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Medical Sample 19
1. Defining OAB
The need to urinate on an abnormally frequent
basis (>8 times/day)
Frequency
– Nocturia defined as need to urinate
OAB =2 times/night
Comprised Sudden need to urinate which is difficult to defer
of urgency, with Urgency
or without urge
incontinence, Involuntary loss of urine
usually with § Urge Leakage accompanied by or
frequency and Urinary preceded by urgency
§ Stress Leakage on effort or exertion; or on
nocturia Incontinence sneezing or coughing
§ Mixed Both urge and stress
§ Other Situational (i.e. with intercourse or
giggle incontinence)
2. OAB/UI Prevalence Estimates
47 Million Patients
2 million
5 million
26 million
14 million
Frequency/Urgency (continent OAB) Urge and Mixed UI (incontinent OAB)
Stress UI Other UI
UI indicates urinary incontinence.
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OAB Is Prevalent in Men and Women but
More Women Are Incontinent
Female OAB* Male OAB*
Total 20.8 million (16.9%) Total 19.7 million (16.0%)
Urge or mixed incontinence
Urge or mixed incontinence
55%
14%
11.4 million 2.7 million
Urgency/Frequency
Urgency/Frequency
45%
86%
9.4 million
17.0 million
*Frequency, urgency, urge UI and mixed UI only
– does not include stress UI or other UI
4. OAB Patients Experience Significant
Sleep Disturbance*
60
50%
50
48%
Patients (%)
40
30 28%
22%
20
10
0
Wake =2x per Night Urinary Symptoms
Affect Sleep
Incontinence With Stress Incontinence Only (n=386)
Urge Component (n=660)
*From September 10 to September 16, 2004 women (N=1046) with self-reported symptoms of urinary
incontinence completed a nationwide survey via electronic mail about the impact of urinary symptoms,
health care provider interactions, treatment practices and expectations, and comorbid conditions.
5. PCPs Report That Patients Need Rapid,
Effective Symptom Relief
It is important to identify patients with 91%
incontinence and to treat effectively
Patients are likely to discontinue
medication if they don't reach a 87%
threshold of satisfaction
Patients expect to see a marked
reduction (=50%) in symptoms within 2 72%
weeks of starting medication
0 10 20 30 40 50 60 70 80 90 100
PCPs Responding Positively (%)
7. Current Brand OAB Market
Chemical
Name Recommended Dose
Brand Formulation Starting Dosage Frequency Indications
5-10 mg QD – adult • OAB with symptoms of UUI,
DITROPAN XL®1 Oxybutynin oral QD
5 mg QD – pediatric urgency, and frequency
• Detrusor overactivity in pediatric
DITROPAN®2 Oxybutynin oral 5 mg BID to TID BID to TID patients ≥6 years associated
with neurologic conditions
Detrol LA®3 Tolterodine 4 mg QD QD • OAB with symptoms of UUI,
Detrol®4 Tolterodine 2 mg BID BID urgency, and frequency
3.9 mg/day delivery rate • OAB with symptoms of UUI,
Oxytrol®5 Oxybutynin patch Twice weekly
39-cm2 patch 2x/wk urgency, and frequency
• OAB with symptoms of UUI,
Sanctura™6 Trospium 20 mg BID BID
urgency, and frequency
• OAB with symptoms of UUI,
Enablex™7 Darifenacin 7.5 mg QD QD
urgency and frequency
• OAB with symptoms of UUI,
VESIcare®8 Solifenacin 5 mg QD QD
urgency and frequency
1. DITROPAN XL® prescribing information. UUI indicates urge urinary incontinence.
2. DITROPAN® prescribing information.
3. Detrol® LA prescribing information. DITROPAN XL and DITROPAN are registered trademarks of ALZA Corporation.
4. Detrol® prescribing information. Detrol is a registered trademark of Pharmacia Corporation.
5. Oxytrol® prescribing information. Oxytrol is a registered trademark of Watson Pharmaceuticals, Inc.
6. Sanctura™ prescribing information. Sanctura is a trademark of Pliva Inc.
7. Enablex™ prescribing information. Enablex is a trademark of Novartis Pharmaceuticals Corporation.
8. VESIcare® prescribing information. VESIcare is a registered trademark of Yamanouchi Pharmaceutical Co.
8. Rapid Reduction of Urge Urinary
Incontinence (UUI)
UUI episodes over 12 weeks with DITROPAN XL 10 mg 1,2
80
70
>70%
Mean % reduction from
60 Reduction
baseline in UUI
in wetting
50 >50% episodes
episodes
at 2 weeks†
Reduction
40 in wetting
episodes
at 2 weeks*
30
20
10
n=559
0
0 2 4 6 8 10 12 Last
Observation ‡
Weeks
9. Pharmacokinetic Profile of DITROPAN XL
Is Unaltered With an Antacid
DITROPAN XL
1.40 Single dose 10 mg
1.20 Alone
Plasma Concentration of
With Antacid
Oxybutynin (ng/mL)
1.00
0.80
0.60
0.40 P = NS
0.20
0.00
0 4 8 12 16 20 24 28 32 36
Hours
Antacid does not alter exposure to DITROPAN XL
10. OROS Delivery System Allows DITROPAN XL to
Provide More Consistent Therapeutic Drug Levels
Semipermeable
Membrane
Color Overcoat
Delivery Orifice
Drug Core
Osmotically Active
Polymeric Push Compartment
11. DITROPAN XL Minimizes Peaks and
Troughs Associated With Oxybutynin
Oxybutynin Plasma Concentrations
Day 4 Steady State
15 IR Oxybutynin, 15 mg/d (5 mg q8 h)
Concentration (ng/mL)
DITROPAN XL, 15 mg/d (15 mg q24 h)
Plasma Oxybutynin
12
9
6
3
0
0 6 12 18 24
Time (h)