Efficacy and Safety of Everolimus Plus Low-Dose Tacrolimus Versus Mycophenolate Mofetil Plus Standard-Dose Tacrolimus in De Novo Renal Transplant Recipients: 12-Month Data
| Autor: | Bruce Kaplan, Fuad S. Shihab, Shamkant Mulgaonkar, Kevin McCague, V R Peddi, Dhavalkumar D. Patel, Serdar Yilmaz, F. Luan, Stephen J. Tomlanovich, David Shaffer, Dean Y Kim, Y. Qazi |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Graft Rejection Male medicine.medical_specialty Adolescent Basiliximab medicine.medical_treatment 030232 urology & nephrology Urology Renal function Equivalence Trials as Topic 030230 surgery Pharmacology Kidney Function Tests Tacrolimus Mycophenolic acid Young Adult 03 medical and health sciences Postoperative Complications 0302 clinical medicine Risk Factors medicine Humans Immunology and Allergy Pharmacology (medical) Everolimus Dosing Kidney transplantation Aged Transplantation business.industry Graft Survival Immunosuppression Middle Aged Mycophenolic Acid Prognosis medicine.disease Kidney Transplantation Kidney Failure Chronic Female Safety business Immunosuppressive Agents Follow-Up Studies Glomerular Filtration Rate medicine.drug |
| Zdroj: | American Journal of Transplantation. 17:1358-1369 |
| ISSN: | 1600-6135 |
| DOI: | 10.1111/ajt.14090 |
| Popis: | In this 12-month, multicenter, randomized, open-label, noninferiority study, de novo renal transplant recipients (RTxRs) were randomized (1:1) to receive everolimus plus low-dose tacrolimus (EVR+LTac) or mycophenolate mofetil plus standard-dose Tac (MMF+STac) with induction therapy (basiliximab or rabbit anti-thymocyte globulin). Noninferiority of composite efficacy failure rate (treated biopsy-proven acute rejection [tBPAR]/graft loss/death/loss to follow-up) in EVR+LTac versus MMF+STac was missed by 1.4%, considering the noninferiority margin of 10% (24.6% vs. 20.4%; 4.2% [-3.0, 11.4]). Incidence of tBPAR (19.1% vs. 11.2%; p < 0.05) was significantly higher, while graft loss (1.3% vs. 3.9%; p < 0.05) and composite of graft loss/death/lost to follow-up (6.1% vs. 10.5%, p = 0.05) were significantly lower in EVR+LTac versus MMF+STac groups, respectively. Mean estimated glomerular filtration rate was similar between EVR+LTac and MMF+STac groups (63.1 [22.0] vs. 63.1 [19.5] mL/min/1.73 m2 ) and safety was comparable. In conclusion, EVR+LTac missed noninferiority versus MMF+STac based on the 10% noninferiority margin. Further studies evaluating optimal immunosuppression for improved efficacy will guide appropriate dosing and target levels of EVR and LTac in RTxRs. |
| Databáze: | OpenAIRE |
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