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| |  FDA Clears Arthrotec For Arthritis Therapy SKOKIE, IL -- December 29, 1997 -- The United States Food and Drug Administration has granted marketing clearance to Searle’s Arthrotec(R) (diclofenac sodium 50 or 75 mg/misoprostol 200 mcg), the first arthritis therapy that provides both non-steroidal anti-inflammatory drug (NSAID) strength and GI mucosal (stomach lining) protection against ulcers. Arthrotec, the only product indicated to relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis in patients at high risk for NSAID-induced ulcers and their complications, demonstrated a 65 to 80 percent lower incidence of such ulcers when compared to other commonly used NSAID therapies in worldwide clinical trials. "At the same time, arthritis sufferers will have a new treatment option available to them to manage their pain while minimising their risk of ulcer complications." NSAIDs work by reducing prostaglandins -- naturally-occurring substances that mediate inflammation in the joints. However, prostaglandins also are responsible for protecting the mucosal lining of the stomach and duodenum. Depleted prostaglandin levels in the stomach from chronic NSAID use can lead to a number of potentially serious side effects, including bleeding ulcers and perforating ulcers. The inclusion of misoprostol in Arthrotec helps to protect the lining of the GI tract by reducing acid production, stimulating secretion of naturally-protective mucus and bicarbonate and promoting adequate blood flow. Studies suggest nearly 25 percent of arthritis patients who chronically take NSAIDs can develop ulcers or lesions, which lead to approximately 7,600 deaths and 76,000 hospitalisations in the U.S. annually. The NSAID-related mortality rate is higher than deaths due to cervical cancer, melanoma and asthma. "There are two key reasons why this is an important public health concern. The first is that a significant sub-population of patients are at high risk for ulcers. Moreover, these patients commonly develop NSAID-induced ulcers without symptoms. It's not unusual to be symptom-free one day and the next day wake up requiring immediate medical attention for a bleeding ulcer," Dr. Simon said. "Secondly, people don't know how to gauge their personal risk. Once physicians and patients understand how to assess risk profiles, treatment decisions can be tailored to meet the medical needs of the individual." Although all NSAID users have a three-fold greater risk of developing serious GI complications over non-NSAID users, there are specific risk factors that increase the likelihood of GI damage even more substantially. One of the biggest risk factors is older age. With increasing age, GI defence mechanisms decrease, causing individuals to be more susceptible to NSAID-induced GI complications such as ulcers. Other risk factors include: history of gastrointestinal bleeding; history of peptic ulcer disease; longer duration of NSAID therapy; co-therapies including oral corticosteroids, anti-coagulants, or concurrent use of H2 receptor antagonists (acid blockers) and antacids; poor general health including cardiovascular disease; co-morbidities such as alcoholism or smoking; H-pylori positive status Level of risk for NSAID-induced GI complications varies from patient to patient. Therefore, experts are developing clinically-based risk calculators to help both healthcare professionals and their patients determine individual risk profiles. The therapeutic benefits of Arthrotec have been demonstrated in controlled, double-blind international clinical trials involving approximately 2,000 patients. Studies have demonstrated its innovative profile - powerful anti-inflammatory and analgesic properties, and GI mucosal protection -- leading to arthritis relief and significantly fewer GI ulcers, compared to diclofenac,4,5 naproxen or piroxicam alone (naproxen and piroxicam studies in U.S. only).
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