Table. Results per Dose After Conversion of ORs to RRs and of SMDs to PANSS Values.
| Dose, mga | Relapse | Rehospitalization | All-cause discontinuation | Dropout due to adverse events | Overall symptoms | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Relapse, % (95% CI) | RR (95% CI) | OR (95% CI) | Rehospitalized, % (95% CI) | RR (95% CI) | OR (95% CI) | Dropout, % (95% CI) | RR (95% CI) | OR (95% CI) | Dropout, % (95% CI) | RR (95% CI) | OR (95% CI) | SMD (95% CI) | PANSS change (95% CI)b | |
| Placebo | 67 | 1 | 1 | 18 | 1 | 1 | 75 | 1 | 1 | 4 | 1 | 1 | 0 | 9.6 |
| 0.5 | 62.1 (60.4 to 63.9) | 0.93 (0.9 to 0.95) | 0.81 (0.75 to 0.87) | 16.4 (15.7 to 17.2) | 0.91 (0.87 to 0.95) | 0.9 (0.85 to 0.94) | 72.3 (71.3 to 73.3) | 0.96 (0.95 to 0.98) | 0.87 (0.83 to 0.92) | 4.1 (3.9 to 4.4) | 1.03 (0.96 to 1.1) | 1.03 (0.96 to 1.11) | −0.07 (−0.09 to −0.05) | 8.46 (8.16 to 8.76) |
| 1.0 | 57 (53.3 to 60.7) | 0.85 (0.8 to 0.91) | 0.65 (0.56 to 0.76) | 15 (13.7 to 16.4) | 0.83 (0.76 to 0.91) | 0.8 (0.72 to 0.89) | 69.5 (67.3 to 71.6) | 0.93 (0.9 to 0.95) | 0.76 (0.69 to 0.84) | 4.3 (3.7 to 4.9) | 1.06 (0.93 to 1.22) | 1.07 (0.93 to 1.23) | −0.14 (−0.18 to −0.1) | 7.31 (6.71 to 7.92) |
| 1.5 | 51.8 (46.2 to 57.3) | 0.77 (0.69 to 0.86) | 0.53 (0.42 to 0.66) | 13.6 (11.8 to 15.6) | 0.76 (0.66 to 0.87) | 0.72 (0.61 to 0.84) | 66.5 (63.1 to 69.8) | 0.89 (0.84 to 0.93) | 0.66 (0.57 to 0.77) | 4.4 (3.6 to 5.4) | 1.1 (0.9 to 1.34) | 1.1 (0.89 to 1.36) | −0.21 (−0.26 to −0.15) | 6.17 (5.27 to 7.08) |
| 2.0 | 46.7 (39.6 to 54) | 0.7 (0.59 to 0.81) | 0.43 (0.32 to 0.58) | 12.4 (10.3 to 14.9) | 0.69 (0.57 to 0.83) | 0.65 (0.52 to 0.8) | 63.5 (58.9 to 68) | 0.85 (0.78 to 0.91) | 0.58 (0.48 to 0.71) | 4.5 (3.5 to 5.9) | 1.13 (0.87 to 1.47) | 1.14 (0.87 to 1.5) | −0.28 (−0.35 to −0.2) | 5.05 (3.85 to 6.25) |
| 2.5 | 42.1 (33.8 to 50.8) | 0.63 (0.5 to 0.76) | 0.36 (0.25 to 0.51) | 11.4 (9 to 14.2) | 0.63 (0.5 to 0.79) | 0.58 (0.45 to 0.76) | 60.7 (54.9 to 66.1) | 0.81 (0.73 to 0.88) | 0.51 (0.41 to 0.65) | 4.7 (3.4 to 6.4) | 1.17 (0.85 to 1.61) | 1.18 (0.84 to 1.65) | −0.34 (−0.43 to −0.25) | 3.98 (2.5 to 5.45) |
| 3.0 | 38 (29.2 to 47.7) | 0.57 (0.44 to 0.71) | 0.3 (0.2 to 0.45) | 10.5 (8 to 13.7) | 0.58 (0.44 to 0.76) | 0.53 (0.39 to 0.72) | 58.1 (51.5 to 64.4) | 0.77 (0.69 to 0.86) | 0.46 (0.35 to 0.6) | 4.8 (3.3 to 7) | 1.21 (0.83 to 1.74) | 1.22 (0.83 to 1.79) | −0.4 (−0.51 to −0.3) | 2.99 (1.27 to 4.72) |
