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17.11.2006 – 12:48

Alliance for Better Bone Health

Study of Over 33,000 Women Comparing Two Most Prescribed Osteoporosis Treatments Shows Significant Difference in Hip Fracture Reduction

Paris, November 17 (ots/PRNewswire)

  • Actonel Almost Halves the Risk of Breaking a Hip When Compared to Alendronate in the First Year of Treatment
  • For Non-US Journalists Only
Data published today from a retrospective study of over 33,000
postmenopausal women showed that among patients newly prescribed one
of the two most popular osteoporosis treatments, patients taking
Actonel(R) (risedronate sodium) were approximately half as likely to
sustain a hip fracture as those taking alendronate in the first year
of treatment. These results were published today in the peer-reviewed
journal Osteoporosis International.(1)
"The rapid onset of fracture reduction observed for risedronate in
this study is consistent with results from randomised clinical trials
of risedronate," says Professor Pierre Delmas, study author,
Université Claude Bernard, Lyon. "Earlier fracture protection means
that fewer patients will suffer the devastating consequences of an
osteoporotic fracture, helping to both preserve patients' quality of
life and to reduce the economic burden of healthcare."
The REAL (RisedronatE, ALendronate) retrospective cohort study
included 33,830 women newly treated with once-weekly doses of either
Actonel or alendronate in 'real-life' clinical practice. Results
showed that at six months patients on Actonel had a 46% (p=0.02)
lower incidence of hip fractures compared to patients on alendronate.
At 12 months similar results were seen, with Actonel resulting in a
43% (p=0.01) greater reduction in risk of hip fracture versus
alendronate. The two treatments were not compared on the basis of
side effects in this study.
This study adds to the body of evidence from randomised controlled
trials demonstrating that Actonel exerts an early onset of fracture
protection, seen as early as six months for clinical vertebral
fracture and non-vertebral fractures.(2-3) No other bisphosphonate
treatments for osteoporosis have been shown in clinical trials to
reduce clinical fractures this early for patients. However, data are
limited that compare therapies directly in the same study on the
basis of fracture reduction - the clinically important endpoint in
osteoporosis treatment.
"In the osteoporosis field it is unlikely that prospective,
head-to-head clinical fracture trials will be conducted due to the
large number of patients required to show a difference between two
effective therapies," said Professor Delmas. "Large, comparative,
retrospective analyses, like the REAL study, are one way to fill the
knowledge gap and should be considered in the total body of evidence
for a drug to optimise treatment decisions and enhance patient care."
Currently 1.6 million hip fractures occur worldwide per year,(4)
accounting for approximately EUR104 billion in worldwide annual
healthcare costs.(5) Among those patients who suffer a hip fracture,
approximately one in five will die within the following year,(6,7)
and 40% will be unable to walk independently one year later.(8)
Notes to Editors:
About the REAL study
The RisedronatE, ALendronate (REAL) cohort study was a
retrospective analysis of a health service utilisation database.
These databases are generated by medical insurers for the payment or
reimbursement of health services. They include longitudinal, patient
specific information such as diagnosis codes for reimbursable
expenses (e.g. fractures) and pharmacy dispensations. The REAL study
utilised a US database of 12 million insured participants. It was a
pooled dataset of one health plan within Ingenix Lab/Rx, and the 100
employer health plans within Medstat Marketscan.
From the dataset, women aged 65 years and older were identified
who were new users of weekly bisphosphonate therapy, either
risedronate 35 mg (N=12,215) or alendronate 35 mg or 70 mg
(N=21,615). Patients had to have at least six months medical history
prior to treatment initiation and were followed for 12 months after
bisphosphonate initiation to assess 6 and 12 month fracture incidence
at both the hip and at a composite group of non-vertebral sites (hip,
wrist, clavicle, humerus, pelvis and leg). Standard statistical
methods were used to compare the incidence of fracture between the
risedronate and alendronate groups (Cox proportional hazard
modelling). As with all retrospective cohort studies, an important
concern is that in real world clinical practice patients are not
randomly assigned to treatment groups, potentially introducing
"selection bias" into the results. The risedronate and alendronate
groups were compared for risk factors for fracture at baseline, and
all results were risk-adjusted for potential differences in baseline
fracture risk.
In the study, patients on Actonel had 46% (p=0.02) and 43%
(p=0.01) lower incidence of hip fracture than patients taking
alendronate at 6 and 12 months, respectively. Prior to risk
adjustment for baseline differences in fracture risk, the crude
incidence of fracture in each population was as follows: At six
months, 0.29% of alendronate patients had sustained a hip fracture,
compared to 0.17% of Actonel patients. At 12 months, 0.58% of
alendronate patients had suffered a hip fracture, compared to 0.37%
of Actonel patients.
With respect to non-vertebral fracture, patients on risedronate
had 19% (p=0.05) and 18% (p=0.03) lower incidence of non-vertebral
