Objective: To evaluate the impact of 2 strategies for switching to iloperidone Methods: In this 12-week randomized (1:1), multicenter, open-label study, 500 adult outpatients with a diagnosis of schizophrenia experiencing suboptimal efficacy or ≥1 predefined tolerability problem with risperidone, olanzapine, or aripiprazole, switched either immediately to iloperidone or gradually tapered their prior antipsychotic dose (to 50% Day 1; 25% Week 1; 0% Week 2) over the first 2 weeks of iloperidone treatment. Iloperidone was titrated to a target dose of 6mg bid by Day 4 (optional increases to 12mg bid permitted). Primary variable: Integrated Clinical Global Impression of Change. Metabolic measures were obtained under fasting conditions. Results: 346 Patients completed the study (168 gradual; 178 immediate). For all patients (iloperidone 12-24mg/d), the proportions with shifts from normal to high levels in fasting metabolic measures from baseline to Week 12 were similar for gradual- and immediate-switch groups, respectively: serum glucose (11.1%, 7.5%), total cholesterol (1.6%, 2.9%), LDL (0%, 1.4%), and triglycerides (8.8%, 8.8%); shifts from normal to low levels in fasting HDL were 16.9% and 7.4%. Mean changes (mg/dL) from baseline to Week 12 for gradual- and immediate-switch groups, respectively, were: serum glucose, +7.7, +7.5; cholesterol, -0.4, -4.3; LDL, -3.2, -1.0; HDL, -0.8, -0.6; and triglycerides, +14.8, -6.3. Respective mean increases in weight were 0.9kg and 0.8kg; 9.6%, and 7.7% of patients experienced a ≥7% weight increase during the study. Conclusions: Proportions of patients experiencing metabolic shifts after switching to iloperidone from risperidone, olanzapine, or aripiprazole ranged from 0% to 16.9%.
Greg Mattingly, MD; Xiangyi Meng, PhD; Farid Kianifard, PhD; Adam Winseck, PhD; Maria Hochfeld, MD
Novartis Pharmaceuticals Corporation