[USWC] Attn: Laurie Jones - Mayo Clinic Proceedings Publishes Overactive Bladder Study Results

[Weber, Justin]

Dear Laurie-
I'm writing to inform you that this month, the Mayo Clinic Proceedings will
publish the results of a study sponsored by ALZA on overactive bladder
medications.
*	Overactive Bladder is:
		-a condition that over 17 million Americans suffer from
		-a condition that at least one-half of the 1.5 million
Americans who reside in nursing homes have, and
		-15 to 30 percent of people over 60 living at home suffer
from
		-a condition that twice as many women are likely to suffer
from, compared to men
*	Attached are two news releases for your review, I can fax a copy of
the manuscript if you would like
*	Please call me (415.356.9657) if you would like to speak to Rodney
Appell, MD of Baylor College of Medicine, Dr. Sam Saks, Group Vice President
of Alza Pharmaceuticals or a patient who has suffered tremendously from this
condition but with treatment leads a normal life

I thought this might be interesting for your segment in womenCONNECT.com.

Regards,

Justin Weber
GCI Group, Health Technology
74 New Montgomery, Suite 450
San Francisco, CA 94105
dir - 415.356.9657
fax - 415.882.0202
____________________________________________________________________________
____

EMBARGOED
HOLD  UNTIL 5am, TUESDAY,  APRIL 10, 2001 5am CDT

Comparison of Overactive Bladder Treatments Published in Mayo Clinic
Proceedings

ROCHESTER, MINN. - A study published in the April Mayo Clinic Proceedings
found that extended-release oxybutynin was more effective than
immediate-release tolterodine in treating overactive bladder, a condition
that is increasing as the population ages.
The symptoms of overactive bladder are urinary urge incontinence, urgency
and frequency. More than 17 million people in the United States are
affected, making it more prevalent than asthma 
(15 million), osteoporosis (10 million), diabetes mellitus (7 million) or
Alzheimer's disease (4 million). The cost of treating overactive bladder is
considerable for patients, families and third-party payers. In 1995, the
estimated cost of urinary incontinence in patients older than 65 years was
$26.3 billion.
"Even though overactive bladder is not life threatening, it nonetheless
decreases the quality of life for many patients," write Daniel Elliott,
M.D., Deborah Lightner, M.D., and Michael Blute, M.D., of Mayo Clinic, in an
accompanying editorial. "The medical dollars spent on this problem are
increasing. Therefore, it is imperative for physicians to remain current on
the latest advances in this field and to prescribe wisely so that their
patients receive the most effective and cost-effective medication with the
least adverse effects for this troublesome medical condition."
The randomized, double-blind trial was done by the Overactive Bladder
Judging Effective Control and Treatment (OBJECT) Study Group comprising 37
physicians. Rodney Appell, M.D. of Baylor College of Medicine, Houston,
Texas, is the first author on the Proceedings article. 
At 37 study centers across the United States, 378 participants were
randomized into two groups 
to receive treatment with extended-release oxybutyinin or with tolterodine.
The study compared the tolerability and efficacy of the two drugs.
At the end of the study, both drugs had improved symptoms of overactive
bladder, but extended-release oxybutynin was more effective than tolterodine
in each of the main outcome measures: weekly urge incontinence, total
incontinence and urination frequency. Both groups had similar rates of dry
mouth, the most common adverse effect of treatment with these drugs, and
other adverse events. 
The study was funded by ALZA Corporation of Mountain View, Calif., the
pharmaceutical company that markets extended-release oxybutynin. The study's
authors also disclosed their financial ties to the company. The
institutional review boards of each participating study center approved the
study, and each subject signed an institutional review board-approved
consent form.
Mayo Clinic Proceedings is a peer-reviewed and indexed general internal
medicine journal, published for 75 years by Mayo Foundation, with a
circulation of 130,000 nationally and internationally.
___________________________________________________________________________

EMBARGOED FOR:  TUESDAY, APRIL 10, 2001, 5:00 A.M. CDT

Contacts:	Jennifer Oswald			AL-463-041001
		GCI Group				
		415/356-9661


ALZA CORPORATION ANNOUNCES POSITIVE RESULTS OF O.B.J.E.C.T. STUDY, COMPARING
LEADING THERAPIES FOR OVERACTIVE BLADDER SYMPTOMS

First Head-to-Head Study Comparing the Efficacy and Tolerability of Ditropan
XL® and Detrol® Published in the Peer-Reviewed Journal Mayo Clinic
Proceedings


