Primary outcomes of treatment at months 6 and 12 of the study
| CYC (N=32) | EC-MPS (N=27) | Unadjusted percentage difference between groups* | Adjusted percentage difference between groups*† | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Variables | No | Per cent | No | Per cent | Per cent | (95% CI) | p Value | % (95% CI) | p Value |
| Complete remission | |||||||||
| At 6th month | 7/25 | 28.00 | 3/25 | 12.00 | 16.00 | (−5.7 to 37.7) | 0.15 | 11.2 (−12.1 to 34.6) | 0.35 |
| At 12th month | 9/25 | 36.00 | 7/24 | 29.17 | 6.83 | (−19.3 to 33.0) | 0.61 | −5.12 (−32.7 to 22.5) | 0.72 |
| Partial remission | |||||||||
| At 6th month | 8/25 | 32.00 | 12/25 | 48.00 | −16.00 | (−42.8 to 10.8) | 0.24 | −12.61 (−41.6 to 16.3) | 0.39 |
| At 12th month | 8/25 | 32.00 | 10/24 | 41.67 | −9.67 | (−34.6 to 17.2) | 0.48 | −12.04 (−40.0 to 15.9) | 0.40 |
| Non-remission | |||||||||
| At 6th month | 10/25 | 40.00 | 10/25 | 40.00 | 0.00 | (−27.2 to 27.2) | 1.00 | −1.20 (−30.6 to 28.3) | 0.94 |
| At 12th month | 8/25 | 32.00 | 7/24 | 29.17 | 2.83 | (−23.0 to 28.6) | 0.83 | 11.40 (−14.4 to 37.1) | 0.39 |
| Discontinuation‡ | |||||||||
| 0–6th month | 7/32 | 21.88 | 2/27 | 7.41 | 14.47 | (−2.9 to 31.9) | 0.10 | 16.90 (1.3 to 32.4) | 0.03 |
| 7–12th month | 0/25 | 0.00 | 1/25 | 4.00 | −4.00 | (−11.7 to 3.7) | 0.31 | −0.40 (−11.5 to 3.5) | 0.30 |
| 0–12th month | 7/32 | 21.88 | 3/27 | 11.1 | 10.76 | (−7.8 to 29.4) | 0.26 | 14.11 (−3.1 to 31.3) | 0.11 |
| Composite outcome§ | |||||||||
| 0–6th month | 17/32 | 53.13 | 12/27 | 44.44 | 8.68 | (−16.8 to 34.2) | 0.51 | 10.68 (−15.7 to 37.1) | 0.43 |
| 7–12th month | 8/25 | 32.00 | 8/25 | 32.00 | 0.00 | (−25.9 to 25.9) | 1.00 | 6.31 (−20.4 to 33.0) | 0.64 |
| 0–12th month | 15/32 | 46.88 | 10/27 | 37.04 | 9.84 | (−15.3 to 35.0) | 0.44 | 12.8 (−11.8 to 37.4) | 0.31 |
*The difference is shown as the value for group 1 minus the value for group 2.
†Adjusted for baseline nephrotic-range proteinuria and estimated glomerular filtration rates.
‡Including either death, major infection, doubling of serum creatinine or loss of follow-up.
§Including either death, doubling of serum creatinine, non-remission or intolerance to treatment.
CYC, cyclophosphamide; EC-MPS, enteric-coated mycophenolate sodium.