New study shows Actonel almost halves the risk of hip fractures compared to alendronate

Data from 33,000 women with osteoporosis published today in Osteoporosis International

FOR NON-US JOURNALISTS ONLY Paris [Friday 17 November 2006] -- 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® (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 nonvertebral 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 €104 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

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For further information please contact: Vicki Norgan
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NOTES TO EDITORS:

About the REAL study
The RisedronatE, ALendronate (REAL) cohort study was a retrospective analysis of a health service utilization 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 utilized a U.S 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 modeling). 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 nonvertebral fracture, patients on risedronate had 19% (p=0.05) and 18% (p=0.03) lower incidence of nonvertebral 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 nonvertebral fracture, compared to 1.14% of Actonel patients. At 12 months, 2.30% of alendronate patients had sustained nonvertebral 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 osteoporosis9 - 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®, Tide®, Ariel®, Always®, Whisper®, Pantene®, Mach3®, Bounty®, Dawn®, Pringles®, Folgers®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Oral-B®, Actonel®, Duracell®, Olay®, Head & Shoulders®, Wella, Gillette®, 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 organization, 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
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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. 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 nonvertebral 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 socioeconomic 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


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