A further study that includes more patients is needed to solve these problems. In conclusion, our study confirmed that the improved urgency and nocturia by solifenacin administration may also improve sleep quality. However, there were no significant differences by administration timing. Although there are various causes of nocturia, this antimuscarinic drug may not only improve storage symptoms by decreasing urgency and nocturia but also improve sleep disruption for OAB patients with sleep disruptions.
Supervision: Moon KH. Writing - original draft: Kwon T. National Center for Biotechnology Information , U. J Korean Med Sci. Published online Jul 4. Find articles by Taekmin Kwon. Find articles by Tae Hee Oh. Find articles by Seong Choi. Find articles by Won Yeol Cho. Find articles by Kweonsik Min. Find articles by Jeong Zoo Lee. Find articles by Kyung Hyun Moon. Author information Article notes Copyright and License information Disclaimer.
Corresponding author. Received Mar 23; Accepted Jun 3. This article has been cited by other articles in PMC. Abstract We compared changes in nocturia and sleep-related parameters between daytime and nighttime solifenacin dosing in patents with overactive bladder OAB and nocturia. Graphical Abstract. Table 1 Baseline demographic and clinical characteristics. Variables Group 1 day Group 2 night P value No.
Open in a separate window. Table 2 Outcome measures among treatment groups. Table 3 Comparison of treatment outcomes by medication timing. References 1. The role of urinary urgency and its measurement in the overactive bladder symptom syndrome: current concepts and future prospects. BJU Int. The standardisation of terminology in nocturia: report from the Standardisation Sub-committee of the International Continence Society.
Neurourol Urodyn. Prevalence, severity, and symptom bother of lower urinary tract symptoms among men in the EPIC study: impact of overactive bladder. Eur Urol. Age related pathogenesis of nocturia in patients with overactive bladder.
J Urol. Miller M. Nocturnal polyuria in older people: pathophysiology and clinical implications. J Am Geriatr Soc. The prevalence of nocturia and its effect on health-related quality of life and sleep in a community sample in the USA.
Productivity, vitality and utility in a group of healthy professionally active individuals with nocturia. Urgency is an independent factor for sleep disturbance in men with obstructive sleep apnea. Int J Urol. Andersson KE. Drug therapy of overactive bladder--what is coming next? Korean J Urol. Naunyn Schmiedebergs Arch Pharmacol. Solifenacin appears effective and well tolerated in patients with symptomatic idiopathic detrusor overactivity in a placebo- and tolterodine-controlled phase 2 dose-finding study.
YM Study Group. Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. Reduction from baseline in the number of micturition and urgency episodes in 24 hours, and episodes of nocturia in patients receiving placebo, 5 mg, or 10 mg of solifenacin in a phase 3 trial drawn from data of Cardozo et al Half of the patients who were incontinent at baseline and received treatment with solifenacin 5 mg and 10 mg were dry at the end of the study period.
Rates of dry mouth were 7. Seven patients 2. A week phase 3a study assessing the efficacy of 5 mg and 10 mg solifenacin was conducted in a multicenter, double-blind, placebo-controlled trial, using 2 mg of immediate release tolterodine as an active comparator Chapple et al b. The primary aim was to assess the efficacy of solifenacin 5 and 10 mg whilst the secondary aims were to compare the safety and efficacy with that of 2 mg immediate release IR tolterodine.
After a 2-week placebo run-in period, subjects were randomized to either 2 mg IR tolterodine twice daily, placebo, solifenacin 5 mg or 10 mg. Baseline to end of study changes in the mean number of urgency, mixed incontinence and urgency incontinence episodes were used as study outcome measures. In addition, the mean number of voids per 24 hours and mean volume voided per void were also assessed. Results of the study showed a statistically significant reduction in the number of urgency and urgency incontinence episodes in the patients receiving solifenacin, when compared with placebo.
These changes were not statistically significant in the tolterodine-treated group when compared with placebo. There was a significant reduction in urinary frequency with all active treatments, this effect being greatest in the solifenacin 10 mg, and then the 5 mg group. There was a statistically significant improvement in volume of urine per void in the solifenacin- and tolterodine-treated groups, when compared with placebo.
