Title: Decision Analysis of Long-Term Use of Extended Release Antimuscarinic Therapy for Overactive Bladder Disorder
1Decision Analysis of Long-Term Use of Extended
Release Antimuscarinic Therapy for Overactive
Bladder Disorder
- Carolyn M. Smith, PharmD, MBA
2Background
- 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.
3Rationale 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.
4Rationale 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.
5Objective
- To determine if long-term use of one
antimuscarinic agent improves tolerability and/or
improves quality of life in patients with
overactive bladder
6Methods
- 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
7Methods
- 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
8Methods
- 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.
9Methods
- 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.
10Baseline 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.
11Mean 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.
12Discontinuation 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.
13Decision Analysis Model
NO Reduced gt3 incontinence episodes/week
14Tolterodine ER Arm
- Hypothetical cohort of 100 patients
NO reduction gt3 incontinence episodes/week
15Limitations
- 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
16Acknowledgement
- Thank You
- Anne P. Spencer, PharmD