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.