To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Health Canada Approves Once-Daily Vioxx For Relief Of Osteoarthritis Symptoms URL: http://www.pslgroup.com/dg/141FCE.htm Doctor's Guide November 4, 1999
MONTREAL, QC -- November 4, 1999 -- Health Canada has approved a once-daily formulation which offers effective proven treatment for the relief of the signs and symptoms of osteoarthritis (OA) in adults. Merck Frosst teams discovered Vioxx(TM) (rofecoxib), a COX-2 specific anti-inflammatory/analgesic agent which offers a superior gastrointestinal (GI) tolerability profile. Vioxx has also been approved for the relief of pain in adults and the treatment of primary dysmenorrhea.
The new medication, which received fast-track review by Health Canada, has been approved in 22 other countries including the US, where it is now the fastest growing prescription arthritis medicine with more than 2.2 million prescriptions since its approval in May. This makes it one of the most successful product introductions in the pharmaceutical industry's history in that country.
"Rofecoxib, known as Vioxx, is an exciting new pharmaceutical option for patients with arthritis where a good balance between tolerability and efficacy is desired," said Dr. Claire Bombardier, rheumatologist at The Toronto Hospital. "Clinical studies have shown Vioxx to be effective and well tolerated in a wide range of patients - including those who are difficult to treat such as the frail and elderly, patients who are taking other medications and those who are allergic to sulfonamides."
In clinical studies, Vioxx has been shown to offer effective proven treatment for the relief of the signs and symptoms of osteoarthritis in adults. In two six-week and one-year trials, involving 1545 and 1467 patients with osteoarthritis respectively, Vioxx was generally well tolerated regardless of age, race or gender of patients. The randomized trials examined Vioxx once-a-day 12.5 mg/25 mg, diclofenac 50 mg three times a day, ibuprofen 800 mg three times a day or placebo. (1,2,3,4) Separate studies evaluating gastrointestinal blood loss and intestinal permeability, both sensitive indicators of GI damage, showed that Vioxx had a safety profile comparable to placebo.(5,6)
A pilot endoscopy study, conducted in healthy volunteers who took up to 250 mg dose of Vioxx (10- to 20-times above the recommended clinical dose range of 12.5 mg to 25 mg per day for osteoarthritis) over a period of one week, demonstrated that there was no significant increase in gastroduodenal erosion with the drug when compared to placebo.(7) Additionally, further studies conducted in high risk osteoarthritis patients, for up to 24 weeks, demonstrated no significant microscopic gastrointestinal tract injury with 25 or 50 mg Vioxx (8,9). Again, this result was comparable to placebo.
The clinical profile of Vioxx has been established across a broad range of patients - even those who are difficult to treat. Clinical studies showed no overall differences in tolerability and efficacy between elderly and younger patient types.(3,4,8,9 ) The advantage of Vioxx was also maintained in higher risk groups that included patients with active Helicobacter pylori infection (often associated with duodenal ulcers), those with baseline gastroduodenal erosions and/or a prior history of perforation, ulcer or bleed (PUB).(8,9,10,11)
Non-steroidal anti-inflammatory drugs (NSAIDs) are currently the most commonly prescribed medications used to relieve the pain and inflammation due to OA. NSAIDs inhibit both COX-1 and COX-2 causing potentially serious gastrointestinal side effects and adverse effects on platelet function. Approximately 10 million NSAID prescriptions are written each year in Canada and it is estimated that between two and four percent of NSAID users suffer chronic or severe gastrointestinal problems that include ulcers, stomach perforations and bleeds. Approximately 38 to 40 percent of elderly patients use NSAIDs to treat osteoarthritis. According to The Arthritis Society of Canada, an estimated 1900 Canadians die every year from complications associated with NSAIDs.
Vioxx is not contraindicated in patients with sulfonamide allergies. Approximately five percent of the Canadian population is susceptible to this form of allergy, which produces hypersensivity reactions such as rashes and GI sensitivities for example nausea, vomiting and diarrhea.
"We believe that Canadian-discovered Vioxx offers a potentially better and a more precise pathway to arthritis pain relief and lower risk of serious gastrointestinal side effects," said Dr. Robert Young, vice-president, Medicinal Chemistry. Vioxx works by inhibiting an enzyme called cyclooxygenase-2 (COX-2) that is considered one of the causes of arthritis pain and inflammation without blocking cyclooxygenase-1 (COX-1), a related enzyme that produces prostaglandins which are critical in protecting the lining of the stomach and for normal platelet function. It will be available in Canada by prescription mid-November, 1999.
Arthritis is a chronic disease now affecting more than four million Canadians. It is characterized by pain and inflammation of the joints, it affects the knees, feet, hips, fingers, shoulders and spine. Osteoarthritis, the most common form of arthritis affecting one in ten Canadians, is a degenerative joint disease characterized by the deterioration of joint cartilage and adjacent bones. As one of Canada's top three chronic conditions, arthritis is the most common cause of long-term disability in the country accounting for more than 25 percent of all long-term disability cases. About 10 years ago, the economic impact of arthritis in Canada was estimated at over $5 billion per year. According to The Arthritis Society, more recent studies suggest that the cost is closer to $10 billion. With the aging of our population, the number of Canadians with arthritis will rise by one million per decade and the costs associated with arthritis are expected to escalate.
References:
1. Saag et al. Arthritis Rheum. 1998;41 (suppl):S196
2. Day R et al. Ann Rheum Dis (EULAR) June 1999, p207 (Abst #860)
3. Cannon et al. Arthritis Rheum. 1998;41 (suppl):S196
4. Acevedo E et al. Ann Rheum Dis (EULAR) June 1999, p206 (Abst#858)
5. Hunt et al. Am J Gastroenterol 1998; 93:16671
6. Bjamason et al. Am J Gastroenterol. 1998; 93:1670
7. Lanza F et al. Aliment Pharmacol Ther 1999 June; 13(6): 761-7
8. Laine et al. Gastroenterol 1999; 116(4): A229
9. Hawkley et al. Annals Rheum Dis 1999; Abstr. 861:207
10. Langman M et al. Gastroenterol 1999; 116(4): A232
11. Langman M et al. Annals Rheum Dis 1999; Abst. 862, p207.
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