Table 2. Risperidone versus active comparators on QT interval in people with mental disorders.
| Outcome | Risk with intervention per 1,000 | Risk with comparator per 1,000 | Relative measure of association | Number of participants (studies) | Quality (GRADE) | Comments† |
|---|---|---|---|---|---|---|
| Risperidone versus aripiprazole in children and adolescents | ||||||
| QTc, msec, >18 months | NR | NR | MD −1.20 (−8.94, 6.54); SMD −0.06 (−0.46, 0.33) | 99 (prospective analysis registry*) (23) | Very low | No difference |
| QTc >450 msec, or QTc prolongation >60 msec, or QTc dispersion >100 msec; subgroup: concomitant stimulant | NR | NR | Adjusted OR 4.23 (1.10, 17.00) | 99 (prospective registry analysis*) (23) | Very low | Favors aripiprazole |
| QTc >500 msec | 0 | 0 | RR undetermined | 99 (prospective analysis registry*) (23) | Very low | No difference |
| Risperidone long-acting Injection versus oral atypical antipsychotics (olanzapine, quetiapine, aripiprazole or amisulpride) in adults | ||||||
| QT prolonged | 0 | 11 | RR 0.35 (0.01, 8.56) | 167 (1 RCT) (39) | Very low | No difference |
| Risperidone or paliperidone versus active control in adults | ||||||
| Torsades/QT prolongation | 18 | 19 | RR 0.94 (0.59, 1.51) | 7,573 (64 RCTs) (21) | Very low | No difference |
| Risperidone 16 mg/d versus haloperidol 15 mg/d in adults | ||||||
| QTc >500 msec | 0 | 0 | RR Undetermined | 52 (1 RCT) (30,38) | Very low | No difference |
| Risperidone 4 mg versus risperidone, 2 mg/d + Haloperidol, 2 mg/d in adults | ||||||
| QTc, msec | NR | NR | MD −1.49 (−14.77, 11.79); SMD −0.06 (−0.57, 0.46) | 58 (1 RCT) (28,29) | Very low | No difference |
| Risperidone versus olanzapine in adults | ||||||
| Torsades de Pointes, sudden cardiac death | NR | NR | Adjusted HR 1.04 (0.88, 1.24) | 459,614 (1 observational study of medicaid database) (33) | Very low | No difference |
| Risperidone versus ziprasidone in adults | ||||||
| QTc | NR | NR | MD −21.80 (−28.13, −15.47); SMD −2.76 (−3.90, −1.62) | 24 (1 RCT) (26,27) | Very low | Favors risperidone |
*, SafEty of NeurolepTics in Infancy and Adolescence (SENTIA) registry (https://sentia.es). †, we concluded that there is no difference in outcomes between active and control interventions based on P value >0.05 and inability to reject null hypotheses but without post-hoc analysis of the statistical power to detect true differences. 95% confidence interval in (); GRADE, Grading of Recommendations Assessment, Development and Evaluation; OR, odds ratio; NNT, number needed to treat to achieve an outcome in one patient; NNT is calculated as 1/absolute risk difference; attributable events per 1,000 treated as the number of excessive or avoided events per 1000 treated that are attributed to active treatment; attributable events per 1,000 treated are calculated as absolute rate difference multiplied by 1,000; RCT, randomized controlled trial; RR, relative risk; MD, mean difference; SMD, standardized mean difference between intervention and comparator where the magnitude of the effect is defined as small (SMD, 0–0.5 standard deviations), moderate (SMD, 0.5–0.8 standard deviations), and large (SMD >0.8 standard deviations); QTc, corrected QT interval; NR, not reported.