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| |  Actonel (Risedronate), For Osteoporosis, Approved In Canada TORONTO/LAVAL, QC -- August 22, 2000 -- Procter & Gamble Pharmaceuticals Canada, Inc. and Aventis Pharma Inc. today announced the approval and availability of 5 mg Actonel® (risedronate sodium tablets) for the treatment and prevention of postmenopausal osteoporosis (PMO). Actonel, a new bisphosphonate, is the only osteoporosis medication currently proven to reduce the risk of vertebral fracture within the first year of treatment. Actonel also prevents nonvertebral osteoporosis-related fractures in postmenopausal osteoporotic women. Additionally, Actonel provides a generally well-tolerated gastrointestinal profile, as well as the flexibility in choice of dosing schedules. Procter & Gamble (P&G), the inventor of Actonel, and Aventis Pharma will market the drug collaboratively. New data show that almost 20 per cent of untreated patients who experience a vertebral fracture will fracture again in just one year. Actonel is the first and only osteoporosis therapy proven to consistently demonstrate a reduction in vertebral (spinal) fracture incidence in just one year of treatment. Actonel significantly reduced the risk of new vertebral fractures by up to 65 per cent in one year in postmenopausal osteoporotic women compared to a control group of women taking supplemental calcium and, if needed, vitamin D. This significant one-year vertebral fracture benefit has been consistently seen across several Actonel studies. In high-risk patients (greater than or equal to two previous vertebral fractures), Actonel significantly reduced the risk of vertebral fractures by up to 74 per cent. "New understanding about osteoporosis suggests it progresses much faster than was originally thought, demonstrating the clear need for fast-acting therapies," said Dr. Rick Adachi, Rheumatologist and Professor, Department of Medicine at St. Joseph's Hospital, McMaster University, Hamilton, Ontario. "With Actonel, patients who act quickly to get diagnosed and treated can significantly reduce their risk of vertebral fractures within just one year." Actonel has been shown to be well-tolerated, even in patients with gastrointestinal (GI) diseases. Clinical trials for Actonel included patients with a history of active GI disease -- including ulcers, esophagitis, and heartburn -- and those taking nonsteroidal anti-inflammatory drugs (NSAIDs), which often cause GI complaints. In fact, more than 60 per cent of patients in the Actonel clinical trials reported use of NSAIDs and/or ASA during the clinical studies, and almost 40 per cent of patients had ongoing GI disease. Even among these patients, the incidence of GI side effects in Actonel treated patients was similar to that of patients taking placebo. Actonel also offers patients a variety of dosing schedules from which to choose, rather than being tied to only one option when taking their medication. Patients can take Actonel first thing in the morning, approximately 30 minutes before eating; during the day, two hours from any food or beverage; or in the evening two hours after last food or beverage of the day. Actonel is taken once daily with at least 120 mLs of plain water and on an empty stomach. Patients should remain in an upright position, either standing or sitting, for at least 30 minutes after taking their medication. Currently, 1.4 million Canadians suffer from osteoporosis, or one-in-four women, and one-in-eight men, over the age of 50. The cost to the health care system is approximately Cdn $1.3 billion annually. "Osteoporosis is a commonly recognized disease, yet it remains greatly misunderstood by Canadians. This is a disease that leads to deformity, disability, loss of independence and death," said Dr. Algis Jovaisas, Rheumatologist, Ottawa Hospital and Assistant Professor of Medicine, Faculty of Medicine at the University of Ottawa. "There is a need for improved diagnosis and treatment of this devastating condition. Actonel is a welcome addition to our treatment options, offering new benefits to Canadian physicians and patients." New science shows that a vertebral fracture increases the risk of additional fractures within just one year. "It is unacceptable to allow this 'domino effect' of fractures to continue," said Mark A. Collar, President, Procter & Gamble Pharmaceuticals Worldwide. "The demonstrated efficacy of Actonel to consistently reduce vertebral fractures in as little as one year is a major advance in the treatment of osteoporosis." Experts know that although many women take calcium, eat right and exercise, these steps are typically not enough to protect the majority from osteoporosis-related fractures. "Because of the aging population, osteoporosis is now a major public health issue; however, the vast majority of women with osteoporosis still go undiagnosed," said Jean-François Leprince, President, Aventis Pharma Inc. "Now more than ever, it is critically important that Canadians recognize the urgency to diagnose and treat osteoporosis." Actonel is the second bisphosphonate invented by Procter & Gamble, which pioneered the use of this class of drug in bone disease with cyclical etidronate and calcium, currently marketed in 22 countries, in Canada under the name Didrocal®. In clinical trials, Actonel was generally well-tolerated. Side effects were mild to moderate and most people did not have to stop taking Actonel. Overall, side effects were comparable to placebo and included abdominal pain, hypertension and joint problems. To date, 19 countries worldwide have agreed to recognize the approval of Actonel for the prevention and treatment of osteoporosis. "Osteoporosis is a major health concern for Canadian seniors, causing fractures that can lead to disability, pain, deformity and even death," said Lillian Morgenthau, President, CARP (Canada's Association for the Fifty Plus). "We are encouraged that new drugs are now being approved and are available in Canada to treat osteoporosis. I urge people with risk factors to consult their physicians about getting tested for low bone mass." Related link: Aventis Pharma Inc.
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