To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: ASBMR: Benefits OF Actonel In Reducing Spinal Fracture Risk Seen After One Year URL: http://www.pslgroup.com/dg/1347D2.htm Doctor's Guide October 1, 1999
ST. LOUIS, MO. -- October 1, 1999 -- In two pivotal studies from one of the largest osteoporosis clinical programs ever conducted, the investigational new drug Actonel (risedronate 5mg sodium tablets) reduced the risk of new vertebral (spinal) fractures by up to 74 percent in post-menopausal women after one year of treatment.
These results, which were presented today at the annual meeting of the American Society for Bone and Mineral Research, suggest that Actonel was effective in providing a fracture benefit in one year and was generally well tolerated. These are the first clinical studies of an osteoporosis therapy which have reported a vertebral fracture benefit in one year.
"The goal of osteoporosis treatment is not just to build bone, but to reduce the risk of fracture as quickly as possible," said Dr. Rick Adachi, Professor, Department of Medicine at St. Joseph's Hospital, McMaster University. "We need a fast-acting medication that can help stop the 'domino effect' often seen in osteoporosis patients, which can lead to fractures in the spine and other parts of the body, such as the hip. In fact, epidemiological studies have shown that those who have suffered a vertebral fracture are five times more likely to suffer another vertebral fracture. And patients who have had two or more vertebral fractures are twelve times more likely to fracture again.
"In these two studies, Actonel worked quickly - within just one year - to reduce the risk of fractures and help interrupt this domino effect," Dr. Adachi said.
Actonel, a pyridinyl bisphosphonate tested in the largest Phase III osteoporosis clinical trial program to date, is under regulatory review in the United States for the treatment and prevention of post-menopausal and corticosteroid-induced osteoporosis. The drug inhibits the breakdown of bone that can lead to low bone mass and an increased risk of fractures.
Procter & Gamble (P&G), the inventor of Actonel, and Hoechst Marion Roussel, the pharmaceutical company of Hoechst AG, are co-developing and co-marketing the drug. P&G and Hoechst Marion Roussel have either filed or plan to file for authorization to market Actonel in Canada and Europe, for the treatment and prevention of both post-menopausal and corticosteroid-induced osteoporosis. Actonel is not currently approved in these regions for these indications.
Osteoporosis, a disorder that weakens bones, is common among older adults, particularly post-menopausal women. One in four Canadian women and one in eight Canadian men over age 50 will suffer from osteoporosis, which leads to increased risk of fracture, according to the Osteoporosis Society of Canada. Complications associated with hip fractures can increase the risk of other serious medical conditions - even death. Expenditures for treating osteoporosis and the fractures it causes are estimated to be $1.3 billion each year in Canada alone. Long term, hospital and chronic care account for the majority of these costs.
Furthermore, the Osteoporosis Society of Canada reports that there are approximately 25,000 hip fractures in Canada each year. Seventy percent of these are osteoporosis-related. Hip fractures result in death in up to 20 percent of cases, and disability in 50 percent of those who survive.
New Trial Results Highlight Speed
Dr. Nelson Watts, professor of medicine at Emory University in Atlanta, and lead study investigator, presented the data on Actonel from two multi-centre, double-blind, placebo-controlled clinical trials that enrolled a total of 3,684 women with post-menopausal osteoporosis and a history of vertebral fracture. One trial took place in North America, while the other took place in Europe and Australia. The average age of the women in both trials was approximately 70.
In the studies, women were randomly assigned to take an oral dose of Actonel 5mg or oral placebo daily for up to three years. Each woman also took 1,000 milligrams (mg) of calcium each day, and those who had a vitamin D deficiency took up to 500 International Units (IU) of vitamin D daily.
Actonel reduced the risk of new vertebral fractures in all patients by 65 percent in the North American trial and 61 percent in the European/Australian trial after just one year, compared with the control group. Significant vertebral and non vertebral fracture reductions were maintained throughout the full three-year trial. In women with two or more fractures at the start of the study - those at the highest risk of further fracture - Actonel reduced the risk of new vertebral fractures by up to 74 percent in the North American trial and 65 percent in the European/Australian trial after just one year, compared with the control group.
"Vertebral fracture prevention is important because these fractures are the most common, and can cause chronic back pain, height loss, and spinal deformity," said Dr. Adachi. "These trial results are encouraging, because they show that Actonel may be a powerful weapon in preventing these debilitating fractures."
Actonel was generally well tolerated. The most common side effects were infection, back pain, and joint pain. These side effects, including gastrointestinal (GI) side effects, occurred at rates similar to placebo. This is particularly significant because patients enrolled in the studies included those with a history of GI problems - such as ulcers or gastroesophageal reflux disease - and/or those who were taking nonsteroidal anti-inflammatory drugs (NSAIDs) and other medications that can increase vulnerability to GI side effects. In fact, 40 percent of patients reported using NSAIDs during the study.
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