Real-world efficacy and safety of two doses of cabazitaxel (20 or 25 mg/m) in patients with castration-resistant prostate cancer: results of a Japanese post-marketing surveillance study.

Background: The recommended starting dose of cabazitaxel for castration-resistant prostate cancer (CRPC) is 25 mg/m in Japan and Europe. Although lower doses are established alternatives based on randomized controlled trials, the safety and efficacy of 25 and 20 mg/m in real-world settings are not well established. Therefore, we investigated the safety and efficacy of cabazitaxel at the recommended starting dose or a lower dose (20 mg/m) in real-world clinical practice.

Cabazitaxel in patients aged ≥80 years with castration-resistant prostate cancer: Results of a post-marketing surveillance study in Japan.

Objectives: Data on the safety and efficacy of cabazitaxel in patients aged ≥80 years with castration-resistant prostate cancer (CRPC) are limited. We report the safety (adverse drug reactions [ADRs]) and efficacy (overall survival [OS], time to treatment failure [TTF], and prostate-specific antigen [PSA] response rates) in patients aged <80 or ≥80 years treated with cabazitaxel for CRPC in clinical practice.

Materials And Methods: We performed post-hoc subgroup analyses of a Japanese post-marketing surveillance study involving 662 patients with CRPC treated with cabazitaxel between September 2014 and June 2016.

Efficacy and safety assessment of basal supported oral therapy (BOT) with insulin glargine in a real-life clinical setting, stratified by concomitant orally administered antidiabetic agent (OAD) regimens including dipeptidyl peptidase-4 inhibitor (DPP-4i): subanalysis of the ALOHA2 study, drug-use surveillance in Japan.

Aims And Introduction: We aimed to explore concomitant orally administered antidiabetic agent (OAD) regimens used in basal supported oral therapy (BOT) with insulin glargine in a real-life setting, and to assess the efficacy and safety of each regimen using data from the Add-on Lantus to Oral Hypoglycemic Agents 2 study, a 24-week observational study in Japanese type 2 diabetes patients.

Materials And Methods: Among 1629 insulin-naïve patients who had a glycosylated hemoglobin (HbA1c) value of ≥6.5 % during the previous 4 weeks and were treated with BOT during the observational period, 1227 patients who retained the same concomitant OAD regimens throughout the period were included in the analysis.

Predictors for achieving target glycemic control in Japanese patients with type 2 diabetes after initiation of basal supported oral therapy using insulin glargine: sub-analysis of the ALOHA2 study, drug use surveillance in Japan.

Objectives: We aimed to identify diabetes-related factors associated with achieving HbA1c <7.0 % after the initiation of basal supported oral therapy (BOT) in insulin-naïve type 2 diabetes patients with an HbA1c value of ≥6.5 % during the previous 4 weeks, using data from Add-on Lantus to Oral Hypoglycemic Agents 2 (ALOHA2) study, a 24-week observational study on Japanese type 2 diabetes patients.

Improved Treatment Satisfaction and Self-reported Health Status after Introduction of Basal-Supported Oral Therapy Using Insulin Glargine in Patients with Type 2 Diabetes: Sub-Analysis of ALOHA2 Study.

Introduction: This study aimed to assess treatment satisfaction and self-reported health status in insulin-naïve patients with type 2 diabetes mellitus (T2DM) who started insulin glargine basal-supported oral therapy (BOT) with glycated hemoglobin (HbA1c) value of ≥6.5%, using data from Add-on Lantus(®) to Oral Hypoglycemic Agents 2 (ALOHA2) study, a 24-week single-arm, observational study of Japanese patients with T2DM, conducted as drug use surveillance in Japan.

Methods: Treatment satisfaction was measured using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and change version (DTSQc) and self-reported health status using EuroQol 5 Dimension (EQ-5D).

Electrochemical detection of HbA1c, a marker [correction of maker] for diabetes, using a flow immunoassay system.

An on-chip electrochemical flow immunoassay system for the detection of hemoglobin A1c (HbA1c) was developed using anti-human hemoglobin (Hb) IgG labeled with ferrocene monocarboxylic acid (Fc-COOH) and boronate-affinity chromatography. An on-chip column packed with boronate-activated agarose beads was used for the separation of HbA1c from both non-glycated Hb and free antibody. Anti-human Hb IgG conjugated to Fc-COOH (Fc-IgG) was used for the electrochemical detection of HbA1c.