title: A trial evaluating gradual- or immediate-switch strategies from risperidone, olanzapine, or aripiprazole to iloperidone in patients with schizophrenia.
abstract: In a 12-week randomized open-label trial, adults diagnosed with schizophrenia experiencing inadequate efficacy and/or poor tolerability on risperidone, olanzapine, or aripiprazole were randomized to switch to iloperidone either gradually (ie, down-titration of current therapy over the first 2weeks [to 50% on Day 1, 25% by Week 1, 0% by Week 2]) or immediately. All patients were titrated on iloperidone to 6mg BID by Day 4, then flexibly dosing between 6 and 12mg BID, as needed. The primary variable was the Integrated Clinical Global Impression of Change (I-CGI-C) and the primary analysis time point was Week 12. A total of 500 patients were randomized and received iloperidone (gradual switch, 240; immediate switch, 260), with 175, 155, and 170 patients switched from risperidone, olanzapine, and aripiprazole, respectively. I-CGI-C Results confirmed improved outcomes at Week 12, with scores that were similar between the gradual- and immediate-switch groups, respectively, for risperidone, 2.82 and 2.67 (95% CI: -0.229, 0.511); olanzapine, 2.87 and 3.03 (95% CI: -0.548, 0.235); and aripiprazole, 2.79 and 2.81 (95% CI: -0.405, 0.368). Incidence of adverse events (AEs) was similar in both switch groups, with the most frequently reported (≥10%) being dizziness, dry mouth, somnolence, and weight increase. In conclusion, switching to iloperidone by either a gradual or an immediate method did not reveal any clinically significant differences in ratings of overall efficacy and safety/tolerability outcomes, based on the I-CGI-C at 12weeks. Similar overall safety/AE profiles were observed regardless of the specific agent from which patients were switched.
authors: University of Illinois at Chicago, UIC Medical Center, 912 South Wood Street, MC 913, Chicago, IL 60612, USA. Electronic address: pweiden@psych.uic.edu.
authors: Peter J
authors: PJ
authors: Weiden
authors: New York Medical College, 40 Sunshine Cottage Road, Valhalla, NY 10595, USA. Electronic address: citrome@cnsconsultant.com.
authors: Leslie
authors: L
authors: Citrome
authors: ATP Clinical Research, 3151 Airway Avenue, Building T, Suite 3, Costa Mesa, CA 92626, USA. Electronic address: galva@theatpgroup.net.
authors: Gus
authors: G
authors: Alva
authors: Memorial Park Psychiatry, 550 Westcott, Suite 520, Houston, TX 77007, USA. Electronic address: bramsmaooffice@aol.com.
authors: Matthew
authors: M
authors: Brams
authors: University School of Medicine Stanford, 251 Campus Drive, Stanford, CA 94305, USA. Electronic address: iraglick@stanford.edu.
authors: Ira D
authors: ID
authors: Glick
authors: Wayne State University, Scott Hall, 540 East Canfield, Detroit, MI 48201, USA. Electronic address: richardjackson2000@yahoo.com.
authors: Richard
authors: R
authors: Jackson
authors: Washington University School of Medicine, 660 South Euclid Avenue, St. Louis, MO 63110, USA. Electronic address: greg@mattingly.com.
authors: Greg
authors: G
authors: Mattingly
authors: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA. Electronic address: Farid.Kianifard@novartis.com.
authors: Farid
authors: F
authors: Kianifard
authors: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA. Electronic address: Xiangyi.Meng@novartis.com.
authors: Xiangyi
authors: X
authors: Meng
authors: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA.
authors: Linda
authors: L
authors: Pestreich
authors: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA.
authors: Marla
authors: M
authors: Hochfeld
authors: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA. Electronic address: Adam.Winseck@novartis.com.
authors: Adam
authors: A
authors: Winseck
mesh_terms: D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001016:Aortic Bodies / Q000187:drug effects; D000068180:Aripiprazole; D001569:Benzodiazepines; D015331:Cohort Studies; D004334:Drug Administration Schedule; D057915:Drug Substitution / Q000379:methods*; D005260:Female; D006801:Humans; D007555:Isoxazoles; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D010879:Piperazines; D010880:Piperidines; D011569:Psychiatric Status Rating Scales; D015363:Quinolones; D018967:Risperidone; D012559:Schizophrenia / Q000188:drug therapy* / Q000378:metabolism; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D007555:Isoxazoles; D010879:Piperazines; D010880:Piperidines; D015363:Quinolones; D001569:Benzodiazepines; D000068180:Aripiprazole; D018967:Risperidone; D000077152:Olanzapine; C081732:iloperidone
keywords: Clinical improvement; Iloperidone; Safety; Schizophrenia; Switch strategy; Tolerability