The changes in study outcome measures are shown in Figure 3. The percentage change from baseline in the mean number of urgency, incontinence, and urge incontinence episodes and mean voids in a hour period Drawn from data of Chapple et al b. Five 1. Constipation was reported in a greater number of patients receiving solifenacin than tolterodine. The study found the 5 and 10 mg doses of solifenacin to be more effective than placebo, in the treatment of OAB.
These preliminary studies lead to the STAR study; a head to head clinical trial comparing the efficacy of the existing market leader tolterodine extended release with dose flexible solifenacin. This was a prospective, double blind, 2 arm, parallel group, week study Chapple et al The study design is described in Figure 4. In this type of study the initial analysis is one of non-inferiority of the test drug, and once established assessment of superiority may follow.
The results of the study showed that solifenacin was not inferior to tolterodine in reducing the number of voids per 24 hours; 2. Solifenacin treatment resulted in a significant improvement in urgency, nocturia, urge incontinence, and overall incontinence when compared with tolterodine.
Reduction in pad usage was significantly greater in the solifenacin-treated group than the tolterodine-treated group 1. The perception of bladder condition questionnaire PBC is a validated single-item questionnaire, which asks people to choose 1 of 6 responses describing the severity of their bladder condition.
Assessment of the PBC questionnaire scores showed a greater improvement in the solifenacin-treated group than the tolterodine-treated group 1. Adverse events were those associated with antimuscarinic therapy and were mild to moderate in severity.
The study concluded that the flexible dosing of solifenacin is more effective in treating OAB compared with the highest licensed dose of extended release tolterodine.
The duration of most clinical trials is 12 weeks, owing, among other factors, to cost constraints, intensity of surveillance, and the ethical considerations of long-term placebo treatment. Patients receive detailed follow up and incentives such as free study medication in order to complete the trial.
Long term real world efficacy and persistence with treatment cannot be easily extrapolated from short-clinical trials. Participants in a week study were offered a week open label extension of solifenacin at both 5 and 10 mg doses. The aim of the study was to assess the long-term efficacy and tolerability of solifenacin Haab et al Participants were followed up at 3 intervals.
Traditional outcome measures such as frequency, urgency, urgency incontinence, and nocturia episodes per hour period and volume voided per void were used. Figure 5 shows the changes in bladder diary variables over the 1-year extension period.
Median percentage reductions in frequency, urgency, and nocturia in long-term solifenacin treated patients. Long term open-label solifenacin treatment associated with persistence with therapy in patients with overactive bladder syndrome. Eur Urol , — More than half of episodes of dry mouth, constipation and blurred vision were mild in severity. The Kings health questionnaire KHQ Kelleher et al b , a domain quality of life instrument designed for the assessment of quality of life among patients with lower urinary tract dysfunction, was used in 2 of the phase 3 studies Chapple et al b ; Cardozo et al and the open label extension study.
Quality of life data analysis of a week trial conducted by Chapple et al b showed a significant improvement in 5 of the domains of the KHQ in patients taking 5 and 10 mg doses of solifenacin compared with placebo role limitations, physical limitations, emotions, severity measures, and symptom severity. Patients taking 10 mg of solifenacin also reported a significantly greater score in the incontinence impact domain. Patients taking the 10 mg dose of solifenacin also reported an improvement in the physical limitations and severity measures domains Figure 6.
Pooled changes from baseline in the KHQ domains for 2 of the phase 3 trials for solifenacin. Quality of life data from the long term extension study showed a significant improvement in 9 of the 10 domains of the KHQ with the exception of the personal relationships domain.
Almost two thirds of this improvement occurred in the first 3 months of treatment and was sustained for the duration of the study. Quality of life improvements continued throughout the week extension period Figure 7. Changes from baseline in the KHQ domains for the open label solifenacin extension study. Previous studies of solifenacin have used changes in micturition frequency as the primary outcome measure of treatment effectiveness.
