Decision Analysis of Long-Term Use of Extended Release Antimuscarinic Therapy for Overactive Bladder Disorder - PowerPoint PPT Presentation

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Decision Analysis of Long-Term Use of Extended Release Antimuscarinic Therapy for Overactive Bladder Disorder

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Minimal clinically important change (MCIC) defined as reduction of 3 incontinence episodes/week ... change in # of incontinence episodes/week from baseline ... – PowerPoint PPT presentation

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Title: Decision Analysis of Long-Term Use of Extended Release Antimuscarinic Therapy for Overactive Bladder Disorder


1
Decision Analysis of Long-Term Use of Extended
Release Antimuscarinic Therapy for Overactive
Bladder Disorder
  • Carolyn M. Smith, PharmD, MBA

2
Background
  • Definition of overactive bladder (OAB)
  • Frequency gt 8 micturations/day
  • Nocturia gt 2 micturations/night
  • Urgency
  • /- Incontinence
  • Issues with current therapy
  • Adverse effects
  • Efficacy

International Continence Society.
www.ICSoffice.org Accessed 4/14/07 DiPiro, et al.
Chapter 83. Urinary Incontinence. 6th edition.
2006. pp 1547-63. Pharmacotherapy.
200626(12)1694-1702.
3
Rationale for Investigation
  • OAB affects 1 in 5 adults gt 40 yo
  • Has been shown to have a negative impact on
    quality of life
  • No one medication has been found to be most
    effective, or declared first line therapy
  • Significant complications associated with OAB
  • Cost to society in 2000 13 Billion
  • Pharmacotherapy. 200626(12)1694-1702.
  • World J Urol. 200320327-36.
  • PT. August 2006. 31(8). 462-74.
  • Am J Managed Care. July 2000. S580-90.
  • December 20, 2004. Supplement A. 642-6.

4
Rationale for Investigation
  • In 2004, 3 new agents entered U.S. market
  • Solifenacin
  • Darifenacin
  • Trospium
  • Current claims
  • Increased compliance
  • Improved tolerability
  • Possibly improve quality of life

PT. August 2006. 31(8). 462-74.
5
Objective
  • To determine if long-term use of one
    antimuscarinic agent improves tolerability and/or
    improves quality of life in patients with
    overactive bladder

6
Methods
  • PubMed literature review conducted
  • Search terms included combinations of
  • Overactive bladder
  • Solifenacin
  • Darifenacin
  • Trospium
  • Tolterodine extended-release
  • Oxybutinin extended-release
  • Long-term therapy
  • Quality of life
  • Persistence
  • Date range 1980 to December 2006
  • Design
  • Decision analysis model

7
Methods
  • Inclusion criteria
  • Only once daily dosing formulations of
    antimuscarinic medications
  • Long-term evaluation (gt12 weeks) of
  • Efficacy
  • Tolerability
  • Quality of life
  • Data collection included
  • Discontinuation due to
  • Adverse events
  • Treatment failure

8
Methods
  • Quality of Life
  • Minimal clinically important change (MCIC)
    defined as reduction of 3 incontinence
    episodes/week
  • Homma Y, et al. Neurourol Urodyn. 2006.
    25228-35.

9
Methods
  • Medications included in decision analysis
  • Tolterodine extended-release
  • Darifenacin
  • Solifenacin
  • Three key trials identified
  • Other trials used for sensitivity analysis
    estimates
  • All other once daily formulations were excluded

Kreder K, et al. Eur Urol. 200241588-95. Haab
F, et al. Eur Urol. 200547376-84. Haab F, et
al. BJU Int. 2006981025-32.
10
Baseline Comparison
1Kreder K, et al. Eur Urol. 200241588-95. 2Haa
b F, et al. Eur Urol. 200547376-84. 3Haab F,
et al. BJU Int. 2006981025-32.
11
Mean Change in Incontinence Episodes/week at 12
months

1Kreder K, et al. Eur Urol. 200241588-95. 2Haab
F, et al. Eur Urol. 200547376-84. 3Haab F, et
al. BJU Int. 2006981025-32.
12
Discontinuation Rates
1Kreder K, et al. Eur Urol. 200241588-95. 2Haab
F, et al. Eur Urol. 200547376-84. 3Haab F, et
al. BJU Int. 2006981025-32.
13
Decision Analysis Model
NO Reduced gt3 incontinence episodes/week
14
Tolterodine ER Arm
  • Hypothetical cohort of 100 patients

NO reduction gt3 incontinence episodes/week
15
Limitations
  • Limited number of studies have evaluated
    anti-muscarinic therapy gt 12 weeks
  • Data not all reported in same measure
  • Excluded some mainstay therapy agents due to
    inclusion criteria
  • i.e. oxybutinin and trospium
  • Using endpoint of MCIC is not a standard
    measurement at this time

16
Acknowledgement
  • Thank You
  • Anne P. Spencer, PharmD
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