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  1. 1. ENABLEX ® in the Treatment of Overactive Bladder ENABLEX ® is a registered trademark of Warner Chilcott Company, LLC. ENABLEX ® (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
  2. 2. Presenter <ul><li>David C. Chaikin, MD, FACS </li></ul><ul><li>Clinical Assistant Professor of Urology </li></ul><ul><li>New York-Presbyterian/Weill Cornell Medical Center </li></ul><ul><li>New York, New York </li></ul><ul><li>Attending Urologist </li></ul><ul><li>Morristown Memorial Hospital </li></ul>
  3. 3. Table of Contents
  4. 4. Overactive Bladder Background: Disease State and Epidemiology
  5. 5. Overactive Bladder Is a Complex Syndrome Coyne KS, et al. Urology. 2011; 77:1081-1087. Urgency 12.6% Urge Urinary Incontinence 9.1% Urgency + Frequency 5.2% 1.2% Urgency + Urge Urinary Incontinence 13.1% Urgency + Urge Urinary Incontinence + Frequency 7.0% Prevalence of Overactive Bladder Symptoms in Poll of 2000 Adults Aged ≥40 Years Urge Urinary Incontinence + Frequency
  6. 6. Overactive Bladder Affects Over 33 Million Americans <ul><li>According to the National Overactive Bladder Evaluation (NOBLE) Program </li></ul>Kelleher CJ. Eur Urol Suppl. 2002;1:11-16. * Overactive bladder dry: ≥4 episodes of urgency during the preceding 4 weeks and either frequency of >8 voids per day or the use of ≥1 coping behaviors to control bladder function. † Overactive bladder wet: same criteria as overactive bladder dry, plus ≥3 episodes of urinary incontinence in the past 4 weeks that could not be explained by stress symptoms. 21.2 million (10.5% of the US adult population) 12.2 million (6.1% of the US adult population) Incontinent (overactive bladder wet † ) Continent (overactive bladder dry * )
  7. 7. Overactive Bladder Risk Factors <ul><li>* Include elevated body mass index (BMI) and diabetes. </li></ul><ul><li>Stewart WF, et al. World J Urol . 2003;20:327-336. </li></ul><ul><li>Teleman PM, et al. BJOG . 2004;111:600-604. </li></ul><ul><li>Rosenberg MT, et al. Cleve Clin J Med . 2007;74(suppl 3):S21-S29. </li></ul><ul><li>Thüroff JW, et al. Eur Urol . 2011;59:387-400. </li></ul>Increased Age 1 Abnormal Metabolic Factors 2 * Medications 3 Pregnancy and Vaginal Delivery (Women) 4 Prostate-related Conditions (Men) 3,4 Pelvic Surgery 3
  8. 8. Comorbidities Associated With Overactive Bladder Brown JS, et al. Am J Manag Care . 2000;6(suppl 11):S574-S579. Falls and Fractures Depression Sleep Disturbances Urinary Tract and Skin Infections
  9. 9. Overactive Bladder Negatively Affects QOL * A standardized questionnaire that measures health-related QOL. Modified from Stewart WF, et al. World J Urol . 2003;20:327-336. Decrease in Mean SF-36 Score (%) QOL Areas of Measure Patients With Overactive Bladder Urge Incontinence Compared With Controls (SF-36)*
  10. 10. Treatment Options: Pharmacologic and Non-Pharmacologic Therapies <ul><li>Thüroff JW, et al. Eur Urol . 2011;59:387-400. </li></ul><ul><li>Yamaguchi O, et al . Int J Urol . 2009;16:126-142. </li></ul>* Recommendations for pharmacologic therapy are from the European Association of Urology (EAU) guidelines for incontinence. Non-Pharmacologic (Behavioral Therapy) 2 <ul><li>Lifestyle management </li></ul><ul><li>Limiting excessive water or caffeine intake </li></ul><ul><li>Bladder training </li></ul><ul><li>Increasing bladder capacity through lengthening of the voiding interval </li></ul><ul><li>Physical therapy </li></ul><ul><li>Pelvic floor exercises </li></ul><ul><li>Biofeedback therapy </li></ul><ul><li>Toileting assistance </li></ul><ul><li>Timed and patterned toileting guidance </li></ul>Pharmacologic Therapy 1* <ul><li>Antimuscarinic drugs </li></ul><ul><li>Drugs acting on membrane channels </li></ul><ul><li>Antidepressants </li></ul><ul><li>Alpha-adrenoreceptor antagonists </li></ul><ul><li>Beta-adrenoreceptor antagonists </li></ul><ul><li>Phosphodiesterase type-5 inhibitors (in men) </li></ul><ul><li>Cyclo-oxygenase (COX) inhibitors </li></ul><ul><li>Hormones </li></ul>
  11. 11. M 3 Receptor Selectivity Allows for Targeting of Tissue of Intent Abrams P, et al. Br J Pharmacol . 2006;148:565-578.
