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Comparison of Safety and Tolerability of Deutetrabenazine During Titration and Maintenance in Patients with Tardive Dyskinesia.
Wilhelm, Amanda; Anderson, Karen E; Fernandez, Hubert H; Barkay, Hadas; Chaijale, Nayla; Send, Alexander F; Savola, Juha-Matti; Gordon, Mark Forrest.
  • Wilhelm A; Teva Pharmaceutical Industries Ltd., West Chester, PA, USA.
  • Anderson KE; Georgetown University, Washington, DC, USA.
  • Fernandez HH; Cleveland Clinic, Cleveland, OH, USA.
  • Barkay H; Teva Pharmaceutical Industries Ltd., Netanya, Israel.
  • Chaijale N; Teva Pharmaceutical Industries Ltd., West Chester, PA, USA.
  • Send AF; Teva Pharmaceutical Industries Ltd., West Chester, PA, USA.
  • Savola JM; Teva Pharmaceutical Industries Ltd., Basel, Switzerland.
  • Gordon MF; Teva Pharmaceutical Industries Ltd., West Chester, PA, USA.
CNS Spectr ; 26(2): 164, 2021 04.
Article in English | MEDLINE | ID: covidwho-1228224
Semantic information from SemMedBD (by NLM)
1. deutetrabenazine TREATS Tardive Dyskinesia
Subject
deutetrabenazine
Predicate
TREATS
Object
Tardive Dyskinesia
2. Tardive Dyskinesia PROCESS_OF Patients
Subject
Tardive Dyskinesia
Predicate
PROCESS_OF
Object
Patients
3. deutetrabenazine TREATS Patients
Subject
deutetrabenazine
Predicate
TREATS
Object
Patients
4. deutetrabenazine TREATS Adult
Subject
deutetrabenazine
Predicate
TREATS
Object
Adult
5. TLE5 gene|AES CAUSES Discontinued
Subject
TLE5 gene|AES
Predicate
CAUSES
Object
Discontinued
6. TLE5 gene|AES compared_with TLE5 gene|AES
Subject
TLE5 gene|AES
Predicate
compared_with
Object
TLE5 gene|AES
7. deutetrabenazine TREATS Tardive Dyskinesia
Subject
deutetrabenazine
Predicate
TREATS
Object
Tardive Dyskinesia
8. Tardive Dyskinesia PROCESS_OF Patients
Subject
Tardive Dyskinesia
Predicate
PROCESS_OF
Object
Patients
9. deutetrabenazine TREATS Patients
Subject
deutetrabenazine
Predicate
TREATS
Object
Patients
10. deutetrabenazine TREATS Adult
Subject
deutetrabenazine
Predicate
TREATS
Object
Adult
11. TLE5 gene|AES CAUSES Discontinued
Subject
TLE5 gene|AES
Predicate
CAUSES
Object
Discontinued
12. TLE5 gene|AES compared_with TLE5 gene|AES
Subject
TLE5 gene|AES
Predicate
compared_with
Object
TLE5 gene|AES
ABSTRACT

BACKGROUND:

Deutetrabenazine is approved to treat tardive dyskinesia (TD) in adults and is titrated weekly by 6 mg/day, from 12 to 48 mg/day, based on dyskinesia control and tolerability. This analysis compared the safety of deutetrabenazine during titration versus maintenance.

METHODS:

Safety was assessed during titration versus maintenance using integrated data from two 12-week placebo-controlled studies (ARM-TD and AIM-TD) and the open-label extension study. Rates were compared for overall and serious adverse events (AEs), AEs leading to discontinuation, treatment-related AEs, common AEs (≥4%), and specific AEs (parkinsonism, suicidal ideation, akathisia, restlessness).

RESULTS:

In titration versus maintenance, AE rates with placebo (n=130) were overall, 43.1% vs 25.4%; serious, 4.6% vs 2.3%; leading to discontinuation, 3.1% vs 0; treatment-related, 26.9% vs 10.0%. For placebo, common AEs during titration were somnolence, headache, nausea, fatigue, and dry mouth; none occurred during maintenance. In titration versus maintenance, AE rates in fixed-dose deutetrabenazine 12-36 mg (n=216) were overall, 33.3-38.9% vs 22.2-29.2%; serious, 2.8-6.9% vs 0-1.4%; leading to discontinuation, 2.8-5.6% vs 0; treatment-related, 8.3-16.7% vs 8.3-13.9%. For fixed-dose deutetrabenazine, common AEs during titration were headache, diarrhea, nasopharyngitis, depression, hypertension, and dry mouth; headache was the only common AE during maintenance. In titration versus maintenance, AE rates with flexible-dose deutetrabenazine (n=168) were overall, 49.4% vs 32.7%; serious, 3.6% vs 2.4%; leading to discontinuation, 2.4% vs 0.6%. For flexible-dose deutetrabenazine, the only common AE during titration was somnolence; none occurred during maintenance. Rates of parkinsonism, suicidal ideation, akathisia, and restlessness were low and comparable in titration and maintenance.

CONCLUSIONS:

Deutetrabenazine was well-tolerated, with AE rates similar to placebo during both phases; AE rates were higher during titration and decreased during maintenance.

FUNDING:

Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Tetrabenazine / Tardive Dyskinesia Type of study: Randomized controlled trials Limits: Humans Language: English Journal: CNS Spectr Journal subject: Neurology Year: 2021 Document Type: Article Affiliation country: S1092852920002643

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Tetrabenazine / Tardive Dyskinesia Type of study: Randomized controlled trials Limits: Humans Language: English Journal: CNS Spectr Journal subject: Neurology Year: 2021 Document Type: Article Affiliation country: S1092852920002643