MOUNTAIN VIEW, Calif. -- April 10, 2000 -- ALZA Corporation (NYSE: AZA)
today announced the results and publication of a head-to-head, Phase IV
clinical study, "Overactive Bladder: Judging Effective Control and
Treatment" (OBJECT), evaluating the two leading medications for the
treatment of overactive bladder.  Published in this month's Mayo Clinic
Proceedings, OBJECT is the first study to directly compare the tolerability
and efficacy of Ditropan XL® (extended-release oxybutynin chloride) and
Detrol® (tolterodine tartrate).
	"This landmark study, which was designed and directed by some of the
nation's pre-eminent thoughtleaders in overactive bladder, provides
additional confirmation to physicians that Ditropan XL® is well-tolerated
and efficacious.  Ditropan XL® has been demonstrated to be effective and
well tolerated by the millions of patients who have been treated for their
symptoms of overactive bladder," said Rodney Appell, M.D., F. Brantley Scott
Professor of Urology, Baylor College of Medicine, the study's author and
principle investigator.  "To physicians who have been prescribing either one
of these two pharmacologic agents, we now have for the first time, objective
results directly comparing their abilities to treat the primary symptoms of
overactive bladder -- urge incontinence, total incontinence and frequency."
	In an accompanying editorial, Daniel S. Elliott, M.D., et al, of the
Mayo Clinic, commented that "Prior to the study by Appell, et al in this
issue of Proceedings, no direct comparison of the two most commonly
prescribed medications, tolterodine and [extended-release] oxybutynin, had
been done....  These results are encouraging and demonstrate progress toward
lessening the problem of bladder dysfunction."
Study Shows Significantly Fewer Wetting Accidents In Patients Treated With
Ditropan XL®
	Final results from this Phase IV clinical study showed that patients
treated with Ditropan XL® experienced significantly fewer episodes of urge
incontinence and urinary frequency.  Specifically, Ditropan XL® patients
experienced 19.5 fewer weekly episodes of urge incontinence or wetting
accidents.  Patients treated with Detrol® experienced 16.3 fewer weekly
episodes of urge incontinence (p=.03).  Urinary frequency decreased by 24.7
episodes per week in patients treated with Ditropan XL®, whereas patients
treated with Detrol® experienced 20.1 fewer weekly episodes of urinary
frequency (p=.02).  
Dry mouth, the most commonly reported side effect with medications used to
treat overactive bladder, was experienced by 28 percent of patients treated
with Ditropan XL®, versus 33 percent of patients treated with tolterodine.
All other adverse events experienced by patients in both treatment groups
occurred at low rates and with similar frequency.  
The double-blind, double-dummy clinical trial was conducted across 37 study
sites in the United States.  Participants were randomized into two parallel
treatment arms and treated with total daily doses of either 10 mg (qd)
Ditropan XL® or 4 mg (2 mg bid) Detrol® for a period of 12 weeks.  To
enhance the integrity of the study design, neither physicians nor patients
could determine which product was being administered.
"When ALZA decided to go ahead with OBJECT, we knew that certain risks were
involved in sponsoring a double-blind, double-dummy, randomized trial
against the leading overactive bladder product, marketed by one of the major
pharmaceutical companies in the world.  It is now clear that our confidence
in Ditropan XL® was well placed, and we are very pleased to be announcing
the publication of the OBJECT data in a prestigious peer-reviewed journal,"
stated Sam Saks, M.D., group vice president of ALZA Pharmaceuticals.  "In
addition to compelling efficacy and tolerability results, the low
discontinuation rate due to adverse events in OBJECT was completely in line
with previous studies evaluating Ditropan XL®."
Overactive bladder is a common, treatable and chronic condition
characterized by symptoms of urge incontinence (sudden and involuntary loss
of bladder control resulting in wetting accidents), urgency (the urgent need
to empty the bladder) and frequency (frequent urination).  
An estimated 17 million Americans suffer from overactive bladder - a
condition most prevalent among women and older adults.  At present,
overactive bladder is widely under-diagnosed and under-treated -- in part
because of embarrassment and the misconception that overactive bladder is a
normal part of aging.  Overactive bladder can have a profound impact on
patients and disrupt daily routines and activities.  Some patients may
become socially isolated or even housebound because they fear the
embarrassment of having urinary accidents in public.  
Ditropan XL® is a once-daily extended-release tablet indicated for the
treatment of overactive bladder with symptoms of urge urinary incontinence,
urgency and frequency.  Ditropan XL® should not be used by patients with
urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma,
and in patients who are at risk for these conditions, or those who have
demonstrated hypersensitivity to the same substance or other components of
the product.  
Full prescribing information for Ditropan XL® is available upon request.
For additional information about Ditropan XL®, call 1-888-DXL-1-A-DAY or
visit <http://www.DitropanXL.com>. 
ALZA recently announced that the company has entered into a merger agreement
with Johnson & Johnson (NYSE: JNJ), the world's most comprehensive and
broadly based manufacturer of health care products.  The merger transaction
is expected to close in the early part of the third quarter in 2001.
ALZA Corporation, headquartered in Mountain View, California, is a
research-based pharmaceutical company with leading drug delivery
technologies.  The company applies its delivery technologies to develop
pharmaceutical products with enhanced therapeutic value for its own
portfolio and for many of the world's leading pharmaceutical companies.
ALZA's sales and marketing efforts are currently focused in urology,
oncology and central nervous system products.  Additional information on
ALZA can be found on the World Wide Web at www.alza.com
<http://www.alza.com/>.