fracture than patients on alendronate at 6 and 12 months,
respectively. Prior to risk adjustment for baseline differences in
fracture risk, the crude incidence of fracture in each population was
as follows: At six months, 1.31% of alendronate patients had
experienced non-vertebral fracture, compared to 1.14% of Actonel
patients. At 12 months, 2.30% of alendronate patients had sustained
non-vertebral fracture, compared to 1.99% of Actonel patients.
Please see the full prescribing information for each treatment to
obtain more information on the adverse events associated with each
therapy.
All study investigators had full access to the complete dataset,
and each of them independently verified the results of the analyses
at their respective institutions. The study was sponsored by The
Alliance for Better Bone Health.
About osteoporosis
Osteoporosis is a skeletal disease that increases bone fragility
and susceptibility to fracture. Fracture is a devastating consequence
of osteoporosis and can occur at any site of the body. A 50-year-old
woman has around a 40% lifetime risk of suffering a fracture from
osteoporosis(9) - equivalent to the women's lifetime risk for
cardiovascular disease.(10)
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble
Pharmaceuticals and Aventis part of the sanofi-aventis Group, in May
1997 to promote bone health and disease awareness through numerous
activities to support physicians and patients around the globe.
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), 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, Gillette(R), and Braun. The P&G community
consists of over 135,000 employees working in over 80 countries
worldwide. Please visit http://www.pg.com for the latest news and
in-depth information about P&G and its brands.
About sanofi-aventis
Sanofi-aventis is the world's third-largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organisation, sanofi-aventis is developing leading positions in seven
major therapeutic areas: cardiovascular, thrombosis, oncology,
metabolic diseases, central nervous system, internal medicine, and
vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN)
and in New York (NYSE: SNY).
Forward Looking Statements
For s-a: This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are statements that are not historical
facts. These statements include financial projections and estimates
and their underlying assumptions, statements regarding plans,
objectives and expectations with respect to future events,
operations, products and services, and statements regarding future
performance. Forward-looking statements are generally identified by
the words "expect," "anticipates," "believes," "intends,"
"estimates," "plans" and similar expressions. Although
sanofi-aventis' management believes that the expectations reflected
in such forward-looking statements are reasonable, investors are
cautioned that forward-looking information and statements are subject
to various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of sanofi-aventis, that
could cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
those discussed or identified in the public filings with the SEC and
the AMF made by sanofi-aventis, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward-Looking
Statements" in sanofi-aventis' annual report on Form 20-F for the
year ended December 31, 2005. Other than as required by applicable
law, sanofi-aventis does not undertake any obligation to update or
revise any forward-looking information or statements.
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 recognise
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. 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.
References:
1. Silverman S, et al. Effectiveness of bisphosphonates on
non-vertebral and hip fractures in the first year of therapy, the
risedronate and alendronate cohort study. Osteoporosis Int 2006
2. Roux C, Seeman E., Eastell R., Adachi J, Jackson RD, Felsenberg
D, Songcharoen S, Rozzoli R, Di Munno O, Horlait S, Valent D, watts
NB, Efficacy of risedronate on clinical vertebral fractures within
six months. Curr Med Res Opin. 2004;20(4):433-9
3. Harrington JT, Ste-Marie LG, Brandi ML, Civitelli R, Fardellone
P, Grauer A, Barton I, Boonen S. Risedronate rapidly reduces the risk
for non-vertebral fractures in women with postmenopausal
osteoporosis. Calcif Tissue Int. 2004; 74: 129-135 .
4. International Osteoporosis Foundation. Facts and statistics
about osteoporosis and its impact.
http://www.osteofound.org/press_centre/fact_sheet.html. Last accessed
7th November 2006
5. Johnell O. The socio-economic burden of fractures: today and in
the 21st century. Am J Med 1997; 103: 20S-26
6. Cooper C, Atkinson EJ, Jacobsen SJ, et al. Population-based
study of survival after osteoporotic fractures. Am J Epidemiol 1993 ;
137: 1001-1005
7. Leibson CL, Tosteson AN, Gabriel SE, et al. Mortality,
disability, and nursing home use for persons with and without hip
fracture: a population-based study. J Am Geriatr Soc 2002; 50:
1644-1650
8. Magaziner J, Simonsick EM, Kashner TM, et al. Predictors of
functional recovery one year following hospital discharge for hip
fracture: a prospective study. J Gerontol 1990; 45: M101-M107
9. Melton LJ et al. Perspective. How many women have osteoporosis?
J Bone Miner Res 1992; 7: 1005-1010
10. Kanis J A. Diagnosis of osteoporosis and assessment of
fracture risk. Lancet 2002; 359: 1929-36

Contact:

For further information please contact: Helen Crow, Tel:
+44-207-611-3654, Email: helen.crow@ketchum.com. Vicki Norgan, Tel:
+44-207-611-3566, Email: vicki.norgan@ketchum.com