Assessment of health-related quality-of-life in patients after heart transplantation under therapy with tacrolimus or cyclosporine.

Reduction of allograft rejections remains a primary goal for patients after orthotopic heart transplantation. In an open, multicentre, prospectively randomised, parallel group study, patients with primary orthotopic heart transplantation under oral immunosuppressive treatments with tacrolimus (FK506) or cyclosporine (sandimmun) were compared with respect to medical outcome data. As health-related quality-of-life (HRQOL) is also supposed to be an important outcome parameter, it was assessed as a secondary variable in these two patient groups. Patients' self-rated generic HRQOL was assessed 6 weeks, 3 months, 6 months and 12 months after surgery with the SF-36 questionnaire, a generic HRQOL instrument. For 70 patients (46 under tacrolimus, 24 under cyclosporine), intent-to-treat analyses were carried out. The tacrolimus group showed improvements in the different HRQOL subscales of the SF-36 compared to the cyclosporine group. Especially the SF-36 subscales 'vitality' and 'mental health' showed statistically higher scores for the tacrolimus group. Aggregating psychological and cognitive subscales in the 'mental component score', patients treated with tacrolimus showed a statistically significant improvement compared to the cyclosporine group. The assessment of HRQOL variables in the evaluation of treatment effects proved to be an outcome parameter in this study. The results demonstrate the benefit of tacrolimus with respect to the HRQOL of patients, especially in the psychological dimension.

RCT Entities:   Population Interventions Outcomes