Enablex (Darifenacin) - Summary

ENABLEX SUMMARY

ENABLEX^® (darifenacin) is an extended-release tablet which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.

ENABLEX^®(darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

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NEWS HIGHLIGHTS

Published Studies Related to Enablex (Darifenacin)

Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy. [2008.11]
INTRODUCTION AND OBJECTIVE: Patient perception of overactive bladder (OAB) treatment outcomes can be a useful indicator of benefit and may help drive persistence on treatment, which is known to be poor in OAB. It remains unclear whether OAB patients dissatisfied with one antimuscarinic can achieve satisfaction with another and supporting data are limited. This study investigated patient-reported outcomes and clinical parameters during darifenacin treatment in OAB patients who expressed dissatisfaction with prior extended-release (ER) oxybutynin or tolterodine therapy (administered for >or= 1 week within the past year)... CONCLUSIONS: In this study, PPBC score and OAB symptoms were significantly improved, and satisfaction was high during treatment with darifenacin (7.5/15 mg) in patients who were dissatisfied with the previous antimuscarinic treatment.

Clinical relevance of health-related quality of life outcomes with darifenacin. [2008.07]
OBJECTIVE: To determine the clinical relevance of changes in health-related quality of life (HRQoL) in patients with overactive bladder (OAB) treated with darifenacin... CONCLUSIONS: Darifenacin treatment was associated with significant, clinically relevant improvements in HRQoL in patients with OAB, shown using the concept of MID to interpret change in KHQ scores.

Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study. [2008]
BACKGROUND AND AIMS: Overactive bladder (OAB), a chronic condition requiring long-term management, is associated with substantial impact on health-related quality of life (HRQoL). The short-term benefits of antimuscarinic drug treatment are well known. Here we investigate the impact on HRQoL of long-term treatment with the M(3)-selective muscarinic receptor antagonist darifenacin over 2 years... CONCLUSIONS: Long-term darifenacin treatment was associated with significant and clinically meaningful improvements in HRQoL for patients with 'wet' OAB over 2 years. (c) 2008 Wiley-Liss, Inc.

Darifenacin treatment of patients >or= 65 years with overactive bladder: results of a randomized, controlled, 12-week trial. [2007.10]
BACKGROUND: Overactive bladder (OAB) increases in prevalence with advancing age. This study specifically investigated patients >or= 65 years, evaluating the efficacy, tolerability, safety and quality of life (QoL) outcomes from darifenacin treatment... CONCLUSIONS: This study demonstrated that marked improvements in OAB symptoms can be achieved in patients >or= 65 years, with significant treatment differences in responder rates, micturition frequency and QoL. Reduction in UUIEs may not be the optimal endpoint in this population, whereas QoL appears to be a sensitive and relevant patient-oriented measure of treatment effect.

Long-term treatment with darifenacin for overactive bladder: results of a 2-year, open-label extension study. [2006.11]
OBJECTIVE: To examine, in a 2-year, non-comparative, open-label extension study, the safety, tolerability and efficacy of darifenacin controlled-release (CR) 7.5/15 mg once daily in patients with overactive bladder (OAB) who completed two 12-week randomized, double-blind, placebo-controlled 'feeder' studies... CONCLUSION: In the first published 2-year, open-label study of a CR antimuscarinic agent, darifenacin 7.5/15 mg once daily had a favourable safety, tolerability and efficacy profile during the long-term treatment of OAB. As such, darifenacin represents a valuable therapeutic option for OAB.

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Clinical Trials Related to Enablex (Darifenacin)

Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects [Completed]
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older

Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder [Completed]
This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.

Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder [Completed]
This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7. 5 mg once daily (o. d.) with voluntary increase up to 15 mg o. d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.

A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder [Completed]
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.

Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over [Completed]

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PATIENT REVIEWS / RATINGS / COMMENTS

Enablex review by 73 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		BLADDER CONTROL
Dosage & duration:		7.5 mg taken 1 per day for the period of 2 weeks
Other conditions:		none
Other drugs taken:		Enalapril (Generic for vasotec)
		Reported Results
Benefits:		There were no benefits. Over-active bladder continued as is.
Side effects:		No side effects.
Comments:		Enablex was the 4th in a series of bladder control medications that I was given over a 2 month period. It had no effect whatsoever on my condition.