Table 11. Aripiprazole on QT interval in children and adolescents 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† |
---|---|---|---|---|---|---|
Aripiprazole versus placebo | ||||||
Prolongation of QT interval | 64 | 0 | RR 7.58 (0.40, 143.03) | 98 (1 RCT) (37,88) | Very low | No difference |
Corrected QT (QTc) changes | NR | NR | MD −2.74 (−4.71, −0.77); SMD −0.13 (−0.22, −0.03) |
1,776 (4 RCTs and 10 non-RCTs) (35,60-62,88) | Low | Favors aripiprazole |
Electrocardiogram QT prolonged at the end of the study | 62 | 35 | RR 1.75 (0.17, 18.28) | 60 (1 RCT) (95) | Very low | No difference |
Aripiprazole, high dose 30 mg/d versus low dose 10 mg/d | ||||||
Prolongation of QT interval | 20 | 10 | RR 1.98 (0.18, 21.48) | 197 (1 RCT) (37,93) | Very low | No difference |
Aripiprazole versus risperidone | ||||||
Prolongation of QT interval | 0 | 0 | RR undetermined | 60 (1CT) (36,37) | Very low | No difference |
QT dispersion (QTd) | NR | NR | MD 1.60 (−1.66, 4.86); SMD 0.25 (−0.26, 0.76) |
60 (1CT) (36,37) | Very low | No difference |
Aripiprazole versus pimozide | ||||||
Prolongation of QT interval | 0 | 40 | RR 0.33 (0.01, 7.81) | 50 (1CT) (37,87) | Very low | No difference |
†, 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; 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.