Table 5.
Summary of clinically important outcomes.
| Outcome | No. of trials reporting the outcome | Total no. of patients in trials | Effects | Odds ratio (95% CI) or mean difference (95% CI) |
|---|---|---|---|---|
| Asenapine vs. placebo | ||||
| Changes to PANSS total | 3 | 689 | Favours ASP (greater reduction with ASP) | –8.98 (–12.73 to –5.23) |
| Changes to CGI-S | 2 | 609 | Favours ASP (greater reduction with ASP) | –0.46 (–0.78 to –0.14) |
| Changes to PANSS negative | 1 | 189 | No difference | –0.1 (–1.25 to 1.05) |
| Changes to PANSS Marder negative | 2 | 609 | Favours ASP (greater reduction with ASP) | –1.54 (–2.25 to –0.84) |
| Incidence of discontinuation due to adverse effects | 3 | 736 | No difference | 0.53 (0.20 to 1.42) |
| Incidence of all adverse effects | 3 | 736 | No difference | 0.91 (0.60 to 1.39) |
| Incidence of serious adverse effects | 3 | 736 | No difference | 0.75 (0.24 to 2.30) |
| Clinically significant increases in body weight (≥7% of baseline) | 3 | 736 | Favours PLC (lower incidence with PLC) | 3.58 (1.13 to 11.31) |
| Incidence of reported akathisia | 2 | 615 | No difference | 2.62 (0.87 to 7.87) |
| Incidence of patients reporting any EPS symptoms | 2 | 615 | No difference | 1.21 (0.40 to 3.67) |
| Incidence of sedation | 1 | 229 | No difference | 1.42 (0.42 to 4.78) |
| Incidence of insomnia | 3 | 736 | No difference | 0.91 (0.40 to 2.06) |
| Worsening schizophrenia | 3 | 736 | No difference | 0.7 (0.22 to 2.26) |
| Agitation | 3 | 736 | Favours ASP (lower incidence with ASP) | 0.54 (0.3 to 0.97) |
| Asenapine vs. olanzapine | ||||
| Changes to PANSS total | 4 | 2242 | No difference | 3.05 (–0.46 to 6.56) |
| Changes to CGI-S | 3 | 2051 | No difference | 0.22 (0.00 to 0.44) |
| Changes to PANSS negative | 3 | 1076 | No difference | –0.23 (–1.02 to 0.55) |
| Changes to PANSS Marder negative | 3 | 2051 | No difference | 0.22 (–1.14 to 1.57) |
| Incidence of discontinuation due to adverse effects | 3 | 1647 | No difference | 1.20 (0.57 to 2.51) |
| Incidence of all adverse effects | 3 | 2148 | No difference | 1.05 (0.78 to 1.40) |
| Incidence of serious adverse effects | 3 | 2168 | Favours OZP (lower incidence with OZP) | 1.84 (1.36 to 2.47) |
| Clinically significant increases in body weight (≥7% of baseline) | 3 | 2168 | Favours ASP (lower incidence with ASP) | 0.35 (0.27 to 0.44) |
| Incidence of reported akathisia | 3 | 2168 | Favours OZP (lower incidence with OZP) | 2.27 (1.45 to 3.55) |
| Incidence of patients reporting any EPS symptoms | 3 | 2168 | Favours OZP (lower incidence with OZP) | 2.06 (1.38 to 3.06) |
| Incidence of sedation | 3 | 2168 | No difference | 0.82 (0.59 to 1.16) |
| Incidence of insomnia | 3 | 2168 | Favours OZP (lower incidence with OZP) | 1.46 (1.13 to 1.90) |
| Worsening schizophrenia | 3 | 2168 | Favours OZP (lower incidence with OZP) | 1.38 (1.05 to 1.82) |
| Agitation | 2 | 949 | No difference | 2.7 (0.82 to 8.95) |
| Asenapine 10 mg vs. asenapine 5 mg | ||||
| Changes to PANSS total | ND | ND | ND | ND |
| Changes to CGI-S | 1 | 214 | No difference | 0.1 (–0.18 to 0.38) |
| Changes to PANSS negative | ND | ND | ND | ND |
| Changes to PANSS Marder negative | 1 | 214 | No difference | 0 (–1.38 to 1.38) |
| Incidence of discontinuation due to adverse effects | 1 | 217 | No difference | 2.2 (0.7 to 6.7) |
| Incidence of all adverse effects | 1 | 217 | No difference | 1.7 (0.92 to 3) |
| Incidence of serious adverse effects | 1 | 217 | No difference | 1.38 (0.49 to 3.84) |
| Clinically significant increases in body weight (≥7% of baseline) | 1 | 217 | No difference | 0.7 (0.19 to 2.5) |
| Incidence of reported akathisia | 1 | 217 | No difference | 2.3 (0.85 to 6.4) |
| Incidence of patients reporting any EPS symptoms | 1 | 217 | No difference | 1.2 (0.6 to 2.5) |
| Incidence of sedation | 1 | 217 | No difference | 0.9 (0.31 to 2.58) |
| Incidence of insomnia | 1 | 217 | No difference | 0.9 (0.45 to 1.7) |
| Worsening schizophrenia | 1 | 217 | No difference | 3.3 (0.9 to 12.7) |
| Agitation | 1 | 217 | No difference | 0.71 (0.3 to 1.95) |
ASP, asenapine; CGI-S, Clinical Global Impression–severity scale; EPS, extrapyramidal symptoms; ND, no data; OZP, olanzapine; PANSS, Positive and Negative Syndrome Scale; PLC, placebo.