PMID- 30103684 OWN - NLM STAT- MEDLINE DCOM- 20190726 LR - 20190726 IS - 1471-2369 (Electronic) IS - 1471-2369 (Linking) VI - 19 IP - 1 DP - 2018 Aug 13 TI - Safety and efficacy of Rapamune(R) (Sirolimus) in kidney transplant recipients: results of a prospective post-marketing surveillance study in Korea. PG - 201 LID - 10.1186/s12882-018-1002-6 [doi] LID - 201 AB - BACKGROUND: Few post-marketing surveillance studies have examined the safety and efficacy of Rapamune(R) (Sirolimus) in Asian countries. This study aimed to better understand safety and efficacy of Rapamune for kidney transplant recipients in the routine clinical practice setting in Korea. METHODS: This was an open-label, non-comparative, observational, prospective, multi-center, post-marketing surveillance study conducted at 15 Korean transplant centers between 31 August 2009 and 24 September 2015. The subjects were administered Rapamune as part of routine practice. The safety was monitored based on reporting of adverse events (AEs). Efficacy endpoints included acute rejection, graft function, graft survival, and patient survival. RESULTS: Rapamune was most commonly used for late conversion therapy after post-transplant 1 year and was substituted for anti-metabolites (63.6%) or calcineurin inhibitors (28.7%). The median treatment duration of Rapamune was 182 days. Among 209 subjects enrolled, AEs and adverse drug reactions (ADRs) were reported in 54.07% and 43.06% of subjects, respectively, in the safety analysis set. Most of the AEs were expected (96.21%), mild (75.83%), did not result in any action taken with regard to the study drug (72.99%), and resolved by the end of the study (75.36%). The most frequently reported AEs/ADRs were pharyngitis and diarrhea. Most of the serious AEs/ADRs occurred in one or two subjects. Unexpected ADRs of renal artery occlusion and cholangitis were reported by one subject each. The incidence of biopsy-proven acute rejection was 2.87%. At the end of the study, 99.51% of the subjects and their grafts had survived. The mean eGFR was 64.72 +/- 19.56 mL/min. CONCLUSIONS: Rapamune had an acceptable safety profile in prevention of kidney allograft rejection in Korea. FAU - Jeon, Hee Jung AU - Jeon HJ AD - Department of Internal Medicine, Hallym University College of Medicine, 150 Seongan-ro, Gangdong-gu, Seoul, 134-701, South Korea. FAU - Lee, Hahn-Ey AU - Lee HE AD - Pfizer Pharmaceuticals Korea Ltd., Pfizer Tower 110, Toegye-ro, Jung-gu, Seoul, 100-771, South Korea. AD - Seoul National University College of Medicine Graduate School, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, South Korea. FAU - Yang, Jaeseok AU - Yang J AUID- ORCID: 0000-0002-5378-7797 AD - Transplantation Center, Department of Surgery, Seoul National University Hospital, Transplantation Research Institute, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, Republic of Korea. jcyjs@dreamwiz.com. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20180813 PL - England TA - BMC Nephrol JT - BMC nephrology JID - 100967793 RN - 0 (Immunosuppressive Agents) RN - W36ZG6FT64 (Sirolimus) MH - Diarrhea/chemically induced MH - Female MH - Graft Rejection/diagnosis/epidemiology/*prevention & control MH - Humans MH - Immunosuppressive Agents/adverse effects/*therapeutic use MH - Kidney Transplantation/adverse effects/*trends MH - Male MH - Pharyngitis/chemically induced MH - Product Surveillance, Postmarketing/*trends MH - Prospective Studies MH - Republic of Korea/epidemiology MH - Sirolimus/adverse effects/*therapeutic use MH - *Transplant Recipients MH - Treatment Outcome PMC - PMC6090799 OTO - NOTNLM OT - Kidney transplantation OT - Post-marketing surveillance OT - Sirolimus COIS- This study was approved by the Institutional Review Boards of Kangdong Sacred Heart Hospital, Maryknoll Medical Center, Seoul National University Hospital, Korea University Anam Hospital, Konkuk University Medical Center, Yeungnam University Medical Center, the Catholic University of Korea Seoul St. Mary's Hospital, Kyungpook National University Hospital, Keimyung University Dongsan Medical Center, Gangnam Severance Hospital, Pusan National University Hospital, Samsung Medical Center, Asan Medical Center, and the Catholic University of Korea Uijeongbu St. Mary's Hospital. The evidence of a personally signed and dated informed consent document indicating that the subject had been informed of all pertinent aspects of the study. For patients aged less than 19 years, informed consent was obtained from both patient and parents or guardians. Not applicable HJJ and JY have no competing interests. HEL has disclosed that she is an employee of Pfizer Pharmaceuticals Korea Ltd. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/08/15 06:00 MHDA- 2019/07/28 06:00 PMCR- 2018/08/13 CRDT- 2018/08/15 06:00 PHST- 2017/01/05 00:00 [received] PHST- 2018/08/06 00:00 [accepted] PHST- 2018/08/15 06:00 [entrez] PHST- 2018/08/15 06:00 [pubmed] PHST- 2019/07/28 06:00 [medline] PHST- 2018/08/13 00:00 [pmc-release] AID - 10.1186/s12882-018-1002-6 [pii] AID - 1002 [pii] AID - 10.1186/s12882-018-1002-6 [doi] PST - epublish SO - BMC Nephrol. 2018 Aug 13;19(1):201. doi: 10.1186/s12882-018-1002-6.