Long-term safety of desmopressin orally disintegrating tablets in men with nocturia due to nocturnal polyuria: Interim results of a specified drug use-results survey in Japan.

OBJECTIVES: This interim report presents the 12-week results of a post-marketing surveillance evaluating the safety of desmopressin orally disintegrating tablets 25 and 50 µg in Japanese men with nocturia due to nocturnal polyuria. METHODS: Of the planned study population of 1000 Japanese men receiving desmopressin for the first time for nocturia due to nocturnal polyuria, 971 cases were enrolled. In this interim analysis, 9 cases, including 6 registry violations and 3 cases of unconfirmed desmopressin dosing, were excluded from the 354 case report forms collected and fixed by the end of December 2021, and data up to 12 weeks after administration in 345 cases were defined as the safety analysis set. RESULTS: The mean age was 74.5 ± 9.9 years and 88.7% of the survey participants were aged ≥65 years. Desmopressin was started at a dose of 25 µg in 153 cases (44.3%). There were 102 adverse drug reactions (ADRs) reported in 71 cases, including 6 serious ADRs in 3 cases (0.9%). The most common ADR was hyponatremia occurring in 29 cases (8.4%). Eight of the hyponatremic cases were asymptomatic. Symptoms were resolved or slightly improved within 4 weeks of onset in 13 of 29 cases of hyponatremia. In addition, hyponatremia occurred in 11 of 217 cases (5.1%), with a serum sodium level before the administration of desmopressin of ≥140 mmol/L, and in 13 of 87 cases (14.9%), with a level of 135-139 mmol/L, and was not measured in 5 hyponatremia cases. Patient characteristics that showed significant differences in the occurrence of hyponatremia included body weight, body mass index, renal function, and pretreatment serum sodium level. Regular monitoring of serum sodium is necessary for early detection of hyponatremia. CONCLUSIONS: Hyponatremia was the most common ADR when desmopressin orally disintegrating tablets were used to treat nocturia due to nocturnal polyuria over a 12-week period.

Real-world safety and efficacy of twice-daily budesonide 2-mg foam in patients with ulcerative colitis: interim analysis of post-marketing surveillance.

Background: Budesonide foam 2 mg twice daily induced complete mucosal healing in patients with mild-to-moderate ulcerative colitis (UC) in a phase 3 study. Post-marketing surveillance is underway to assess the real-world outcomes in UC patients.Research design and methods: The authors performed an interim analysis of post-marketing surveillance in 182 patients with mild-to-moderate UC who received 2 mg budesonide foam rectally.Results: Budesonide foam was prescribed twice daily to 76.4% of patients for 7.6 ± 3.8 weeks (mean ± standard deviation). Seven patients (3.8%) had at least one adverse drug reaction (ADR). A serious ADR of enteritis infectious and glucocorticoid-related ADRs of acne and hypertrichosis were observed in one patient (0.5%) each. The partial Mayo scores significantly decreased from baseline to week 2 in patients with proctitis, left-sided colitis, and pancolitis (p < 0.01 versus baseline each). Clinical response and remission at week 6 were 75.9% (60/79) and 68.4% (54/79), respectively. At week 6, 72.6% (77/106) of the patients reported as 'good compliance' and 54.7% (58/106) of the patients as 'very easy' for administration, using a self-administered questionnaire.Conclusions: Budesonide foam appeared to be safe, efficacious, and well-accepted in a real-world cohort of patients with UC. Trial registration: JapicCTI-183858.

Post-Marketing Surveillance of Silodosin in Patients with Benign Prostatic Hyperplasia and Poor Response to Existing Alpha-1 Blockers: The SPLASH Study.

OBJECTIVES: Our objective was to investigate the effectiveness and safety of silodosin in patients with benign prostatic hyperplasia (BPH) who switched to silodosin from another α1 blocker because of inadequate response. METHODS: This was a prospective observational study conducted at 715 medical facilities in Japan in patients with BPH who received an α1 blocker other than silodosin for at least 3 months but had experienced unsatisfactory treatment outcomes. Patients completed questionnaires, including the International Prostate Symptom Score (IPSS), quality of life (QOL) score and Overactive Bladder Symptom Score (OABSS) at baseline (time of switching) and after 3 months of treatment with silodosin. RESULTS: Overall, 3355 patients were assessed for safety and 3144 patients for effectiveness. Mean ± standard deviation age was 73.1 ± 8.2 years, and most patients had been receiving tamsulosin (53.6%) or naftopidil (45.5%) before silodosin. Silodosin was well tolerated, with an overall incidence of adverse drug reactions of 8.1% and no unexpected safety signals. Significant improvements were observed after switching to silodosin in all effectiveness outcome measures, including total IPSS, all IPSS subscale scores, QOL score, total OABSS, all OABSS subscale scores and residual urine volume. Significant improvements in total IPSS were seen in patients who had been receiving tamsulosin or naftopidil before switching and in almost all other patient subgroups, with the exception of patients with mild symptoms (total IPSS ≤ 7) at baseline. CONCLUSIONS: This post-marketing analysis indicates that switching to silodosin from tamsulosin or naftopidil significantly improved symptoms associated with BPH, and silodosin was well tolerated in Japanese patients.