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ACTONE OFFERED FOR PREVENTION/TREATMENT OF OSTEOPOROSIS.


Procter & Gamble Pharmaceuticals Canada, Inc. and Aventis Pharma Inc. have introduced 5mg Actonel(R) (risedronate sodium risedronate sodium

Actonel

Pharmacologic class: Bisphosphonate

Therapeutic class: Calcium regulator

Pregnancy risk category C

Action

 tablets) for the treatment and prevention of postmenopausal post·men·o·paus·al
adj.
Of or occurring in the time following menopause.


postmenopausal Change of life Gynecology adjective Referring to the time in ♀ when menstrual periods stop for ≥ 1 yr
 osteoporosis (PMO PMO Prime Minister's Office
PMO Premier Oil Plc (stock symbol)
PMO Pasteurized Milk Ordinance (USA Milk Industry)
PMO Provost Marshal's Office
PMO Postmenopausal Osteoporosis
). Actonel, a new bisphosphonate, is the only osteoporosis medication currently proven to reduce the risk of vertebral ver·te·bral
adj.
1. Of, relating to, or of the nature of a vertebra.

2. Having or consisting of vertebrae.

3. Having a spinal column.
 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.

UNIQUE BENEFITS OF ACTONEL

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 vitamin D

Any of a group of fat-soluble alcohols important in calcium metabolism in animals to form strong bones and teeth and prevent rickets and osteoporosis. It is formed by ultraviolet radiation (sunlight) of sterols (see steroid) present in the skin.
. 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 rheumatologist /rheu·ma·tol·o·gist/ (roo?mah-tol´ah-jist) a specialist in rheumatology.

rheu·ma·tol·o·gist
n.
A specialist in the diagnosis and treatment of rheumatic disorders.
 and Professor, Department of Medicine at St. Joseph's Hospital St. Joseph's Hospital may refer to:

In the United States:
  • St. Joseph's Hospital — Atlanta, Georgia
  • St. Joseph's Hospital — Breese, Illinois
  • St. Joseph's Hospital — Chippewa Falls, Wisconsin
  • Cloud County Health Center (Formerly "St.
, 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 esophagitis /esoph·a·gi·tis/ (e-sof?ah-ji´tis) inflammation of the esophagus.

chronic peptic esophagitis  reflux e.
, and heartburn heartburn, burning sensation beneath the breastbone, also called pyrosis. Heartburn does not indicate heart malfunction but results from nervous tension or overindulgence in food or drink.  -- and those taking nonsteroidal anti-inflammatory drugs Nonsteroidal Anti-Inflammatory Drugs Definition

Nonsteroidal anti-inflammatory drugs are medicines that relieve pain, swelling, stiffness, and inflammation.
 (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 Asa (ā`sə), in the Bible, king of Judah, son and successor of Abijah. He was a good king, zealous in his extirpation of idols. When Baasha of Israel took Ramah (a few miles N of Jerusalem), Asa bought the help of Benhadad of Damascus and  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 Side effects

Effects of a proposed project on other parts of the firm.
 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.

OSTEOPOROSIS IN CANADA

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 $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 Deformity
See also Lameness.

Calmady, Sir Richard

born without lower legs. [Br. Lit.: Sir Richard Calmady, Walsh Modern, 84]

Carey, Philip

embittered young man with club foot seeks fulfillment. [Br. Lit.
, 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
The University of Ottawa or Université d'Ottawa in French (also known as uOttawa or nicknamed U of O or Ottawa U) is a bilingual [1], research-intensive, non-denominational, international university in Ottawa, Ontario.
. "There is a need for improved diagnosis and treatment of this devastating dev·as·tate  
tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates
1. To lay waste; destroy.

2. To overwhelm; confound; stun: was devastated by the rude remark.
 condition. Actonel is a welcome addition to our treatment options, offering new benefits to Canadian physicians and patients."

Clinical trials were conducted primarily in North America and Europe, including 13 sites in Canada.

SHIFT IN DIAGNOSIS AND TREATMENT OF OSTEOPOROSIS

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-Francois Leprince, President, Aventis Pharma Inc. "Now more than ever, it is critically important that Canadians recognize the urgency to diagnose and treat osteoporosis."

ABOUT ACTONEL

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(R).

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."

THE ALLIANCE FOR BETTER BONE HEALTH - P&G AND AVENTIS PHARMA

Procter & Gamble, which developed Didrocal(R) (etidronate disodium et·i·dro·nate disodium
n.
A drug that affects bone resorption and is used in the treatment of Paget's disease, heterotopic ossification, and hypercalcemia of malignancy.
 and calcium carbonate calcium carbonate, CaCO3, white chemical compound that is the most common nonsiliceous mineral. It occurs in two crystal forms: calcite, which is hexagonal, and aragonite, which is rhombohedral. ), the first bisphosphonate approved in Canada for postmenopausal osteoporosis, and Aventis Pharma Inc. formed The Alliance for Better Bone Health in May 1997 to develop and market Actonel. The innovative nature of the Alliance serves to advance the cutting edge of bone disease awareness, prevention and treatment.

Procter & Gamble Pharmaceuticals is a part of Procter & Gamble Health Care, a division of The Procter & Gamble Company -- a US $38 billion global leader in the development, manufacturing, and marketing of a broad range of consumer goods consumer goods

Any tangible commodity purchased by households to satisfy their wants and needs. Consumer goods may be durable or nondurable. Durable goods (e.g., autos, furniture, and appliances) have a significant life span, often defined as three years or more, and
. In prescription drugs, P&G is focusing on musculoskeletal musculoskeletal /mus·cu·lo·skel·e·tal/ (-skel´e-t'l) pertaining to or comprising the skeleton and muscles.

mus·cu·lo·skel·e·tal
adj.
Relating to or involving the muscles and the skeleton.
 and cardiovascular health, as well as anti-infective therapies. Two of P&G's leading prescription products are Didrocal(R) (etidronate disodium & calcium carbonate) and Asacol(R) (mesalamine). The Canadian head office of P&G is based in Toronto.

Aventis Pharma Inc. is the Canadian pharmaceutical business of Aventis S.A., one of the world's leading life sciences companies focusing on two core areas -- pharmaceuticals and agriculture. Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at satisfying unmet medical needs. The corporate headquarters of Aventis Pharma is in Frankfurt, Germany. The Canadian operations employ 690 people and are headquartered in Laval, Quebec.

For further information, call (604)488-1100.
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Publication:Worldwide Biotech
Date:Oct 1, 2000
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