isoxicam and Joint-Diseases

Topics: Acute Disease; Adult; Aged; Anti-Inflammatory Agents; Clinical Trials as Topic; Female; Gout; Humans; Joint Diseases; Male; Middle Aged; Piroxicam; Thiazines

A new nonsteroidal anti-inflammatory drug, isoxicam (Maxicam), was studied in patients with degenerative joint disease of the knee or hip. During a six-week, double-blind, placebo-controlled phase involving 176 patients, isoxicam at a dosage of 200 mg once daily was significantly superior to placebo in parameters (knee) of night pain, pain on walking, starting pain, pain on motion, swelling, tenderness, maximal extension, maximal flexion, and limitation of range of motion, and in the parameter (hip) of pain on walking. In patients with knee involvement and those with hip involvement, isoxicam was superior to placebo in overall and global assessments of its efficacy by physicians and patients. When 165 patients continued in a long-term, open-label phase and received isoxicam, a further alleviation of symptoms was noted in those patients who had received isoxicam in the double-blind phase, and a marked and sustained improvement was seen in patients who had received placebo in the double-blind phase.

Topics: Adult; Aged; Clinical Trials as Topic; Double-Blind Method; Drug Evaluation; Female; Hip Joint; Humans; Joint Diseases; Knee Joint; Male; Middle Aged; Pain; Piroxicam; Thiazines

A three-month, double-blind, indomethacin-controlled, European multicenter study of isoxicam (Maxicam), a nonsteroidal anti-inflammatory drug, was conducted in 365 patients who had degenerative joint disease of the knee or hip. Patients were randomly assigned to receive one of two treatments: isoxicam, 133 mg per day (Week 1), 166 mg per day (Week 2), and 200 mg per day (Weeks 3 to 12); or indomethacin, 100 mg per day (Week 1), 125 mg per day (Week 2), and 150 mg per day (Weeks 3 to 12). Efficacy measurements included, for patients with knee or hip involvement, intensity of starting pain on motion, pain on walking, night pain, overall assessment by physician and patient, and global assessment at the end of treatment; maximal extension and flexion (knee); extent of pain-free abduction and maximal abduction (hip). The results of the efficacy measurements favor isoxicam over indomethacin, although the differences are not statistically significant. The isoxicam group had significantly fewer adverse reactions than the indomethacin group.

Topics: Administration, Oral; Adult; Aged; Clinical Trials as Topic; Double-Blind Method; Drug Evaluation; Female; Hip Joint; Humans; Indomethacin; Joint Diseases; Knee Joint; Male; Middle Aged; Piroxicam; Random Allocation; Thiazines

Data collected from more than 1,800 patients with rheumatoid arthritis or degenerative joint disease in Phase 3 clinical studies of isoxicam (Maxicam) indicated that the drug is well tolerated on both a short-term and a long-term basis. The most common type of adverse reaction to all medications (isoxicam, aspirin, and indomethacin) was gastrointestinal: 22.6 percent with isoxicam, at a dosage greater than 200 mg per day; 14.2 percent with isoxicam at 200 mg per day; 31.6 percent with buffered aspirin at 3,600 to 4,800 mg per day; 24.6 percent with indomethacin at 150 mg per day; and 7.2 percent with placebo. The incidence of tinnitus and deafness was significantly greater with buffered aspirin than with isoxicam, and the number of patients who had at least one episode of dizziness, vertigo, or headache was significantly greater with indomethacin than with isoxicam. In open-label, long-term studies, in which approximately 70 percent of the patients participated, the types and frequencies of adverse effects were similar to those observed with isoxicam during the controlled studies. The overall frequency of withdrawal for adverse reactions during the long-term studies was 11.5 percent, similar to that during the controlled studies. At the recommended dosage for isoxicam of 200 mg per day, the incidence of gastrointestinal ulcers was 0.81 percent, well within the range expected among arthritic patients receiving nonsteroidal anti-inflammatory drugs. From the data collected in Phase 3 clinical studies, it may be concluded that isoxicam is better tolerated than either aspirin or indomethacin and should not create unusual problems in the short-term or long-term treatment of rheumatoid arthritis or degenerative joint disease.

Topics: Aged; Arthritis, Rheumatoid; Aspirin; Clinical Trials as Topic; Double-Blind Method; Drug Evaluation; Gastrointestinal Diseases; Hip Joint; Humans; Indomethacin; Joint Diseases; Knee Joint; Middle Aged; Piroxicam; Safety; Thiazines