کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
8773322 | 1599155 | 2010 | 5 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Interchangeability of ciclosporin formulations in stable adult renal transplant recipients: comparison of Equoral and Neoral capsules in an international, multicenter, randomized, open-label trial
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
پزشکی و دندانپزشکی
بیماریهای کلیوی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Interchangeability of ciclosporin formulations in stable adult renal transplant recipients: comparison of Equoral and Neoral capsules in an international, multicenter, randomized, open-label trial Interchangeability of ciclosporin formulations in stable adult renal transplant recipients: comparison of Equoral and Neoral capsules in an international, multicenter, randomized, open-label trial](/preview/png/8773322.png)
چکیده انگلیسی
The cost of immunosuppression following transplantation can be reduced by using generic ciclosporin (for example, Equoral) rather than innovator ciclosporin drugs such as Neoral. Thus, this study aims to evaluate the interchangeability, safety, and tolerability of Equoral, a generic ciclosporin, with Neoral in stable adult renal transplant recipients. This was a multicenter, randomized, open-label, parallel-group clinical trial in stable renal transplant patients, comparing 6 months of treatment with Equoral with the same treatment period on Neoral. The primary end point was the between-treatment comparison of the total daily ciclosporin dose at the end of the study. A total of 99 patients were enrolled and constituted the full analysis/safety population, and 78 patients forming the per-protocol population were assessed for efficacy. Equoral was found to be equivalent to Neoral with regard to the primary end point of daily dose at the end of the study. This was supported by comparable serum ciclosporin levels at the end of the study. There were no renal transplant rejection incidents, but there was one death (in the Neoral group). Drug tolerability and incidence of adverse events were comparable between the treatment groups. In conclusion, Equoral and Neoral are interchangeable in stable renal transplant patients, and both drugs are associated with a similar safety and tolerability profile.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Kidney International - Volume 77, Supplement 115, March 2010, Pages S12-S16
Journal: Kidney International - Volume 77, Supplement 115, March 2010, Pages S12-S16
نویسندگان
Å tefan VÃtko, Marek Ferkl,