Table 1
Clinical Global Impression-Improvement (CGI-I) scale. To calculate the CGI-I Scale, the clinician compares the patient’s overall clinical condition to the one-week period just prior to the initiation of medication use, known as the baseline visit. The CGI score is first documented at this baseline visit, and for CGI-I, the comparison above is considered [25].
| SCORE | INTERPRETATION |
|---|---|
| 1 | Very much improved |
| 2 | Much improved |
| 3 | Minimally improved |
| 4 | No change from baseline (initiation of treatment) |
| 5 | Minimally worse |
| 6 | Much worse |
| 7 | Very much worse since the initiation of treatment |
Table 2
Population demographics of children prescribed VMAT2 inhibitors, and number of unique prescriptions.
| TETRABENAZINE | DEUTETRABENAZINE | VALBENAZINE | |
|---|---|---|---|
| Number of patients (N) | 334 | 20 | 5 |
| Mean Age (Years) | 11.8 | 13.4 | 15 |
| Sex | |||
| Male | 217 | 11 | 5 |
| Female | 117 | 9 | 0 |
| Indication | |||
| Tics | 260 | 12 | 4 |
| Chorea | 30 | 3 | 1 |
| Stereotypy | 27 | 1 | 0 |
| Dystonia | 21 | 1 | 0 |
| Tardive dyskinesia | 3 | 1 | 0 |
| Akathisia | 1 | 0 | 0 |
| Myoclonus | 1 | 1 | 0 |
Figure 1
Average total mg/day dosing of VMAT2 inhibitors (black bar indicating standard deviation).
Figure 2
Percentage of patients undergoing treatment with VMAT2 inhibitor with resultant Clinical Global Impression-Improvement.
Figure 3
Average CGI-I by indication (black bar indicating standard deviation). Calculation of CGI-I score is outlined within the methods with lower scores indicating increased clinical improvement.
Table 3
Adverse effects reported by patients taking VMAT2 inhibitors.
| CATEGORY | ADVERSE EFFECT | ALL VMAT2 | TETRABENAZINE | DEUTETRABENAZINE | VALBENAZINE |
|---|---|---|---|---|---|
| None | None | 125 (36%) | 114 (44.5%) | 8 (53.3%) | 3 (75%) |
| Central Nervous System | Drowsiness/Somnolence | 99 (45.4%) | 95 (37.1%) | 4 (26.7%) | 0 (0%) |
| Increased Seizures | 3 (1.4%) | 3 (1.2%) | 0 (0%) | 0 (0%) | |
| Cognitive Side Effects | 2 (0.9%) | 2 (0.8%) | 0 (0%) | 0 (0%) | |
| Dizziness | 4 (1.8%) | 4 (1.6%) | 0 (0%) | 0 (0%) | |
| Movement Disorders | Akathisia | 5 (2.3%) | 5 (2%) | 0 (0%) | 0 (0%) |
| Neuroleptic Malignant Syndrome* | 1 (0.5%) | 1 (0.4%) | 0 (0%) | 0 (0%) | |
| Acute Dystonic Reactions* | 15 (6.9%) | 13 (5.1%) | 1 (6.7%) | 1 (25%) | |
| Parkinsonism | 5 (2.3%) | 5 (2%) | 0 (0%) | 0 (0%) | |
| Tremor | 1 (0.5%) | 1 (0.4%) | 0 (0%) | 0 (0%) | |
| Worsening of underlying symptom | 6 (2.8%) | 4 (1.6%) | 2 (13.3%) | 0 (0%) | |
| Gastrointestinal | Nausea/Vomiting | 7 (3.2%) | 7 (2.7%) | 0 (0%) | 0 (0%) |
| Diarrhea | 2 (0.9%) | 2 (0.8%) | 0 (0%) | 0 (0%) | |
| Dysphagia | 1 (0.5%) | 1 (0.4%) | 0 (0%) | 0 (0%) | |
| Weight Gain | 5 (2.3%) | 5 (2%) | 0 (0%) | 0 (0%) | |
| Psychiatric | Suicidal Ideation | 3 (1.4%) | 3 (1.2%) | 0 (0%) | 0 (0%) |
| Anger/Agitation | 8 (3.7%) | 8 (3.1%) | 0 (0%) | 0 (0%) | |
| Depression | 17 (7.8%) | 16 (6.3%) | 1 (6.7%) | 0 (0%) | |
| Anxiety | 9 (4.1%) | 8 (3.1%) | 1 (6.7%) | 0 (0%) | |
| Mood Instability | 8 (3.7%) | 8 (3.1%) | 0 (0%) | 0 (0%) | |
| Insomnia | 1 (0.5%) | 1 (0.4%) | 0 (0%) | 0 (0%) | |
| Nightmares | 1 (0.5%) | 1 (0.4%) | 0 (0%) | 0 (0%) | |
| Cardiovascular | Palpitations | 2 (0.9%) | 2 (0.8%) | 0 (0%) | 0 (0%) |
| Bradycardia | 2 (0.9%) | 1 (0.4%) | 0 (0%) | 0 (0%) | |
| Other | Irregular menses | 1 (0.5%) | 1 (0.4%) | 0 (0%) | 0 (0%) |
| Sweating | 1 (0.5%) | 1 (0.4%) | 0 (0%) | 0 (0%) | |
| Fever | 1 (0.5%) | 1 (0.4%) | 0 (0%) | 0 (0%) | |
| Rash | 1 (0.5%) | 1 (0.4%) | 0 (0%) | 0 (0%) | |
| Blurry Vision | 1 (0.5%) | 1 (0.4%) | 0 (0%) | 0 (0%) |
[i] *Patients were concurrently taking dopamine receptor blocking medication(s).