Adverse events in patients treated with deutetrabenazine were more common during titration than maintenance, a finding that provides “important context for the dosing schedule to providers and patients.”
Researchers reported on safety and tolerability of the tardive dyskinesia drug during titration compared with maintenance in a poster at Psych Congress 2020.
“Deutetrabenazine is titrated weekly based on dyskinesia control and tolerability,” they wrote in the poster abstract. “This analysis compared the safety of deutetrabenazine during titration versus maintenance using data from two 12-week placebo-controlled studies and an open-label extension study.”
In 216 patients taking fixed-dose deutetrabenazine, rates of adverse events during titration were between 33.3% and 38.9%, researchers reported, compared with 22.2% to 29.2% during maintenance. Common adverse events during titration were headache, diarrhea, nasopharyngitis, depression, hypertension, and dry mouth. During maintenance, the only common adverse event was headache.
In 168 patients taking flexible-dose deutetrabenazine, rates of adverse events were 49.4% during titration and 32.7% during maintenance. Participants experienced just one common adverse event during titration: somnolence. There were no common adverse events with flexible-dose deutetrabenazine during maintenance.
Meanwhile, in 130 patients taking placebo, rates of adverse events were 43.1% during titration and 25.4% during maintenance, according to the poster abstract. Common adverse events during titration were somnolence, headache, nausea, fatigue, and dry mouth. During maintenance, no common adverse events were reported.
Rates of parkinsonism, suicidal ideation, akathisia, and restlessness with deutetrabenazine were low during both titration and maintenance, researchers noted.
“Overall,” they concluded, “deutetrabenazine was generally well tolerated in patients with tardive dyskinesia, with adverse event rates similar to placebo during both the titration and maintenance periods.”
Teva Pharmaceutical Industries sponsored the study.
Wilhelm A, Anderson KE, Fernandez HH, et al. Comparison of safety and tolerability of deutetrabenazine during titration and maintenance in patients with tardive dyskinesia. Poster presented at Psych Congress 2020; September 10-13, 2020; Virtual.