isoxicam and Osteoarthritis

Topics: Adult; Aged; Animals; Anti-Inflammatory Agents; Arthritis, Experimental; Arthritis, Rheumatoid; Clinical Trials as Topic; Collagen; Drug Interactions; Drug Tolerance; Edema; Half-Life; Humans; Kinetics; Muscular Diseases; Osteoarthritis; Oxygenases; Piroxicam; Rats; Thiazines

Within the context of a double blind randomized controlled parallel trial of 2 nonsteroidal antiinflammatory drugs, we validated WOMAC, a new multidimensional, self-administered health status instrument for patients with osteoarthritis of the hip or knee. The pain, stiffness and physical function subscales fulfil conventional criteria for face, content and construct validity, reliability, responsiveness and relative efficiency. WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials.

Topics: Aged; Aged, 80 and over; Clinical Trials as Topic; Consumer Behavior; Double-Blind Method; Evaluation Studies as Topic; Female; Health Status Indicators; Health Surveys; Hip Joint; Humans; Knee Joint; Male; Middle Aged; Osteoarthritis; Pain; Piroxicam; Random Allocation

The therapeutic efficacy and tolerability of a new controlled-release 1000 mg tablet of naproxen (naproxen CR) were compared with 200 mg isoxicam in 100 out-patients with osteoarthritis. Medications were administered once daily for 4 weeks in a controlled, randomized, double-blind, parallel trial. Patients were assessed for duration of stiffness, global pain, pain in the worst affected joint, night pain, pain on full passive movement, and pain on selected activity. No statistically significant differences were found between naproxen CR and isoxicam for any of the efficacy variables. Only 3 patients (2 with naproxen CR, 1 with isoxicam) reported adverse events, all mild to moderate; no patient withdrew from the study. At the conclusion of the study, patients and physician evaluated therapeutic response independently; both drugs provided steady improvement as judged by patients and physician. Both physician and patients evaluated naproxen CR as very good or good for 36 (72%) patients, and isoxicam as good or very good for 35 (73%) patients. Naproxen CR and isoxicam proved equally effective and well-tolerated for the treatment of osteoarthritis in this study.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Naproxen; Osteoarthritis; Piroxicam; Random Allocation

1 Fifty-seven elderly patients with primary osteoarthritis of the hip and knee were entered into a double-blind, randomized, controlled parallel group trail to compare the efficacy and tolerability of isoxicam (maximum = 200 mg day-1) and piroxicam (maximum = 20 mg day-1). 2 Clinical assessments were made following a 1 week NSAID-free washout period and at biweekly intervals during the next 6 weeks of active treatment. 3 The majority of patients in both groups experienced a clinically important and statistically significant therapeutic response. 4 No statistically significant between-group differences were noted with respect to drug efficacy. 5 One patient was withdrawn from the piroxicam group because of lack of effect, but there were no such withdrawals from the isoxicam group. 6 Five patients were withdrawn from the piroxicam group because of adverse reactions compared to only one withdrawal from the isoxicam group. 7 This study indicates that isoxicam is an efficacious and well-tolerated once-daily NSAID for elderly patients with osteoarthritis.

Topics: Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Female; Hip; Humans; Knee; Male; Middle Aged; Osteoarthritis; Piroxicam; Random Allocation

1 Two multicentre, parallel group, randomised, double-blind, double-dummy comparison studies were conducted between isoxicam in the usual dose of 200 mg once daily and naproxen 500 mg twice daily. 2 The drugs were administered for 4 weeks to 230 patients suffering from osteoarthritis of the hip and/or knee in the first trial and to 249 patients suffering from rheumatoid arthritis in the second. 3 The studies compared treatments for both safety and overall effectiveness in the relief of pain. 4 In the osteoarthritis trial, overall pain was reduced by both drugs after 2 weeks of therapy but only isoxicam produced further improvement after 4 weeks. 5 Isoxicam produced reductions comparable to those produced by naproxen in pain on standing from the sitting position, pain on walking, and pain on movement of the affected joint, after 2 and 4 weeks. 6 After 4 weeks, isoxicam given once daily in the morning was significantly more effective than naproxen given in the morning and the evening in relieving not only total pain as assessed by a visual analogue scale but, as importantly, night pain. 7 Compared to naproxen therapy, isoxicam therapy was associated with significantly more patients whose disease state was improved at 2 weeks, as assessed by physicians. 8 In the rheumatoid arthritis trial, isoxicam was equally as effective as naproxen in reducing joint tenderness, joint swelling, and pain; at 4 weeks there was a trend in favour of isoxicam in reduction of joint swelling and pain. 9 Isoxicam reduced morning stiffness significantly more than naproxen after 4 weeks; this trend was apparent at 2 weeks.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Double-Blind Method; Female; Humans; Male; Middle Aged; Naproxen; Osteoarthritis; Pain Measurement; Piroxicam; Random Allocation

