Regimens With Everolimus and Mycophenolate Mofetil Result in Comparable Changes in Lipid Profiles After Cardiac Transplantation: Presented at ATC

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Title: Regimens With Everolimus and Mycophenolate Mofetil Result in Comparable Changes in Lipid Profiles After Cardiac Transplantation: Presented at ATC
URL: http://www.pslgroup.com/dg/222F5E.htm
Doctor's Guide
June 4, 2008

By Thomas S. May

TORONTO -- June 4, 2008 -- The deleterious effects of everolimus on lipid profiles of heart transplant patients is comparable to that of mycophenolate mofetil (MMF), results of a recent study indicate. Data from the 1-year, randomised, multicentre, open-label study were presented here on May 31, during a poster session, at the 2008 American Transplant Congress (ATC).

Gaia Magnani, S. Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy, and the RAD A2411 Study Group investigators enrolled 176 de novo primary cardiac transplant recipients for their study, conducted to determine the impact after cardiac transplantation of immunosuppressant regimens.

Patients were randomised to receive either everolimus at a target trough level of 3 to 8 ng/mL plus reduced-exposure cyclosporine A microemulsion (CsA-ME, n = 92) or MMF 1,500 mg BID plus standard-exposure CsA (n = 84), both with corticosteroids. More than 90% of patients in each cohort also received statin therapy, even when the patient did not have an elevated cholesterol level at baseline.

Lipid profiles were measured multiple times during the first year.

From baseline to month 3, there was a significant increase in total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol in both treatment groups.

At 12 months, total cholesterol and triglycerides were significantly higher in the everolimus group than in the MMF group.

With respect to all lipids, however, there was no statistically significant difference between the 2 groups. And both groups were in the same strata (except for total cholesterol) when stratifying according to American Heart Association (AHA) risk classification. The difference between groups in LDL cholesterol was not significant, and HDL-cholesterol levels were comparable between the 2 cohorts.

According to the scientists, these data indicate that both MMF- and everolimus-based immunosuppressive regimens following de novo cardiac transplantation are associated with a significant rise in lipid parameters, despite the use of statin therapy.

Compared with MMF, everolimus does not induce clinically meaningful changes in triglycerides and LDL- or HDL-cholesterol levels, the researchers concluded.

"From a clinical standpoint, everolimus does not exacerbate lipid levels in a clinically meaningful way compared to MMF in the presence of statin therapy," they noted.

Funding for this study was provided by Novartis Pharma AG.

[Presentation title: Everolimus- vs MMF-Based Immunosuppression: Comparable Lipid Profiles at One Year After Cardiac Transplantation. Abstract 626]

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