. At 1 year, the patients given sirolimus 2 mg/day had a mean cholesterol level 17 mg/dL greater and a mean triglyceride level 59 mg/dL greater than the controls. Among the patients given sirolimus 5 mg/day, mean cholesterol was 30 mg/dL greater and mean triglycerides were 103 mg/dL greater than the controls. Treatment with statins and fibrates was effective in reducing cholesterol and triglyceride levels, respectively, in the sirolimus-treated patients. The Framingham risk model predicted that the 17 mg/dL elevation in cholesterol would increase the incidence of coronary heart disease (CHD) by 1.5 new cases per 1000 persons per year and CHD death by 0.7 events per 1000 persons per year.
Lipid elevations observed in the sirolimus-treated patients were manageable, improved over time, and responded to lipid-lowering therapy. Based on the Framingham risk model, the CHD risks associated with these cholesterol elevations are small compared with the baseline risks of the transplant population.