Meta-Analysis
Copyright ©The Author(s) 2017.
World J Transplant. Apr 24, 2017; 7(2): 144-151
Published online Apr 24, 2017. doi: 10.5500/wjt.v7.i2.144
Table 3 Summary of outcomes in Different Early Conversion Clinical Trials
Ref.Renal function (Gp1 vs Gp 2)BPAR (Gp1 vs Gp 2)Adverse event (Gp1 vs Gp 2)Remarks
Everolimus
Budde et al[23], 2011, (ZEUS Study)12 mo Sr. Cr: 141.7 ± 44 μmol/L vs 137.0 ± 43 μmol/L (P = NS) eGFR: 71.8 ± 18 mL/min vs 61.2 ± 16 mL/min (P = 0.000)9.7% vs 3.4% (P = 0.03)SAE/Infection: 61% vs 59% (P = NS) UTI: 57.0% vs 53% (P = NS) Diarrhoea: 36% vs 27% (P = NS) HPL: 14% vs 10% (P = NS)Graft survival: 100% vs 100% (P = NS) Patient survival 100% vs 99% (P = NS)
Mjornstedt et al[24], 2012 (CENTRAL trial)12 mo Sr. Cr: 122.0 ± 35 μmol/L vs 132.0 ± 45 μmol/L (P = NS) eGFR: 68.1 ± 21.5 mL/min vs 69.4 ± 22.9 mL/min (P = NS)27.5% vs 11.0% (P = 0.004)SAE/Infection: 53.9% vs 38.0% (P = 0.025) CMV infection: 8.8% vs 13.0% (P = NS) Edema: 29.4% vs 21.0% (P = NS) Anaemia: 16.7% vs 6.0% (P = 0.02) HPL: 12.7% vs 9.0% (P = NS) Proteinuria: 4.9% vs 0% (P = 0.06) Acne: 12.7% vs 2.0% (P = 0.006) Mouth Ulceration: 12.7% vs 2.0 % (P = 0.001)Graft survival: 100% vs 100% (P = NS) Patient survival 98% vs 98% (P = NS)
Sirolimus
Lebranchu et al[25], 2009 (CONCEPT Study)12 mo: Sr. Cr: 117.4 μmol/L vs 132.3 μmol/L (P < 0.001) eGFR: 68.9 mL/min vs 64.4 mL/min (P = 0.017)16.8% vs 8.2% (P = NS)Peripheral Edema: 28.1% vs 22.6% (P = NS) SAE/infection: 60% vs 44% (P = 0.025) Diarrhoea: 30.2% vs 9.2% (P < 0.001) Dyslipidemia: 5.20% vs 4.12% (P = NS) Proteinuria: 9.3% vs 3.09 % (P = NS) NODAT: 3.1% vs 2.06% (P = NS) Apthous Stomatitis: 45.8% vs 5.15% (P < 0.001)Graft Survival: 99% (P = NS) Patient Survival 97% (P = NS)
Guba et al[26], 2010, (SMART Trial)12 mo: Sr Cr: 111.5 ± 45 mg/dL vs 142.6 ± 74 mg/dL (P = 0.004) eGFR: 64.5 ± 25.2 mL/min vs 53.4 ± 18.0 mL/min (P = 0.001)17.4% vs 15.5% (P = NS)Wound Healing Disorder: 10.1% vs 11.3%, (P = NS) Infection: 52.2% vs 60.6% (P = NS) CMV: 7.3% vs 28.2% (P < 0.001) HPL: 20.3% vs 7.0% (P = 0.02) Diarrhoea: 13.0% vs 9.9% (P = NS) Lymphocele: 27.5% vs 23.9% (P = NS)Graft Survival: 99% vs 97% (P = NS) Patient Survival 99% vs 99% (P = NS)
Weir et al[27], 2010 (Spare the Nephron Trial)12 mo Sr. Cr: 126.2 ± 82.8 μmol/L vs 145.0 ± 96.5 μmol/L (P = NS) eGFR: 74.6 ± 17.9 mL/min vs 71.5 ± 21.2 mL/min (P = 0.06)7.4% vs 6.0% (P = NS)Infection: 16.2% vs 18.3% (P = NS) HPL: 24.3% vs 10.5% (P = 0.000) CMV: 4.7% vs 9.2% (P = NS) Polyoma virus: 2% vs 4% (P = NS) Diarrhoea: 29.7% vs 9.8% (P = 0.001) Malignancy: 4.7% vs 6.5% (P = NS)Graft Survival: 98% vs 97.4% (P = NS) Patient Survival 100% vs 98% (P = NS)
Heilman et al[28], 201112 mo Sr. Cr: 96.1 ± 28 μmol/L vs 106.1 ± 61 μmol/L (P = NS) eGFR: 63.0 ± 19.1 mL/min vs 59.8 ± 18.9 mL/min (P = NS)13% vs 5% (P = NS)CMV: 13% vs 13% (P = NS) Polyoma virus: 2% vs 4% (P = NS)NA