دورية أكاديمية

Safety and effectiveness of everolimus in maintenance kidney transplant patients in the real-world setting: results from a 2-year post-marketing surveillance study in Japan.

التفاصيل البيبلوغرافية
العنوان: Safety and effectiveness of everolimus in maintenance kidney transplant patients in the real-world setting: results from a 2-year post-marketing surveillance study in Japan.
المؤلفون: Hayase N; Novartis Pharma K.K. Medical Division, 23-1, Toranomon 1-chome, Minato-ku, Tokyo, 105-6333, Japan. naomi.hayase@novartis.com., Yamada M; Patient Safety Japan Re-Examination Department, Novartis Pharma K.K., Tokyo, Japan., Kaneko S; Biostatistics Pharma, Integrated Biostatistics Japan, Clinical Development & Analytics Japan, Novartis Pharma K.K., Tokyo, Japan., Watanabe Y; Immunology, Hepatology & Dermatology Clinical Development Department, Clinical Development & Analytics Japan, Novartis Pharma K.K., Tokyo, Japan.
المصدر: Clinical and experimental nephrology [Clin Exp Nephrol] 2021 Jun; Vol. 25 (6), pp. 660-673. Date of Electronic Publication: 2021 Feb 11.
نوع المنشور: Journal Article; Multicenter Study; Observational Study
اللغة: English
بيانات الدورية: Publisher: Springer Country of Publication: Japan NLM ID: 9709923 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1437-7799 (Electronic) Linking ISSN: 13421751 NLM ISO Abbreviation: Clin Exp Nephrol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2008- : Tokyo : Springer
Original Publication: Tokyo : Published for the Japanese Society of Nephrology by Churchill Livingstone, c1997-
مواضيع طبية MeSH: Everolimus/*administration & dosage , Graft Rejection/*prevention & control , Graft Survival/*drug effects , Immunosuppressive Agents/*administration & dosage , Kidney Transplantation/*adverse effects, Adult ; Aged ; Cyclosporine/administration & dosage ; Drug Therapy, Combination ; Everolimus/adverse effects ; Female ; Graft Rejection/immunology ; Humans ; Immunosuppressive Agents/adverse effects ; Japan ; Male ; Middle Aged ; Product Surveillance, Postmarketing ; Tacrolimus/administration & dosage ; Time Factors ; Treatment Outcome
مستخلص: Background: Data on real-world use of everolimus (EVR) in Japanese maintenance kidney transplant (KTx) patients are limited. This post-marketing surveillance study was conducted to assess the safety and effectiveness of EVR, and identify factors affecting renal impairment.
Methods: Adult maintenance KTx patients were enrolled within 14 days of initiating EVR. Patient medical data were collected using electronic data capture case report forms at 6 months, 1, and 2 years after initiating EVR, or at discontinuation.
Results: All patients receiving EVR in Japan during the surveillance period were enrolled (N = 263). Mean time from transplantation to EVR initiation was 75.7 months. Decreased renal function (31.56%) was the primary reason for initiating EVR. In combination with EVR, the mean daily dose of tacrolimus and cyclosporine could be reduced to ~ 79 and ~ 64%, by 2 years, respectively. Incidences of serious adverse events and adverse drug reactions were 15.97 and 49.43%, respectively. Two-year graft survival rate was 95.82% and low in patients with baseline estimated glomerular filtration rate (eGFR; modification of diet in renal disease) < 30 mL/min/1.73 m 2 (69.57%; P < 0.0001) and urinary protein/creatinine ratio (UPCR) ≥ 0.55 g/gCr (84.21%; P = 0.0206). Throughout the survey, mean eGFR values were stable (> 55 mL/min/1.73 m 2 ). Renal impairment was influenced by patient and donor age, eGFR, and UPCR at baseline.
Conclusions: No new safety concerns for the use of EVR in adult maintenance KTx patients were identified. Early EVR initiation may be considered in these patients before renal function deterioration occurs.
References: Transplantation. 2007 Apr 27;83(8):1027-34. (PMID: 17452891)
Transplant Proc. 2017 Oct;49(8):1724-1728. (PMID: 28923615)
Am J Transplant. 2017 Jul;17(7):1853-1867. (PMID: 28027625)
Lancet. 2011 Mar 5;377(9768):837-47. (PMID: 21334736)
Transplant Proc. 2019 Jun;51(5):1378-1381. (PMID: 31056252)
World J Transplant. 2018 Sep 10;8(5):150-155. (PMID: 30211023)
Transplant Res. 2013 Jul 16;2(1):14. (PMID: 23866828)
Am J Transplant. 2019 Nov;19(11):3018-3034. (PMID: 31152476)
Transplant Rev (Orlando). 2016 Jan;30(1):3-12. (PMID: 26603484)
Transplantation. 2012 Feb 27;93(4):398-405. (PMID: 22245871)
Transplantation. 2011 Aug 27;92(4):410-8. (PMID: 21697773)
Transplant Proc. 2017 Jan - Feb;49(1):41-44. (PMID: 28104155)
Am J Kidney Dis. 2009 Jun;53(6):982-92. (PMID: 19339088)
Am J Transplant. 2003 Feb;3(2):178-85. (PMID: 12603213)
Transplantation. 2004 Aug 27;78(4):557-65. (PMID: 15446315)
Am J Transplant. 2012 Oct;12(10):2744-53. (PMID: 22812414)
Am J Transplant. 2011 Apr;11(4):693-7. (PMID: 21446974)
Transplantation. 2006 Sep 15;82(5):603-11. (PMID: 16969281)
Nat Clin Pract Nephrol. 2006 Jul;2(7):398-404; quiz following 404. (PMID: 16932468)
Expert Rev Clin Pharmacol. 2018 Jun;11(6):581-588. (PMID: 29779413)
Am J Transplant. 2015 Jan;15(1):119-28. (PMID: 25521535)
فهرسة مساهمة: Keywords: Everolimus; Maintenance kidney transplant patients; Observational study; Post-marketing surveillance; Renal impairment
المشرفين على المادة: 0 (Immunosuppressive Agents)
83HN0GTJ6D (Cyclosporine)
9HW64Q8G6G (Everolimus)
WM0HAQ4WNM (Tacrolimus)
تواريخ الأحداث: Date Created: 20210212 Date Completed: 20211117 Latest Revision: 20211117
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC8106613
DOI: 10.1007/s10157-021-02024-9
PMID: 33575935
قاعدة البيانات: MEDLINE
الوصف
تدمد:1437-7799
DOI:10.1007/s10157-021-02024-9