Publications by authors named "Kenji Kochi"
Introduction: An increased rate of gastrointestinal (GI) symptoms is reported in patients with type 2 diabetes receiving imeglimin plus metformin vs monotherapy or in combination with other antidiabetic drugs. This post-hoc analysis explored GI symptom incidence, risk factors for their occurrence, and the impact on therapeutic efficacy during imeglimin and metformin combination therapy.
Materials And Methods: Data were derived from the 52-week, open-label, phase 3 TIMES-2 trial in Japanese type 2 diabetes patients.
Aim: To explore differences in imeglimin response among type 2 diabetes (T2D) patient clusters using data-driven cluster analysis.
Methods: Data-driven cluster analysis (non-hierarchical k-means clustering) was performed on randomized, double-blind, imeglimin monotherapy and adjunctive (to insulin) therapy trials based on four baseline variables: (1) disease duration; (2) body mass index (BMI); (3) HbA1c; and (4a) homeostatic model assessment of β-cell function (HOMA-β) (monotherapy trials) or (4b) insulin total daily dose (adjunctive trial).
Results: Four clusters were identified with distinct clinical characteristics in both monotherapy (1-4) and adjunctive therapy (I-IV) trials; clusters 1 and I had lower values across all four indices versus the overall population, clusters 2 and II had a longer diabetes duration, cluster 3 had higher baseline BMI and HOMA-β, and cluster III had higher baseline BMI and insulin total daily dose, while clusters 4 and IV had higher baseline HbA1c.
Aims/introduction: To investigate the effect of patient characteristics on imeglimin effectiveness in Japanese patients with type 2 diabetes mellitus.
Materials And Methods: Data were pooled from two randomized, placebo-controlled, 24-week, double-blind studies of imeglimin monotherapy in Japanese adults with type 2 diabetes mellitus, with the proportion of responders (glycated hemoglobin [HbA1c] < 7.0%) and sustained responders (i.
Aims/introduction: Substantial variability in demographic and clinical characteristics exists among patients with type 2 diabetes mellitus, which may impact treatment. This post-hoc analysis evaluated the efficacy and safety of imeglimin 1,000 mg twice daily (BID) monotherapy in type 2 diabetes mellitus patients according to demographic and clinical characteristics.
Materials And Methods: Data were pooled from two placebo-controlled, 24 week, randomized, double-blind studies in adults with type 2 diabetes mellitus.
Article Synopsis
- The study examines antipsychotic prescription trends among Japanese children and adolescents (≤17 years) in outpatient settings from 2006 to 2012, using a large dataset.
- It found that 65.1% of the patients were aged 13-17 and 52.9% were male, with an increase in second-generation antipsychotic monotherapy prescriptions from 53.8% to 78.3% during the study period.
- Risperidone was the most commonly prescribed drug, and about 25% of patients received initial doses that were lower than recommended.
Patients with dementia with Lewy bodies (DLB) experience worsening axial symptoms with disease progression, which can negatively affect quality of life. Previous phase 2 and 3 clinical trials conducted in Japan showed that zonisamide improved parkinsonism in patients with DLB. In the present study, we performed a post hoc analysis of pooled data from the previous phase 2 and 3 trials to examine the effect of zonisamide on axial symptoms in this patient group.
View Article and Find Full Text PDFBackground: Although previous phase II and III clinical trials conducted in Japan showed that zonisamide improved parkinsonism in patients with dementia with Lewy bodies (DLB), some differences in efficacy outcomes were observed between the trials.
Objective: We aimed to further examine the efficacy and safety of zonisamide in DLB patients with parkinsonism in a post hoc analysis of pooled data from the previous phase II and III trials.
Methods: Both trials featured a 4-week run-in period followed by a 12-week treatment period with a double-blind, placebo-controlled, parallel-group, randomized, multicenter trial design.
Purpose: This study aimed to assess the trends in antipsychotic prescriptions for outpatients in Japan, where a community-based approach to mental healthcare is emphasized.
Methods: This descriptive epidemiological study used claims data from 1038 community pharmacies across Japan. Outpatients who were ≥18 years old and receiving their initial antipsychotic prescription during 2006-2012 were evaluated.
Background: Previously, we reported 50 mg/d zonisamide improved wearing-off without increasing dyskinesia in patients with Parkinson's disease (PD).
Methods: To determine the efficacy of zonisamide for treatment of "off" time in PD patients, we conducted a multicenter, randomized, double-blind, parallel-group, placebo-controlled study in Japan. Patients with PD and wearing-off received placebo for 4 weeks and then were treated for 12 weeks with zonisamide 25 or 50 mg/d or placebo, in addition to their previous therapy.