[A clinical study on the anti-inflammatory activity and gastrointestinal tolerability of amtolmetin guacyl, a new NSAID, compared with diclofenac in aged patients with osteoarticular diseases].
The study was conducted in a cohort of 50 female patients, all in the active phase of various osteoarthritic diseases. All had a documented past history of gastric distress requiring pre- and post-treatment endoscopic monitoring. The 50 subjects were divided randomly into two 25-patient groups. One group received amtolmetin guacyl (1200 mg/day orally in two daily administrations on an empty stomach for the first three days of treatment and 600 mg/day once daily on an empty stomach for the remaining 27 days) and the other received diclofenac (150 mg/day orally in three daily administrations on a full stomach for the duration of the treatment period). The statistical significances of the antiphlogistic activity of the two drugs were very close to one another. The gastric tolerability verified at T0 and T30 through endoscopic monitoring of the mucosal conditions was excellent for Artromed (slight improvement after 30 days) and critical for diclofenac (significant (P < or = 0.01) deterioration after 30 days). All of the patients in the Artromed group terminated the period of therapy whilst 3 patients from the diclofenac group were obliged to abandon the study through accumulation of undesirable side-effects (12%).
Tavella
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A
Instituto Policlinico San Matteo I.R.C.C.S.-Pavia, Clinica Ortopedica.
Ursini
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G
D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004361:Drug Tolerance; D005260:Female; D005753:Gastric Mucosa / Q000187:drug effects; D005773:Gastroscopy; D005998:Glycine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects; D008875:Middle Aged; D008991:Monitoring, Physiologic; D010003:Osteoarthritis / Q000188:drug therapy*; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011758:Pyrroles; C065762:ST 679; D004008:Diclofenac; D005998:Glycine
Studio clinico sull'attività antiinfiammatoria e sulla tollerabilità gastro-enterica di amtolmètineguacil, un nuovo FANS, in confronto a diclofenac su pazienti anziani con patologie osteoarticolari.