A Cochrane review [Abstract] 1 included 3 studies with a total of 1 104 subjects. There were no statistically significant differences between sertindole (8, 12 or 20 mg) and placebo for the incidence of extrapyramidal symptoms, extrapyramidal related events or use of medication to avoid extrapyramidal symptoms, for the movement disorders akathisia, cogwheel rigidity, hypertonia and tremor or somnolence. At one year, a greater number of participants who were treated with haloperidol as compared to sertindole (24 mg/day) were leaving the study early due to any reason (1 study, n=282, RR 0.6, CI 0.4 to 1.0, NNH 8.8, CI 4.7 to 74.0) More participants treated with haloperidol experienced akathisia, tremor and hypertonia than those treated with sertindole. At one year, more participants taking sertindole (24 mg/day) had put on weight compared to those taking haloperidol (1 study, n=282, RR 6.3, CI 1.9 to 20.9, NNH 8.8, CI 5.7 to 19.1). At eight weeks a statistically significant difference between placebo and all sertindole groups (8, 12 and 20 mg) for mean change from baseline in the QT and QTc intervals were observed (p values and SD were not reported). For one long term study only one participant from the sertindole group (24 mg) had a QT interval that exceeded 500 msec (1 study, n=282, RR 3.0 CI 0.1 to 73.0), but 11 participants treated with sertindole had QTc intervals of at least 500 msec, compared to none in the haloperidol treated group (1 study, n=282, RR 23.0, CI 1.4 to 386.6, NNH 12.8, CI 8.2 to 29.6).
Comment: The quality of evidence is downgraded by imprecise results (limited study size for each comparison, together with poor reporting of the results). Due to suspicions of sudden cardiac deaths associated with the use of sertindol, it is not considered a first-line antipsychotic for any group of patients.
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