New-Onset Diabetes Mellitus in Cyclosporine-Treated Organ Transplant Patients in Taiwan: Interim Analysis (6 Months) of Postmarketing Surveillance

doi:10.1016/j.transproceed.2012.01.099

CNU IR > Pharmacy and Science > Dept. of Health and Nutrition (including master's program) > Periodical Articles > Item 310902800/27665

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Title:	New-Onset Diabetes Mellitus in Cyclosporine-Treated Organ Transplant Patients in Taiwan: Interim Analysis (6 Months) of Postmarketing Surveillance
Authors:	Tian, Y.-F. Tsai, C.-S. Lee, P.-C. Chu, S.-H. Chien, Y.-S. Loong, C.-C. Chen, C.-H. Wu, M.-S. Chu, S.-H. Lian, J.-D.
Contributors:	保健營養系
Keywords:	Kidney-Transplantation Renal-Transplantation Immunosuppressive Therapy Tacrolimus Recipients
Date:	2012-04
Issue Date:	2014-03-21 16:16:57 (UTC+8)
Publisher:	Elsevier Science Inc
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.
Relation:	Transplantation Proceedings v.44 n.3 pp.661-666
Appears in Collections:	[Dept. of Health and Nutrition (including master's program)] Periodical Articles

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