Emerging treatments in the management of schizophrenia – focus on sertindole

Figures & data

Table 1 Five published efficacy trials of sertindole in schizophrenia

Authors/year of publication	Study design	Trial duration	Diagnosis, setting, (number of patients; % total discontinuation) and age of randomized patients	Sertindole regimen (n of patients; % discontinuation)	Active comparator regimen (n of patients; % discontinuation)	Placebo (n of patients; % discontinuation)	Outcome measures	Main efficacy results
van Kammen et al (1996)	Multicenter, randomized, placebo-controlled	8 weeks	Schizophrenia inpatients (n = 205) Age range: 20–66 years	Total (n = 157; 33%) 8 mg/day (n = 52; 33%) 12 mg/day (n = 51; 31%) 20 mg/day (n = 54; 35%)	NA	Placebo (n = 48; 39%)	PANSS BPRS CGI BAS SAS AIMS	PANSS, BPRS, CGI: S 20 mg/day more effective than Pl
Zimbroff et al (1997)	Multicenter, double-blind, placebo-controlled	8 weeks	Schizophrenia (n = 497; 51%) Age range: 18–65 years	Total (n = 216; NA 12 mg/day (n = 76) 20 mg/day (n = 68) 24 mg/day (n = 72)	Haloperidol (n = 208; NA) 4 mg/day (n = 71) 8 mg/day (n = 67) 16 mg/day (n = 70)	Placebo (n = 73; NA)	PANSS BPRS SANS CGI BAS SAS AIMS	PANSS-P: S 20 mg/day and 24 mg/day and each H dose range more effective than Pl; SANS: Only S 20 mg/day more effective than Pl
Daniel et al (1998)	Multicenter, randomized, double-blind	5 weeks 1-year follow-up	Schizophrenia outpatients (n = 282) Age range: 18–66 years	24 mg/day (n = 141; 19%)	Haloperidol 10 mg/day (n = 141; 21%)	NA	PANSS SANS	PANSS-T: S more effective than H after 5 weeks; no statistically significant differences at 1-year follow-up
Hale et al (2000)	Multicenter, randomized, double-blind	8 weeks	Schizophrenia inpatients (n = 617; 39%) Age range: 17–66 years	Total (n = 492; 27%) 8 mg/day (n = 120; 44%) 16 mg/day (n = 127; 37%) 20 mg/day (n = 128; 36%) 24 mg/day (n = 117; 38%)	Haloperidol 10 mg/day (n = 125; 39%)	NA	PANSS CGI BAS SAS AIMS	PANSS-T: efficacy for S 16 and 24 mg/day and H 10 mg/day
Azorin et al (2006)	Multicenter, randomized, double-blind, flexible-dose	12 weeks	Schizophrenia (n = 186; 35%) Age range: 18–65 years	Sertindole 12–24 mg/day, mean dose = 16,2 mg/day n = 97; 39%)	Risperidone 4–10 mg/day, mean dose = 6.6 mg/day (n = 89; 31%)	NA	PANSS CGI DAI GAF	PANSS-T: no statistical differences between S and R; PANSS-N: greater reduction for S-treated patients

Abbreviations: H, haloperidol; Pl, placebo; R, risperidone; S, sertindole; PANSS-T (N, P), positive and negative syndrome scale-total (negative and positive subscales); BPRS, brief psychiatric rating scale; CGI, clinical global impression scale; SANS, scale for the assessment of negative symptoms; BAS, barnes akathisia scale; SAS, simpson-angus scale; AIMS, abnormal involuntary movement scale; NA, not available.

Table 2 Mortality rates from clinical trials and European Safety and Exposure Survey (ESES)

	Clinical trials	ESES
Patients (n)	3031	8608
Deaths (n)	29	35
All-cause mortality/100 PYE (CI)*	1.52 (0.96–2.13)	0.92 (0.64–1.35)
Cardiac mortality/100 PYE (CI)*	0.31 (0.11–0.688)	0.35 (0.17–0.65)

* CI = 95% Confidence Intervals.