title: Wound events in kidney transplant patients receiving de novo everolimus: a pooled analysis of three randomized controlled trials.
abstract: Data were pooled from three prospective, multicenter trials in which 1996 de novo kidney transplant recipients were randomized to everolimus 1.5 or 3.0 mg or mycophenolic acid (MPA), with cyclosporine and steroids. Wound healing complications reported as adverse events were retrospectively reviewed in a blinded manner. The incidence of wound healing adverse events was 17.6% (351 of 1996) by day 90 and was similar for everolimus 1.5 mg (16.6% [110 of 661]) vs. MPA (14.3% [95 of 665]) (p = 0.255), but higher with everolimus 3.0 mg (21.8% [146 of 670]) (p < 0.001 vs. MPA). Similar results were observed for wound healing complications reported as serious adverse events. The 12-month incidence of lymphocele was 11.2% with everolimus 1.5 mg and 8.9% with MPA (p = 0.171), but lymphocele reported as a serious adverse event were more frequent with everolimus 1.5 mg (6.5% vs. 3.5%; p = 0.012). The hazard ratio (HR) for any wound healing complication vs. MPA was not significantly higher for everolimus <3 ng/mL (HR 1.33; 95% CI 0.94-1.88; p = 0.104), but increased to 1.46 (95% CI 1.12-1.90; p = 0.005) for 3-8 ng/mL and 1.69 (95% CI 1.20-2.38; p = 0.002) for >8 ng/mL. These results suggest that de novo kidney transplant patients receiving an initial everolimus dose of 1.5 mg do not appear to have a pronounced increased risk of wound healing complications vs. patients receiving MPA.
authors.affiliation: Medstar Georgetown Transplant Institute, Washington, DC, USA.
authors.forename: M
authors.initials: M
authors.lastname: Cooper
authors.forename: A C
authors.initials: AC
authors.lastname: Wiseman
authors.forename: G
authors.initials: G
authors.lastname: Zibari
authors.forename: K
authors.initials: K
authors.lastname: McCague
authors.forename: Y
authors.initials: Y
authors.lastname: Kim
authors.forename: F
authors.initials: F
authors.lastname: Geissler
authors.forename: B
authors.initials: B
authors.lastname: Nashan
mesh_terms: D000328:Adult; D016572:Cyclosporine / Q000627:therapeutic use; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D011379:Prognosis; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012307:Risk Factors; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D000068338:Everolimus; D009173:Mycophenolic Acid; D020123:Sirolimus
keywords: complications; everolimus; kidney transplantation; lymphocele; wound healing