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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.

more studies >>

Clinical Trials Related to Enablex (Darifenacin)

Preoperative Use of Darifenacin (Enablex) to Alleviate Postoperative Ureteral Stent Pain [Recruiting]
This will be a randomized two arm prospective study to evaluate postoperative ureteral stent pain. One arm will be given 3 days of preoperative darifenacin and the control group will have the standard of care which is no preoperative anticholinergic medication. The primary endpoints will be decreased pain scores and less ER visits and hospital admissions for stent difficulty. These will be assessed by a pain diary completed by the participant as well as a questionnaire when the participant returns to clinic for stent removal. Also included in evaluation of the primary end point will be patient phone calls, ER visits and admissions for stent difficulty. Secondary endpoints will be narcotic and postoperative anticholinergic use. This will also be assessed with the pain diary completed by the participant. Participants will be included in the study if they are undergoing a procedure that a stent will likely be required. This will include participants who will have ureteroscopy or extracorporeal shock wave lithotripsy and a stone 1 cm or larger. Also participants with stones smaller than 1 cm who due to anatomy of the ureter or kidney will likely need a stent on preoperative evaluation will also be included in the study. Included as well in the study are participants who will undergo renal or ureteral surgery that a ureteral stent will be utilized. Participants will be randomized after consent is obtained into two groups. One group will receive standard of care which is no preoperative anticholinergic medications. The second group will receive the three day treatment with darifenacin pre procedure. Participants in the second group will be instructed on side effects of darifenacin and given appropriate contact information prior to initiation of the medication. Both groups will be followed postoperatively with a pain diary. Postoperative follow up will continue until the stent is removed 1-2 weeks after the procedure. The exact time of stent removal will depend on the success and nature of the surgery and will be at the discretion of the surgeon. Participants will be able to voluntarily stop the medication for any reason as well as if they have serious side effects from the medication. Data to be collected from each group includes age, gender, race, prior ureteral stents, prior renal or ureteral surgery, past medical history, allergies, current medications and urinary complaints.

Single Dose Two-periods Crossover Bioequivalence Study of Darifenacin Tablets in Healthy Volunteers. [Not yet recruiting]
The present study was designed to assess the bioequivalence and pharmacokinetic profiling of a brand generic formulation of darifenacin [Darisec(R)]vs. the innovator [Enablex(R)]in healthy volunteers after a high fat breakfast.

The bioequivalence will be evaluated using:

- the Area Under the Curve (AUC) and,

- the peak plasma concentration (Cmax).

Safety will be evaluated recording:

- vital signs

- adverse events,

- laboratory analysis.

- EKG and chest XRays.

Bioequivalence will be claimed if the drugs comply with local regulatory requirement, eg.:

- mean AUCt/AUCr and 90% confidence interval within 0. 80-1. 25

- mean Cmaxt/Cmaxr and 90% confidence interval within 0. 80-1. 25.

Single Dose Bioequivalence Study of Darifenacin Tablets 7.5 mg in Fed Healthy Volunteers. [Not yet recruiting]
The proposed study was designed as a randomized two-sequence, two period crossover trial to assess the bioequivalence, pharmacokinetic profiling and safety of a brand generic formulation of darifenacin [Darisec(R) 7. 5 mg] vs. the innovator [Enablex(R)7. 5 mg]in healthy volunteers in postprandial state.

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

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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