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New Medicine Used In Acute Injury Management

MEDIACOM-RELEASE-MERCK SHARP & DOHME

NEW MEDICINE USED IN ACUTE INJURY MANAGEMENT

The Highlanders have begun using a new medicine for pain and inflammation as a part of their management of acute injuries in the Super 12.

Team members requiring prescription treatment for these complaints are being introduced by their team doctor, Steve Bentley, to Vioxx? (rofecoxib, msd), which was given its New Zealand launch at the home of the Highlanders, Carisbrook, in Dunedin today (Wednesday 22 March 2000).

Vioxx has been approved by the Ministry of Health for the management of acute pain in adults, the relief of the signs and symptoms of osteoarthritis (OA), and treatment of menstrual pain (primary dysmenorrhea).

Vioxx belongs to a new class of medicine, designated by the World Health Organisation as coxibs, which offer relief of pain and inflammation equal to that of the highest doses of non-steroidal anti-inflammatory drugs (NSAIDs) but with fewer side effects.

How Vioxx Works

At recommended doses, scientists believe Vioxx blocks the enzyme that triggers pain and inflammation (COX-2), while sparing a related enzyme that helps maintain the normal stomach lining (COX-1). In general, traditional NSAIDs block both enzymes. They treat pain and inflammation, but may damage the stomach lining, potentially leading to ulcers in some patients.

"Everyday Victories"

Speaking at the launch of Vioxx, Alister Brown - managing director of pharmaceutical company Merck Sharp & Dohme (NZ) Ltd. - said the arrival of Vioxx would prove significant for New Zealand sufferers of pain and inflammation.

"Vioxx can't take away the pain of losing but it may help New Zealand's elite sports men and women and their fans win everyday victories over pain and inflammation. "We are proud that our new medicine may help some of the world's top rugby players who regularly grace Carisbrook. While we expect the biggest market in New Zealand for Vioxx will be among people with osteoarthritis and pain, the proven advantages of Vioxx over NSAIDs may see it used widely by sports enthusiasts at all levels."

Important information:

Vioxx was evaluated for the treatment of the signs and symptoms of OA in placebo- and active-controlled clinical trials of six to 86 weeks that included approximately 3,900 patients. The effectiveness of Vioxx 12.5 mg and 25 mg once a day was shown to be comparable to prescription-strength non-steroidal, anti-inflammatory drugs (NSAIDs) ibuprofen 800 mg three times a day and diclofenac 50 mg three times a day for treatment of the signs and symptoms of OA. The ibuprofen studies were six-week studies; the diclofenac studies were 12-month studies in which patients could receive additional arthritis medication during the last six months. In all OA clinical studies, once-daily treatment in the morning with Vioxx 12.5 mg and 25 mg was associated with a significant reduction in joint stiffness upon first awakening in the morning.

Furthermore, in two six-month studies of OA patients, treatment with Vioxx 25 mg daily or 50 mg daily was associated with a significantly lower percentage of patients with gastroduodenal ulcers, as detected by an endoscope, than treatment with ibuprofen 2,400 mg daily. An endoscope is an instrument designed to look inside the stomach. The correlation between findings of endoscopic studies, and the relative incidence of clinically serious upper gastrointestinal (GI) events that may be observed with different products, has not been fully established. Serious clinically significant upper GI bleeding has been observed in patients receiving Vioxx in controlled trials, albeit infrequently. Prospective, long-term studies required to compare the incidence of serious, clinically significant upper GI adverse events in patients taking Vioxx versus comparator NSAID products have not been performed.

In studies of post-operative dental pain, post-orthopedic surgical pain, and primary dysmenorrhea, Vioxx relieved pain that was rated by patients as moderate to severe. Studies lasted up to five days. The analgesic effect (including onset of action) of a single 50 mg dose of Vioxx was generally similar to naproxen sodium 550 mg or ibuprofen 400 mg.

Selected Cautionary Information

The most common side effects reported in clinical trials with Vioxx were upper-respiratory infection, diarrhea and nausea. People who have had an allergic reaction to Vioxx, aspirin or other traditional NSAIDs should not take Vioxx.

Although Vioxx has a low potential for stomach ulcers, serious GI ulcers can occur without warning symptoms. Physicians and patients should remain alert for signs and symptoms of GI bleeding. Vioxx should not be taken by women in late pregnancy. Safety and effectiveness in children have not been evaluated.

Dosing Information

The recommended dose for OA is 12.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 25 mg once daily. For acute pain, the recommended dose is Vioxx 50 mg once daily. Use of Vioxx for more than five days for the management of pain has not been studied.

The US parent company of Merck Sharp & Dohme (NZ) Ltd. - Merck & Co., Inc. - is a global, research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of human and animal health products.

MEDIA RELEASE

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