Satoshi Uno

Persistence and adherence to overactive bladder medications in Japan: A large nationwide real‐world analysis

To evaluate persistence and adherence to mirabegron and antimuscarinics in Japan using data from two administrative databases.

A case of pelvic malignant paraganglioma

Abstract We report a rare case of pelvic malignant paraganglioma that was treated with surgery, combination chemotherapy and radiation. A 47‐year‐old man was diagnosed with pelvic malignant paraganglioma that had metastasised to the thoracic vertebrae. The pelvic mass, which was 6 cm in size, was on the posterior side of the bladder and had invaded the prostate, seminal vesicle and bladder neck. We resected the intrapelvic tumor and lymph nodes using cystoprostatectomy. Metastases to bilateral obturator lymph nodes and the right internal iliac lymph node were shown by pathology. Adjuvant therapies included six courses of the combination chemotherapy (cyclophosphamide, vincristine and dacarbazine), and 12 courses of VP‐16 therapy. Radiation therapy was done for metastasis of the thoracic vertebrae. Local recurrence, progression of bone metastasis and new metastasis have not been detected since these treatments. The patient has been clinically stable during 20 months of follow‐up. Chemotherapy of cyclophosphamide, vincristine and dacarbazine and VP‐16 with radiation appears to be effective in treating advanced malignant paraganglioma.

Safety, Efficacy, and Persistence of Long-Term Mirabegron Treatment for Overactive Bladder in the Daily Clinical Setting: Interim (1-Year) Report from a Japanese Post-Marketing Surveillance Study: Mirabegron Safety, Efficacy, Persistence

To report interim 1‐year results from a 3‐year surveillance study evaluating safety, efficacy, and persistence of long‐term mirabegron for overactive bladder (OAB).

Safety and effectiveness of once-daily, prolonged-release tacrolimus in de novo kidney transplant recipients: 5-year, multicenter post-marketing surveillance in Japan

This study reported 5-year data on the safety and effectiveness of prolonged-release tacrolimus (PR-T) in de novo kidney transplant recipients (KTRs) in Japanese routine clinical practice. METHODS This was an open-label, prospective, noncomparative, observational, postmarketing surveillance study of de novo KTRs who initiated PR-T as part of routine clinical practice in 43 sites in Japan between March 2009 and March 2011. Follow-up period was March 2010 to March 2016. Effectiveness outcomes included Kaplan-Meier estimated patient survival, graft survival, graft rejection, estimated glomerular filtration rate (eGFR; Modification of Diet in Renal Disease-4), and creatinine clearance. Adverse drug reactions (ADRs) were recorded. RESULTS The safety analysis set comprised 250 de novo KTRs (mean age 45.9 [SD, 14.2] years); 249 patients formed the efficacy analysis set. Mean PR-T daily dose decreased during the study (0.14 [SD, 0.05], 0.09 [SD, 0.05], and 0.05 [SD, 0.03] mg/kg at day 0 [transplant], week 24, and year 5, respectively), as did tacrolimus trough levels (15.9 [SD, 13.4] to 4.0 [SD, 1.4] ng/mL between day 1 and year 5). Year 5 Kaplan-Meier estimated patient survival, graft survival, and rejection rates were 96.7%, 93.4%, and 26.9%, respectively. Mean eGFR and serum creatinine levels remained stable from week 4 to year 5 post transplant (eGFR, 48.3 [SD, 16.9] vs 48.7 [SD, 13.8] mL/min/1.73 m2, respectively; serum creatinine, 1.39 [SD, 0.89] vs 1.25 [SD, 0.50] mg/dL). Overall, 230 ADRs were reported in 129 (51.6%) patients. Eight patients died during follow-up. CONCLUSION PR-T-based immunosuppression was effective, and renal function remained stable up to 5 years post transplant in routine clinical practice in Japan. Incidence of ADRs was low, and no new safety signals were identified.

Safety and effectiveness of conversion from ciclosporin to once-daily, prolonged release tacrolimus in stable kidney transplant patients: a multicenter observational study in Japan

