Edema (% recipients) | Wound complications (% recipients) | Ulcers (% recipients) | Bile duct complications (% recipients) | Infections (% recipients) | Dermatological effects (% recipients) | Hematological effects (% recipients) | |
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De novo dosing | |||||||
Levy et al. Liver Transpl. 2006; 12: 1640–8 [52] | CMV disease: 3.3, 3.6, 6.7, and 9.7 (placebo versus EVR 1, 2, and 4 mg/day, respectively, P = NS for all comparisons) | Thrombocytopenia: 10.0, 14.3, 20.0, and 19.4 Leukopenia: 0, 14.3, 6.7, and 6.5 (placebo, EVR 1, 2, and 4 mg/day, PS = NS for all comparisons) |
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Early conversion (≤3 months after transplantation) | |||||||
De Simone et al. Am J Transplant. 2012; 12: 3008–20 [87] | 17.6 versus 10.8 (EVR + TAC-RD versus TAC-SD, RR 1.63, 95% CI 1.03, 2.56) | Wound complications: 11.0 versus 7.9 (EVR + TAC-RD versus TAC-SD, RR 1.40, 95% CI 0.80, 2.45) Incisional hernia: 2.9 versus 1.2 (RR 2.30, 95% CI, 0.60, 8.77) |
Leukopenia: 11.8 versus 5.0 (EVR + TAC-RD versus TAC-SD, RR 2.38, 95% CI 1.24, 4.55) Thrombocytopenia: 5.3 versus 1.7 Anemia: 7.8 versus 8.3 (EVR + TAC-RD versus TAC-SD, RR 0.93, 95% CI 0.51, 1.71) |
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Fischer et al. Am J Transplant. 2012; 12: 1855–65 [50] | Wound complications: 2 versus 3.9 Incisional hernia: 11.9 versus 9.8 Wound dehiscence: 0 versus 1 Wound hemorrhage: 1 versus 0 (all EVR versus CNI) |
Infections and infestations: 73.3 versus 59.8 (EVR versus CNI) | Anemia: 18.8 versus 10.8 Leukopenia: 20.8 versus 9.8* Thrombocytopenia: 7.9 versus 6.9 (all EVR versus CNI, P = NS for anemia and thrombocytopenia) |
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Masetti et al. Am J Transplant. 2010; 10: 2252–62 [89] | Inferior limb edema: 9.6 versus 0 (EVR versus CsA, P = NS) | Incisional hernia: 46.1 versus 26.9 (EVR versus CsA, P = NS) | Biliary complications (stenosis/leak): 21.1 versus 30.8 (EVR versus CsA, P = NS) | Infections: 46.1 versus 46.1 (EVR versus CsA, P = NS) CMV: 19.2 versus 23.1 (EVR versus CsA, P = NS) |
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Late conversion (>3 months after transplantation) | |||||||
Bilbao et al. Transplant Proc. 2009; 41: 2172–6 [92] | Mucositis: 4 | Sepsis in the context of graft-versus-host disease: 4 | |||||
Casanovas et al. Transplant Proc. 2011; 43: 2216–9 [93] | Anemia, leukopenia, and thrombocytopenia: 11.4 | ||||||
De Simone et al. Transpl Int. 2009; 22: 279–86 [95] | Oral ulcers/stomatitis: 22.5 | Lower urinary tract infection: 5 | Pruritis and acne: 7.5 | ||||
De Simone et al. Liver Transpl. 2009; 15: 1262–9 [96] | Mouth ulcers: 26.4 versus 0.0 (EVR versus SNI, P < 0.01) | Infections: 31.9 versus 21.9, of which 15.3 versus 1.4 were suspected to be drug-related (EVR versus CNI) | Rash/dry skin/eczema: 6.9 versus 0.0 (EVR versus CNI, P = 0.028) | Leukopenia: 12.5 versus 5.5 Thrombocytopenia: 5.6 versus 1.4 Anemia: 9.7 versus 4.1 (all EVR versus CNI) |
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Saliba et al. Liver Transpl. 2011; 17: 905–13 [98] | Edema: 16.3 | Stomatitis/mouth ulcers: 14.2 | Bacterial infection: 12.5 | Rash: 18.8 | Anemia: 12.9 Leukopenia: 9.2 Thrombocytopenia: 6.3 |
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Vallin et al. Clin Transplant. 2011; 25: 660–9 [99] | Edema: 7 | Mucositis: 15 | Infection: 3 | Dermatitis: 19 |
CMV: cytomegalovirus; CNI: calcineurin inhibitor; CsA: cyclosporine A; EVR: everolimus; NS: nonsignificant; SRL: sirolimus; RR: relative risk; 95% CI: 95% confidence interval; TAC: tacrolimus; TAC-RD: reduced-dose tacrolimus (C0: 3–5 ng/mL); TAC-SD: standard-dose tacrolimus (C0: 6–10 ng/mL).
P values are included where available *Treatment group differences with an exploratory P value of P ≤ 0.05.