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Gastrointestinal safety of amtolmetin guacyl in comparison with celecoxib in patients with rheumatoid arthritis.

OBJECTIVE: Selective inhibitors of cyclo-oxygenase-2 (COX-2) appear to be safer than conventional NSAIDs on the gastrointestinal (GI) tract. Amtolmetin guacyl (AMG), a NSAID that inhibits both COX-1 and COX-2, has an anti-inflammatory effect comparable to that of traditional NSAIDs, with a better GI safety profile. The primary end-point of this study was to evaluate the gastrointestinal safety of amtolmetin guacyl in comparison with celecoxib in patients affected with rheumatoid arthritis. The assessment of efficacy was the secondary end-point. METHODS: This study was a 24-week, randomized, parallel group, double-blind, double dummy, multicentre trial; 235 patients were enrolled and 180 patients (85 in the AMG group and 95 in the celecoxib group) completed the study. Each patient received twice daily amtolmetin guacyl 600 mg or celecoxib 200 mg. Assessment of safety was performed by upper GI endoscopy, gastrointestinal symptoms evaluation, electrocardiography, blood and urine laboratory tests, adverse events recording. Assessment of efficacy was performed by using the American College of Rheumatology (ACR-20) responder index. RESULTS: Neither amtolmetin guacyl nor celecoxib determined a worsening of baseline gastro-duodenal endoscopy findings. The percentage of patients with normal findings did not significantly change after treatment with both drugs, being virtually identical with AMG (i.e. 75.29%) and increasing from 75.79% to 77.66% with celecoxib. Moreover an evaluation of the other safety parameters did not reveal any difference between the two treatment groups. Therapeutic efficacy was equivalent in both groups, with no statistical difference between the two drugs at all time intervals. CONCLUSIONS: In patients affected with rheumatoid arthritis, AMG and celecoxib proved to be equivalent, showing comparable gastrointestinal safety and therapeutic efficacy of treatment.

Adult↗

PubMedDate not supplied

[Defects in opsonization activity of the serum of patients with chronic arthritis].

The opsonizing capacity of sera from 22 patients with rheumatoid arthritis (RA), from 14 with psoriatic arthritis (AP), from seven with ankylosing spondylitis, and from healthy control persons was investigated by luminol-dependent chemiluminescence, induced during yeast phagocytosis of normal polymorphonuclear leukocytes. The chemiluminescence response using opsonizing sera was compared to that induced by no-opsonized yeast and the opsonizing capacity was expressed as a percentage. For the opsonization, fresh native serum, in some experiments Mg2+-EGTA and EDTA-treated serum, was used. In RA and AP sera, a significantly diminished opsonizing capacity (p less than 0.005) was observed. In healthy controls and in SPA patients, the opsonizing capacity of their sera was over 200%, while in seronegative RA patients, it was only 175%, in seropositive RA 125%, and in AP 150% was measured. There was no correlation between opsonizing capacity and complement or immunoglobulin content of the investigated sera. The amount of C3b, IgG and IgM covalently bound to yeast particles was determined, too. Yeast particles bind significantly less (p less than 0.01) IgG when opsonized with RA and AP sera, while a higher relative amount of IgM (p less than 0.01) was bound to yeast incubated in the sera of seropositive RA patients. No significant differences in the C3b binding were observed.

Arthritis↗