Comparison of conventional tacrolimus versus prolong release formula as initial therapy in heart transplantation.
Urbanowicz T, Baszynska-Wachowiak H, et al.Annals of Transplantation 2014; 19: 295-299.
Aims
To compare the safety and efficacy of Advagraf versus Prograf in heart transplant recipients.
Interventions
Patients were administered with either Advagraf or Prograf and all heart transplants were performed using the Lower-Shumway technique. Patients were also treated with standard triple immunosuppressive regimens.
Participants
19 heart transplant recipients.
Outcomes
The outcomes included the incidence of biopsy proven acute rejection, incidence of renal insufficiency, arterial hypertension and diabetes mellitus.
Follow-up
290+/-92 days
CET Conclusions
This small study (19 patients) randomised de-novo cardiac transplant recipients to either standard treatment (Prograf) or modified-release tacrolimus (Advagraf). The study authors report no difference between the groups other than a higher dose requirement in the Prograf arm. The study is poorly reported, with no indication as to the method of randomisation or indication as to whether recipients or clinicians were blinded. More importantly, no power calculation is reported. An equivalence trial of this type would need to randomise hundreds of recipients to prove that there is no significant difference in outcomes between the drugs. Therefore the results presented here do not support the author’s conclusion that Advagraf is equivalent to Prograf in cardiac transplant recipients.
Data analysis
Per protocol analysis
Trial registration
Not reported.