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Arthrotec Significantly Better Than Acetaminophen (Tylenol) For Osteoarthritis

  [ 58 votes ]   [ Discuss This Article ]
By News Release • • January 19, 2000

BOSTON, MA -- Results of a study comparing Arthrotec and acetaminophen (APAP)* [for] arthritis were presented in three abstracts, including one as a podium presentation given by Dr. Theodore Pincus, at this week's 63rd Annual Meeting of the American College of Rheumatology. In this clinical trial, Arthrotec significantly improved osteoarthritis (OA) patients' condition by reducing pain and stiffness, increasing physical function and positively affecting overall quality of life.

Arthrotec (diclofenac sodium 50/75 mg and misoprostol 200 mcg) is the only arthritis therapy combining misoprostol and a nonsteroidal anti-inflammatory drug (NSAID) approved to treat the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients who are at high risk of NSAID-induced stomach ulcers and their complications.

This multi-center study used a randomized, double-blind cross-over trial design to compare six weeks of therapy with Arthrotec 75 twice a day (diclofenac sodium 75 mg/misoprostol 200 mcg) for a total dose of 150 mg, versus acetaminophen four times daily, for a total dose of 4,000 mg.

*Acetaminophen is marketed by Ortho McNeil in the U.S. under the brand name Tylenol.

Patients were treated for six weeks, and following a washout period, crossed over to the other treatment. One hundred and eighty patients with osteoarthritis of the hip or knee, all of whom were over 40 years old and had a score of 3 centimeters or greater on a pain scale (0-10 cm), completed both treatments. The study was supported by Searle.

Three standard patient questionnaires were used in the study to evaluate clinical pain, functional status and quality of life. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assesses pain, stiffness and physical function; the modified health assessment questionnaire (MHAQ) evaluates functional status in activities of daily living, such as walking, eating, dressing, as well as pain and global status; and the SF-36 is a quality of life questionnaire, which evaluates eight areas of health status, including physical functioning, role limitations due to physical and emotional problems, bodily pain, mental health, social functioning, vitality and general health perceptions.

A comparison of WOMAC scores suggests that Arthrotec has greater efficacy than acetaminophen in improving pain, stiffness and disability of patients with OA of the hip or knee; pain improvement was also seen on the MHAQ and the SF-36 pain scales. An analysis of patient responses from all three widely used a validated outcomes questionnaires indicated that Arthrotec had a positive effect on functional ability and health-related quality-of-life greater than that of acetaminophen.

"We are pleased that clear quality of life improvements were demonstrated for patients receiving Arthrotec, regardless of treatment sequence or the assessments used to measure the improvements," said Dr. Theodore Pincus, lead investigator. "These results, when combined with the fact that Arthrotec carries a lower risk for causing GI ulcers (when compared to diclofenac alone), offer substantial evidence that this drug is an excellent treatment option for high risk osteoarthritis patients."

A greater number of gastrointestinal adverse events (like diarrhea, nausea, abdominal pain and dyspepsia) were reported by patients in this study when they took Arthrotec compared to acetaminophen and the MHAQ GI distress score was increased in patients who took Arthrotec. Diarrhea, a recognized adverse event associated with the misoprostol component of Arthrotec, was reported by 19 percent of patients while on Arthrotec, but also by 16 percent of patients while they took acetaminophen.

Arthrotec consists of an outer layer containing misoprostol (a drug that activates the stomach's natural protection and has been proven to significantly reduce the incidence of NSAID-induced stomach ulcers) that surrounds a core of diclofenac, an NSAID, coated to bypass the stomach and be absorbed in the intestine. The inclusion of misoprostol in a unique formulation tablet provides gastrointestinal mucosal protection, while maintaining the efficacy of diclofenac.

Although Arthrotec contains misoprostol, which has been shown to reduce the incidence of endoscopically diagnosed NSAID-induced gastric and duodenal ulcers, serious GI toxicity, such as inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.

Arthrotec is contraindicated in women who are pregnant or who may become pregnant. Arthrotec can cause miscarriage, often associated with bleeding, which may result in other serious complications. Arthrotec is also contraindicated in patients with hypersensitivity to diclofenac or misoprostol or other prostaglandins, and in patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to diclofenac sodium have been reported.

Source: Searle & Co.

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