Characterization of symptom bother and health-related quality of life in Japanese female patients with overactive bladder.

AIMS: To analyze the impact of overactive bladder (OAB) symptoms and patient characteristics on symptom bother and quality of life (QOL). METHODS: An analysis of the data of 967 patients from SET-Q, a prospective, multicenter, open, observational study in the post-marketing setting, was performed. The eligible subjects were treatment-naive female patients with OAB who complained of an urgency episode at least once a week. Symptom bother and QOL were assessed by the OAB-questionnaire (OAB-q), and severity of OAB symptoms was estimated by the OAB symptom score (OABSS). Multiple regression analysis was utilized for clarifying how OAB symptom severity affects QOL. RESULTS: The symptoms with the highest bother score were daytime frequency and urgency in the under-50s age group, urgency in the 50s, 60s, and 70s age groups, night-time frequency and urgency incontinence in the over-80s age group, respectively. With an increase in severity of OAB as well as severity of urgency assessed by the OABSS, an increase in symptom bother and impairment in health-related quality of life (HRQL) in the OAB-q were observed. Multiple regression analysis demonstrated the significant relationship with urgency and nighttime frequency to symptom bother, and also significant interaction between age and urgency incontinence, associated with further negative effect on HRQLs in elderly patients. CONCLUSIONS: This large sample study, by utilizing the scored questionnaire for symptom severity, bother and HRQL, showed that the symptoms with the highest bother were age-dependent. It was also confirmed that symptom bother will be inferred by the OABSS.

Impact of symptom improvement on patients' bother and quality of life in female patients with overactive bladder treated by solifenacin (SET-Q).

OBJECTIVES: To analyze the relationship between symptom improvement and health-related quality of life in female overactive bladder patients treated with solifenacin. METHODS: We carried out a prospective, multicenter, open-label study. Eligible patients were treatment-naive female patients with overactive bladder, with an urgency episode at least once a week. Symptoms were quantitatively assessed by the Overactive Bladder Symptom Score, and quality of life by the Overactive Bladder questionnaire. Changes of symptom severity, bother, and quality of life were assessed at baseline and 12 weeks after treatment with solifenacin 5, 7.5 or 10 mg once daily. RESULTS: Data from 523 patients (mean age 66 years) were analyzed. Solifenacin significantly improved the total Overactive Bladder Symptom Score and also all subscores for the four symptoms (daytime frequency, urgency, night-time frequency and urgency incontinence). Solifenacin also significantly improved the four quality of life subscales, total quality of life and symptom bother scores of the Overactive Bladder questionnaire. The severity of night-time frequency at baseline positively affected the improvement in the quality of life subscale of Sleep, and the severity of daytime frequency at baseline positively affected the improvement of coping and social interaction. Improvement of severity in various symptoms positively affected the improvement of bother and the quality of life subscales. CONCLUSIONS: Solifenacin provides an overall improvement of bother and quality of life in female overactive bladder patients. Symptom severity before treatment and improvement of symptom severity seem to variably affect this improvement.

[Safety and efficacy of midazolam in children under mechanical ventilation in the intensive care unit].

BACKGROUND: The use of midazolam for children was approved in March, 2010. Since the efficacy and safety data of midazolam used in children, excluding low-birth-weight infants and newborns, for "sedation under artificial respiration in intensive care units" were quite limited, a post-marketing survey was carried out to confirm the validity of the established dosage and administration. METHODS: A consecutive enrollment method was adopted. Based on the data of 153 patients collected from 8 institutes, efficacy and safety profiles were analyzed. RESULTS: Among the 149 patients included in the safety analysis set, 6 adverse reactions were reported in 6 patients. The incidence of adverse events was 4.0% (6/149). Reported adverse reactions included depressed level of consciousness: 1 event, delirium: 1 event, psychomotor hyperactivity: 1 event, hypotension: 2 events, and blood pressure increase: 1 event. Serious adverse drug reaction (ADR) reported in this survey was depressed level of consciousness. This ADR resolved on the following day after the treatment with flumazenil. Paradoxical reactions were reported in 1 patient, and tolerance was reported in 2 patients. The efficacy rate was 96.5% (138/143). CONCLUSIONS: No additional safety issues (status of adverse reactions, status of adverse events, status of serious adverse events, etc.) and efficacy issue were manifest in the patients treated with the dosage and administration method established at the approval of the drug.

Evaluation of the safety and efficacy of micafungin in Japanese patients with deep mycosis: a post-marketing survey report.

The safety and efficacy of micafungin were evaluated in a Japanese post-marketing survey involving 1,142 patients with deep mycosis caused by Candida or Aspergillus. The overall clinical response was 83.0%, and the respective responses for patients with candidiasis or aspergillosis were 86.3 and 70.8%. With regard to drug reactions, 562 adverse reactions were observed in 28.5% of patients. Among the 83 serious adverse drug reactions reported by 53 patients, a causal relationship with micafungin was assessed as definite or probable for 6 reactions in 5 patients. Age and baseline hepatic and renal function status did not affect the incidence of adverse reactions, although incidence increased significantly in proportion to the severity of mycosis and daily dose (p < 0.01). In multiple logistic regression analysis, neither baseline hepatic impairment nor increased daily dose of micafungin affected the incidence of hepatobiliary disorders, however, the severity of mycosis was found to correlate significantly with hepatobiliary disorders (p = 0.031). Taken together, our post-marketing findings show that micafungin is effective against deep mycosis caused by Candida or Aspergillus in patients across a range of backgrounds.