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While evidence-based clinical practice guidelines promote high-quality care, their absence may create unwarranted variation in disease management, leading to suboptimal outcomes. This study aimed to identify existing clinical practice guidelines for tardive dyskinesia (TD) in France, Germany, Italy, Spain, and the United Kingdom (EU4+UK), assessing the evidence for recommended TD treatments.
Methods
MEDLINE, PubMed, and other sources (e.g., government/public agencies, associations, patient/research organizations) were searched to identify clinical practice guidelines for TD published between January 2000 and February 2025 in EU4+UK. Mentions of TD treatments in identified documents were classified as “recommendations” or “descriptions.” Recommendations were ranked according to the Scottish Intercollegiate Guidelines Network grading system or received a “no-rank” label. Subanalyses on tetrabenazine and tiapride, were performed.
Results
Of the 31 documents identified, only two were TD-specific, with the remainder primarily developed for schizophrenia, major depressive disorder, and bipolar disorder. Data extraction led to 112 mentions of TD treatments (40 recommendations, 72 descriptions). Most recommendations focused on antipsychotic regimen modification (75%) and had no rank (88%). Only five recommendations (no rank) proposed a pharmaceutical (add-on) treatment: three for tetrabenazine and one each for amantadine and buspirone. Neither of the TD-specific guidelines contained TD treatment recommendations.
Conclusions
No specific clinical practice guidelines for TD in EU4 + UK were found, although TD management was mentioned in guidelines for other disorders. Most recommendations were not supported by high-quality evidence. To improve quality of care for patients with TD in Europe, updated treatment recommendations are needed based on high-quality studies.
Individuals 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.
Methods
Participants 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).
Results
At 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).
Conclusions
Valbenazine was well-tolerated and persistent improvements in TD were found in adults who received once-daily treatment for >1 year.
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