This analysis combined data from two large Actonel clinical trials, VERT-NA and VERT-MN, which included postmenopausal women with either one prevalent vertebral fracture and low bone mineral density (BMD), or with at least two prevalent vertebral fractures. The objective of this analysis was to compare the incidence of moderate or severe vertebral fracture at one year in women who received Actonel or placebo. Fracture severity was determined using the fracture severity scoring system developed by Harry Genant, M.D., Professor of Radiology, Medicine, Epidemiology and Orthopaedic Surgery at the University of California, San Francisco, an investigator and pioneer of the assessment method used in the analysis.
Recent studies show severity of prevalent vertebral fractures is a predictor of future vertebral and non-vertebral fracture risk; patients with more severe baseline vertebral fractures are more likely to experience subsequent vertebral and non-vertebral fractures. Therefore, reducing the incidence of moderate or severe vertebral fractures may help decrease the risk of future fractures.
"The ultimate goal of osteoporosis treatment is to prevent fractures," said Dr. Genant, "These new findings, combined with previous Actonel clinical data showing reductions in both risk of first vertebral fracture and multiple vertebral fractures, suggest that Actonel reduces fracture risk across a range of osteoporotic severity."
According to the National Osteoporosis Foundation, vertebral fractures are the most common osteoporotic fracture. In the U.S., an estimated 700,000 vertebral fractures occur every year. Data show that among postmenopausal women who sustain a vertebral fracture, one out of five will suffer their next vertebral fracture within just one year, potentially leading to a fracture "cascade".
In the combined VERT studies, a total of 1,994 postmenopausal women with osteoporosis were randomized to receive either placebo or Actonel 5 mg daily. All patients received 1 g per day calcium supplementation and up to 500 I.U. vitamin D per day if serum levels were low at baseline. During the first year, only 1.4 percent of patients in the Actonel-treated group experienced a new moderate or severe vertebral fracture, compared with 4.6 percent in the placebo group. In Actonel treated patients, the risk reduction in moderate and severe vertebral fractures at one year was 70.7 percent (p<0.001). If all incident vertebral fractures (e.g., mild, moderate and severe) are included in the analysis, the vertebral fracture risk reduction for Actonel-treated patients is 63.9 percent (p<0.01) at one year.
About Actonel ® (risedronate sodium tablets)
Actonel is co-developed 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 is also indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (? 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).
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis in May 1997 to develop and market Actonel collaboratively in Europe, the United States and Canada. The Alliance promotes bone health and disease awareness through numerous activities to support physicians and patients around the globe.
About Procter & Gamble
Procter & Gamble (P&G) is celebrating 165 years of providing trusted quality brands that make every day better for the world's consumers. We market nearly 300 brands in more than 160 countries around the world. The P&G community consists of nearly 102,000 employees working in almost 80 countries worldwide. P&G Pharmaceuticals is part of P&G's Health Care global business unit. P&G Pharmaceuticals is focusing in the areas of endocrinology, cardiovascular and musculoskeletal diseases as well as anti-infective therapies. Some of P&G's leading prescription products include Actonel® (risedronate sodium tablets), Didronel® (etidronate disodium), Asacol® (mesalamine) and Macrobid® (nitrofurantoin monohydrate macrocrystals). Please visit www.pg.com for the latest news and in-depth information about P&G and its brands.
About Aventis
Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes, respiratory/allergy, anti-infectives as well as on human vaccines. In 2001, Aventis generated sales of € 17.7 billion ($15.9 billion), invested approx. € 3 billion ($2.7 billion) in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters is 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, please visit: www.aventis.com.
Please see full prescribing information for Actonel by visiting www.actonel.com. Copies of this release are available on the Procter & Gamble Pharmaceuticals Web site at http://www.pgpharma.com, the Aventis Pharmaceuticals U.S. Web site at http://www.aventispharmaus.com, or by calling 800/207-8049.
All statements, other than statements of historical fact included in this presentation, 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 presentation, there are certain factors that could cause results for The Procter & Gamble Company to differ materially from those anticipated by some of the statements made. These include:(1) the successful execution of Organization 2005, including achievement of expected cost and tax savings and successful management of organizational and work process restructuring; (2) the ability to achieve business plan projections, including volume growth and pricing plans; (3) the ability to maintain key customer relationships including, without limitation, K-mart; (4) the achievement of growth in significant developing markets such as China, Korea, Mexico, the Southern Cone of Latin America and the countries of Central and Eastern Europe; (5) the successful integration of the Clairol business; (6) the continued political and/or economic uncertainty in Latin America and the Middle East; (7) any political and/or economic uncertainty due to terrorist activities; (8) the ability to successfully manage regulatory, tax and legal matters, including resolution of pending matters within current estimates; and (9) the ability to successfully manage current, interest rate and certain commodity cost exposures. 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 may vary materially from the forward-looking statements made herein.
Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of 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.