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

April 27, 2011

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

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

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)


(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.


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.

Source: newswire

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