A long-term, open-label study of valbenazine for tardive dyskinesia
| Autor: | Christopher F. O'Brien, Jean-Pierre Lindenmayer, Cherian Verghese, Joshua Burke, Roland Jimenez, Grace S. Liang, Scott Siegert, Stephen R. Marder |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Tetrabenazine Tardive dyskinesia Patient satisfaction Double-Blind Method Internal medicine medicine Humans Tardive Dyskinesia Valbenazine Dosing Adverse effect Aged Adrenergic Uptake Inhibitors business.industry Incidence (epidemiology) Valine Middle Aged medicine.disease Psychiatry and Mental health Treatment Outcome Tolerability Patient Satisfaction Clinical Global Impression Female Neurology (clinical) business |
| Zdroj: | CNS Spectrums. 26:345-353 |
| ISSN: | 2165-6509 1092-8529 |
| DOI: | 10.1017/s109285292000108x |
| Popis: | BackgroundIndividuals with tardive dyskinesia (TD) who completed a long-term study (KINECT 3 or KINECT 4) of valbenazine (40 or 80 mg/day, once-daily for up to 48 weeks followed by 4-week washout) were enrolled in a subsequent study (NCT02736955) that was primarily designed to further evaluate the long-term safety of valbenazine.MethodsParticipants were initiated at 40 mg/day (following prior valbenazine washout). At week 4, dosing was escalated to 80 mg/day based on tolerability and clinical assessment of TD; reduction to 40 mg/day was allowed for tolerability. The study was planned for 72 weeks or until termination due to commercial availability of valbenazine. Assessments included the Clinical Global Impression of Severity-TD (CGIS-TD), Patient Satisfaction Questionnaire (PSQ), and treatment-emergent adverse events (TEAEs).ResultsAt study termination, 85.7% (138/161) of participants were still active. Four participants had reached week 60, and none reached week 72. The percentage of participants with a CGIS-TD score ≤2 (normal/not ill or borderline ill) increased from study baseline (14.5% [23/159]) to week 48 (64.3% [36/56]). At baseline, 98.8% (158/160) of participants rated their prior valbenazine experience with a PSQ score ≤2 (very satisfied or somewhat satisfied). At week 48, 98.2% (55/56) remained satisfied. Before week 4 (dose escalation), 9.4% of participants had ≥1 TEAE. After week 4, the TEAE incidence was 49.0%. No TEAE occurred in ≥5% of participants during treatment (before or after week 4).ConclusionsValbenazine was well-tolerated and persistent improvements in TD were found in adults who received once-daily treatment for >1 year. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|