Clinical and gastroscopic evaluation of amtolmetin guacyl versus diclofenac in patients with rheumatoid arthritis.

Abstract

AIM:

Amtolmetin guacyl (2-[2[1-methyl-5-(4-methylbenzoyl) pyrrol-2-yl] acetamido] acetic acid 2-methoxyphenyl ester) is a recently developed drug which, in preliminary studies, has shown effective anti-inflammatory properties with improved gastrointestinal safety. Our study was designed to investigate the efficacy and tolerability of amtolmetin guacyl 600 mg bid when compared to diclofenac 50 mg tid for 4 weeks.

PATIENTS AND METHODS:

A total of 64 patients aged 18-80 years, suffering from rheumatoid arthritis for more than 6 months and American Rheumatism Association functional class I, II or III were randomized in a double blind manner to amtolmetin guacyl or diclofenac for 4 weeks. Clinical and endoscopic evaluation were performed at baseline and at the end of the treatment. The mucosa was graded by means of a rating system emphasizing mucosal erosions. Only patients with endoscopy grade 0-1 entered the trial.

RESULTS:

The median post-treatment endoscopy injury scores were 0 (range 0-4) in the amtolmetin guacyl-treated patients and 2 (range 0-4) in the diclofenac-treated patients (p = 0.005). There were nine gastric ulcers: 1/32 (3%) in the amtolmetin guacyl group and 8/32 (25%) in the diclofenac group (p < 0.05; 95% confidence interval, -30-5%). 16/32 (50%) patients in amtolmetin guacyl group and 8/32 (25%) in diclofenac group had normal gastroduodenal findings (score = 0) (p < 0.05; 95% confidence interval, 5-50%). In patients with a history of peptic ulcer, a recurrence of gastric damage (score 3-4) was observed in 18% in the amtolmetin guacyl and in 53% in the diclofenac group (p < 0.05). The incidence of gastrointestinal symptoms did not differ in the two groups. Amtolmetin guacyl significantly reduced the number of swollen and painful joints, and the functional disability index; diclofenac significantly reduced the number of painful joints and the functional disability index score (p = ns).

CONCLUSIONS:

Amtolmetin guacyl effectively controlled the symptoms of rheumatoid arthritis, with very limited gastric toxicity. If these findings are confirmed on a wider scale, the drug might become a valid alternative to current therapies, especially for patients at risk, such as those with rheumatoid arthritis simultaneously requiring steroids and second-line drugs, or those with a history of peptic ulcer.

• Authors: G Bianchi Porro, F Montrone, M Lazzaroni, G Manzionna, I Caruso
• Journal: Italian journal of gastroenterology and hepatology (Ital J Gastroenterol Hepatol) 1999 Jun-Jul Vol. 31 Issue 5 Pg. 378-85 ISSN: 1125-8055 [Print] Italy
• PMID: 10470596 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Pyrroles
• ST 679
• Diclofenac
• Glycine

Topics

• Adolescent
• Adult
• Aged
• Anti-Inflammatory Agents, Non-Steroidal (adverse effects, therapeutic use)
• Arthritis, Rheumatoid (complications, drug therapy, pathology)
• Diclofenac (adverse effects, therapeutic use)
• Double-Blind Method
• Gastric Mucosa (drug effects, pathology)
• Gastroscopy
• Glycine (adverse effects, analogs & derivatives, therapeutic use)
• Helicobacter Infections (chemically induced, pathology)
• Helicobacter pylori
• Humans
• Middle Aged
• Pyrroles (adverse effects, therapeutic use)
• Stomach Ulcer (chemically induced, pathology)