To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Clears Arthrotec For Arthritis Therapy URL: http://www.pslgroup.com/dg/4F692.htm Doctor's Guide December 29, 1997
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. The dual action of Arthrotec results from its unique formulation, consisting of an enteric-coated core containing diclofenac sodium (50 or 75 mg) surrounded by an outer mantle containing misoprostol (200 mcg). Diclofenac is one of the most widely-used NSAIDs in the world, while misoprostol is the only medication proven to reduce the incidence of NSAID-induced stomach and duodenal (upper small intestine) ulcers and their serious complications. "For the first time in the U.S., there truly is an arthritis treatment that delivers both NSAID efficacy and improved GI mucosal safety in a single tablet. Physicians continually balance the risks and benefits of NSAID therapy especially for those patients at high risk who could develop a serious GI complication," said Lee Simon, MD, associate professor of medicine at Harvard Medical School/Beth Israel Deaconess Medical Center and an Arthrotec clinical investigator. "Arthrotec will provide a new level of confidence for physicians who treat this vulnerable patient population. "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). Arthrotec was well-tolerated by most patients in clinical trials. The most common side effects, which were usually mild and transient, lasting less than one week, include abdominal pain, diarrhea and stomach upset. Because Arthrotec is an NSAID-containing formulation, there remains a risk of ulcers and GI bleeding, though two-to-three times less than with diclofenac and the other studied NSAIDs. Arthrotec contraindications include use in women who are pregnant or who may become pregnant. Today, Arthrotec is available in over 40 countries, and now ranks among the best-selling branded NSAIDs in Germany, the United Kingdom, Sweden, the Netherlands and Canada. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.