Long-term safety and tolerability of lumateperone 42 mg in patients with stable symptoms of schizophrenia: Results from a 1-year open-label study.
Christoph U Correll, Suresh Durgam, Susan G Kozauer et al.
✦ AI-curated · Sources linked
In 30 seconds
This 1-year, open-label, Phase 3 study assessed the safety and efficacy of lumateperone 42 mg once daily in adults with stable schizophrenia. Of 602 treated patients, 229 (38.0%) completed treatment. Treatment-emergent adverse events occurred in 390 patients (64.8%); the most common were decreased weight, diarrhea, dry mouth, and headache. At Day 368, PANSS Total score improved by a mean of -4.2 (95% CI = -5.6 to -2.8), while weight and several cardiometabolic and prolactin measures also improved. The authors reported no notable changes in extrapyramidal symptom scales.
Key findings
- Treatment-emergent adverse events occurred in 390 patients (64.8%); decreased weight was most common (10.1%).
- At Day 368, PANSS Total score changed by a mean of -4.2 (95% CI = -5.6 to -2.8; P < .001).
- Weight, body mass index, and waist circumference decreased through Day 368 (P < .001); cholesterol, prolactin, and triglycerides also improved.
- No notable changes were observed on extrapyramidal symptom-related scales.
Why it matters
Longer-term tolerability is important when treating schizophrenia. These findings describe adverse events and symptom and metabolic changes during a year of lumateperone treatment in patients whose symptoms were stable at entry. The results may inform discussions of longer-term treatment experience, while the open-label design means observed improvements cannot establish comparative benefit or attribute changes definitively to the medication.
What to keep in mind
The study was open-label and had no comparator; only 229 of 602 treated patients completed 1-year treatment.