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| 標題: | New-Onset Diabetes Mellitus in Cyclosporine-Treated Organ Transplant Patients in Taiwan: Interim Analysis (6 Months) of Postmarketing Surveillance |
| 作者: | 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. |
| 貢獻者: | 保健營養系 |
| 關鍵字: | Kidney-Transplantation
Renal-Transplantation
Immunosuppressive Therapy
Tacrolimus
Recipients |
| 日期: | 2012-04 |
| 上傳時間: | 2014-03-21 16:16:57 (UTC+8) |
| 出版者: | Elsevier Science Inc |
| 摘要: | 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. |
| 關聯: | Transplantation Proceedings v.44 n.3 pp.661-666 |
| 顯示於類別: | [保健營養系(所) ] 期刊論文
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