imidafenacin and Nocturia

Antimuscarinics (AMs) are the mainstay of pharmacological treatment of overactive bladder (OAB), a symptom complex defined by the presence of urinary urgency, usually associated with frequency and nocturia, with or without urgency urinary incontinence. The AMs used to treat OAB differ in their pharmacological profiles, which may affect their potential for causing adverse effects (AEs).. The present article aims to review the literature about pharmacokinetics (PK) of the different AMs used in the treatment of OAB. Furthermore, the AEs related to the use of these drugs and their incidence are presented. This systematic review is based on material searched and obtained via Medline, Pubmed and EMBASE up to March 2012 using the search terms "adverse events, pharmacokinetics, tolerability" in combination with "darifenacin, fesoterodine, imidafenacin, oxybutynin, propiverine, solifenacin, tolterodine, and trospium.". Antimuscarinics are the first-line pharmacological treatment for OAB. Despite the development of new molecules that improve their efficacy/safety profile, there are some drugs that are pharmacokinetically more appropriate to be prescribed in specific populations such as patients with neurological disease or the elderly. Moreover, research should be encouraged in evaluating antimuscarinics in conjunction with other drugs such as estrogens or beta-agonists. The identification of prognostic criteria for pharmacological therapy would be helpful.

Topics: Benzhydryl Compounds; Benzilates; Benzofurans; Chronic Disease; Cresols; Drug Combinations; Female; Humans; Imidazoles; Mandelic Acids; Muscarinic Antagonists; Nocturia; Phenylpropanolamine; Pyrrolidines; Quinuclidines; Solifenacin Succinate; Tetrahydroisoquinolines; Tolterodine Tartrate; Urinary Bladder, Overactive; Urinary Incontinence

To evaluate the efficacy and safety of imidafenacin (IM), a novel short half-life anticholinergic, as add-on therapy for male LUTS with nocturia and nocturnal polyuria.. This multicenter, prospective, randomized, open-labelled study was conducted and involved men who had frequency, urgency, and nocturia despite receiving a stable dose of α1-blocker for ≥1 month. Subjects were randomised to control (α1-blocker alone), IM twice/day (α1-blocker +0.1 mg imidafenacin twice daily), or IM nightly (α1-blocker plus 0.1 mg imidafenacin nightly) group; the treatment period was 8 weeks. Primary endpoints included improvements in night-time frequency and Nocturia Quality of Life Questionnaire (N-QOL) scores. Secondary endpoints included changes from the baseline in frequency volume chart variables, and post-void residual volume.. Compared with the controls, IM twice/day and IM nightly patients had a significantly lower night-time frequency (changes from baseline: 0.1 ± 0.8 in control, -0.6 ± 0.9 in IM twice/day, and -0.4 ± 1.0 in IM nightly, p = 0.5227, 0.0006 and 0.0143, respectively). The hours of undisturbed sleep and N-QOL score were significantly improved in IM twice/day group, though not IM nightly group. Nocturnal urine volume was significantly reduced in IM nightly group, although total urine volume remained unchanged.. A short half-life anticholinergic is suggested to be safe and effective as an add-on therapy for residual nocturia in patients with male LUTS receiving α1-blocker treatment. Anticholinergic administration nightly could reduce the nocturnal urine volume.

Topics: Adrenergic alpha-1 Receptor Antagonists; Aged; Aged, 80 and over; Cholinergic Antagonists; Drug Therapy, Combination; Half-Life; Humans; Imidazoles; Incidence; Japan; Lower Urinary Tract Symptoms; Male; Nocturia; Prospective Studies; Quality of Life; Surveys and Questionnaires; Treatment Outcome

To evaluate the efficacy of imidafenacin for nocturia and nocturnal polyuria in patients with overactive bladder.. A stratified analysis was conducted on data from a phase III randomized, double-blind, controlled trial of imidafenacin performed at 158 centers in Japan. The subjects received imidafenacin (0.1 mg) twice daily (group I) or placebo twice daily (group P). The 24-hour urine volume, daytime and nighttime voiding frequency, and volume voided/micturition were evaluated from 3-day voiding diaries recorded every 4 weeks during the 12-week study period. Longitudinal data analysis was performed, with all values expressed as the least squares mean ± standard error.. A total of 46 patients (mean age 66.54 ± 9.38 years, 9 men and 37 women) with nocturia and nocturnal polyuria (>33% of urine production at night) were enrolled. Group I (n = 35) and group P (n = 11) showed no baseline differences in the daily voided volume, concomitant diseases, age, or body weight. However, the average daily number of micturitions differed (11.22 ± 2.17 vs 14.45 ± 2.85). Therefore, longitudinal data analysis was performed for each micturition pattern. After 12 weeks of treatment, nighttime micturition was significantly less frequent in group I than in group P (P = .0292), and the nocturnal percentage of 24-hour production was significantly smaller (P = .0053). The interval to the first nighttime void was significantly longer in group I than in group P, but no difference was found in the first nighttime voided volume.. The novel antimuscarinic agent, imidafenacin, decreases the number of urinations and reduces nocturnal urine production, thereby improving both nocturia and nocturnal polyuria.