| 3.5 | 34.7 (25.7 to 44.9) | 0.52 (0.38 to 0.67) | 0.26 (0.17 to 0.4) | 9.8 (7.2 to 13.2) | 0.54 (0.4 to 0.73) | 0.49 (0.35 to 0.69) | 55.9 (48.9 to 62.7) | 0.75 (0.65 to 0.84) | 0.42 (0.32 to 0.56) | 5 (3.3 to 7.4) | 1.25 (0.83 to 1.86) | 1.26 (0.82 to 1.93) | −0.45 (−0.57 to −0.34) | 2.13 (0.19 to 4.07) |
| 4.0 | 32.2 (23.4 to 42.4) | 0.48 (0.35 to 0.63) | 0.23 (0.15 to 0.36) | 9.2 (6.6 to 12.7) | 0.51 (0.37 to 0.71) | 0.46 (0.32 to 0.67) | 54.3 (47.2 to 61.2) | 0.72 (0.63 to 0.82) | 0.4 (0.3 to 0.53) | 5.2 (3.3 to 7.9) | 1.29 (0.83 to 1.97) | 1.3 (0.83 to 2.05) | −0.5 (−0.62 to −0.37) | 1.42 (−0.67 to 3.52) |
| 4.5 | 30.3 (22 to 40.2) | 0.45 (0.33 to 0.6) | 0.21 (0.14 to 0.33) | 8.9 (6.3 to 12.5) | 0.49 (0.35 to 0.69) | 0.44 (0.3 to 0.65) | 53.1 (46.2 to 59.8) | 0.71 (0.62 to 0.8) | 0.38 (0.29 to 0.5) | 5.3 (3.4 to 8.3) | 1.33 (0.85 to 2.07) | 1.35 (0.84 to 2.16) | −0.53 (−0.66 to −0.39) | 0.91 (−1.29 to 3.11) |
| 5.0 | 28.9 (21.1 to 38.3) | 0.43 (0.31 to 0.57) | 0.2 (0.13 to 0.31) | 8.7 (6.1 to 12.3) | 0.48 (0.34 to 0.68) | 0.43 (0.3 to 0.64) | 52.2 (45.7 to 58.6) | 0.7 (0.61 to 0.78) | 0.36 (0.28 to 0.47) | 5.5 (3.5 to 8.6) | 1.38 (0.87 to 2.15) | 1.4 (0.87 to 2.25) | −0.55 (−0.68 to −0.41) | 0.6 (−1.64 to 2.84) |
| 5.5 | 27.9 (20.5 to 36.7) | 0.42 (0.31 to 0.55) | 0.19 (0.13 to 0.29) | 8.6 (6.1 to 12.2) | 0.48 (0.34 to 0.68) | 0.43 (0.29 to 0.63) | 51.6 (45.6 to 57.5) | 0.69 (0.61 to 0.77) | 0.36 (0.28 to 0.45) | 5.7 (3.6 to 8.9) | 1.43 (0.9 to 2.22) | 1.45 (0.9 to 2.34) | −0.55 (−0.69 to −0.42) | 0.45 (−1.79 to 2.69) |
| 6.0 | 27.1 (20.1 to 35.5) | 0.4 (0.3 to 0.53) | 0.18 (0.12 to 0.27) | 8.7 (6.1 to 12.1) | 0.48 (0.34 to 0.67) | 0.43 (0.3 to 0.63) | 51.2 (45.6 to 56.7) | 0.68 (0.61 to 0.76) | 0.35 (0.28 to 0.44) | 5.9 (3.8 to 9.1) | 1.47 (0.94 to 2.29) | 1.5 (0.94 to 2.42) | −0.56 (−0.69 to −0.42) | 0.4 (−1.82 to 2.62) |
| 6.5 | 26.4 (19.6 to 34.5) | 0.39 (0.29 to 0.51) | 0.18 (0.12 to 0.26) | 8.7 (6.2 to 12.2) | 0.49 (0.35 to 0.68) | 0.44 (0.3 to 0.63) | 50.8 (45.5 to 56) | 0.68 (0.61 to 0.75) | 0.34 (0.28 to 0.42) | 6.1 (3.9 to 9.4) | 1.52 (0.97 to 2.36) | 1.56 (0.97 to 2.5) | −0.56 (−0.69 to −0.42) | 0.42 (−1.78 to 2.61) |
| 7.0 | 25.7 (19 to 33.7) | 0.38 (0.28 to 0.5) | 0.17 (0.12 to 0.25) | 8.8 (6.3 to 12.2) | 0.49 (0.35 to 0.68) | 0.44 (0.31 to 0.63) | 50.4 (45.1 to 55.6) | 0.67 (0.6 to 0.74) | 0.34 (0.27 to 0.42) | 6.3 (4 to 9.7) | 1.58 (1.01 to 2.43) | 1.62 (1.01 to 2.58) | −0.55 (−0.69 to −0.42) | 0.44 (−1.74 to 2.63) |
