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Metabolic Sequelae of Everolimus Treatment After Cardiac Transplant: A Hypothesis-Generating Study
Lisa M Raven1, Christopher A Muir2, Jim Pouliopoulos3
1Department of Diabetes and Endocrinology, St Vincent's Hospital, Sydney, NSW, Australia; Clinical Diabetes, Appetite and Metabolism Laboratory, Garvan Institute of Medical Research, Sydney, NSW, Australia; School of Clinical Medicine, St Vincent's Campus, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.
Background:
Although modern immunosuppressants improve survival post-transplant, they are associated with long-term metabolic complications, such as post-transplant diabetes mellitus (PTDM). Calcineurin inhibitor-sparing regimens using everolimus attenuate some complications such as left ventricular hypertrophy. However, the metabolic effects of everolimus following transplant are less clear.
Methods:
Post-hoc analysis to compare PTDM and other metabolic outcomes in participants of a randomised open-label clinical trial of low-dose everolimus and tacrolimus versus standard-dose tacrolimus in heart transplant recipients (RADTAC1 study).
Results:
There were 39 participants in the trial; mean follow-up was 6.4±1.5 years. There was a high rate of pre-existing diabetes (26%) and newly diagnosed PTDM (36%) during follow-up. Half the patients who developed PTDM in the everolimus-tacrolimus group (n=4/8) ceased diabetes medications during follow-up, which was not observed in patients on standard tacrolimus (n=0/6). In the first 12 months there was a higher use of non-insulin treatment for diabetes in the everolimus-tacrolimus group compared to the standard tacrolimus group.
Conclusions:
This study suggests that treatment with everolimus may be associated with improved glycaemic control of PTDM relative to treatment with standard doses of calcineurin inhibitor. These findings should be further studied in prospective randomised trials.
Insights
Everolimus-based immunosuppression in heart transplant recipients may improve post-transplant diabetes mellitus (PTDM) control. Patients on everolimus and tacrolimus showed better glycemic management compared to standard tacrolimus, with some discontinuing diabetes medications.
Area of Science:
- Transplantation Medicine
- Immunosuppression
- Metabolic Complications
Background:
- Modern immunosuppressants improve transplant survival but cause metabolic issues like post-transplant diabetes mellitus (PTDM).
- Everolimus-based regimens may reduce some complications, but its specific metabolic effects, particularly on PTDM, require further investigation.
Purpose of the Study:
- To compare PTDM and other metabolic outcomes in heart transplant recipients on low-dose everolimus plus tacrolimus versus standard-dose tacrolimus.
- To evaluate the long-term metabolic effects of everolimus in heart transplant patients.
Main Methods:
- Post-hoc analysis of the randomized RADTAC clinical trial.
- Comparison of PTDM incidence, glycemic control, and diabetes medication use between treatment groups.
Main Results:
- High rates of pre-existing and newly diagnosed PTDM were observed (26% and 36%, respectively).
- Half of PTDM patients in the everolimus-tacrolimus group ceased diabetes medications, unlike the standard tacrolimus group.
- Everolimus-tacrolimus group showed higher use of non-insulin diabetes treatments in the first year.
Conclusions:
- Everolimus treatment may be linked to better glycemic control in PTDM patients compared to standard calcineurin inhibitor doses.
- Further prospective randomized trials are recommended to confirm these findings.
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