Publications by authors named "Mieko Nagano"
Article Synopsis
- - The study analyzed the efficacy and safety of valbenazine, a treatment for tardive dyskinesia (TD), specifically in elderly Japanese patients, to fill a data gap identified in previous non-Asian trials.
- - In the J-KINECT study, results showed significant improvement in TD symptoms for elderly patients using valbenazine compared to placebo, with better scores compared to nonelderly patients.
- - Although elderly patients experienced a higher rate of treatment-emergent adverse events leading to discontinuation, there was no significant increase in the overall incidence of adverse events, suggesting valbenazine is a viable treatment option for elderly patients with TD.
Purpose: This post hoc analysis investigated whether a patient's underlying psychiatric disease (schizophrenia/schizoaffective disorder [SCHZ] or bipolar disorder/depressive disorder [MOOD]) influenced the efficacy or safety of valbenazine for tardive dyskinesia (TD) in an Asian population.
Methods: We analyzed data from J-KINECT, a multicenter, phase II/III, randomized, double-blind study, which consisted of a 6-week placebo-controlled period followed by a 42-week extension where Japanese patients with TD received once-daily 40- or 80-mg valbenazine. We compared the change from baseline in Abnormal Involuntary Movement Scale total score and Clinical Global Impression of TD score between patients with SCHZ and those with MOOD, and incidence of treatment-emergent adverse events.
Background: Pediatric ulcerative colitis (UC) is typically more extensive and has a more active disease course than adult UC, and requires early treatment augmentation to achieve and maintain disease remission. The present study aimed to investigate the efficacy, safety, and pharmacokinetic profile of infliximab (IFX) in pediatric patients with moderate-to-severe UC and inadequate response to existing treatment.
Methods: This open-label, uncontrolled, multicenter, Phase 3 trial was conducted at 17 centers in Japan between April 2012 and September 2014.
Objectives: The prevalence of pediatric Crohn's disease (CD) is increasing in Japan and other countries, and many patients are unresponsive to or do not tolerate current treatment options. This study aimed to investigate the efficacy, safety, and pharmacokinetic profile of infliximab (IFX) in pediatric patients with moderate-to-severe CD and inadequate response to existing treatment.
Study Design: This was an open-label, uncontrolled, multicenter Phase 3 study conducted at nine sites in Japan between April 2012 and March 2015.