Results from a Phase III
clinical trial evaluating the efficacy and safety of risedronate 150 mg
once monthly for the treatment of postmenopausal osteoporosis were
presented at the American Society for Bone and Mineral Research (ASBMR)
29th Annual Meeting. In the non-inferiority study comparing risedronate 150
mg once monthly to risedronate 5 mg daily [Actonel(R) (risedronate sodium
tablets)] increases in bone mineral density (BMD) were similar for patients
taking either the monthly or daily dosing regimens.
In the study, BMD was measured at the lumbar spine, total hip, femoral
neck, and femoral trochanter. There were no statistically significant
differences in BMD increases between the risedronate 150 mg once monthly
and the 5 mg daily dose groups at 12 months. In the study, the tolerability
and safety profiles were also similar for the monthly and daily dosing
regimens of risedronate.
"Risedronate is already approved to reduce the risk of both spinal and
nonspinal fractures," said Michael McClung, M.D., Founding Director of the
Oregon Osteoporosis Center in Portland, Oregon. "For patients who prefer
less frequent dosing, risedronate 150 mg, if approved, would provide the
convenience of a once monthly dosing option."
About the Study
The MERIT-OP (Monthly Evaluation of Risedronate Trial in Osteoporosis)
study is a 2-year, randomized, double-blind, active-control (5 mg daily
risedronate) clinical trial which evaluated 1,292 postmenopausal women (94%
Caucasian) between 50 and 88 years old, mean age 64.9, from 47 clinical
centers in 13 countries. The participants had osteoporosis, defined as a
lumbar spine (LS) BMD T-score less than -2.5 or a LS BMD T-score less than
- 2.0 and at least one prevalent vertebral fracture. Patients were
randomized to dosing regimens of either risedronate 150 mg monthly or
risedronate 5 mg daily and received daily supplements of calcium (1,000 mg)
and vitamin D (400-1000 IU). The primary efficacy endpoint of the study was
to demonstrate non- inferiority of the risedronate 150 mg monthly regimen
to the risedronate 5 mg daily regimen as assessed by percent change from
baseline in LS BMD at 12 months. The 24 month results will be reported at a
later time. At 12 months, the mean LS BMD increases were 3.54% and 3.43%
for the monthly and daily regimens, respectively. The most common adverse
events for risedronate 5 mg and risedronate 150 mg, respectively, were
upper abdominal pain (6.1% vs. 8.2%), influenza (4.2% vs. 8.9%) and
constipation (7.3% vs. 5.8%).
The trial was sponsored by The Alliance for Better Bone Health.
About Actonel(R) (risedronate sodium tablets)
Actonel is approved for the prevention and treatment of osteoporosis in
postmenopausal women. Actonel has been proven to reduce the incidence of
vertebral fractures, and nonvertebral fractures at a composite endpoint of
leg, hip, pelvis, clavicle, humerus and wrist. The following doses are
approved: Actonel 5 mg daily, Actonel 35 mg once-a-week, and Actonel 75 mg
two consecutive days per month.
In clinical trials, Actonel was generally well tolerated. Actonel is
contraindicated in patients with hypocalcemia, known hypersensitivity to
any component of this product, or inability to stand or sit upright for at
least 30 minutes. Hypocalcemia and other disturbances of bone and mineral
metabolism should be effectively treated before starting Actonel therapy.
Actonel is not recommended for use in patients with severe renal impairment
(creatinine clearance < 30 mL/min).
Bisphosphonates may cause upper gastrointestinal disorders such as
dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay
particular attention to the dosing instructions, as failure to take the
drug according to instructions may compromise clinical benefits and may
increase the risk of adverse events.
Among patients treated with bisphosphonates, there have been infrequent
reports of severe and occasionally incapacitating bone, joint and/or muscle
pain. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have
been reported in patients receiving bisphosphonates. Most ONJ cases have
occurred in cancer patients undergoing dental procedures. In the majority
of cases reported, patients had received intravenous bisphosphonate
therapy.
In clinical trials of up to 3-years duration, the overall incidence of
adverse events with Actonel 5 mg daily was comparable to placebo. The most
commonly reported adverse events regardless of causality were infection
(primarily upper respiratory, placebo 29.7% vs Actonel 5 mg 29.9%), back
pain (23.6% vs 26.1%), and arthralgia (21.1% vs 23.7%).
