Multicenter study of the safety/efficacy of misoprostol in the prevention and treatment of NSAID-induced gastroduodenal lesions.

Gastrointestinal symptoms and lesions are often associated with the clinical use of non-steroidal antiinflammatory drugs (NSAIDs). An open-label, single arm multicenter Italian study evaluated if misoprostol, a prostaglandin E1 analogue with gastroduodenal mucosal protective activity, was effective in the prevention and treatment of NSAID-induced gastroduodenal lesions. Patients affected by rheumatoid arthritis (RA) or osteoarthritis (OA), in treatment with NSAIDs and suffering from gastric symptoms or gastroduodenal lesions related to NSAID use, were admitted to the study. Gastrointestinal and arthritic symptoms were assessed before and after 4 weeks co-administration of an NSAID (the most frequent was diclofenac, used in 35% of the RA and in 22% of the OA patients, followed by piroxicam and tenoxicam respectively) + misoprostol (200 mcg two times daily in 58% of the cases, 200 mcg three times daily in 39%, 200 mcg four times daily in 3%). On admission and after 4 weeks of therapy a gastrointestinal endoscopy was performed to evaluate the condition of the gastroduodenal mucosa. Final results showed that: (i) NSAID-related gastric lesions were more frequent than duodenal lesions; (ii) when patients were given misoprostol and NSAIDs, 96% of them did not develop gastric lesions and 97% did not develop duodenal lesions; (iii) even when NSAID therapy was continued, gastric or duodenal lesions induced by NSAIDs healed or in any case did not worsen in 92% and 91% respectively of the cases; (iv) during the period of coadministration of NSAIDs+misoprostol, NSAID-related UGI symptoms disappeared or improved in 77% of the cases.(ABSTRACT TRUNCATED AT 250 WORDS)

[Tolerance and efficacy of proglumetacine in patients with rheumatoid arthritis]. / Tollerabilità ed efficacia della proglumetacina in pazienti affetti da artrite reumatoide.

The efficacy of proglumetacin , a new non-steroidal antiinflammatory drug, was assessed in 32 patients with rheumatoid arthritis. During treatment with 400-650 mg daily of proglumetacin over a period of 7-14 days, morning stiffness and side-effects were checked weekly or in severely ill patients daily. All patients but one completed the period of treatment. In spite of the short period of observation, a significant improvement was seen in the majority of cases (55%), while in 39% proglumetacin was not more effective than treatments before the admission to the study. In the group of patients treated for 14 days, morning stiffness parameters showed a significant improvement after 7 days and at the end of the period of study. Overall , only 3 patients referred side-effects: 1 case of transient headache and 2 cases of severe gastric pain. In our preliminary study, proglumetacin results to be effective as an antiinflammatory drug also in severe rheumatoid arthritis and safe for its low incidence of side-effects.