Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Leas BF, Uhl S, Sawinski DL, Trofe-Clark J, Tuteja S, Kaczmarek JL, Umscheid CA. Calcineurin inhibitors for renal transplant. Rockville: Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review No. 166. 2016 Authors' objectives The calcineurin inhibitors (CNIs) tacrolimus and cyclosporine A (CsA) are effective immunosuppressive agents for renal transplantation, but they must be managed carefully to avoid toxicity. Routine therapeutic monitoring guides dosing, but uncertainty surrounds different monitoring methods and timepoints. Additionally, the effectiveness of strategies to reduce CNI exposure with lower therapeutic levels and other imunosuppressants is unclear. This systematic review evaluates the evidence for three Key Questions. Key Question 1 compares immunoassay analysis with liquid chromatographic or mass spectrometric analytical techniques for therapeutic monitoring of CNIs. Key Question 2 examines CsA monitoring timepoints. Key Question 3 evaluates alternatives to full-dose CNI regimens. Authors' conclusions Most studies of CNI monitoring do not directly compare strategies or assess clinical validity or utility, and are insufficient to evaluate clinical outcomes. Few studies compare 2-hour with trough monitoring of CsA, and current evidence is insufficient to suggest a superior approach. Many studies suggest that early initiation of low-dose CNIs results in improved renal function and reduced risk of harm. Strategies that employ conversion from CNIs to mTOR (mammalian target of rapamycin) inhibitors are associated with improved renal function. Regimens that withdraw CNIs are not associated with improved renal function and may increase the risk of acute rejection. Avoidance strategies based on de novo use of alternative immunosuppressive drugs are not widely studied. Indexing Status Subject indexing assigned by CRD MeSH Calcineurin Inhibitors; Cyclosporine; Humans; Immunosuppressive Agents; Kidney Transplantation Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence AHRQ, Center for Outcomes and Evidence Technology Assessment Program, 540 Gaither Road, Rockville, MD 20850, USA Email: AHRQTAP@ahrq.hhs.gov AccessionNumber 32016000544 Date abstract record published 16/03/2016 |