Two recent trials have used urgency as the primary outcome variable. The Venus trial Vesicare efficacy and safety in patients with urgency study investigated the efficacy and safety of 5 and 10 mg doses of solifenacin using a novel outcome measure of urgency called warning time. Warning time was measured using a stopwatch for a 1-day period prior to study-related visits. The results of the study showed a significant increase in warning time in patients receiving solifenacin, Qualitative measures of urgency were evaluated using the urgency perception scale UPS ; a validated three point scale and the Indevus urgency severity scale IUSS ; a single item patient reported measure of urgency severity Toglia et al a.
Full data from this trial had not been published at the time of preparing of this manuscript. Previous clinical trials evaluating tolterodine and darifenacin have used warning time as an endpoint measure; however have failed to show a significant increase in warning time Toglia b ; Zinner et al Cardozo et al have previously shown a significant improvement in warning time for darifenacin compared to placebo in a randomized, double blind, placebo controlled study.
The dose of darifenacin used was 30 mg, namely twice the maximal licensed dose for the treatment of OAB. The week Sunrise study solifenacin in the treatment of urgency symptoms of OAB in a rising dose, randomized, placebo controlled, double blind, efficacy trial assessed the effects of 5 and 10 mg solifenacin on urgency severity and bother.
The majority of clinical trials of OAB treatments use frequency and incontinence episodes as primary outcome variables as they are easy to objectively measure. Urgency is difficult to measure but remains the defining and most bothersome symptom of OAB and as such of greatest importance to patients and prescribers Cardozo et al a. Urgency severity and bother were chosen as the primary end points for the study.
The perception of bladder condition PBC which is a validated, single item questionnaire, and a treatment satisfaction visual analogue scale were also used.
Traditional bladder diary measurements namely, frequency, urgency and incontinence episodes per 24 hours were used as secondary outcome variables.
Patients receiving solifenacin achieved a significantly greater reduction in urgency, frequency, and urge incontinence episodes when compared with placebo. These trends were also reflected in the qualitative measures. There was a Treatment satisfaction was significantly increased. The incidences of dry mouth and constipation were higher in patients receiving solifenacin The rate of blurred vision was equivocal.
Discontinuation rates for solifenacin and placebo were similar Full data from this trial had not been published at the time of preparing this manuscript. Solifenacin was launched in as the first once-daily, flexible-dose, M3-receptor-selective antimuscarinic for the treatment of OAB. Long-term safety, efficacy, tolerability, and persistence with treatment have been established in an open label week continuation study.
Higher doses of solifenacin are not associated with higher rates of discontinuation. In addition, recent studies utilizing an array of measures of urgency have shown that irrespective of the measure used urgency is improved by solifenacin.
A large post-marketing head-to-head study comparing solifenacin flexible dose and extended release tolterodine fixed dose showed a significant benefit of solifenacin treatment. In clinical practice, patients are commenced on 5 mg of solifenacin and offered dose titration at 4—6 weeks of treatment. This may enhance treatment efficacy, and allow optimum control of OAB. Whether optimal dose titration in clinical practice mirrors that seen in clinical trials is yet to be established.
Conflicts of interest Ramandeep Basra has no conflicts of interest. National Center for Biotechnology Information , U. Ther Clin Risk Manag. Published online Feb.
Ramandeep Basra and Con Kelleher. Author information Copyright and License information Disclaimer. Solifenacin starts to relax the muscle in your bladder after 3 to 8 hours of taking your first dose. However, it can take up to 4 weeks for it to reach its full effect and for your symptoms to get better. After 4 weeks your doctor will check that solifenacin is helping your symptoms.
Take solifenacin until your doctor tells you to stop. Do not stop taking it just because you feel better. Do not take solifenacin for longer than you need to.
Your doctor will check every 6 to 12 months that your treatment is still needed. There may be an increased risk of confusion and possibly dementia in people taking solifenacin, but more study needs to be done.
