Health Canada Approves VIMOVO, the First NSAID-PPI Combination to Treat Osteoarthritis Pain and Inflammation While Reducing the Risk of NSAID-associated Ulcers

Without GI protection, 87 per cent of NSAID users are at increased risk of developing GI complications

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MISSISSAUGA, ON, April 27 /PRNewswire/ - AstraZeneca Canada Inc. announced today that Health Canada has approved VIMOVO^® modified-release tablets for the treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric ulcers.ⁱ  VIMOVO is the first fixed-dose combination of enteric-coated naproxen, an NSAID, and immediate-release esomeprazole, a proton pump inhibitor (PPI).

The approval of VIMOVO was supported by data from a clinical development program, including results from the PN400-301 and PN400- 302 studies, which demonstrated that subjects taking VIMOVO experienced significantly fewer gastric ulcers and NSAID-associated upper GI adverse events, had significantly less treatment discontinuations, and as measured through patient reports of dyspepsia and heartburn, had better upper gastrointestinal tolerability compared to subjects receiving enteric-coated naproxen alone.ⁱⁱ

"While NSAIDs are effective at relieving the pain and inflammation associated with osteoarthritis, many patients discontinue use and live in pain due to gastrointestinal side-effects or safety concerns," says Dr. Peter Lin, family physician in Toronto. "VIMOVO combines an NSAID and PPI together into one pill allowing patients to have pain relief while protecting their stomach."

Osteoarthritis, which affects three million Canadians,ⁱⁱⁱ is the most common form of arthritis and is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints. A common misconception is that arthritis is a disease of the elderly. In fact almost 60 per cent (58 per cent) of arthritis patients are under the age of 65.^iv While many patients with osteoarthritis treat their symptoms with NSAIDs, 87 per cent of chronic NSAID-users are at increased risk of gastrointestinal (GI) complications.^v

An estimated 1,900 Canadians die every year from complications associated with NSAID consumption.^vi Risk factors for NSAID-associated upper GI clinical events include: age, history of GI events, concomitant use of oral corticosteroids and anticoagulants, high-dose/multiple NSAID use and concomitant use of aspirin.^vii

A new survey of Canadian osteoarthritis patients found 37 per cent of patients at risk of NSAID-associated GI complications were not aware they were at risk and the majority could not identify risk factors for developing GI side effects associated with NSAID use.^viii In addition, 33 per cent of patients with osteoarthritis discontinued their GI medication because they started to "feel better" (45 per cent) and preferred to take less medication (40 per cent).^viii Thirty per cent of respondents experienced GI complications as a result of stopping their GI medication continuing on their NSAID therapy.^viii

References
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ⁱ VIMOVO ® Canadian Product Monograph. AstraZeneca Canada Inc. January 13, 2011. ⁱⁱ Goldstein, et al. PN 400 significantly reduces the incidence of gastric ulcers compared with enteric-coated naproxen in patients requiring chronic NSAID therapy regardless of low-dose aspirin use: results from two prospective, randomized controlled trials. Alimentary Pharmacology & Therapeutics 2010; 32: 401-413. ⁱⁱⁱ The Arthritis Society. Osteoarthritis. http://www.arthritis.ca/types%20of%20arthritis/osteoarthritis/default.asp?s=1&province=qc. Accessed January 29, 2011. ^iv Public Health Agency of Canada. 2010 life with arthritis in Canada - A personal and public health challenge. http://www.phac-aspc.gc.ca/cd-mc/arthritis-arthrite/lwaic-vaaac-10/index-eng.php. Accessed February 18, 2011. ^v Lanas, et al. Assessment of gastrointestinal and cardiovascular risk in patients with osteoarthritis who require NSAIDs: the LOGICA study. Ann Rheum Dis 2010;69:1453-1458. ^vi Hunt, et al. Recommendations for the appropriate use of anti-inflammatory drugs in the era of coxibs: Defining the role of gastroprotective agents. Canadian Journal of Gastroenterology 2002;16 (4): 231-240. ^vii Rostom, et al. Canadian consensus guidelines on long-term nonsteroidal anti-inflammatory drug therapy and the need for gastroprotection: benefits versus risks. Alimentary Pharmacology & Therapeutics 2009;29: 481-496 ^viii Leger Marketing. Osteoarthritis Survey. January 29, 2011.

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About AstraZeneca Canada

AstraZeneca is committed to the research, development and manufacturing of valuable prescription medicines. We have an extensive product portfolio spanning six therapeutic areas: gastrointestinal, cardiovascular, infection, neuroscience, oncology and respiratory. AstraZeneca's Canadian headquarters are located in Mississauga, Ontario, and a state-of-the art drug discovery centre is based in Montreal, Quebec.  For more information, please visit the company's website at www.astrazeneca.ca.

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SOURCE AstraZeneca Canada Inc.