  12. 12. Targets for Muscarinic Receptor Inhibition <ul><li>Abrams P, et al. Br J Pharmacol . 2006;148:565-578. </li></ul><ul><li>Sarria B, et al. Am J Physiol Lung Cell Mol Physiol. 2002;283:L1125-L1132 . </li></ul>Impacts: Memory, cognitive function, saliva, tear secretion Impacts: Heart rate, tear secretion, bronchodilation Impacts: Bladder contraction,* bowel motility, saliva, tear secretion, visual accommodation Cerebral cortex Hippocampus Eyes Salivary glands Cardiac muscle Eyes Smooth muscle (bronchus) Hippocampus Hind brain Smooth muscle (bladder, bowel) Salivary glands Eyes Brain
  13. 13. M 3 -specific Targeted Therapy for Overactive Bladder <ul><li>High affinity for the M 3 receptor 1-3 </li></ul><ul><ul><li>Targets the smooth muscle to minimize leaks </li></ul></ul><ul><ul><li>and accidents 1 </li></ul></ul><ul><ul><li>Minimizes potential CNS- and CV-related side effects 2,3 </li></ul></ul><ul><li>M 3 -selective antagonists do not significantly affect memory 3 </li></ul><ul><ul><li>Compared with placebo </li></ul></ul><ul><ul><li>Significant memory deterioration has been demonstrated with less-selective agents, such as oxybutynin </li></ul></ul><ul><li>Abrams P, et al. Br J Pharmacol . 2006;148:565-578. </li></ul><ul><li>Lipton RB, et al. J Urol . 2005;173:493-498. </li></ul><ul><li>Kay G, et al. Eur Urol. 2006;50:317-326. </li></ul>CNS=central nervous system; CV=cardiovascular.
  14. 14. ENABLEX ® : Muscarinic Receptor Selectivity <ul><li>M 3 receptors are the primary mediators of detrusor contractility in the bladder 1 </li></ul><ul><li>M 3 receptors are also involved in gastrointestinal smooth-muscle contraction, saliva production, and iris sphincter function 1,2 </li></ul><ul><li>NA=not available. </li></ul><ul><li>Abrams P, et al. Br J Pharmacol . 2006;148:565-578. </li></ul><ul><li>ENABLEX® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. </li></ul><ul><li>Geriatric Consultant Resources LLC. http://www.gcrweb.com/OABdss/comprehensive/comp-02a-muscar.htm. Accessed March 25, 2011. </li></ul>
  15. 15. Likelihood of Muscarinic Agents Crossing the BBB <ul><li>Less-selective agents have been associated with more impairment of cognitive function 1 </li></ul><ul><li>Lipton RB, et al. J Urol . 2005;173:493-498. </li></ul><ul><li>Kay G, et al. Clin Ther. 2005;27:127-138. </li></ul><ul><li>VESIcare ® [package insert]. Deerfield, IL: Astellas Pharma US, Inc; 2011. </li></ul><ul><li>Geriatric Consultant Resources, LLC. http://www.gcrweb.com/OABdss/comprehensive/comp-02b-pham.htm. Accessed March 23, 2011. </li></ul>BBB= blood-brain barrier. * kDa=kiloDalton.
  16. 16. ENABLEX ® as a Treatment Option for Patients With Overactive Bladder Proven Efficacy and Safety by Clinical Trials
  17. 17. ENABLEX ® : Prescribing Information <ul><li>ENABLEX ® (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency </li></ul>ENABLEX ® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. Indication and Usage
  18. 18. ENABLEX ® : Prescribing Information <ul><li>ENABLEX ® (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency </li></ul><ul><li>ENABLEX ® (darifenacin) extended-release tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. ENABLEX ® is also contraindicated in patients with known hypersensitivity to the drug or any of its ingredients </li></ul>ENABLEX ® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. Indication and Usage Contraindications
  19. 19. ENABLEX ® : Prescribing Information <ul><li>ENABLEX ® (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency </li></ul><ul><li>ENABLEX ® (darifenacin) extended-release tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. ENABLEX ® is also contraindicated in patients with known hypersensitivity to the drug or any of its ingredients </li></ul>ENABLEX ® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. Indication and Usage Contraindications ENABLEX ® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention; gastrointestinal obstructive disorders because of the risk of gastric retention; severe constipation, ulcerative colitis, or myasthenia gravis. In patients being treated for narrow-angle glaucoma, ENABLEX ® should be used with caution and only where the potential benefits outweigh the risks. Angioedema of the face, lips, tongue, and/or larynx have been reported with darifenacin, in some cases, after the first dose. Angioedema associated with upper airway swelling may be life threatening. Patients should be advised to promptly discontinue darifenacin therapy and seek immediate medical attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing.
  20. 20. <ul><li>ENABLEX ® has been evaluated in 3 randomized, fixed-dose, placebo-controlled, multicenter, double-blind, 12-week studies and 1 randomized, double-blind, placebo-controlled, multicenter, dose-titration study </li></ul><ul><li>In clinical studies, dry mouth and constipation were the most commonly reported adverse events (AEs) </li></ul>ENABLEX ® : Prescribing Information ENABLEX ® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011.
  21. 21. ENABLEX ® : Effective Treatment for Overactive Bladder <ul><li>ENABLEX ® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. </li></ul><ul><li>Serra DB, et al . J Clin Pharmacol . 2005;45:1038-1047. </li></ul><ul><li>Haab F, et al. BJU Int. 2006;98:1025-1032. </li></ul>
  22. 22. ENABLEX ® Pooled Analysis of Phase 3 Studies Chapple C, et al. BJU Int. 2005;95:993-1001. 0 2 6 12 ENABLEX ® 7.5 mg Once Daily (n=337) Placebo Once Daily (n=388) Up to 4 weeks (as needed) Study Visits (weeks) Washout Treatments ENABLEX ® 15 mg Once Daily (n=334) Randomization Primary Efficacy Change in number of incontinence episodes per week Secondary Efficacy Number of significant leaks per week Voiding frequency Bladder capacity Frequency and severity of urgency Number of nocturnal awakenings caused by overactive bladder Subject population similar between treatment arms <ul><ul><li>Symptoms of overactive bladder ≥6 months </li></ul></ul>3 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Fixed-dose, 12-week Studies
  23. 23. 7.5 mg ENABLEX ® Significantly Reduces Incontinence Episodes by ~70% Chapple C, et al. BJU Int. 2005;95:993-1001. * P =.004 vs placebo; data missing for 2 subjects. Treatment Darifenacin 7.5 mg * Placebo Data from a pooled analysis of 3 phase 3, fixed-dose, double-blind, placebo-controlled, parallel-group, 12-week clinical trials (1001, 1002, 1041). A total of 1059 subjects were included in the analysis (darifenacin 7.5 mg: n=337; darifenacin 15 mg: n=334; placebo: n=388). Absolute changes from baseline (last observation carried forward [LOCF]) to Week 12 for subjects on darifenacin: number of weekly incontinence episodes: –8.8 (7.5 mg) and –10.6 (15 mg). n=335 n=271
  24. 24. 15 mg ENABLEX ® Significantly Reduces Incontinence Episodes by >75% Chapple C, et al. BJU Int. 2005;95:993-1001. * P <.001 vs placebo; data missing for 4 subjects. Treatment Darifenacin 15 mg * Placebo Data from a pooled analysis of 3 phase 3, fixed-dose, double-blind, placebo-controlled, parallel-group, 12-week clinical trials (1001, 1002, 1041). A total of 1059 subjects were included in the analysis (darifenacin 7.5 mg: n=337; darifenacin 15 mg: n=334; placebo: n=388). Absolute changes from baseline (last observation carried forward [LOCF]) to Week 12 for subjects on darifenacin: number of weekly incontinence episodes: –8.8 (7.5 mg) and –10.6 (15 mg). n=330 n=384
  25. 25. 7.5 mg ENABLEX ® Significantly Reduces the Number of Urgency Episodes Chapple C, et al. BJU Int. 2005;95:993-1001. * P <.005 compared with corresponding placebo. 37% 24%
  26. 26. 15 mg ENABLEX ® Significantly Reduces the Number of Urgency Episodes Chapple C, et al. BJU Int. 2005;95:993-1001. 39% 23% * P <.01 compared with corresponding placebo. * 49% 34% *
  27. 27. ENABLEX ® Is Well-tolerated <ul><li>UTI=urinary tract infection. </li></ul><ul><li>ENABLEX ® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. </li></ul><ul><li>Chapple C, et al. BJU Int. 2005;95:993-1001 . </li></ul>Treatment-emergent AEs (TEAEs) Over 1 Year 1,2
  28. 28. Few Discontinuations Over 12 Weeks Chapple C, et al. BJU Int. 2005;95:993-1001.
  29. 29. ENABLEX ® Long-term Efficacy Up to 2 Years Haab F, et al . BJU Int . 2006;98:1025-1032. Subjects recruited from 1 of 2 phase 3, randomized, double-blind, 12-week studies ENABLEX ® 7.5 mg Once Daily 12-week Studies Long-term Study (24 months) ENABLEX ® 15 mg Once Daily ENABLEX ® 7.5 mg for 2 Weeks Study 1 (n=526) ENABLEX ® 3.75, 7.5, 15 mg, and Placebo Study 2 (n=357) ENABLEX ® 7.5, 15 mg, and Placebo Multicenter, Long-term, Noncomparative, Open-label Study Primary Objective Assess long-term safety and tolerability Secondary Objective Evaluate long-term efficacy
  30. 30. ENABLEX ® Significantly Reduces Incontinence Episodes Up to 2 Years Treatment Duration (months) <ul><li>Haab F, et al . BJU Int . 2006;98:1025-1032. </li></ul><ul><li>Hill S, et al. Curr Med Res Opin . 2007;23:2697-2704. </li></ul>Results from an open-label, nonrandomized, multicenter, 2-year extension study . Subjects were enrolled from two 12-week, phase 3, double-blind, placebo-controlled pivotal trials 1,2 P <.001 vs pivotal study baseline n=667 n=598 n=541 n=495 n=464
  31. 31. Low Discontinuation Rates Through 2 Years <ul><li>Haab F, et al . BJU Int . 2006;98:1025-1032. </li></ul><ul><li>Haab F, et al. Eur Urol . 2004;45:420-429. </li></ul><ul><li>Steers W, et al. BJU Int. 2005;95:580-586. </li></ul>Most commonly reported TEAEs were similar to pivotal studies and included dry mouth, constipation, dyspepsia, and headache 1-3
  32. 32. Efficacy in Subjects on Previous Overactive Bladder Therapy PPBC=Patient Perception of Bladder Condition. Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674 . <ul><li>Subjects were ENABLEX ® -naïve and reported lack of sufficient effect and/or AEs on previous treatments with either oxybutynin or tolterodine </li></ul>2-3 weeks Screening/Washout Treatments (optional dose escalation after 2 weeks) Baseline 1 week 10 weeks 2 weeks Primary Efficacy Change in PPBC score from baseline to end of study Secondary Efficacy Micturition frequency Urgency Urge urinary incontinence episodes after 2, 6, and 12 weeks of treatment compared with baseline ENABLEX ® 7.5 mg Once Daily (n=180) ENABLEX ® 15 mg Once Daily (n=302) ENABLEX ® 7.5 mg Once Daily (n=497) Enrollment (n=500) 12-Week, Open-label, Single-arm, Multicenter Study
  33. 33. ENABLEX ® Significantly* Improves Patient -reported Bladder Control Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674 . Results of PPBC p <0.0001.
  34. 34. ENABLEX ® : Cognitive Function in Older Subjects Kay G, et al . Eur Urol . 2006;50:317-326. 0 1 2 3 Cognitive Function Tests (weeks) Washout Treatments Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, 3-week Study Primary Efficacy Effect on recent (delayed) memory using Name-Face Association Test at Week 3 Secondary Efficacy Recall on First-Last Name Association Test Misplaced Objects Test Delayed recall scores at weeks 1 and 2 Effects on immediate memory Visual attention Information processing Psychomotor/reaction time
  35. 35. ENABLEX ® : Memory Sparing * P <.05 vs placebo; † P <.05 vs ENABLEX ® (ANCOVA, adjusted for baseline score, age, and gender). ANCOVA=analysis of covariance. Kay G, et al . Eur Urol . 2006;50:317-326. <ul><li>No significant effects on memory </li></ul>® * † * †
  36. 36. ENABLEX ® : Effect on QT Interval QTcF=Fridericia-corrected QT interval. Serra DB, et al . J Clin Pharmacol . 2005;45:1038-1047. ENABLEX ® 15 mg Once Daily (n=47) Moxifloxacin 400 mg Once Daily (n=48) Treatment Period (Days 1-6) ENABLEX ® 75 mg Once Daily (n=46) Placebo Run-in (Day –1) Placebo (n=47) 7-Day, Single-center, Randomized, Parallel-group Study in Healthy Subjects Primary Efficacy Change from mean baseline in QTcF at T max Secondary Efficacy Mean change from baseline in QT/QTcF Maximum QT interval postdose change from baseline
  37. 37. ENABLEX ® : Minimal Effect on QT Interval <ul><li>No significant changes occurred when ENABLEX ® was given at 75 mg (10 times the starting dose) </li></ul>Serra DB, et al . J Clin Pharmacol . 2005;45:1038-1047. Change From Baseline in Mean QTcF at T max (ms) Placebo (n=44) – 2.6 ENABLEX ® 15 mg (n=46) – 2.6
  38. 38. ENABLEX ® Clinical Trial Data: Established Efficacy and Safety <ul><li>Chapple C, et al. BJU Int. 2005;95:993-1001 . </li></ul><ul><li>Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674 . </li></ul><ul><li>ENABLEX ® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. </li></ul><ul><li>Kay G, et al . Eur Urol . 2006;50:317-326. </li></ul><ul><li>Serra DB, et al . J Clin Pharmacol . 2005;45:1038-1047. </li></ul><ul><li>Haab F, et al . BJU Int . 2006;98:1025-1032. </li></ul><ul><li>Hill S, et al. Curr Med Res Opin . 2007;23:2697-2704. </li></ul>Efficacy <ul><ul><li>Significant reduction in number of incontinence and urgency episodes per week 1 </li></ul></ul><ul><ul><li>Overactive bladder symptoms significantly improved in subjects who were dissatisfied with prior antimuscarinic therapy 2 </li></ul></ul>Specificity <ul><ul><li>Strong affinity for M 3 receptors 3 </li></ul></ul><ul><ul><li>No significant effects on delayed or immediate recall memory in older subjects 4 </li></ul></ul><ul><ul><li>No significant change in QTcF 5 </li></ul></ul>Well Studied <ul><ul><li>2-year extension study demonstrated a favorable safety, tolerability, and efficacy profile 6,7 </li></ul></ul><ul><ul><li>In subjects ≥65 years of age, ENABLEX ® was well tolerated; no overall differences in safety or efficacy were observed 3,7 </li></ul></ul>
  39. 39. ENABLEX ® as a Treatment Option for Patients With Overactive Bladder Case Studies
  40. 40. Amy S. <ul><li>52-year-old woman with overactive bladder </li></ul><ul><li>Active lifestyle </li></ul><ul><li>Overactive bladder treatment-naive </li></ul>Case Study 1 Case studies are illustrative examples and not based on actual patient records.
  41. 41. Amy S. <ul><li>52-year-old, teacher, mother of 4 </li></ul><ul><li>Active lifestyle (skis, golfs) </li></ul><ul><li>Tried Kegel exercises </li></ul><ul><li>No other significant medical history </li></ul><ul><ul><li>Meds: statin, NSAIDs </li></ul></ul><ul><li>CC: Strong urge to urinate during the day </li></ul><ul><ul><li>Every 30 minutes </li></ul></ul>Medical History
  42. 42. Amy S. (cont’d) Medical History <ul><li>No incontinence with coughing, sneezing, laughing, or exercise unless bladder is full </li></ul><ul><li>Overactive bladder increasingly difficult to control </li></ul><ul><ul><li>Accidents have hindered activities </li></ul></ul><ul><li>No history of previous overactive bladder medication use </li></ul><ul><ul><li>Embarrassed by her overactive bladder symptoms </li></ul></ul><ul><li>Desires a safe and effective treatment </li></ul>
  43. 43. Assessment <ul><li>Amy S. is a 52-year-old woman with an active lifestyle </li></ul><ul><li>Based on history and symptoms, you agree with the diagnosis of overactive bladder </li></ul><ul><li>You perform a physical exam and order routine tests to rule out other causes </li></ul>
  44. 44. Treatment Plan After considering Amy’s medical history, how would you manage her overactive bladder?
  45. 45. Treatment Plan Chapple C, et al. BJU Int. 2005;95:993-1001 . <ul><li>After considering Amy’s medical history, how would you manage her overactive bladder? </li></ul><ul><li>ENABLEX ® as an Option </li></ul><ul><li>In clinical studies, ENABLEX ® has demonstrated significant reductions in incontinence and urgency episodes </li></ul>
  46. 46. Treatment Plan <ul><li>Chapple C, et al. BJU Int. 2005;95:993-1001 . </li></ul><ul><li>Serra DB, et al . J Clin Pharmacol . 2005;45:1038-1047. </li></ul><ul><li>After considering Amy’s medical history, how would you manage her overactive bladder? </li></ul><ul><li>ENABLEX ® as an Option </li></ul><ul><li>In clinical studies, ENABLEX ® has demonstrated significant reductions in incontinence and urgency episodes 1 </li></ul><ul><li>Discontinuation rates from 3 phase 3 studies were minimal 1,2 </li></ul>
  47. 47. George R. <ul><li>69-year-old man </li></ul><ul><li>Dissatisfied with current overactive bladder therapy </li></ul><ul><li>Considering changing medication for overactive bladder </li></ul>Case Study 2 Case studies are illustrative examples and not based on actual patient records.
  48. 48. George R. <ul><li>69-year-old retired businessman </li></ul><ul><li>Overactive bladder diagnosed </li></ul><ul><li>6 years ago </li></ul><ul><li>Reluctant to change overactive bladder medication because the first one failed </li></ul><ul><li>CC: Despite treatment, patient complains of strong and frequent urges to void </li></ul>Medical History
  49. 49. George R. (cont’d) <ul><li>Medications </li></ul><ul><ul><li>ACE inhibitor </li></ul></ul><ul><ul><li>Oral hypoglycemic </li></ul></ul><ul><li>Concerned that switching treatments may have potential side effects and not provide further symptom relief </li></ul><ul><li>Seeks an alternative treatment that is safe, effective, and can be used longterm </li></ul>Medical History
  50. 50. Assessment <ul><li>George R. is a 69-year-old man requesting treatment for his symptoms </li></ul><ul><li>Based on history and symptoms, you agree with the diagnosis of overactive bladder </li></ul><ul><li>Perform a physical exam , including prostate exam, and order routine tests, to rule out other causes </li></ul>
  51. 51. Treatment Plan After considering George’s medical history and chief complaint of strong and frequent urges to urinate, how would you manage his overactive bladder?
  52. 52. Treatment Plan <ul><li>Chughtai B, et al. Clin Interv Aging. 2008;3:503-509. </li></ul><ul><li>After considering George’s medical history and chief complaint of strong and frequent urges to urinate, how would you manage his overactive bladder? </li></ul><ul><li>ENABLEX ® as an Option </li></ul><ul><li>Antimuscarinics are currently the treatment of choice in elderly patients with overactive bladder 1 </li></ul>
  53. 53. Treatment Plan <ul><li>Chughtai B, et al. Clin Interv Aging. 2008;3:503-509. </li></ul><ul><li>Zinner N, et al. Int J Clin Pract . 2008;62:1664-1674 . </li></ul><ul><li>After considering George’s medical history and chief complaint of strong and frequent urges to urinate, how would you manage his overactive bladder? </li></ul><ul><li>ENABLEX ® as an Option </li></ul><ul><li>Antimuscarinics are currently the treatment of choice in elderly patients with overactive bladder 1 </li></ul><ul><li>Significant improvements in PPBC scores at week 12 in patients switching from other overactive bladder treatments 2 </li></ul>
  54. 54. Treatment Plan <ul><li>Chughtai B, et al. Clin Interv Aging. 2008;3:503-509. 2. Zinner N, et al. Int J Clin Pract . 2008;62:1664-1674 . 3. Lipton RB, et al. J Urol . 2005;173:493-498 . 4. Kay G, et al. Eur Urol. 2006;50:317-326. </li></ul><ul><li>After considering George’s medical history and chief complaint of strong and frequent urges to urinate, how would you manage his overactive bladder? </li></ul><ul><li>ENABLEX ® as an Option </li></ul><ul><li>Antimuscarinics are currently the treatment of choice in elderly patients with overactive bladder 1 </li></ul><ul><li>Significant improvements in PPBC scores at week 12 in patients switching from other overactive bladder treatments 2 </li></ul><ul><li>High M 3 specificity with no significant effect on memory 3,4 </li></ul>
  55. 55. Treatment Plan 1. Chughtai_B, et al. Clin Interventions Aging. 2008; 3:503-509. 2. Zinner N, et al. Int J Clin Pract . 2008;62:1664-1674 . 3. Lipton RB, et al. J Urol . 2005;173:493-498. 4. Kay G, et al. Eur Urol. 2006;50:317-326. 5. Haab F, et al . BJU Int . 2006;98:1025-1032. 6. Hill S, et al. Curr Med Res Opin . 2007;23:2697-2704. 7. Steers W, et al. BJU Int. 2005;95:580-586. <ul><li>After considering George’s medical history and chief complaint of strong and frequent urges to urinate, how would you manage his overactive bladder? </li></ul><ul><li>ENABLEX ® as an Option </li></ul><ul><li>Antimuscarinics are currently the treatment of choice in elderly patients with overactive bladder 1 </li></ul><ul><li>Significant improvements in PPBC scores at week 12 in patients switching from other overactive bladder treatments 2 </li></ul><ul><li>High M 3 specificity with no significant effect on memory 3,4 </li></ul><ul><li>Consistent efficacy and safety in 12-week pivotal studies and a 2-year extension study 5-7 </li></ul>
  56. 56. Joanne J. <ul><li>78-year-old woman </li></ul><ul><li>Worried about side effects of overactive bladder treatment </li></ul><ul><li>History of memory loss </li></ul>Case Study 3 Case studies are illustrative examples and not based on actual patient records.
  57. 57. Joanne J. <ul><li>78-year-old retired waitress with dementia </li></ul><ul><ul><li>Lives with daughter </li></ul></ul><ul><li>Overactive bladder for >15 years </li></ul><ul><li>CC: Incontinence limiting her activity </li></ul><ul><li>Concerned that overactive bladder medications can further compromise her memory </li></ul>Medical History
  58. 58. Joanne J. (cont’d) <ul><li>Medications: </li></ul><ul><ul><li>ACE inhibitor </li></ul></ul><ul><ul><li>Cardioselective beta blocker </li></ul></ul><ul><ul><li>Antihyperlipidemic </li></ul></ul><ul><li>Wants to decrease her frequent accidents and subsequent burden on family </li></ul>Medical History
  59. 59. Assessment <ul><li>Joanne J. is a 78-year-old woman with history of memory loss who presents with her caretaker (daughter) requesting alternative treatment for her overactive bladder symptoms </li></ul><ul><li>Based on history and symptoms, you agree with the diagnosis of overactive bladder </li></ul><ul><li>You perform a physical exam and order routine tests, including a urine analysis, to rule out other causes </li></ul>
  60. 60. Treatment Plan After reviewing Joanne’s history and treatment concerns, how would you manage her overactive bladder?