A study was conducted in general practice to assess the efficacy and safety of isoxicam 200 mg once daily compared with indomethacin 25 mg 3 times a day in the treatment of acute exacerbations of osteo-arthritis. The trial was conducted as a multicentre, double-blind, randomized parallel-group study with 'dummy loading' of the medications. Thirty-one general practitioners entered 309 patients in the study. Of these, 139 patients on isoxicam and 137 on indomethacin completed the treatment. The most common sites of osteo-arthritis were the knee (100 patients) and the hip (79 patients). On examination at 7 days and 14 days there was a significant improvement in both treatment groups. After 7 days the reduction of pain and clinical symptoms of osteo-arthritis of the hip and knee was significant for both drugs at the P less than 0,001 level. There thus appeared to be no difference in clinical efficacy between the drugs. Eight patients in the isoxicam group experienced definite drug-related adverse reactions as against 19 in the indomethacin group. A total of 38 patients (18 on isoxicam and 20 on indomethacin) suffered probably drug-related effects. Isoxicam therefore appeared to be better tolerated than indomethacin.

Topics: Acute Disease; Adult; Aged; Anti-Inflammatory Agents; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Indomethacin; Male; Middle Aged; Osteoarthritis; Palliative Care; Piroxicam; Thiazines

Thirteen patients with osteo-arthritis entered a 12-month open-label assessment of the efficacy and safety of a single morning dose of isoxicam 200 mg. Pain scale scores were significantly reduced and this was accompanied by improvement in most of the symptoms. No patients suffered adverse reactions considered to be definitely related to the use of isoxicam and only 3 patients reported adverse reactions (mild weight gain, stomatitis, constipation) probably related to treatment. Isoxicam 200 mg once a day was effective and well tolerated in the long-term symptomatic treatment of osteo-arthritis.

Topics: Aged; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Osteoarthritis; Pain; Piroxicam; Thiazines; Time Factors

Topics: Adult; Anti-Inflammatory Agents; Arthritis, Rheumatoid; Aspirin; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Indomethacin; Osteoarthritis; Piroxicam; Spondylitis, Ankylosing; Thiazines

Topics: Adolescent; Adult; Aged; Animals; Anti-Inflammatory Agents; Arthritis, Rheumatoid; Clinical Trials as Topic; Drug Interactions; Humans; Kinetics; Middle Aged; Osteoarthritis; Piroxicam; Spondylitis, Ankylosing; Thiazines

The frequencies of adverse reactions in patients younger than 65 years and 65 and older were compared for dosages of isoxicam ranging from 200 to 600 mg per day. Data were collected from the records of 2,184 patients younger than 65 years and 1,059 patients 65 years or older from controlled and open studies of patients with osteoarthritis, rheumatoid arthritis, or musculoskeletal disorders. For both age groups, the most common adverse reactions were gastrointestinal. For other adverse reactions, the frequencies were notably lower than for gastrointestinal reactions. For virtually all adverse reactions, the frequencies were similar for the two age groups. Among patients who received only the recommended dosage of 200 mg per day, the frequencies of all reactions were lower than among the entire population and were similar between the two age groups. On the basis of this study, it appears that isoxicam is equally well tolerated in patients who are younger than 65 and those 65 and older.

Topics: Aged; Aging; Arthritis, Rheumatoid; Clinical Trials as Topic; Edema; Female; Gastrointestinal Diseases; Humans; Male; Middle Aged; Osteoarthritis; Piroxicam; Thiazines

Topics: Aged; Anti-Inflammatory Agents; Arthritis, Rheumatoid; Double-Blind Method; Female; Half-Life; Humans; Male; Osteoarthritis; Piroxicam; Thiazines

Topics: Adult; Aged; Animals; Anti-Inflammatory Agents; Arthritis, Experimental; Arthritis, Rheumatoid; Clinical Trials as Topic; Collagen; Drug Interactions; Drug Tolerance; Edema; Half-Life; Humans; Kinetics; Muscular Diseases; Osteoarthritis; Oxygenases; Piroxicam; Rats; Thiazines

Topics: Adult; Aged; Animals; Anti-Inflammatory Agents; Arthritis; Drug Tolerance; Hip Joint; Humans; Knee Joint; Male; Middle Aged; Osteoarthritis; Piroxicam; Thiazines

Topics: Adult; Aged; Anti-Inflammatory Agents; Arthritis, Rheumatoid; Drug Tolerance; Female; Humans; Male; Middle Aged; Osteoarthritis; Piroxicam; Thiazines