Table 4. Ziprasidone versus haloperidol 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† |
|---|---|---|---|---|---|---|
| Ziprasidone oral | ||||||
| QTc interval ≥450 msec | 28 | 11 | RR 1.86 (0.57, 6.04) | 569 (4 RCTs) (47) | Low | |
| 450 msec ≤ QTc interval <480 msec | 24 | 0 | RR 4.12 (0.89, 19.09) | 569 (4 RCTs) (47) | Low | |
| QTc interval ≥480 msec | 4 | 12 | RR 0.61 (0.03, 11.80) | 509 (3 RCTs) (38,47) | Low | |
| QTc prolongation | NR | NR | MD 15.30 (6.22, 24.38); SMD 0.92 (0.34, 1.49) | 52 (1 RCT) (38,43) | Very low | Favors haloperidol |
| QT change from baseline | NR | NR | MD 4.70 (3.30, 6.10); SMD 0.23 (0.16, 0.29) | 5,339(44)* | Very low | Favors haloperidol |
| Peak measured QTc ≥450 msec | 8 | 3 | RR 2.64 (0.81, 8.59) | 5,339 (44)* | Very low | No difference |
| Peak measured QTc ≥480 msec | 0 | 0 | RR 0.72 (0.03, 17.67) | 5,339 (44)* | Very low | No difference |
| Peak measured QTc ≥500 msec | 0 | 0 | RR 0.72 (0.03, 17.67) | 5,339 (44)* | Very low | No difference |
| Maximal QTc change from baseline ≥30 msec | 90 | 60 attributable events per 1,000 treated 30 [13, 47] | RR 1.51 (1.16, 1.95); NNT 33 (21, 74) | 5,339 (44)* | Low | Favors haloperidol |
| Maximal QTc change from baseline ≥60 msec | 7 | 3 | RR 2.40 (0.73, 7.85) | 5,339 (44)* | Very low | No difference |
| Maximal QTc change from baseline ≥75 msec | 3 | 1 | RR 2.88 (0.37, 22.11) | 5,339 (44)* | Very low | No difference |
| Ziprasidone, intramuscular | ||||||
| QTc change from baseline | NR | NR | MD 1.10 (−2.59, 4.79); SMD 0.04 (−0.09, 0.18) | 960 (44)* | Low | No difference |
| Peak measured QTc ≥450 msec | 8 | 17 | RR 0.46 (0.13, 1.57) | 960 (44)* | Very low | No difference |
| Peak measured QTc ≥480 msec | 2 | 7 | RR 0.23 (0.02, 2.52) | 960 (44)* | Very low | No difference |
| Peak measured QTc ≥500 msec | 0 | 3 | RR 0.15 (0.01, 3.75) | 960 (44)* | Very low | No difference |
| Maximal QTc change from baseline ≥30 msec | 81 | 70 | RR 1.16 (0.71, 1.88) | 960 (44)* | Very low | No difference |
| Maximal QTc change from baseline ≥60 msec | 14 | 23 | RR 0.59 (0.22, 1.57) | 960 (44)* | Very low | No difference |
| Maximal QTc change from baseline ≥75 msec | 5 | 17 | RR 0.28 (0.07, 1.14) | 960 (44)* | Very low | No difference |
*, individual patient data network meta-analysis of 40 Pfizer-sponsored phase II–IV RCTs in schizophrenia or bipolar disorder patients including 5 pediatric RCTs. †, 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; 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 1,000 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;