This poster was presented at the 30th annual Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.
Background: The clinical trials of valbenazine (INGREZZA) that led to FDA-approval for tardive dyskinesia (TD) in adults allowed for the use of concomitant antipsychotics. As select antipsychotics have been associated with clinically significant weight gain, glucose dysregulation, and dyslipidemia, data from 3 randomized, double-blind, placebo-controlled trials were analyzed to assess changes in metabolic parameters in participants treated with once-daily valbenazine.
Methods: Valbenazine doses (40mg, 80mg) and placebo were pooled from 3 studies: KINECT (NCT01688037), KINECT 2 (NCT01733121), KINECT 3 (NCT02274558). Treatment-emergent adverse events (TEAEs) and mean changes from baseline to Week 6 in body weight and laboratory values (glucose, cholesterol, triglycerides) were analyzed descriptively. Shifts in laboratory parameters from normal at baseline to low/high during treatment were also evaluated.
Results: The pooled safety population included 400 participants (40mg, n=110; 80mg, n=112; placebo, n=178), 84.0% of whom were taking ≥1 concomitant antipsychotic medication. Increased weight was the most common metabolic-related TEAE found in this population (40mg, 0.9%; 80mg, 1.8%; placebo, 0.6%). For body weight and laboratory parameters, mean changes from baseline to Week 6 were small and not clinically relevant: weight, kg (40mg, 0.2; 80mg, 0.4; placebo, 0.2); glucose, mg/dL (40mg, 3.24; 80mg, 3.24; placebo, -4.50); cholesterol, mg/dL (40mg, 3.94; 80mg, 3.71; placebo, -0.35); and triglycerides, mg/dL (40mg, 1.24; 80mg, -8.05; placebo, -5.84). No clinically important shifts in metabolic laboratory parameters were found.
Conclusion: Once-daily treatment with valbenazine was not associated with clinically significant changes in weight or metabolic parameters in adults with TD receiving concomitant antipsychotic treatment.