| 7.5 | 25 (18.3 to 33.2) | 0.37 (0.27 to 0.5) | 0.16 (0.11 to 0.24) | 8.9 (6.4 to 12.3) | 0.5 (0.36 to 0.68) | 0.45 (0.31 to 0.64) | 50 (44.6 to 55.4) | 0.67 (0.59 to 0.74) | 0.33 (0.27 to 0.41) | 6.5 (4.2 to 10) | 1.63 (1.05 to 2.51) | 1.68 (1.05 to 2.67) | −0.55 (−0.69 to −0.42) | 0.47 (−1.72 to 2.66) |
| 8.0 | 24.3 (17.4 to 32.9) | 0.36 (0.26 to 0.49) | 0.16 (0.1 to 0.24) | 9 (6.5 to 12.4) | 0.5 (0.36 to 0.69) | 0.45 (0.31 to 0.65) | 49.6 (43.8 to 55.3) | 0.66 (0.58 to 0.74) | 0.33 (0.26 to 0.41) | 6.8 (4.3 to 10.4) | 1.69 (1.08 to 2.59) | 1.74 (1.09 to 2.78) | −0.55 (−0.69 to −0.42) | 0.5 (−1.71 to 2.7) |
| 8.5 | 23.7 (16.5 to 32.7) | 0.35 (0.25 to 0.49) | 0.15 (0.1 to 0.24) | 9.1 (6.5 to 12.6) | 0.51 (0.36 to 0.7) | 0.46 (0.32 to 0.66) | 49.2 (42.9 to 55.5) | 0.66 (0.57 to 0.74) | 0.32 (0.25 to 0.42) | 7 (4.5 to 10.7) | 1.75 (1.12 to 2.68) | 1.8 (1.12 to 2.89) | −0.55 (−0.69 to −0.41) | 0.52 (−1.72 to 2.76) |
| 9.0 | 23 (15.6 to 32.7) | 0.34 (0.23 to 0.49) | 0.15 (0.09 to 0.24) | 9.2 (6.5 to 12.8) | 0.51 (0.36 to 0.71) | 0.46 (0.32 to 0.67) | 48.8 (41.9 to 55.7) | 0.65 (0.56 to 0.74) | 0.32 (0.24 to 0.42) | 7.2 (4.6 to 11.1) | 1.8 (1.15 to 2.78) | 1.87 (1.16 to 3.01) | −0.55 (−0.69 to −0.41) | 0.55 (−1.74 to 2.84) |
| 9.5 | 22.4 (14.6 to 32.8) | 0.33 (0.22 to 0.49) | 0.14 (0.08 to 0.24) | 9.3 (6.6 to 13) | 0.52 (0.36 to 0.72) | 0.47 (0.32 to 0.68) | 48.4 (40.8 to 56.1) | 0.65 (0.54 to 0.75) | 0.31 (0.23 to 0.43) | 7.5 (4.7 to 11.6) | 1.87 (1.19 to 2.89) | 1.94 (1.2 to 3.14) | −0.55 (−0.69 to −0.4) | 0.57 (−1.78 to 2.93) |
| 10.0 | 21.8 (13.6 to 33) | 0.32 (0.2 to 0.49) | 0.14 (0.08 to 0.24) | 9.4 (6.6 to 13.3) | 0.52 (0.36 to 0.74) | 0.47 (0.32 to 0.7) | 48 (39.6 to 56.5) | 0.64 (0.53 to 0.75) | 0.31 (0.22 to 0.43) | 7.7 (4.9 to 12) | 1.93 (1.22 to 3) | 2.01 (1.23 to 3.28) | −0.55 (−0.69 to −0.4) | 0.6 (−1.82 to 3.03) |
| 15.0 | 16.2 (6 to 37) | 0.24 (0.09 to 0.55) | 0.1 (0.03 to 0.29) | 10.4 (6.1 to 17.4) | 0.58 (0.34 to 0.97) | 0.53 (0.29 to 0.96) | 44.1 (27.5 to 62.2) | 0.59 (0.37 to 0.83) | 0.26 (0.13 to 0.55) | 10.7 (6 to 18.5) | 2.68 (1.49 to 4.62) | 2.88 (1.52 to 5.45) | −0.53 (−0.75 to −0.31) | 0.86 (−2.76 to 4.48) |
Abbreviations: OR, odds ratio; PANSS, Positive and Negative Syndrome Scale total score change from baseline to end point; RR, relative risk; SMD, standardized mean difference for PANSS change from baseline drug vs placebo.
a
Dose is indicated in risperidone equivalents.
b
Positive values indicate worsening; negative values indicate improvement.