Effect of everolimus vs calcineurin inhibitors on quality of life in heart transplant recipients during a 3-year follow-up: Results of a randomized controlled trial (SCHEDULE)

The Scandinavian heart transplant everolimus de novo study with early calcineurin inhibitors avoidance (SCHEDULE) trial was a 12month, randomized, open-label, parallel-group trial that compared everolimus (EVR; n=56) to conventional CsA (n=59) immunosuppression. Previously, we reported that EVR outperformed CsA in improving renal function and coronary artery vasculopathy, despite a higher rejection rate with EVR. This study aimed to compare the effects of these treatments on quality of life (QoL). Within five post-operative days, patients (mean age 50 +/- 13years, 27% women) were randomized to EVR or a standard CsA dosage (CsA group). This study assessed quality of life (QoL), based on the Short Form-36, EuroQol-5D, and Beck Depression Inventory (BDI). Assessments were performed pre-HTx and 12 and 36months post-HTx. At 12 and 36months, the groups showed similar improvements in Short Form-36 measures (at pre-HTx, 12 and 36months the values were as follows: Physical component summary: EVR: 31.5 +/- 110.9, 49.1 +/- 9.7, and 47.9 +/- 10.6; P<.01; CsA: 32.5 +/- 8.2, 48.4 +/- 8.5, and 46.5 +/- 11.5; P<.01; mental component summary: EVR: 46.0 +/- 12.0, 51.7 +/- 11.9, and 52.1 +/- 13.0; P<.01; CsA: 38.2 +/- 12.5, 53.4 +/- 7.1, and 54.3 +/- 13.0; P<.01); similar decrease in mean BDI (EVR: 10.9 +/- 10.2, 5.4 +/- 4.7, and 8.1 +/- 9.0; P<.01; CsA: 11.8 +/- 7.1, 6.3 +/- 5.4, and 6.2 +/- 6.5; P<.01); and similar Euro Qol-improvements. Thus, in this small-sized study, EVR-based and conventional CsA immunosuppressive strategies produced similar QoL improvements.