title: New-onset diabetes mellitus in cyclosporine-treated organ transplant patients in Taiwan: interim analysis (6 months) of postmarketing surveillance.
abstract: Posttransplant new-onset diabetes mellitus (NODM) is an important complication among patients receiving immunosuppressants. It has a considerable impact on chronic allograft dysfunction. Calcineurin inhibitors have been implicated in the development of posttransplant NODM. Since high-risk candidates also undergo transplantation, prevention and control of posttransplant NODM is important. A 3-year postmarketing surveillance study is currently underway in Taiwan to evaluate the incidence and risk factors leading to development of NODM among de novo and maintenance solid-organ transplant patients receiving cyclosporine (CsA)-based immunosuppressive therapy. Concomitant therapy consisted of basiliximab, mycophenolate mofetil or enteric-coated mycophenolate sodium, and corticosteroids. Diabetes was diagnosed according to the American Diabetes Association criteria. This 6-month protocol-defined interim analysis included 101 patients (84 de novo, 17 maintenance) who received renal (n = 77), liver (n = 13), or heart (n = 11) transplantation. At the end of 6 months, 8/101 (7.92%) patients experienced NODM. The mean time to NODM was 3.05 months. No significant difference was observed between NODM and non-NODM patients for risk factors: age, body mass index, blood pressure, gender, high-density lipoproteins/triglycerides hdl/tg, and anti-hepatitis C virus. The composite endpoint of biopsy-proven acute rejection, graft loss, or death was reached in four patients, with a mean time to event of 3.81 months. Infections were noted in 34 subjects but, no malignancies. Among 389 adverse events reported in 91 patients (90.1%), the majority were of mild to moderate severity. Two deaths were reported: heart transplant recipients with acute rejection and cytomegalovirus meningitis with respiratory failure. Long-term enrollment with follow-up evaluation of these NODM patients up to 3 years will help evaluate the NODM incidence rates and exact graft survival and overall survival rates of CsA-treated transplant patients in Taiwan.
authors.affiliation: Division of General Surgery, Chi Mei Medical Center, Chia Nan University of Pharmacy & Science, Tainan, Taiwan.
authors.forename: Y-F
authors.initials: YF
authors.lastname: Tian
authors.forename: C-S
authors.initials: CS
authors.lastname: Tsai
authors.forename: P-C
authors.initials: PC
authors.lastname: Lee
authors.forename: S-H
authors.initials: SH
authors.lastname: Chu
authors.forename: Y-S
authors.initials: YS
authors.lastname: Chien
authors.forename: C-C
authors.initials: CC
authors.lastname: Loong
authors.forename: C-H
authors.initials: CH
authors.lastname: Chen
authors.forename: M-S
authors.initials: MS
authors.lastname: Wu
authors.forename: S-H
authors.initials: SH
authors.lastname: Chu
authors.forename: J-D
authors.initials: JD
authors.lastname: Lian
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000009:adverse effects* / Q000627:therapeutic use; D003920:Diabetes Mellitus / Q000139:chemically induced* / Q000453:epidemiology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016377:Organ Transplantation; D011358:Product Surveillance, Postmarketing; D013624:Taiwan / Q000453:epidemiology
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine