Franklin Sun

Pfizer Inc., New York City, New York, United States

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Publications (13)40.55 Total impact

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    ABSTRACT: To determine clinical and demographic characteristics associated with antimuscarinic treatment response using a regression model. Adults with overactive bladder (OAB) symptoms for >3 months and ≥1 urgency urinary incontinence (UUI) episode and ≥8 micturitions per 24 hours at baseline were randomized to fesoterodine (8 mg), tolterodine extended-release (4 mg), or placebo in two 12-week, double-blind, head-to-head studies. Fesoterodine-treated patients received 4 mg/d during the first week and 8 mg/d thereafter. Patients completed 3-day bladder diaries and the Overactive Bladder Questionnaire at baseline and week 12. Pooled data for changes from baseline to week 12 in winsorized UUI episodes, micturitions, and urgency episodes per 24 hours and Overactive Bladder Questionnaire Symptom Bother and health-related quality of life scores were analyzed posthoc using a regression model that selects outcome predictors from baseline values and patient characteristics while retaining baseline values and treatment, with stepwise inclusion of significant covariates and assessment of treatment interactions. Logistic regression was used for analysis of diary-dry rates. Younger age, lack of previous antimuscarinic treatment, shorter duration of OAB diagnosis, and female gender were common predictors of larger changes in outcomes from baseline to week 12. Baseline measures often interacted with treatment, such that poorer baseline outcomes were predictive of larger treatment differences. Longer duration since OAB diagnosis predicted greater treatment differences for UUI episodes and in diary-dry rate, and increased age predicted greater treatment differences for micturitions. Symptom severity and duration, age, gender, and previous antimuscarinic pharmacotherapy impact the response to antimuscarinic treatment.
    Urology 02/2014; · 2.42 Impact Factor
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    ABSTRACT: We evaluated the efficacy and safety of flexible-dose fesoterodine in medically complex vulnerable elderly subjects with urgency urinary incontinence (UUI). This was a 12-week, randomized, double-blind, flexible-dose, placebo-controlled trial. Subjects were community-dwelling men and women aged ≤65 years with scores ≤3 on the Vulnerable Elders Survey and ≤20 on the Mini-Mental State Examination and 2-15 UUI episodes and ≤8 micturitions/24 hours on 3-day baseline diaries. Subjects randomized to fesoterodine received 4 mg once daily for 4 weeks and could then escalate to 8 mg based on discussion with the investigator. Subjects receiving 8 mg could de-escalate to 4 mg at any time (sham escalation and de-escalation for placebo). Primary outcome measure was change in daily UUI episodes; secondary outcomes included changes in other diary variables and patient-reported quality of life measures. Safety evaluations included self-reported symptoms and postvoiding residual volume. 562 patients were randomized (mean age, 75 years; 50.4% aged ≤75 years). Subjects had high rates of comorbidities, polypharmacy, and functional impairment. At week 12, the fesoterodine group had significantly greater improvements in UUI episodes/24 hours (-2.84 vs -2.20; P=0.002) and most other diary variables and quality of life, and higher diary-dry rate (50.8% vs 36.0%; P=0.002). Adverse effects were generally similar to younger populations, including urinary retention risk. This is the first antimuscarinic study in community-based, significantly older, medically complex elderly patients with UUI. Flexible-dose fesoterodine significantly improved UUI episodes and other outcomes versus placebo and was generally well tolerated.
    The Journal of urology 08/2013; · 4.02 Impact Factor
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    ABSTRACT: We analyzed the effects of baseline symptom severity and placebo response magnitude on the decision to dose escalate in a 12-week, randomized, double-blind, flexible dose antimuscarinic trial of subjects with overactive bladder symptoms. Data from the placebo arm of the trial were used for this post hoc analysis. Subjects could elect dose escalation at week 2. Those in the placebo arm received sham escalation. Most placebo treated subjects who continued to week 2 elected dose escalation (75% or 325 of 435). Overactive bladder symptoms at baseline were similar between placebo escalators and nonescalators. Nonescalators showed a significantly larger placebo response than escalators, as measured by improvements in bladder diary end points and patient reported outcomes, and by the incidence rate of adverse events before and after sham escalation. These findings suggest that the decision to dose escalate among placebo treated subjects is independent of baseline symptom severity but may be influenced by the placebo response magnitude for efficacy assessment and adverse events. Placebo nonescalators showed a rapid, large placebo response while placebo escalators showed a smaller placebo response even after sham escalation. These observations may have important implications for the design and interpretation of flexible dose trials using a placebo control.
    The Journal of urology 03/2012; 187(5):1721-6. · 4.02 Impact Factor
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    ABSTRACT: Study Type - Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Male lower urinary tract symptoms are often attributed to bladder outlet obstruction secondary to benign prostatic hyperplasia and treated with drugs targeting the prostate. However, many men with storage lower urinary tract symptoms may not respond adequately to these agents. Antimuscarinics, with or without an α-blocker, may be effective for the treatment of the storage symptoms of overactive bladder in some men. Flexible-dose fesoterodine as an add-on treatment significantly improved urinary frequency and symptom bother, but not urgency episodes (primary endpoint), versus add-on placebo and was well tolerated in men with persistent overactive bladder symptoms despite receiving α-blocker. • To evaluate flexible-dose fesoterodine vs placebo in men with persistent overactive bladder (OAB) symptoms despite receiving α-blocker treatment • This was a double-blind, 12-week, flexible-dose trial. • Men with persistent storage symptoms (≥ 8 micturitions and ≥ 3 urgency episodes per 24 h) after receiving an α-blocker for ≥ 6 weeks were randomized to add-on fesoterodine 4 mg or placebo, with optional dose escalation to 8 mg at week 4 and reduction back to 4 mg at week 8 (or matching placebo adjustments). • Subjects completed 3-day diaries, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) at baseline and weeks 4 and 12. • A total of 943 men were randomized and received at least one dose of study treatment (fesoterodine, n= 471; placebo, n= 472). • Among these, 251 (53%) in the fesoterodine group and 300 (64%) in the placebo group requested dose escalation at week 4 and 35 (7%) and 15 (3%) requested dose reduction at week 8. Changes from baseline to week 12 in urgency episodes (primary endpoint) in the fesoterodine (-3.2) and placebo (-2.9) groups were not significantly different (P= 0.196), but improvements in micturitions (P= 0.009) and OAB-q symptom bother score (P= 0.007) were significantly greater with fesoterodine. • At week 4, significantly greater improvements in micturitions (P= 0.006), severe urgency episodes (P= 0.006), IPSS storage score (P= 0.022), OAB-q symptom bother score (P= 0.004), and OAB-q health-related quality of life (P= 0.041), but not urgency episodes (P= 0.062), were observed with add-on fesoterodine. • Dry mouth (fesoterodine, 21%; placebo, 6%) and constipation (fesoterodine, 6%; placebo, 2%) were the most common adverse events. Dysuria and urinary retention were reported by 3% and 2% of subjects, respectively, in the fesoterodine add-on group vs 1% and <1% of subjects, respectively in the placebo add-on group. One subject in each group had acute urinary retention requiring catheterization. • Flexible-dose fesoterodine was well tolerated as an add-on treatment in men with persistent storage symptoms. • Changes in urgency episodes at week 12 (primary endpoint) and many secondary endpoints were not significantly different between fesoterodine and placebo add-on treatment; however, improvements in frequency and symptom bother were significantly greater with fesoterodine. • These data suggest that there remains a limited understanding of the optimal evaluation and treatment of men with LUTS.
    BJU International 10/2011; 109(12):1831-40. · 3.05 Impact Factor
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    ABSTRACT: To characterize the response to fesoterodine treatment for overactive bladder (OAB) in subjects who did or did not choose to dose escalate in a flexible-dose study. Subjects were randomized to fesoterodine 4  mg or placebo. At week 2, subjects could remain on 4  mg (non-escalators) or choose to increase to 8  mg (escalators) for the remaining 10 weeks (sham escalation for placebo). Subjects completed 3-day bladder diaries at baseline, week 2 and week 12 noting micturitions, urgency episodes, and urgency urinary incontinence (UUI) episodes. Sixty-three per cent of 438 subjects randomized to fesoterodine and 73% of 445 randomized to placebo dose escalated. At baseline, fesoterodine escalators had significantly more micturitions and urgency episodes than fesoterodine non-escalators (P < 0.001); at week 2, before dose escalation, diary-dry rate and improvement in micturitions and urgency episodes were significantly greater among fesoterodine non-escalators versus escalators (P < 0.001); and by week 12, after dose escalation, diary-dry rate and improvements in micturitions and UUI episodes were similar between fesoterodine non-escalators and escalators (P > 0.05). The placebo escalator group did not demonstrate a similar response over placebo non-escalators following the dose escalation decision point. A rapid and robust response to fesoterodine 4  mg was demonstrated in non-escalators. Subjects who chose to dose escalate to fesoterodine 8  mg at week 2 showed significant improvement by week 12 versus baseline and week 2 (prior to escalation), as well as versus placebo. Dose escalation to 8  mg fesoterodine provided subjects with efficacy and tolerability similar to those who were satisfied with the 4-mg dose.
    Neurourology and Urodynamics 05/2011; 30(8):1480-5. · 2.67 Impact Factor
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    ABSTRACT: To assess the effects of tolterodine extended release (ER) plus behavioral intervention on urgency and other patient-reported outcomes in subjects with overactive bladder (OAB) who were previously dissatisfied with antimuscarinic treatment. In this 16-week, multicenter, open-label study, eligible adults (aged > or = 18 y) reported dissatisfaction with their most recent antimuscarinic OAB medication; > or = 8 micturitions and > or = 2 urgency episodes per 24 hours and > or = 1 UUI episode in 5 day bladder diaries; and OAB symptoms for > or = 3 months. Subjects received tolterodine ER plus a behavioral educational handout with verbal reinforcement of behavioral intervention content for 8 weeks. Those satisfied with treatment at week 8 continued with this therapy; those dissatisfied received tolterodine ER plus individualized behavioral intervention (pelvic floor muscle training, tailored behavioral techniques) for 8 weeks. Endpoints were changes from baseline in daytime and nocturnal micturition-related urgency episodes and frequency-urgency sum (a measure of urgency severity and frequency) reported in 5 day bladder diaries at weeks 4, 8, 12, and 16; Patient Perception of Bladder Condition (PPBC), Overactive Bladder Questionnaire (OAB-q), and Urgency Perception Scale (UPS) scores at weeks 8 and 16. Daytime and nocturnal urgency episodes and frequency-urgency sum were significantly reduced at all time points (all p < 0.0001). Significant improvements were also observed in PPBC, OAB-q Symptom Bother and Health-Related Quality of Life, and UPS scores at weeks 8 and 16 (all p < 0.0001). Patients with OAB who are dissatisfied with antimuscarinic therapy may experience improved treatment outcomes by adding a self-administered behavioral intervention to their drug regimen.
    The Canadian Journal of Urology 08/2010; 17(4):5283-90. · 0.74 Impact Factor
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    ABSTRACT: To evaluate the efficacy and tolerability of flexible-dose fesoterodine vs placebo in subjects with overactive bladder (OAB). In a 12-week double-blind trial, subjects were randomized to fesoterodine 4 mg or placebo once daily, taken within 4 hours of bedtime. At week 2, subjects could increase the fesoterodine dose to 8 mg (sham escalation for placebo). Subjects completed 3-day bladder diaries, Patient Perception of Bladder Condition, and Urgency Perception Scale at baseline and weeks 2, 6, and 12 as well as OAB Questionnaire at baseline and week 12. Of 883 subjects, 63% and 73% of the fesoterodine (n = 438) and placebo (n = 445) groups, respectively, opted for dose escalation. Week 12 improvements from baseline in total micturitions, urgency episodes, urgency urinary incontinence episodes, frequency-urgency sum, and all OAB Questionnaire scales and domains, but not nocturnal micturitions or nocturnal urgency episodes, were significantly greater with fesoterodine than placebo (all P <.05). Treatment differences in micturitions and frequency-urgency sum were significant by week 2 and in urgency urinary incontinence and urgency episodes by week 6. Significantly greater percentages of subjects taking fesoterodine had improved Patient Perception of Bladder Condition and Urgency Perception Scale scores at weeks 2, 6, and 12 (P <.05). Dry mouth (fesoterodine, 26%; placebo, 8%) and constipation (fesoterodine, 11%; placebo, 6%) were the most common adverse events. In both groups, 87% of the subjects completed the trial; 8% and 5% of the fesoterodine and placebo groups, respectively, discontinued because of an adverse event. Flexible-dose fesoterodine was efficacious and generally well tolerated for treatment of OAB symptoms.
    Urology 11/2009; 75(1):62-8. · 2.42 Impact Factor
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    ABSTRACT: To assess the effects of tolterodine extended release (ER) on patient-reported outcomes (PROs) in sexually active women with overactive bladder (OAB) and urgency urinary incontinence (UUI). This multicenter, double-blind, placebo controlled trial included 411 women aged > or =18 years reporting OAB symptoms for > or =3 months; > or =8 micturitions per 24 hours (including > or =0.6 UUI episodes and > or =3 OAB micturitions) in 5-day bladder diaries at baseline, and being in a sexually active relationship for > or =6 months. Subjects randomized to placebo or tolterodine ER completed validated OAB- or incontinence-specific questionnaires, including the Patient Perception of Bladder Condition (PPBC), Overactive Bladder Questionnaire (OAB-q), Urgency Perception Scale (UPS), and the Incontinence Impact Questionnaire (IIQ) at baseline and week 12, as well as the Perception of Treatment Benefit and Treatment Satisfaction questions at week 12. This study is registered with ClinicalTrials.Gov (identifier: NCT00143481). The mean age of enrolled women was approximately 48 years. Compared with placebo, the tolterodine ER group reported significant baseline to week 12 improvements in PPBC responses (p = 0.0048); OAB-q Symptom Bother, total Health-Related Quality of Life (HRQL), and HRQL domain scores (all p < 0.05); IIQ Emotional Health domain scores (p < 0.05); proportions of subjects reporting treatment benefit (79 vs. 54%; p < 0.0001) and satisfaction (78 vs. 59%; p < 0.0001). Improvements on the UPS were not significantly different. Tolterodine ER treatment was associated with improvements in multiple OAB- and incontinence-specific PROs in a sexually active, relatively young, and racially diverse population of women. The findings provide clinicians with new insights into the impact of OAB and its treatment on HRQL in this population, which has been underrepresented in previous OAB studies. Study limitations include a potential underestimation of the impact of OAB symptoms resulting from the exclusion of women who may not be sexually active because of their urinary symptoms.
    Current Medical Research and Opinion 07/2009; 25(9):2159-65. · 2.37 Impact Factor
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    ABSTRACT: We assessed the effect of tolterodine extended release plus behavioral intervention on treatment satisfaction and bladder diary variables in patients with overactive bladder who had been previously treated and were dissatisfied with tolterodine or other antimuscarinics. This 16-week, multicenter, open label study included eligible patients 18 years old or older who reported overactive bladder symptoms 3 months or greater in duration, 8 or greater micturitions and 2 or greater urgency related micturitions per 24 hours, and 1 or greater urgency urinary incontinence episodes in a 5-day bladder diary at baseline as well as dissatisfaction with prior antimuscarinic medication. Patients received tolterodine extended release plus self-administered behavioral intervention, consisting of an educational pamphlet with verbal reinforcement, for 8 weeks. Satisfied patients continued with this therapy and dissatisfied patients received tolterodine extended release plus individualized behavioral intervention, consisting of in-depth interaction with a clinician to refine behavioral techniques, for 8 weeks thereafter. Patients rated treatment satisfaction at weeks 8 and 16, and completed a 5-day bladder diary at weeks 4, 8, 12 and 16, respectively. At weeks 8 and 16, 346 and 357 patients or 91% of the total cohort reported being at least a little satisfied with tolterodine extended release plus behavioral intervention, including 201 (53%) and 252 (64%), respectively, who were very satisfied. Of the 33 patients who were dissatisfied at week 8, 25 (76%) reported treatment satisfaction at week 16 after individualized behavioral intervention. Compared with baseline all bladder diary variables were significantly improved by week 4 (p <0.0001). Patients who were dissatisfied with prior tolterodine or other antimuscarinic treatment reported similar results. Tolterodine extended release plus behavioral intervention resulted in high treatment satisfaction and improved bladder diary variables in patients who had previously been treated and were dissatisfied with tolterodine or other antimuscarinics.
    The Journal of urology 04/2009; 181(6):2599-607. · 4.02 Impact Factor
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    ABSTRACT: Improvements in overactive bladder (OAB) symptoms and health-related quality of life (HRQL) were assessed during a 24-week study of tolterodine extended release (TOL ER) in sexually active women with OAB and urgency urinary incontinence (UUI). A 12-week, double-blind, randomized, placebo-controlled trial was followed by a 12-week open-label phase. Sexually active women reported symptoms for >or=3 months. Subjects completed bladder diaries and HRQL measures at baseline and weeks 12 and 24. One hundred sixty-one women received TOL ER for 24 weeks. Women reported significant improvements in all end points at week 12 that were maintained or improved at 24 weeks. At week 24, 70% of subjects reported no UUI episodes. TOL ER resulted in improvements in OAB symptoms and HRQL that were maintained or greater with 6 months of use. Long-term compliance with OAB pharmacotherapy may be important for optimal treatment outcomes.
    International Urogynecology Journal 02/2009; 20(4):381-5. · 2.17 Impact Factor
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    ABSTRACT: Some men receiving alpha-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder (OAB). To evaluate the efficacy of tolterodine extended release (ER) in men on alpha-blocker therapy. This double-blind trial included men aged > or = 40 yr with frequency, urgency, and at least moderate problems reported on the Patient Perception of Bladder Condition (PPBC), despite being on a stable dose of alpha-blocker for > or = 1 mo. Subjects were randomized to tolterodine ER 4 mg per day or placebo for 12 wk while continuing their prescribed alpha-blocker therapy. At baseline and week 12, subjects completed the PPBC, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), and 5-d bladder diaries using the five-point Urinary Sensation Scale (USS). Frequency-urgency sum was defined as the sum of USS ratings for all micturitions. PPBC improvement from baseline to week 12 was reported by 63.6% and 61.6% of subjects receiving tolterodine ER plus alpha-blocker and placebo plus alpha-blocker, respectively; this treatment difference, which was the primary end point, was not statistically significant (p>0.6699). At week 12, subjects receiving tolterodine ER plus alpha-blocker had significantly greater improvements versus placebo plus alpha-blocker in 24-h micturitions (-1.8 vs -1.2; p=0.0079) and daytime micturitions (-1.3 vs -0.8; p=0.0123); 24-h urgency episodes (-2.9 vs -1.8; p=0.0010), daytime urgency episodes (-2.2 vs -1.4; p=0.0017), and nocturnal urgency episodes (-0.5 vs -0.3; p=0.0378); frequency-urgency sum (-7.8 vs -5.1; p=0.0065); IPSS storage subscale (-2.6 vs -2.1; p=0.0370); and OAB-q symptom bother scale (-17.9 vs -14.4; p=0.0086) and coping domain (15.4 vs 12.4; p=0.0491). Acute urinary retention requiring catheterization occurred in < 1% of either group. There were no clinically meaningful changes in postvoid residual volume or maximum urinary flow rate. Men with bothersome OAB symptoms despite continued alpha-blocker therapy showed significantly greater improvements in diary variables, IPSS Storage scores, and symptom bother when receiving additional tolterodine ER versus placebo plus alpha-blocker.
    European Urology 11/2008; 56(3):534-41. · 10.48 Impact Factor
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    ABSTRACT: We evaluated overactive bladder (OAB) symptoms and sexual and emotional health in sexually active women with OAB/urgency urinary incontinence (UUI) treated with tolterodine extended release (ER). Sexually active women with OAB symptoms were randomized to placebo or tolterodine ER. Five-day bladder diaries, Sexual Quality of Life Questionnaire-Female (SQOL-F), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), and Hospital Anxiety and Depression Scale (HAD) were completed at baseline and week 12. Tolterodine ER (n = 201; mean +/- SD age, 49 +/- 12 years) reduced UUI episodes (P = 0.0029), total (P = 0.0006) and OAB (P < 0.0001) micturitions, and pad use per 24 h (P = 0.0024), and was associated with improvements in SQOL-F (P = 0.004), PISQ total (P = 0.009), and HAD Anxiety (P = 0.03) scores versus placebo (n = 210; mean +/- SD age, 47 +/- 12 years). OAB symptoms improved with tolterodine ER as did the scores of sexual health and anxiety measures in sexually active women with OAB.
    International Urogynecology Journal 08/2008; 19(11):1551-7. · 2.17 Impact Factor
  • Journal of Urology - J UROL. 01/2008; 179(4):443-443.

Publication Stats

176 Citations
40.55 Total Impact Points

Institutions

  • 2008–2014
    • Pfizer Inc.
      New York City, New York, United States
    • Sheffield Teaching Hospitals NHS Foundation Trust
      Sheffield, England, United Kingdom
    • University of New Mexico
      • Department of Obstetrics & Gynecology
      Albuquerque, NM, United States
  • 2013
    • University of Massachusetts Medical School
      Worcester, Massachusetts, United States
  • 2011
    • Weill Cornell Medical College
      • Department of Urology
      New York City, New York, United States
  • 2010
    • University of Minnesota Twin Cities
      • School of Nursing
      Minneapolis, MN, United States
  • 2009
    • University of Washington Seattle
      • Department of Surgery
      Seattle, WA, United States