Amiprilose hydrochloride for the treatment of rheumatoid arthritis.

The intent of this study was to compare, in a monotherapy framework, an optimal dose of the synthetic hexose sugar, amiprilose hydrochloride (HCl), to a placebo in the treatment of rheumatoid arthritis. In this double-blind, randomized, multi-center study, patients first underwent a washout period from disease-modifying antirheumatic drugs. Those who subsequently met flare criteria within 14 days of discontinuing previously stable doses of nonsteroidal anti-inflammatory drugs were randomized to amiprilose HCl (103 patients) or a placebo (115 patients) for the subsequent 20 weeks. Glucocorticoid or nonsteroidal anti-inflammatory drugs use was not permitted. At the baseline, demographic and disease characteristics were similar in both groups. Of patients completing the course of therapy, 73% were in the amiprilose HCl group and 66% were in the placebo group. Using an intent-to-treat analysis, numeric trends favoring amiprilose HCl treatment were found for clinical and laboratory parameters of disease activity. Compared with the placebo group, statistically significant degrees of improvement were achieved for the number of swollen joints (p /= \50% reduction in swollen joints (p

Decreased ulnar bending stiffness in osteoporotic Caucasian women.

Mechanical response tissue analysis (MRTA) is a noninvasive measure of ulnar bending stiffness in vivo. It is unique in that the mechanical response to the lower range of vibrational frequencies is used to determine the average cross-sectional bending stiffness. The objective of this study was to compare ulnar bending stiffness among normal, osteopenic, and osteoporotic Caucasian women. World Health Organization criteria were used to define cohorts. Ulnar bending stiffness was expressed as the product of Young's modulus of elasticity (E) and the cross-sectional moment of inertia (I) in units of square Newton meters using MRTA. There was no difference in the mean body weight between cohorts but mean age was significantly different (p < 0.0001, analysis of variance): normal women, 34 +/- 12 yr (n = 55); women with age-related/idiopathic osteopenia, 52 +/- l l yr (n = 36(; and women with osteoporosis, 65 +/- 10 yr (n = 24). The mean EI of osteoporotic Caucasian women (25 Nm(2)) was 25% lower than normal subjects (33.1 Nm(2)) (p < 0.0001). However, there was no significant difference between EI of normal women and osteopenic women (30.l Nm(2)). EI was significantly but weakly correlated (i.e., the greatest r(2) value was 37%) to all dual X-ray absorptiometry variables, ulnar width, age, and body weight. In summary, results with MRTA were consistent with previous studies using classical ex vivo biomechanical techniques and in vivo vibrational techniques, showing decreased strength (i.e., bending stiffness) in osteoporotic bone compared with normal bone and a generalized decrease in bending stiffness with increasing age.

Comparison of azathioprine, methotrexate, and the combination of both in the treatment of rheumatoid arthritis. A controlled clinical trial.

OBJECTIVE: To compare the relative safety and efficacy of azathioprine (AZA), methotrexate (MTX), and the combination of both in the treatment of active rheumatoid arthritis (RA). METHODS: Two hundred twelve patients with active RA were entered into a 24-week prospective, controlled, double-blind, multicenter trial and were randomly assigned to 1 of 3 treatment groups. RESULTS: One hundred fifty-eight patients finished 24 weeks of the study. There were no remissions seen but response rates were greater than 30% for all outcome measures. Combination therapy was not statistically superior to MTX therapy alone, but both combination therapy and MTX alone were superior to AZA alone when patients were analyzed by intent-to-treat and with withdrawals treated as therapy failures. If only patients who continued taking the therapy were analyzed, the mean improvement was greater for AZA therapy than for MTX, while the combination remained the most active. Adverse effects on the gastrointestinal tract and elevations of liver enzyme levels were the most frequent causes for discontinuations. CONCLUSION: Both combination therapy and MTX alone were superior to therapy with AZA alone for active RA but were not statistically different in their effect on outcome assessment.