This study investigated the safety and effectiveness of conversion from cyclosporine- to prolonged-release tacrolimus (PR-T)-based immunosuppression in kidney transplant recipients (KTRs) in Japanese routine clinical practice. MATERIALS AND METHODS This was a prospective observational study of stable KTRs who were converted from cyclosporine to PR-T according to local clinical practice. Clinical data were collected up to 12 months postconversion. Study outcomes included conversion dosing ratios, PR-T dose and trough levels, change in estimated glomerular filtration rate between conversion and month 12, graft/patient survival, and rejection rate (Kaplan-Meier). Outcomes of ongoing preconversion hypertrichosis, gingival hypertrophy, and cyclosporine-related renal toxicity were detailed. Data for adverse drug reactions were collected. RESULTS Overall, 266 patients (mean ± SD age 51.9 ± 13.5 years) were included. The mean ± SD conversion ratio (PR-T:cyclosporine, mg:mg) was 0.029 ± 0.017. After an initial decrease between conversion and month 3, mean ± SD PR-T daily dose remained stable up to month 12 (2.4 ± 1.5 mg at months 3 and 12), as did tacrolimus trough blood levels (3.5 ± 1.8 vs 3.6 ± 1.7 ng/mL, respectively). Estimated glomerular filtration rate was stable over 12 months (mean ± SD change from conversion to month 12 was 0.3 ± 7.8 mL/min/1.73m2). Month 12 Kaplan-Meier patient and graft survival rates were 99.6% and 95.5%, respectively. Eight patients reported 9 rejection episodes. PR-T demonstrated potential to improve cyclosporine-related renal toxicity, hypertrichosis, and gingival hypertrophy. Postconversion, 46 adverse drug reactions were reported in 39 patients (14.7%); there was 1 death. CONCLUSIONS Conversion from cyclosporine to PR-T in Japanese stable KTRs was effective and tolerable over 12 months, with low rates of rejection reported.

Three-year safety, efficacy and persistence data following the daily use of mirabegron for overactive bladder in the clinical setting: A Japanese post-marketing surveillance study

The aim of this study was to report the final 3‐year results from a surveillance study evaluating the safety, efficacy, and persistence of mirabegron for treating overactive bladder (OAB) symptoms.

Anticholinergic burden in the Japanese elderly population: Use of antimuscarinic medications for overactive bladder patients

To assess anticholinergic use, especially the use of antimuscarinics, in the elderly (aged ≥65 years) Japanese overactive bladder and non‐overactive bladder populations.

Safety and efficacy of ipragliflozin in elderly versus non-elderly Japanese patients with type 2 diabetes mellitus: a subgroup analysis of the STELLA-LONG TERM study

ABSTRACT Background: This subgroup analysis of STELLA-LONG TERM interim data explored the long-term safety and efficacy of ipragliflozin in non-elderly vs. elderly Japanese type 2 diabetes mellitus (T2DM) patients. Research design and methods: STELLA-LONG TERM is an ongoing 3-year prospective surveillance study of Japanese T2DM patients receiving ipragliflozin 50 mg once daily. In this subgroup analysis, patient characteristics, laboratory variables, and adverse drug reactions (ADRs) were compared between non-elderly (<65 years) and elderly (≥65 years) patients. Results: Non-elderly patients had significantly higher body mass index and low-density lipoprotein cholesterol than elderly patients (P < 0.001). The proportion of patients with hemoglobin A1c (HbA1c) <8.0% was significantly higher among elderly patients (P < 0.001). HbA1c, fasting plasma glucose, and body weight significantly decreased from baseline to 3 and 12 months in both groups (all P < 0.05 vs. baseline). The ADR incidence was 10.83% vs. 10.42% in non-elderly and elderly patients. The incidence of skin complications was 0.98% vs. 1.65% and that of renal disorder was 0.47% vs. 0.95% in non-elderly and elderly patients (both P = 0.003). Conclusions: Ipragliflozin was effective in non-elderly and elderly Japanese T2DM patients in a real-world clinical setting. The incidence of renal disorder and skin complications was significantly higher in elderly vs. non-elderly patients.

Safety and efficacy of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice: interim results of the STELLA-LONG TERM post-marketing surveillance study

ABSTRACT Background: Data regarding the efficacy and safety of sodium–glucose cotransporter 2 inhibitors in the real-world setting in Japan are limited. The STELLA-LONG TERM study is an ongoing 3-year post-marketing surveillance study of ipragliflozin in type 2 diabetes (T2D) patients. Here, we report the interim results (including 3-, 12-, and 24-month data). Research design and methods: All Japanese patients with T2D who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan were registered in STELLA-LONG TERM. Results: At 3, 12, and 24 months, the safety analysis set comprised 11,053, 5475, and 138 patients, respectively; the efficacy analysis set comprised 8757 patients. Ipragliflozin treatment resulted in statistically significant improvements versus baseline in hemoglobin A1c, fasting plasma glucose concentration, body weight, blood pressure, heart rate, and serum concentrations of low-density lipoprotein cholesterol and triglycerides. The adverse drug reaction incidence rate was 10.71%, the most common reactions being renal and urinary disorders (5.06%), infections and infestations (1.24%), and skin and subcutaneous tissue disorders (1.14%). Conclusions: Ipragliflozin was well tolerated and effective in Japanese patients with T2D; no new safety issues were identified.