A REVIEW OF THE SAFETY AND TOLERABILITY OF SERTINDOLE

The safety and efficacy of sertindole have been established in three d ouble-blind randomized controlled studies conducted in the United Stat es, North America and Europe. In these three studies the tendency for sertindole to cause extrapyramidal side effects (EPS), a critical fact or affecting compliance, was investigated. At 12-24 mg/day, sertindole was associated with placebo levels of EPS, which were significantly l ower than for all doses of haloperidol. In the European study, 24 mg s ertindole demonstrated slightly, but statistically significantly, more EPS than 8 mg (P = 0.05). However, the incidence of EPS-related event s was comparable with that reported for placebo in the United States a nd North American studies. The frequency of use of anti-EPS medication was also comparable in the sertindole and placebo groups. Slight prol ongation of the Q-T interval was seen with sertindole in early clinica l 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 hypokalaemi a and in those patients undergoing concomitant treatment with other me dication known to prolong the Q-T interval. Most of the other adverse events reported for sertindole are related to its alpha(1) antagonisti c activity. Int Clin Psychopharmacol 13 (suppl 3):S65-S70 (C) 1998 Lip pincott-Raven Publishers.