Safety and efficacy of Rapamune® (Sirolimus) in kidney transplant recipients: results of a prospective post-marketing surveillance study in Korea

• DOI: 10.1186/s12882-018-1002-6
• Publication Date: 2018-08-13T08:26:49Z
• Authors: Hee Jung Jeon; Hahn-Ey Lee; Jaeseok Yang
• Keywords: Postmarketing surveillance; Sirolimus; Nephrology

Few post-marketing surveillance studies have examined the safety and efficacy of Rapamune® (Sirolimus) in Asian countries. This study aimed to better understand Rapamune for kidney transplant recipients routine clinical practice setting Korea. was an open-label, non-comparative, observational, prospective, multi-center, conducted at 15 Korean centers between 31 August 2009 24 September 2015. The subjects were administered as part practice. monitored based on reporting adverse events (AEs). Efficacy endpoints included acute rejection, graft function, survival, patient survival. most commonly used late conversion therapy after post-transplant 1 year substituted anti-metabolites (63.6%) or calcineurin inhibitors (28.7%). median treatment duration 182 days. Among 209 enrolled, AEs drug reactions (ADRs) reported 54.07% 43.06% subjects, respectively, analysis set. Most expected (96.21%), mild (75.83%), did not result any action taken with regard (72.99%), resolved by end (75.36%). frequently AEs/ADRs pharyngitis diarrhea. serious occurred one two subjects. Unexpected ADRs renal artery occlusion cholangitis subject each. incidence biopsy-proven rejection 2.87%. At study, 99.51% their grafts had survived. mean eGFR 64.72 ± 19.56 mL/min. acceptable profile prevention allograft