Utilization of glucagon-like peptide-1 receptor agonists and changes in clinical characteristics in patients with type 2 diabetes by chronic kidney disease stage in Japan: A descriptive observational study using a nationwide electronic medical records database.

AIM: To describe the utilization of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and changes in clinical characteristics before and after GLP-1 RA initiation in patients with type 2 diabetes (T2D) by chronic kidney disease (CKD) stage. MATERIALS AND METHODS: In this retrospective descriptive study using a nationwide electronic medical records database in Japan, we included patients with GLP-1 RA prescriptions from June 2010 to October 2019. Clinical characteristics at GLP-1 RA initiation, persistence proportion, and changes in clinical measurements after GLP-1 RA initiation were described for all patients and by CKD stage, defined by baseline estimated glomerular filtration rate (eGFR). RESULTS: We included 8049 patients. During the study period, the proportion of patients with T2D initiating GLP-1 RAs increased from 1.5% in 2010 to 3.3% in 2019. Also, the mean (95% confidence interval) of baseline age and eGFR ranged from 58.6 (56.7-60.4) to 66.3 (65.5-67.2) years and from 72.9 (68.0-77.9) to 64.0 (62.2-65.8) mL/min/1.73m2 , respectively. The persistence proportion at 12 months was 49.5% overall, 37.8% in T2D patients with CKD with a baseline eGFR of less than 30 mL/min/1.73m2 , and 34.6% in those undergoing dialysis. The rate of deterioration in renal function reduced after GLP-1 RA initiation. CONCLUSIONS: The utilization of GLP-1 RAs has been increasing over the past decade, and GLP-1 RAs have been used in patients with limited treatment options, such as the elderly or those with CKD. In T2D patients with CKD, the persistence proportion of GLP-1 RAs was not low, and the renal dysfunction may be moderated by GLP-1 RA initiation.

Safety and effectiveness of ramucirumab and docetaxel: a single-arm, prospective, multicenter, non-interventional, observational, post-marketing safety study of NSCLC in Japan.

BACKGROUND: This study evaluated the safety and effectiveness of ramucirumab and docetaxel for non-small cell lung cancer (NSCLC) in real-world settings. RESEARCH DESIGN AND METHODS: This single-arm, prospective, multicenter, non-interventional, post-marketing study was conducted in Japan between August 2016 and January 2020. Patients diagnosed with unresectable advanced/recurrent NSCLC were eligible for study inclusion. Data on adverse events (AEs) and survival were collected electronically. RESULTS: Of 401 enrolled patients, 398 were eligible for study inclusion. Most patients were male (68.6%) with a median age of 67.0 years. Patients were predominantly diagnosed with adenocarcinoma (78.1%) or squamous cell carcinoma (16.6%); 46.2% received prior treatment with bevacizumab and 38.7% with immune-checkpoint inhibitors. AEs (any grade) were observed in 323 patients (81.2%; grade ≥ 3: n = 174, 43.7%). The most common AEs (any grade) were malaise (14.3%), decreased appetite (13.0%), and neutrophil count decrease (11.6%). At 12 months from treatment commencement, 93.2% of patients had discontinued, mostly due to progressive disease (53.4%) or AEs (28.3%). The 12-month survival rate was 56.7% (95% confidence interval: 51.5-61.8). CONCLUSIONS: Data from real-world settings demonstrate ramucirumab and docetaxel treatment appears to be tolerable and effective in Japanese patients regardless of patient baseline characteristics and prior treatment.

A post-marketing observational study of ramucirumab in patients with gastric cancer in Japan.

BACKGROUND: This study evaluated the safety and effectiveness of ramucirumab monotherapy and combination therapy for advanced gastric cancer in the real-world setting. METHODS: This single-arm, prospective, multicenter, non-interventional, observational, post-marketing study was conducted in Japan from August 2015 to March 2019. Patients with unresectable advanced or recurrent gastric cancer and newly prescribed ramucirumab were followed for up to 12 months after first treatment. Data on adverse events and survival were collected via Electronic Data Capture. RESULTS: Of 687 enrolled patients, 658 were eligible for analysis. Most patients received either ramucirumab monotherapy (123/658; 18.7%) or ramucirumab plus paclitaxel combination therapy (528/658; 80.2%). The majority of patients reported ≥ 1 adverse events in both the combination therapy (any grade, 479/528; 90.7%; ≥ Grade 3, 321/528; 60.8%) and monotherapy groups (any grade, 77/123; 62.6%; ≥ Grade 3, 42/123; 34.2%). The most common any grade adverse events were neutropenia (combination: 49.6%; monotherapy: 8.9%), fatigue (combination: 19.5%; monotherapy: 13.8%), and decreased appetite (combination: 18.2%; monotherapy: 10.6%). Grade 5 adverse events were reported in 4 patients, including metastases to meninges, pneumonia aspiration, death, and gastric perforation; of these, gastric perforation was deemed treatment-related. Median survival time was 5.7 months (95% confidence interval: 4.1-6.8 months) following monotherapy and 11.0 months (95% confidence interval: 9.8-12.2 months) following combination therapy. CONCLUSIONS: This analysis adds to the limited data available on ramucirumab use in a real-world setting, demonstrating similar safety and effectiveness for ramucirumab in treating advanced gastric cancer in routine clinical practice in Japan to that of global clinical trials.