Data were presented this week from a study that included women within six months to five years after menopause who received treatment with Actonel 5 mg or placebo daily for 1 year. Calcium supplementation was not provided to patients in the study. Analysis of iliac crest biopsy samples showed that after only one year, women in the placebo group (n=12) had already experienced significant deterioration in the microarchitecture of trabecular bone -- despite an only modest loss in lumbar spine BMD (-3.3 per cent). Over the same period, trabecular bone microarchitecture was maintained in women who received Actonel (n=14). These patients also saw a gain in lumbar spine BMD (2.1per cent).
"Osteoporosis has been defined as a skeletal disease characterized by a combination of low BMD and bone microarchitectural alterations that are responsible for increased skeletal fragility," said Robert Lindsay, M.D., Ph.D., Chief of Internal Medicine at Helen Hayes Hospital, Professor of Clinical Medicine, Columbia University. "While BMD plays an important role in the diagnosis of osteoporosis, not all of the effects of bisphosphonates can be explained by increases in BMD. Protection of bone microarchitecture may play an important role in bone health." Recent publications suggest that BMD increases explain less than one-third of the observed fracture reduction for a given therapy.
In the study reported today, iliac crest biopsies collected from patients were analyzed by 3D microcomputed tomography for microarchitecture parameters, including bone volume, trabecular number, and trabecular separation. The data showed significant deterioration in the placebo group for these three parameters at one year versus baseline: bone volume decreased 20.3 per cent (p= 0.032), trabecular number decreased 13.5 per cent (p=0.025) and trabecular separation increased 13.1 per cent (p=0.014). In the Actonel group over the same period there was no significant deterioration versus baseline in any of the microarchitecture parameters analyzed.
About Osteoporosis
According to the International Osteoporosis Foundation, an estimated 200 million women suffer from osteoporosis worldwide. In the United States, the National Osteoporosis Foundation estimates that the overall lifetime risk of experiencing a fracture due to osteoporosis for women over the age of 50 is 40 per cent – or two out of every five. Postmenopausal osteoporosis is the most common form of osteoporosis
About Actonel ® (risedronate sodium tablets)
Actonel is co-developed and co-marketed by Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals. 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 per cent vs. Actonel 5 mg 29.9 per cent), back pain (23.6 per cent vs. 26.1 per cent), and arthralgia (21.1 per cent vs. 23.7 per cent).
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 per cent vs. Actonel 5 mg 19.0 per cent), arthralgia (14.2 per cent vs. 11.5 per cent) and constipation (12.2 per cent vs. 12.5 per cent).
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis Pharma 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 Pharmaceuticals
Procter & Gamble Pharmaceuticals is a part of Procter & Gamble Health Care, a division of The Procter & Gamble Company (NYSE:PG) – a $40 billion global leader in the development, manufacturing and marketing of a broad range of consumer goods. In prescription drugs, P&G 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, Didronel? (etidronate disodium), Asacol? (mesalamine) and Macrobid? (nitrofurantoin monohydrate macrocrystals).
About Aventis Pharmaceuticals
Aventis Pharmaceuticals conducts the U.S. prescription drug business of Aventis. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, osteoporosis, allergy and respiratory, diabetes, and the central nervous system.
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 and respiratory disorders 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 approx. 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. 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 and the Aventis Pharmaceuticals U.S. Web site at http://www.aventispharmaus.com, or call 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.
Contacts: Mary Johnson
Procter & Gamble
(513) 622-5291
johnson.mb.3@pg.com
Susan Brooks
Aventis
(908) 243-7564
susan.brooks@aventis.com