Blood Pressure in De novo Heart Transplant Recipients Treated with Everolimus Compared with a Cyclosporine-Based Regimen: Results from the Randomized SCHEDULE Trial.Andreassen AK, Broch K, et al.
Transplantation, 2018; [record in progress].
To determine whether hypertension is less prevalent in patients allocated to everolimus than in patients allocated to CNI-based treatment.
Adult, de novo heart transplant recipients were randomized in the SCHEDULE trial to receive either low dose everolimus, low dose cyclosporine, mycophenolate mofetil (MMF) and corticosteroids with elimination of cyclosporine and step-up to full-dose everolimus after 7-11 weeks (everolimus arm); or conventional treatment with cyclosporine, MMF and corticosteroids. Ambulatory, 24-hour blood pressure monitoring was performed.
For this secondary endpoint of the SCHEDULE trial, 24-hour ambulatory monitoring was used to measure blood pressure (average daytime values, and average nighttime values for systolic and diastolic blood pressures) up to 3 years after heart transplantation.
This manuscript reports a secondary analysis of the SCHEDULE trial, where de novo heart transplant recipients were randomized to everolimus- or cyclosporine-based immunosuppression. The preplanned analysis investigated the effects of everolimus on blood pressure up to 36 months post-transplant. Both arms saw small falls in systolic blood pressure, with the fall being 13mmHg greater in the everolimus arm. Analysis was per intent-to-treat, and blood pressure measurements were documented by 24-hour ambulatory monitoring. It should be noted that the cohort included is only a subset of around 70% of the patients in the overall SCHEDULE trial, which does raise the risk of inclusion bias. However, the improvement in blood pressure, coupled with the earlier-published improvements in renal function, suggests that everolimus may be a useful alternative to CNI in these patients.
ClinicalTrials.gov - NCT01266148