A review of the safety and tolerability of sertindole.

The safety and efficacy of sertindole have been established in three double-blind randomized controlled studies conducted in the United States, North America and Europe. In these three studies the tendency for sertindole to cause extrapyramidal side effects (EPS), a critical factor affecting compliance, was investigated. At 12-24 mg/day, sertindole was associated with placebo levels of EPS, which were significantly lower than for all doses of haloperidol. In the European study, 24 mg sertindole demonstrated slightly, but statistically significantly, more EPS than 8 mg (P = 0.05). However, the incidence of EPS-related events was comparable with that reported for placebo in the United States and North American studies. The frequency of use of anti-EPS medication was also comparable in the sertindole and placebo groups. Slight prolongation of the Q-T interval was seen with sertindole in early clinical trials. Although no patients reported any clinical problems related to Q-T prolongation in these three studies, its use is contraindicated in patients suffering from underlying cardiac diseases or hypokalaemia and in those patients undergoing concomitant treatment with other medication known to prolong the Q-T interval. Most of the other adverse events reported for sertindole are related to its alpha, antagonistic activity.