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OAB, OverActive Bladder
MEDICAL MANAGEMENT
Dr Clarence Lei Chang Moh, FRCS Urol,
Consultant Urologist
• Adjunct Professor, Universiti Malaysia Sarawak
• Honorary Consultant to SGH & HKL
• c/o Kidney & Urology Centre, Normah Hospital, KUCHING.
BORNEO REGIONAL UROLOGY WORKSHOP, Kota Kinabalu, 9-10 July 2011
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DRUGS: Anticholinergics
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Ideal medication for OAB
• an ideal agent must balance– Efficacy (rapid onset of action, relief of OAB symptoms)
– Tolerability (side effects e.g. dry mouth)
• compliance
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• Combined calcium channel & phosphodiesterase inhibition + local anesthetic:
– flavoxate (URISPAS)
• Combined antimuscarinic & calcium channel inhibitor:
– Oxybutynin (DITROPAN 5mg 8 hrly)
– Propiverine (MICTONORM 15mg 1-4 OD)
• Pure antimuscarinic:
– Trospium (SPASMOLYT 20mg 1 12 hrly)
– tolterodine (DETRUSITOL 2 mg 12 hrly or SR 4 mg OD)
– solifenacin (Vesicare® 5-10 mg daily)
Medications for OAB
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Chemical formulas for antimuscarinics
OH
O
ON
Oxybutynin
O
N Tolterodine
O
N
O
NDarifenacin
N
NO
O
OH
O
OH
O
Vesicare®
(solifenacin succinate)
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Vesicare• Solifenacin is well tolerated
– Phase I studies showed no decrease in salivary flow with solifenacin 5 mg
– Adverse event profile limited to common class effectsPharmacokinetics
– Similar in age, gender, and ethnic groups– No dose adjustment required with concomitant drug
use but dose should be restricted to 5 mg when used simultaneously with potent CYP3A4 inhibitors
Patient-friendly dosing regimen:
– Once daily; with or without food
Smulders RA et al., ICS 2002. CL-002 Poster Smith N et al. ICS 2002 CL010 Poster
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Vesicare®: “rapid” onset of action
Cardozo L, et al. BJU Int 2008;102:1120–1127
Solifenacin
• Solifenacin showed significant improvement in urgency as early as day 3 of treatment
• There was also an early onset of significant treatment effect for micturition frequency, incontinence episodes, and urgency incontinence episodes
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Efficacy results
Placebo 5 mg Solifenacin 10 mg Solifenacin
Cardozo L et al. Urology 2004 172; 1919-1924
-3
-2
-1
0
Mea
n r
edu
ctio
n in
mea
n n
um
ber
of
mic
turi
tion
s/24
h
P=0.0002
P=0.0001
-13%
-20%
-22%
N=281 N=261 N=290
Micturition frequency /24hr
PP=0.014=0.014-1.5
-1
-0.5
0
Mea
n r
edu
ctio
n in
mea
n n
um
ber
of
urg
e in
con
tin
ence
ep
isod
es/2
4 h
PP=0.042=0.042
-43%
-63%-57%
N=126 N=141 N=138
Urge incontinence episodes/24hr
-3
-2
-1
0
Mea
n r
edu
ctio
n in
mea
n n
um
ber
of
urg
ency
ep
isod
es/2
4 h
PP=0.005=0.005PP=0.0001=0.0001
-33%
-51%-52%
N=278 N=284 N=298
Urgency episodes/24hr
0
10
20
30
40
Mea
n in
crea
se in
vol
um
e vo
ided
(m
L)
per
mic
turi
tion
P=0.0001
P=0.0001
7%
21%
25%
N=281 N=286 N=290
Volume voided/micturition
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Reduction in key efficacy parametersby exposure time
Frequency
Nocturia
-100%
-80%
-60%
-40%
-20%
0%4 Weeks 8 Weeks 12 Weeks 16 Weeks 28 Weeks 40 Weeks 52 Weeks
Urgency
Urge incontinence
Mea
n p
erce
nta
ge
red
uct
ion
Haab F et al. Eur Urol 2005.
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Tolerability at 52 weeks compared with placebo-controlled studies
Solifenacin 10mg (n=575)
Solifenacin 5mg (n=578)
Placebo (n=568)
Per
cen
tage
ad
vers
e ev
ents
12 week data
0
5
10
15
20
25
Dry Mouth Constipation
4%
11%
19%
2%
5%
9%
Solifenacin 5mg
Solifenacin 10mg
Solifenacin All
Per
cen
tage
ad
vers
e ev
ents
52 week data
0
5
10
15
20
25
Dry Mouth Constipation
10%
17%
21%
5%
8%10%
Haab F et al. Eur Urol 2005.
