Table 3.
Summary risk difference comparison of adverse events
| Safety Outcome | Unadjusted Risk Difference | Adjusted Risk Difference | ||||
|---|---|---|---|---|---|---|
| DTB vs TBZ | 95% CI | p-value | DTB vs TBZ | 95% CI | p-value | |
| Any AE, % | −20.7 | −47.9, 6.4 | 0.135 | −35.3 | −72.4, 1.8 | 0.063 |
| Moderate to severe | −39.6 | −67.1, −12.2 | 0.005 | −46.4 | −79.4, −13.3 | 0.006 |
| Mild | 18.9 | −9.6, 47.4 | 0.194 | 11.1 | −24.4, 46.6 | 0.540 |
| At least one SAE, % | −7.4 | −16.7, 1.9 | 0.117 | −8.2 | −17.4, 1.0 | 0.080 |
| Discontinuation for any reason, % | −8.1 | −20.6, 4.3 | 0.201 | −10.1 | −23.4, 3.2 | 0.136 |
| Discontinuation due to AE, % | −9.3 | −19.1, 0.6 | 0.065 | −10.4 | −20.3, −0.4 | 0.041 |
| Dose reduction due to AE | −41.1 | −59.1, −23.1 | <0.001 | −40.5 | −62.0, −19.0 | <0.001 |
| Dose reduction/suspension due to AE | −41.1 | −60.0, −22.3 | <0.001 | −41.6 | −63.9, −19.3 | <0.001 |
| Individual AEsa | ||||||
| Agitation, % | −12.6 | −23.0, −2.2 | 0.018 | −14.2 | −24.6, −3.8 | 0.007 |
| Akathisia (PI), % | −18.5 | −30.5, −6.5 | 0.003 | −18.9 | −32.0, −5.8 | 0.005 |
| Anxiety, % | −11.5 | −24.4, 1.5 | 0.083 | −12.0 | −25.2, 1.2 | 0.074 |
| Coughing, % | 2.6 | −10.2, 15.4 | 0.692 | 2.6 | −10.2, 15.4 | 0.692 |
| Depression, % | −19.3 | −32.0, −6.6 | 0.003 | −20.8 | −33.8, −7.8 | 0.002 |
| Depression/agitated depression, % | −17.0 | −30.4, −3.7 | 0.013 | −20.2 | −33.9, −6.5 | 0.004 |
| Diarrhea, % | 11.5 | −3.8, 26.8 | 0.141 | 9.7 | −9.4, 28.7 | 0.320 |
| Drowsiness/somnolence, % | −21.5 | −39.2, −3.7 | 0.018 | −22.9 | −44.9, −0.8 | 0.042 |
| Fall, % | −7.8 | −26.5, 11.0 | 0.417 | −10.6 | −32.1, 10.9 | 0.336 |
| Fatigue, % | −6.7 | −25.6, 12.3 | 0.491 | −8.3 | −28.3, 11.7 | 0.416 |
| Insomnia, % | −23.7 | −38.7, −8.7 | 0.002 | −24.3 | −40.9, −7.6 | 0.004 |
| Nausea, % | −8.5 | −23.2, 6.1 | 0.255 | −9.7 | −24.7, 5.4 | 0.207 |
| Parkinsonism (PI), % | −14.8 | −24.3, −5.3 | 0.002 | −14.8 | −24.3, −5.3 | 0.002 |
| Vomiting, % | −8.9 | −20.4, 2.6 | 0.129 | −8.7 | −21.1, 3.8 | 0.173 |
AE adverse event, CI confidence interval, DTB deutetrabenazine, SAE serious adverse event, TBZ tetrabenazine
aThose safety outcomes sourced from the tetrabenazine FDA-approved prescribing information have been identified by “(PI)”. Bolded values indicate significant risk differences between deutetrabenazine and tetrabenazine (p < 0.05)