If you're worried about this, talk to your doctor. If you've been taking solifenacin for at least 6 months your doctor may suggest that you stop taking the medicine for up to 4 weeks to see how your symptoms change without it. Some people find that the improvement in their symptoms continues after they've stopped taking the medicine. Talk to your doctor if you're thinking about stopping your medicine. Solifenacin belongs to a group of medicines called antimuscarinics.
There are other antimuscarinics that can be used for overactive bladder:. They all seem to work just as well as solifenacin. However, if you get side effects with one antimuscarinic a different one may suit you better. Also, solifenacin is taken once a day but some of the other medicines you have to take twice a day or more.
If antimuscarinics are unsuitable for you, they have not helped your overactive bladder, or you have had side effects, you may be offered a medicine called mirabegron , which works in a slightly different way.
Try to avoid drinking alcohol when you first start taking solifenacin, or if your dose is increased, to see how you feel.
Solifenacin combined with alcohol can make you feel very sleepy. Drinking alcohol may make you more likely to need to get up in the night to pee. You can eat normally while taking solifenacin. If you have urinary incontinence, cut down on alcohol and drinks containing caffeine, such as tea, coffee and cola.
However, very rarely solifenacin can make you feel less hungry, so you may lose weight. If you start to have problems with your weight while taking solifenacin, talk to your pharmacist or doctor. Solifenacin does not affect any type of contraception, including the combined pill or emergency contraception.
However, if solifenacin makes you sick or have severe diarrhoea, your contraceptive pills may not protect you from pregnancy. Look on the pill packet to find out what to do. Read more about what to do if you're on the pill and you're being sick or have diarrhoea. However, speak to a pharmacist or your doctor before taking it if you're trying to get pregnant. Do not drive a car, ride a bike, use tools or operate machinery if solifenacin makes you sleepy, gives you blurred vision, or makes you feel dizzy, clumsy or unable to concentrate or make decisions.
This may be more likely when you first start taking it, but could happen at any time. For example, it could happen when you increase the dose or start another medicine.
Talk to a doctor or pharmacist if you're not sure whether it's safe for you to drive while taking solifenacin. There are some lifestyle changes that may help your symptoms. Page last reviewed: 11 June Next review due: 11 June Solifenacin - Brand name: Vesicare On this page About solifenacin Key facts Who can and cannot take solifenacin How and when to take solifenacin Side effects How to cope with side effects of solifenacin Pregnancy and breastfeeding Cautions with other medicines Common questions about solifenacin.
About solifenacin Solifenacin is a medicine used to treat symptoms of an overactive bladder. These can include: a sudden and urgent need to pee urinary urgency needing to pee more often than usual urinary frequency wetting yourself if you cannot make it to the loo in time urinary incontinence Solifenacin works by relaxing the muscles around your bladder.
Common side effects include dry mouth and blurred vision. You will usually take this medicine long term to help keep your symptoms under control. Solifenacin starts to work within 3 to 8 hours, but it can take up to 4 weeks to reach its full effect. Solifenacin can be taken by adults aged 18 years and over. To make sure it's safe for you, tell your doctor or pharmacist before starting solifenacin if you: have ever had an allergic reaction to solifenacin or any other medicine have liver or kidney problems have myasthenia gravis , a rare long-term condition that causes muscle weakness have glaucoma , as solifenacin can increase pressure in your eye have a severe stomach or bowel condition, including a rare complication of ulcerative colitis or Crohn's disease called toxic megacolon are not able to pee or empty your bladder completely urinary retention are pregnant, trying to get pregnant or breastfeeding.
Always read the information that comes with your medicine. Dosage The usual dose of solifenacin is 5mg, taken once a day. What if I forget to take it? Do not take a double dose to make up for a missed dose. What if I take too much? Taking 1 extra dose of solifenacin is unlikely to harm you. However, you may get more side effects, such as a dry mouth or headache.
You've taken more than your usual dose of solifenacin and you have: a fast heartbeat breathing problems. Urgent advice: Contact for advice now if:. You've taken 2 or more extra doses of solifenacin and you: have hallucinations feel very restless or excited have dilated pupils in your eyes are not able to pee Call or go to
0コメント