Vesicare (Solifenacin Succinate) - Summary

VESICARE SUMMARY

VESIcare^®  (solifenacin succinate) is a muscarinic receptor antagonist.

VESIcare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

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NEWS HIGHLIGHTS

Published Studies Related to Vesicare (Solifenacin)

Safety and Tolerability of Solifenacin Add-on Therapy to alpha-Blocker Treated Men With Residual Urgency and Frequency. [2009.10.16]
PURPOSE: VICTOR was a 12-week, double-blind, placebo controlled trial assessing the safety and tolerability of solifenacin plus tamsulosin in men with residual overactive bladder symptoms after tamsulosin monotherapy. Efficacy of solifenacin plus tamsulosin vs placebo plus tamsulosin was also evaluated... CONCLUSIONS: Solifenacin plus tamsulosin was well tolerated. There was a low incidence of urinary retention requiring catheterization. At week 12 solifenacin plus tamsulosin decreased daily micturitions and urgency episodes. Only urgency reached statistical significance vs placebo plus tamsulosin.

Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. [2009.09]
OBJECTIVE: Overactive bladder (OAB) is a prevalent, chronic condition that can negatively affect health-related quality of life (HRQL). Treatment goals are to improve symptoms and HRQL. We assessed the efficacy of solifenacin in OAB patients using several patient-reported outcome (PRO) measures, with a focus on urgency severity. Results for the primary endpoint, reductions in daily urgency episodes, and other bladder-diary variables have been recently reported... CONCLUSION: Flexibly dosed, once-daily solifenacin was associated with statistically significant and clinically meaningful improvements in urgency and other symptom-specific bother and HRQL compared with placebo.

Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. [2009.01]
OBJECTIVES: In this double-blind, placebo-controlled trial, we assessed the efficacy and tolerability of solifenacin treatment for overactive bladder (OAB) with a focus on urgency-related endpoints. Changes in number of urgency episodes were evaluated as the primary endpoint; secondary endpoints included changes in conventional diary-based OAB symptoms. We also measured warning time (defined as the time from first sensation of urgency to voiding)... CONCLUSIONS: Solifenacin treatment significantly reduced episodes of urgency and other key symptoms of OAB. Solifenacin is the first antimuscarinic to demonstrate significant warning time improvement at approved dosing, as shown in a large OAB study population. This is the largest OAB clinical trial yet conducted to evaluate warning time and diary variables in the same study population.

Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. [2008.11]
OBJECTIVES: To examine the effects of the antimuscarinic agent solifenacin on urinary urgency, using a range of novel and established outcome measures, as urgency is the principal symptom of the overactive bladder syndrome (OAB)... CONCLUSION: Solifenacin significantly reduced the number of urgency episodes and the extent of urgency bother, and was well tolerated; it was effective as early as day 3 of treatment.

Randomized, double-blind, placebo- and propiverine-controlled trial of the once-daily antimuscarinic agent solifenacin in Japanese patients with overactive bladder. [2007.09]
OBJECTIVES To compare solifenacin succinate (5 and 10 mg once-daily) to placebo and propiverine hydrochloride (20 mg once-daily), respectively, in Japanese patients with overactive bladder syndrome (OAB). PATIENTS AND METHODS A multicentre, 12-week, double-blind phase III trial randomized men and women aged >/= 20 years with OAB to solifenacin 5 or 10 mg, propiverine 20 mg, or placebo...

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Clinical Trials Related to Vesicare (Solifenacin)

Open-Label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms [Completed]
To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder [Completed]
To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes

A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR) [Active, not recruiting]
This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.

A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB) [Completed]
The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.

Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR) [Active, not recruiting]
The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

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PATIENT REVIEWS / RATINGS / COMMENTS

Vesicare review by 62 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		overactive bladder
Dosage & duration:		5 mgm. by mouth, once a day taken daily for the period of 1 year and ongoing
Other conditions:		pelvic prolapse;mild asthma; allergic rhinitis; hypothyroidism
Other drugs taken:		Allegra; Nasacort; Premarin; Levoxyl; Advair Diskus
		Reported Results
Benefits:		Urinary frequency and urgency have been substantially reduced; I have a vastly improved lifestyle because these problems no longer inhibit my activities.
Side effects:		I experienced mild constipation in the beginning but because I eat a vegetarian diet I have been able to manage this side effect easily by increasing dietary fiber. No other measures have been necessary.
Comments:		My gynecologist changed me to Vesicare when I complained about side effects from the previous Rx I was on for overactive bladder. (These were dry mouth and constipation.) After beginning to take Vesicare daily, I noticed an immediate improvement, i.e., sharp decrease in the negative side effects. I plan to continue the use of Vesicare because there seem to be no prohibitions to its long term use. It may also possibly postpone surgical repair of the pelvic prolapse.

Vesicare review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		frequent urination
Dosage & duration:		10mg taken 1/day for the period of continue
Other conditions:		lack of sleep
Other drugs taken:		n/a
		Reported Results
Benefits:		I was able to hold and wait to use restroom and urges were less frequent.
Side effects:		dry mouth constipation
Comments:		I've been taking 5 mg per day for a month and I felt it was losing effectiveness so incresed to 10 mg and been taking 3 month so far. I still have some what of problem before period and have more frequent urge to goto restroom than other people but I am able to hole and wait. It is much more controlable than I wasn't taking anything.

Vesicare review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		frequent urination
Dosage & duration:		10mg taken 1/day for the period of continue
Other conditions:		lack of sleep
Other drugs taken:		n/a
		Reported Results
Benefits:		I was able to hold and wait to use restroom and urges were less frequent.
Side effects:		dry mouth constipation
Comments:		I've been taking 5 mg per day for a month and I felt it was losing effectiveness so incresed to 10 mg and been taking 3 month so far. I still have some what of problem before period and have more frequent urge to goto restroom than other people but I am able to hole and wait. It is much more controlable than I wasn't taking anything.