Topics: Aged; Double-Blind Method; Female; Humans; Imidazoles; Male; Middle Aged; Muscarinic Antagonists; Nocturia; Polyuria; Time Factors; Urination; Urine

We investigated the influence of nocturia and sleep disturbance on health-related quality of life(HRQOL) using the Medical Outcomes Study 8-item Short Form Health Survey (SF-8) in patients with nocturia. We also assessed the effect of therapeutic intervention by means of an anticholinergic agent on the results of the SF-8. One hundred and eighty-four patients who voided at least once per night were surveyed using the SF-8, Overactive Bladder Symptom Score (OABSS), Pittsburgh Sleep Quality Index (PSQI), and Epworth Sleepiness Scale (ESS). These parameters were also evaluated before and after 12 weeks of imidafenacin treatment in 51 patients with OAB accompanied by nocturia. The SF-8 physical component summary score (PCS) showed a significant decrease as nighttime voiding frequency increased. The mental health component summary score was 47.1 and 47.6 (which were lower than the standard value of 50) in the group with a nighttime frequency of once and ≥3/night, respectively. The SF-8 PCS and 6 subscales were negatively associated with nighttime voiding frequency, while the PSQI global score was positively associated with it. Imidafenacin significantly improved the OABSS, PSQI, and ESS, as well as the SF-8 score. This is the first study using the SF-8 to show that nocturia and sleep disturbance have a major influence on comprehensive HRQOL and that the SF-8 can be used to monitor HRQOL in OAB patients receiving treatment for nocturia.

Topics: Aged; Aged, 80 and over; Cholinergic Antagonists; Female; Health Status; Humans; Imidazoles; Male; Middle Aged; Nocturia; Predictive Value of Tests; Quality of Life; Sleep; Sleep Wake Disorders; Surveys and Questionnaires; Time Factors; Treatment Outcome; Urinary Bladder; Urinary Bladder, Overactive; Urodynamics

The effect of imidafenacin for the treatment of over active bladder (OAB), in 100 patients with urgency, nocturia or sleep disorders was examined by an open-labeled, non-randomized,non-controlled study. Prior to administration and at 4 weeks after administration (0.1 or 0 2 mg/day, p. o,), symptoms and sleep disorders were assessed using the Over Active Bladder Symptom Score (OABSS) and the Athens Insomnia Scale (AIS), respectively. After administration, OABSS scores and AIS scales were improved significantly when compared to baseline values. The change of nocturia scores was correlated closely with that of AIS scales. Imidafenacin was effective in OAB patients with urgency and nocturia. In addition, imidafenacin secondarily mitigated sleep disorders significantly.

Topics: Aged; Cholinergic Antagonists; Female; Humans; Imidazoles; Male; Nocturia; Sleep Wake Disorders; Urinary Bladder, Overactive

To evaluate the efficacy of imidafenacin on nocturia and sleep disorder in patients with overactive bladder (OAB).. A prospective multicenter study of imidafenacin 0.1 mg twice daily for patients with OAB and nocturia was conducted. At baseline and at week 4 and 8, patients were assessed using the overactive bladder symptom score (OABSS), frequency volume charts (FVC) and the Pittsburgh Sleep Quality Index (PSQI).. Treatment with imidafenacin significantly improved OAB symptoms. Imidafenacin also improved PSQI, especially subjective sleep quality, sleep latency and daytime dysfunction. In FVC, the number of daytime voids and nighttime voids significantly decreased and average voided volume significantly increased after imidafenacin. Subanalysis of FVC based on the patients' age revealed that nocturnal polyuria was more often found in patients aged 75 years or over than in those aged under 75 years (79 vs. 55%, p < 0.05). Treatment with imidafenacin significantly reduced the nocturnal polyuria index only in patients aged 75 years or over.. Imidafenacin can improve nocturia and sleep disorder in patients with OAB. The efficacy of imidafenacin on nocturia is attributable to an increase in bladder capacity and a decrease in nocturnal urine volume. We conclude that imidafenacin is an effective and safe drug for nocturia in patients with OAB.

Topics: Aged; Aged, 80 and over; Female; Humans; Imidazoles; Male; Middle Aged; Muscarinic Antagonists; Nocturia; Polyuria; Sleep; Sleep Wake Disorders; Time Factors; Urinary Bladder, Overactive; Urodynamics