Olanzapine 15 mg/day produced significantly greater improvements than placebo on both the PANSS total score (-28.7 vs. -16.0 placebo) and CGI-S (-1.5 vs. -1.1 placebo). A total of 64% of patients on olanzapine demonstrated a 30% or more improvement on the PANSS total score from baseline versus 38% on placebo. Patients on olanzapine reported a 3.1 kg (6.8 lbs) increase in median weight gain at study endpoint. The incidence of clinically significant weight gain (greater than or equal to 7% increase from baseline to study endpoint) for olanzapine was 34.4% vs. 7.0% placebo. Olanzapine-treated patients had a greater increase in lipid parameters versus placebo (median change: total cholesterol 9.0 mg/dL vs. -5.0 mg/dL placebo; and triglycerides 24.0 mg/dL vs. -1.0 mg/dL placebo at study endpoint). The most commonly reported adverse events for olanzapine (greater than 5% and at least twice the rate of placebo) were increased weight (20.5% vs. 5.2% placebo), sedation (13.9% vs. 3.4% placebo), dry mouth (9.8% vs. 0.9% placebo), somnolence (9.0% vs. 4.3% placebo) and akathisia (7.4% vs. 0.9% placebo).

The company has submitted the results of the trial for presentation at a scientific meeting at the end of this year.

PEARL 2 Study Overview

This randomized, fixed-dose, placebo-controlled, double-blind, multinational clinical trial was conducted at 52 sites worldwide primarily in hospital settings. Twenty-five sites in the United States randomized 286 patients, 18 sites in Asia randomized 115 patients, five sites in South America randomized 48 patients and four sites in Europe randomized 29 patients.

Patients were diagnosed with schizophrenia (using DSM-IV criteria) and were required to have an acute exacerbation of psychotic symptoms with a PANSS total score of 80 or higher at study baseline. Trial participants had a mean age of 37.7 years with an average PANSS score of 96.6 at baseline. Patients had been diagnosed with schizophrenia, on average, for more than 13 years and most had been previously hospitalized prior to entering the study. Multiple safety assessments were done, including vital signs, weight, ECGs, movement disorder scales (SAS, BAS, AIMS), and laboratory assessments.

Source: dsp-america