"Fracture reduction is the clinically relevant endpoint for evaluating osteoporosis therapies," said Nelson B. Watts, MD, presenting author and Director, University of Cincinnati Bone Health and Osteoporosis Center. "While only head-to-head clinical trials comparing fracture efficacy can confirm differences in efficacy between osteoporosis therapies, the results for risedronate in this analysis are consistent with the early fracture reduction that has been shown for this agent in clinical trials."
About the Analysis
The retrospective analysis was based on data from a large medical and pharmaceutical managed care claims database. A one-year analysis assessed nonvertebral fracture risk in 5,024 patients who began treatment with risedronate (5 mg daily or 30 mg weekly), alendronate (5/10 mg daily or 35/70 mg weekly) or nasal calcitonin (200 I.U. daily), between July 2000 and June 2001. Nonvertebral fractures were defined as osteoporotic fractures of the clavicle, upper arm, forearm, pelvis, hip and leg.
Patients in the analysis were age 45 and older (93 percent women, mean age 69 years). Patients with prescriptions in the prior six months for a bisphosphonate, nasal calcitonin or raloxifene were excluded. All risk estimates were adjusted for age, sex, estrogen use, prior fragility fractures and a general morbidity indicator (number of concomitant medications). A six-month analysis was also done involving 7081 patients initiating therapy between July 2000 and December 2001. At six months risedronate patients had a statistically significant 69 percent (p<0.05) lower risk of nonvertebral fracture compared to patients taking nasal calcitonin and a non-statistically significant reduction in risk of 54 percent (p=0.067) compared to patients taking alendronate.
About Osteoporosis
Osteoporosis is a disease characterized by reduced bone strength predisposing a person to an increased risk of fracture. According to the National Osteoporosis Foundation (NOF), 8 million women in the U.S. have osteoporosis, and 1.2 million osteoporotic fractures occur annually. The NOF estimates that every 20 seconds an osteoporosis-related fracture occurs. Risk factors for osteoporosis in postmenopausal women include age, personal history or family history of fracture, low bone mineral density, cigarette use, and race.
Studies show that among postmenopausal women with osteoporosis who experience a spinal fracture, one out of five will suffer their next spinal fracture within just one year, potentially leading to a fracture cascade. Fractures can progress quickly if osteoporosis is left untreated. The NOF, National Institutes of Health, and American Association of Clinical Endocrinologists agree that fracture risk reduction is the efficacy endpoint by which osteoporosis therapies should be evaluated.
Preventive measures, such as not smoking, maintaining a balanced diet supplemented with calcium and vitamin D, if needed, and engaging in weight-bearing exercise, like walking, can reduce an individual's chances of developing osteoporosis. However, in some women, these preventive measures may not be enough, and prescription medications such as Actonel may be beneficial.
About Actonel
Actonel® (risedronate sodium tablets) is developed by Procter & Gamble Pharmaceuticals and co-marketed by Procter & Gamble Pharmaceuticals and Aventis.
Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention and treatment of osteoporosis in postmenopausal women. Actonel 5 mg daily also is indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (greater than or equal to 7.5 mg/d prednisone or equivalent) for chronic diseases.
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.
In clinical trials, 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 percent vs. Actonel 5 mg 29.9 percent), back pain (23.6 percent vs. 26.1 percent), and arthralgia (21.1 percent vs. 23.7 percent).
In a one-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6 percent vs. Actonel 5 mg 19.0 percent), arthralgia (14.2 percent vs. 11.5 percent) and constipation (12.2 percent vs. 12.5 percent). Please visit www.actonel.com for full prescribing information.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe.
About Procter & Gamble
Two billion times a day, P&G brands touch the lives of people around the world. Some of the nearly 300 P&G brands consumers know and use with confidence in over 160 countries around the world include: Pampers®, Tide®, Ariel®, Always®, Whisper®, Pantene®, Bounty®, Pringles®, Folgers®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Olay®, and Clairol Nice 'n Easy®. Some of P&G Pharmaceuticals leading prescription products include Actonel® (risedronate sodium tablets), Asacol® (mesalamine), and Macrobid® (nitrofurantoin monohydrate macrocrystals). The P&G community consists of nearly 102,000 employees working in almost 80 countries worldwide. Please visit www.pg.com for the latest news and in-depth information about P&G and its brands.
About Aventis
Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, Aventis generated sales of € 17.6 billion (US $16.6 billion), invested € 3.1 billion (US $3 billion) in research and development and employed approximately 71,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information about Aventis in the U.S., please visit: www.aventis-us.com.
Copies of this release are available on the Procter & Gamble Pharmaceuticals Web site at www.pgpharma.com, on the Aventis Pharmaceuticals U.S. Web site at www.aventis-us.com, or by calling (800) 207-8049.
For P&G: All statements, other than statements of historical fact included in this news release, are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. In addition to the risks and uncertainties noted in this news 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 achievement of expected cost and tax savings associated with changes in the Company's organization structure; (2) the ability to achieve business plans, including growing volume profitably, despite high levels of competitive activity, especially with respect to the product categories and geographical markets in which the Company has chosen to focus; (3) the ability to manage and maintain key customer relationships; (4) the achievement of growth in significant developing markets such as China, Turkey, Mexico, the Southern Cone of Latin America, the countries of Central and Eastern Europe and the countries of Southeast Asia; (5) the ability to successfully manage regulatory, tax and legal matters, including resolution of pending matters within current estimates; (6) the ability to successfully implement, achieve and sustain cost improvement plans in manufacturing and overhead areas; (7) the ability to successfully manage currency (including currency issues in Latin America), interest rate and certain commodity cost exposures; (8) the ability to manage the continued political and/or economic uncertainty in Latin America (including Venezuela) and war in the Middle East, as well as any political and/or economic uncertainty due to terrorist activities or war (including Korea); and (9) the successful acquisition, transition, integration, and operation of the Wella business. If the Company's assumptions and estimates are incorrect or do not come to fruition, or if the Company does not achieve all of these key factors, then the Company's actual results might differ materially from the forward-looking statements made herein.
For Aventis: Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -"Document de Référence"- on file with the "Commission des Opérations de Bourse" in France.