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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.


See all Enablex indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Enablex (Darifenacin)

Time-to-effect with darifenacin in overactive bladder: a pooled analysis. [2011]
with darifenacin in patients with overactive bladder (OAB)... CONCLUSIONS: Darifenacin 7.5 and 15 mg significantly reduced OAB symptoms

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.

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Clinical Trials Related to Enablex (Darifenacin)

2 Week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Yrs) With Neurogenic Detrusor Overactivity [Recruiting]
This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity. The results will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.

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.

more trials >>

Reports of Suspected Enablex (Darifenacin) Side Effects

Drug Ineffective (7)Constipation (4)Fatigue (4)Urinary Tract Infection (4)Cerebrovascular Accident (4)Amnesia (4)Agitation (3)Confusional State (3)Glaucoma (3)Dementia (3)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Enablex has an overall score of 1. The effectiveness score is 2 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

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.

See all Enablex reviews / ratings >>

Page last updated: 2013-02-10

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