Summary of findings 5. RISPERIDONE DEPOT compared with ORAL ARIPIPRAZOLE for schizophrenia.
| RISPERIDONE DEPOT compared with ORAL ARIPIPRAZOLE for schizophrenia | ||||||
| Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: ORAL ARIPIPRAZOLE | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| ORAL ARIPIPRAZOLE | RISPERIDONE DEPOT | |||||
| Global state: Relapse (any reason) ‐ long term Assessed by 5 blinded raters in accordance with study criteria (see comment). | Moderate | RR 1.05 (0.83 to 1.33) | 349 (1 study) | ⊕⊕⊝⊝ low2,3 | Criteria for relapse were derived from Csernansky 2002. | |
| 436 per 10001 | 458 per 1000 (362 to 580) | |||||
| Mental state: Average change scores‐ long term PANSS total score (30 to 210), higher scores are worse. | The mean mental state: average change scores‐ long term in the intervention groups was 0.1 lower (3.15 lower to 2.95 higher) | 349 (1 study) | ⊕⊕⊝⊝ low2,3 | |||
| Leaving the study early: Any reason ‐ long term | Study population | RR 0.83 (0.53 to 1.3) | 723 (2 studies) | ⊕⊝⊝⊝ very low5,6 | ||
| 387 per 10004 | 321 per 1000 (205 to 503) | |||||
| Moderate | ||||||
| 531 per 10004 | 441 per 1000 (281 to 690) | |||||
| Adverse events: General ‐ serious Unclear how these events were reported | Study population | RR 0.96 (0.66 to 1.39) | 729 (2 studies) | ⊕⊝⊝⊝ very low5,6 | ||
| 190 per 10004 | 182 per 1000 (125 to 264) | |||||
| Moderate | ||||||
| 177 per 10004 | 170 per 1000 (117 to 246) | |||||
| Adverse events: Movement disorder ‐ any extra pyramidal symptoms | Study population | RR 1.19 (0.91 to 1.55) | 729 (2 studies) | ⊕⊝⊝⊝ very low5,6 | ||
| 285 per 10004 | 339 per 1000 (259 to 442) | |||||
| Moderate | ||||||
| 196 per 10004 | 233 per 1000 (178 to 304) | |||||
| Adverse events: Specific ‐ weight increase | Moderate | RR 1.57 (0.38 to 6.45) | 374 (1 study) | ⊕⊕⊝⊝ low2,3 | ||
| 44 per 10001 | 69 per 1000 (17 to 284) | |||||
| Adverse events: Specific ‐ prolactin‐related | Study population | RR 9.91 (2.78 to 35.29) | 729 (2 studies) | ⊕⊝⊝⊝ very low5,6 | ||
| 9 per 10004 | 90 per 1000 (25 to 319) | |||||
| Moderate | ||||||
| 6 per 10004 | 59 per 1000 (17 to 212) | |||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1 Assumed risk: mean baseline risk presented for one individual study. 2 Risk of bias: 'very serious' ‐ a number of the study authors were employed by the manufacturers of risperidone depot at the time of the study. 3 Risk of bias: 'serious' ‐ serious risk of bias due to the open nature label of the study. 4 Assumed risk: median control group risk from the studies. 5 Risk of bias: 'very serious' ‐ serious risk of bias as both studies were open‐label and supported by the manufacturers of risperidone depot. 6 Imprecision: 'serious' ‐ possibly serious risk of imprecision in Gaebel 2010* as the aripiprazole arm of this study was very small (n = 45) compared to the risperidone depot (n = 329) arm.