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Completion and withdrawal rates during a 12-month, open-label study
of tolterodine*
Kreder K, et al. Eur Urol. 2002;41:588-95.
*4 mg od
70.6
10.0 9.9
Per
cen
t
Completion rate
Withdrawal due to lack of efficacy
Withdrawal due to adverse events
0
20
40
60
80
100
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STAR study• Vesicare® (solifenacin) 5mg showed greater
improvements than tolterodine ER 4mg across all symptoms of OAB at 4 weeks
1.71
1.22
1.98
1.3
0.51
1.21
1.47
0.91
1.67
0.9
0.44
0.8
0
0.5
1
1.5
2
2.5
Micturitionfrequency
Urgeincontinence
Urgency Overallincontinence
Nocturia Pad use
Solifenacin 5mg N=578
tolterodine ER 4mg N=599
Mean improvement in OAB symptoms at 4 weeks
Mea
n s
ymp
tom
imp
rove
men
t
P<0.05P<0.05
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Adverse Events for Solifenacin 5 mg
Adverse EventSolifenacin 5 mg
(%)
Dry mouth 17.5
Constipation 11.6
Blurred vision 2.3
Discontinued due to all AEs 3.6
Data on file. Astellas Pharma US, Inc.
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Why Do We Treat Men Differently than Women When It Comes to OAB?
FemaleFemale MaleMale
ProstateProstate
• In men and women, symptoms of OAB are the same; anatomy is In men and women, symptoms of OAB are the same; anatomy is differentdifferent
• In men, LUTS are considered related predominantly to the prostate In men, LUTS are considered related predominantly to the prostate due to BPHdue to BPH
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BPH, LUTS lower urinary tract symptoms
Voiding symptoms, caused by an enlarged prostate Weak urinary stream Prolonged voiding Abdominal straining Hesitancy Intermittency Incomplete bladder emptying Terminal and post-void
dribbling
Storage symptoms, which can result from enlarged prostate or overactive bladder (OAB)FrequencyNocturiaUrgencyIncontinence
LUTS are not specific to BPH – not all men with LUTS have BPH and not all men with BPH have LUTS
Associated symptoms of BPH include: DysuriaHaematuriaHaematospermia
For medical healthcare professionals’ information only
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Men: BPH + OAB
• OAB symptoms often persist after pharmacologic or surgical treatment of BOO
• Studies provide evidence of the safety and usefulness of anticholinergics in men with OAB who also have BOO
• There was no increase in urinary retention in 4 recent studies when anticholinergics used in men with BOO
• Combination therapy provide improved symptom relief for men with LUTS
Lee et al. BJU Int. 2004;94:817-820 .Athanasopoulos et al. J Urol. 2003;169:2253-2256.
Kaplan S et al. Abstract. AUA 2004.Abrams et al. Neurourol Urodyn. 2001;20:5547-548.IR = immediate release; ER = extended release.
Please see full prescribing information.
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How long do I take medications?
• “Forever” NO !• "Long term, till better, trial off medications,
followup”
Can I be cured?Can be controlled, adjust lifestyle, trial of medications
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Summary
Vesicare® showed rapid onset of action
Vesicare® is effective across all the main symptoms of OAB, especially urgency (including measurements by warning time)
This effect improves over the long-term with the majority of patients staying on treatment
Vesicare® offers good balance between efficacy and tolerability
Vesicare® 5/10mg have been shown to be superior to tolterodine ER 4mg across the main parameters of OAB
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SARAWAK – Dr Lei
Enjoy? TQ !
Hilton Batang Air Borneo Heights
Tree hse
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Q & A
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ALTERNATIVE THERAPY(non medicinal)
• Sacromodulation
• TENS
• Acupuncture
• Acupressure
• Reflexology
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ALTERNATIVE THERAPY• Saw Palmetto/Pumpkin
• Zn/Selenium
• Traditional Chinese
* Saw Palmetto for BPH. NEJM 2006; 354: 557-66
* Saw Palmetto not active. J Urol 2002; 168: 150-4
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LUTS + Pain
NEGATIVE urine, scan, US etc.
• Urethral Syndrome
• PBS
• CPPS
• Chronic testicular pain
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LUTS + Pain + PCNEGATIVE culture
• I.C. - interstitial cystitis
• TB
• ketamine
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LUTS & Sex
eg Cialis 5 mg OD - Sex rehab, better LUTS
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UNWILLING, unable to payCost, cut tab, cheaper
PRN treatment vs“lifelong”
Plavix, statins
Should drs use expensive drugs like Vesicare? etc
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THANK YOU !
Normah Medical Specialist Centre(wholly owned by Sarawak State Government)
USA