"Osteoporosis is treated over a number of years, so long-term protection against fractures is critical," said Jean-Marc Kaufman, M.D., PhD, Unit for Osteoporosis and Metabolic Bone Disease, Ghent University Hospital, Belgium. "This is the longest clinical trial of risedronate to date, and it provides reassurance that the fracture benefits and favorable safety profile of risedronate are sustained over 7 years."
The study measured fracture incidence in 2 groups of postmenopausal women. One group received Actonel 5 mg daily for 7 years; the other received placebo for 5 years and was then switched to Actonel 5 mg daily for 2 years. For those women treated with Actonel for 7 years, the annualized incidence of new vertebral fractures for years 0-3, 4-5, and 6-7 was 4.7 percent, 5.2 percent, and 3.8 percent, respectively. These data suggest a sustained benefit of Actonel over 7 years of therapy. In the 5-year placebo/2-year Actonel group, the annualized incidence of new vertebral fracture dropped to 3.8 percent during years 6-7 while taking Actonel, down from an incidence of 12.3 percent experienced during years 4-5 on placebo. The incidence of new vertebral fractures in these patients was reduced during years 6 and 7 to a level comparable to those of the treatment group during the 7 years of the study.
Adverse events in years 6-7, including upper gastrointestinal adverse events, were similar to those in patients taking placebo during the first 5 years of the study.
Study Details
This study was the second 2-year extension of an original 3-year placebo-controlled study with Actonel 5mg daily for the treatment of postmenopausal osteoporosis. This open-label extension study evaluated a total of 164 women: 83 patients received Actonel 5 mg daily for 7 years; 81 patients received placebo for 5 years and then were treated with Actonel 5 mg daily for 2 years. The original placebo group was switched to active therapy during years 6 and 7 for ethical reasons. Throughout the 7 years of the study, all patients received 1,000 mg daily calcium and, if baseline levels were low, up to 500 IU Vitamin D daily. The objective of the study was to evaluate the safety and tolerability of 7 years of Actonel treatment.
About Osteoporosis
Osteoporosis is a skeletal disorder characterized by reduced bone strength predisposing a person to an increased risk of fracture. According to the National Osteoporosis Foundation, 1.2 million women suffer osteoporotic fractures in the U.S. each year. Risk factors for osteoporosis and subsequent fractures include loss of estrogen production, advanced age, preexisting fractures, and low bone mineral density. 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.
Preventive measures, such as not smoking, maintaining a balanced diet supplemented with calcium and vitamin D, and engaging in weight-bearing exercise like walking, can reduce an individual's chances of developing osteoporosis. However, in some people these preventive measures may not be enough, and medications like Actonel may be beneficial.
About Actonel® (risedronate sodium tablets)
Actonel 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 is also 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 for Actonel.
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®, Charmie®, 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 http://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: http://www.aventis-us.com.
Copies of this release are available on the Procter & Gamble Pharmaceuticals Web site at http://www.pgpharma.com, on the Aventis Pharmaceuticals U.S. Web site at http://www.aventis-us.com, or by calling 1-800-207-8049.
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 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.
Additional Contact Info: Paula Koenigs Procter & Gamble 513-622-3923 koenigs.pm@pg.com