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A trial evaluating gradual- or immediate-switch strategies from risperidone, olanzapine, or aripiprazole to
Peter J Weiden1, Leslie Citrome2, Gus Alva3
1University of Illinois at Chicago, UIC Medical Center, 912 South Wood Street, MC 913, Chicago, IL 60612, USA.
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.
Insights
Switching to iloperidone for schizophrenia treatment showed similar efficacy and safety whether done gradually or immediately. Both methods resulted in comparable outcomes and adverse events at 12 weeks.
Area of Science:
- Psychiatry
- Pharmacology
- Clinical Trials
Background:
- Schizophrenia treatment often involves switching antipsychotics due to inadequate efficacy or tolerability.
- Iloperidone is an atypical antipsychotic used for schizophrenia management.
- Optimizing the switching strategy between antipsychotics is crucial for patient outcomes.
Purpose of the Study:
- To compare the efficacy and safety of a gradual versus immediate switch to iloperidone in adults with schizophrenia.
- To evaluate outcomes based on the Integrated Clinical Global Impression of Change (I-CGI-C) at 12 weeks.
Main Methods:
- A 12-week, randomized, open-label trial involving 500 adults with schizophrenia.
- Patients inadequately treated with risperidone, olanzapine, or aripiprazole were randomized to switch to iloperidone either gradually or immediately.
- Iloperidone dosing was initiated and adjusted over the trial period.
Main Results:
- No clinically significant differences in I-CGI-C scores were observed between the gradual and immediate switch groups at 12 weeks.
- Adverse event profiles were similar across both switching methods and across different prior antipsychotic agents.
- Common adverse events included dizziness, dry mouth, somnolence, and weight increase.
Conclusions:
- Both gradual and immediate switching strategies to iloperidone are effective and well-tolerated for patients with schizophrenia.
- The method of switching does not appear to significantly impact overall efficacy or safety outcomes.
- Iloperidone offers a viable treatment option with comparable results regardless of the switching approach.
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