In a clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5
mg daily for 1 year, the overall safety and tolerability profiles of the
two dosing regimens were similar. The most commonly reported adverse events
regardless of causality were infection (Actonel 35 mg 20.6% vs Actonel 5 mg
19.0%), arthralgia (14.2% vs 11.5%) and constipation (12.2% vs 12.5%).
In a clinical trial comparing Actonel 75 mg two consecutive days/month
and Actonel 5 mg daily for 1 year, the overall safety and tolerability
profiles of the two dosing regimens were similar. The most commonly
reported adverse events regardless of causality were arthralgia (Actonel 75
mg 10.4% vs Actonel 5 mg 9.5%), dyspepsia (9.1% vs 7.3%), and back pain
(8.8% vs 10.8%).
Please see full prescribing information for Actonel(R) (risedronate
sodium tablets) for additional safety information. For a copy of the full
prescribing information for Actonel visit the Actonel Web site at
actonel.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed in May 1997 to promote
bone health and disease awareness through numerous activities to support
physicians and patients around the globe. It is a collaboration between
Procter & Gamble Pharmaceuticals and sanofi-aventis U.S.
About Procter & Gamble (NYSE: PG)
Three billion times a day, P&G brands touch the lives of people around
the world. The company has one of the strongest portfolios of trusted,
quality, leadership brands, including Pampers(R), Tide(R), Ariel(R),
Always(R), Whisper(R), Pantene(R), Mach3(R), Bounty(R), Dawn(R), Gain(R),
Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R),
Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella(R),
Gillette(R), and Braun(R). The P&G community consists of 138,000 employees
working in over 80 countries worldwide. Please visit pg for
the latest news and in-depth information about P&G and its brands.
About Sanofi Aventis
Sanofi-aventis is one of the world leaders in the pharmaceutical
industry, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven major
therapeutic areas: cardiovascular, thrombosis, oncology, metabolic
diseases, central nervous system, internal medicine and vaccines.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:
SNY).
For P&G: All statements, other than statements of historical fact
included in this release, are forward-looking statements, as that term is
defined in the Private Securities Litigation Reform Act of 1995. Such
statements are based on financial data, market assumptions and business
plans available only as of the time the statements are made, which may
become out of date or incomplete. We assume no obligation to update any
forward-looking statement as a result of new information, future events or
other factors. Forward- looking statements are inherently uncertain, and
investors must recognize that events could differ significantly from our
expectations. In addition to the risks and uncertainties noted in this
release, there are certain factors that could cause actual results to
differ materially from those anticipated by some of the statements made.
These include: (1) the ability to achieve business plans, including with
respect to lower income consumers and growing existing sales and volume
profitably despite high levels of competitive activity, especially with
respect to the product categories and geographical markets (including
developing markets) in which the Company has chosen to focus; (2) the
ability to successfully execute, manage and integrate key acquisitions and
mergers, including (i) the Domination and Profit Transfer Agreement with
Wella, and (ii) the Company's merger with The Gillette Company, and to
achieve the cost and growth synergies in accordance with the stated goals
of these transactions; (3) the ability to manage and maintain key customer
relationships; (4) the ability to maintain key manufacturing and supply
sources (including sole supplier and plant manufacturing sources); (5) the
ability to successfully manage regulatory, tax and legal matters (including
product liability, patent, and intellectual property matters as well as
those related to the integration of Gillette and its subsidiaries), and to
resolve pending matters within current estimates; (6) the ability to
successfully implement, achieve and sustain cost improvement plans in
manufacturing and overhead areas, including the Company's outsourcing
projects; (7) the ability to successfully manage currency (including
currency issues in volatile countries), debt, interest rate and commodity
cost exposures; (8) the ability to manage continued global political and/or
economic uncertainty and disruptions, especially in the Company's
significant geographical markets, as well as any political and/or economic
uncertainty and disruptions due to terrorist activities; (9) the ability to
successfully manage competitive factors, including prices, promotional
incentives and trade terms for products; (10) the ability to obtain patents
and respond to technological advances attained by competitors and patents
granted to competitors; (11) the ability to successfully manage increases
in the prices of raw materials used to make the Company's products; (12)
the ability to stay close to consumers in an era of increased media
fragmentation; and (13) the ability to stay on the leading edge of
innovation and maintain a positive reputation on our brands. For additional
information concerning factors that could cause actual results to
materially differ from those projected herein, please refer to our most
recent 10-K, 10-Q and 8-K reports.
The Alliance for Better Bone Health
pg
View drug information on Actonel.
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