  61. 61. Treatment Plan <ul><li>Chapple C, et al. BJU Int. 2005;95:993-1001. </li></ul><ul><li>After reviewing Joanne’s history and treatment concerns, how would you manage her overactive bladder? </li></ul><ul><li>ENABLEX ® as an Option </li></ul><ul><li>As bladder contractions are mediated primarily by </li></ul><ul><li>M 3 receptors, antimuscarinics with high M 3 specificity </li></ul><ul><li>are ideal for patients with overactive bladder 1 </li></ul>
  62. 62. Treatment Plan 1. Chapple C, et al. BJU Int. 2005;95:993-1001. 2. Kay G, et al . Eur Urol . 2006;50:317-326. 3. Serra DB, et al . J Clin Pharmacol . 2005;45:1038-1047 . <ul><li>After reviewing Joanne’s history and treatment concerns, how would you manage her overactive bladder? </li></ul><ul><li>ENABLEX ® as an Option </li></ul><ul><li>As bladder contractions are mediated primarily by </li></ul><ul><li>M 3 receptors, antimuscarinics with high M 3 specificity </li></ul><ul><li>are ideal for patients with overactive bladder 1 </li></ul><ul><li>This is particularly important in elderly patients, who are more vulnerable to potential CNS and other safety concerns 2,3 </li></ul>
  63. 63. ENABLEX ® Treatment in a Wide Range of Patients With Overactive Bladder Summary
  64. 64. ENABLEX ® : Effective Treatment for Overactive Bladder Patients 1. Chapple C, et al. BJU Int. 2005;95:993-1001. 2. Zinner N, et al. Int J Clin Pract. 2008;62:1664-1674 . 3. ENABLEX ® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011. 4. Kay G, et al . Eur Urol . 2006;50:317-326. 5. Serra DB, et al . J Clin Pharmacol . 2005;45:1038-1047. 6. Haab F, et al . BJU Int. 2006;98:1025-1032. 7. Hill S, et al. Curr Med Res Opin . 2007;23:2697-2704.
  65. 65. ENABLEX ® : Overactive Bladder Treatment for a Wide Range of Patients <ul><li>First-line therapy for the active 52-year-old woman </li></ul><ul><ul><li>Significant reductions in incontinence and urgency episodes </li></ul></ul><ul><ul><li>Minimal discontinuation rates </li></ul></ul><ul><li>Treatment for the 69-year-old man who was dissatisfied with </li></ul><ul><li>previous therapy </li></ul><ul><ul><li>Significant improvements in PPBC in patients switching from other overactive bladder therapies </li></ul></ul><ul><ul><li>Consistent efficacy and safety in 12-week pivotal studies and a 2-year </li></ul></ul><ul><ul><li>extension study </li></ul></ul><ul><li>Therapy for the 78-year-old woman with safety concerns </li></ul><ul><ul><li>High M 3 selectivity </li></ul></ul><ul><ul><li>Low risk of memory deterioration and other AEs </li></ul></ul><ul><li>Who is your patient? </li></ul>
  66. 66. ENABLEX ® : Important Safety Information <ul><li>ENABLEX ® (darifenacin) extended-release tablets is contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions. ENABLEX ® is also contraindicated in patients with known hypersensitivity to the drug or any of its ingredients. </li></ul><ul><li>Daily dose should not exceed 7.5 mg when used with potent CYP3A4 inhibitors or in patients with moderate hepatic impairment. ENABLEX ® is not recommended for patients with severe hepatic impairment. </li></ul><ul><li>ENABLEX ® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention; gastrointestinal obstructive disorders because of the risk of gastric retention; severe constipation, ulcerative colitis, or myasthenia gravis. In patients being treated for narrow-angle glaucoma, ENABLEX ® should be used with caution and only where the potential benefits outweigh the risks. </li></ul><ul><li>Angioedema of the face, lips, tongue, and/or larynx have been reported with darifenacin, in some cases after the first dose. Angioedema associated with upper airway swelling may be life threatening. Patients should be advised to promptly discontinue darifenacin therapy and seek immediate medical attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing. </li></ul><ul><li>In controlled clinical studies the incidence of the most frequently reported adverse events for ENABLEX ® 7.5 mg or 15 mg and greater than placebo was: dry mouth (20.2%, 35.3%, 8.2%); constipation (14.8%, 21.3%, 6.2%); dyspepsia (2.7%, 8.4%, 2.6%); abdominal pain (2.4%, 3.9%, 0.5%); nausea (2.7%, 1.5%, 1.5%); diarrhea (2.1%, 0.9%, 1.8%); urinary tract infection (4.7%, 4.5%, 2.6%); dizziness (0.9%, 2.1%, 1.3%); asthenia (1.5%, 2.7%, 1.3%); and dry eyes (1.5%, 2.1%, 0.5%). </li></ul><ul><li>Please see full Prescribing Information for ENABLEX ® at www.enablex.com. </li></ul>ENABLEX ® [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC; 2011.

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