title: Nabumetone induces less gastrointestinal mucosal changes than diclofenac retard.
abstract: The aim of the study was to compare the efficacy and the effects on the mucosa of the gastrointestinal tract (GIT) of nabumetone and diclofenac retard in patients with osteoarthritis (OA). An open, multicentre, randomised, comparative, endoscopy-blind parallel group study included 201 patients with nabumetone and 193 patients with diclofenac retard suffering from moderate to severe OA of the knee or hip joint. Twelve clinical efficacy variables were assessed and a portion of the population underwent gastroduodenoscopy. All patients exhibited significant improvement in pain severity and pain relief (p < 0.001 and p < 0.0001, respectively) but there were no differences between the groups for all the efficacy variables. Eleven per cent of patients on nabumetone and 19% on diclofenac experienced GIT side-effects. Sixty-nine patients with nabumetone and 61 with diclofenac underwent gastroduodenoscopy. The differences in the mucosal grade for the oesophagus, stomach and duodenum at baseline were not significant. In the oesophagus there were significantly less changes after treatment with nabumetone (p = 0.007) than with diclofenac; there were similar findings in the stomach (p < 0.001) but the difference in the duodenum was not significant. This study indicates that nabumetone and diclofenac retard have similar efficacy in the treatment of OA, but nabumetone has significantly fewer GIT side-effects.
authors.affiliation: Institute of Rheumatology, Prague, Czech Republic.
authors.forename: R
authors.initials: R
authors.lastname: Becvár
authors.forename: Z
authors.initials: Z
authors.lastname: Urbanová
authors.forename: V
authors.initials: V
authors.lastname: Vlasáková
authors.forename: J
authors.initials: J
authors.lastname: Vítová
authors.forename: I
authors.initials: I
authors.lastname: Rybár
authors.forename: H
authors.initials: H
authors.lastname: Maldyk
authors.forename: A
authors.initials: A
authors.lastname: Filipowicz-Sosnowska
authors.forename: K
authors.initials: K
authors.lastname: Bernacka
authors.forename: S
authors.initials: S
authors.lastname: Mackiewicz
authors.forename: B
authors.initials: B
authors.lastname: Gömör
authors.forename: B
authors.initials: B
authors.lastname: Rojkovich
authors.forename: B
authors.initials: B
authors.lastname: Siro
authors.forename: J
authors.initials: J
authors.lastname: Bereczki
authors.forename: K
authors.initials: K
authors.lastname: Toth
authors.forename: S
authors.initials: S
authors.lastname: Sukenik
authors.forename: L
authors.initials: L
authors.lastname: Green
authors.forename: M
authors.initials: M
authors.lastname: Ehrenfeld
authors.forename: K
authors.initials: K
authors.lastname: Pavelka
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use; D002074:Butanones / Q000009:adverse effects* / Q000627:therapeutic use; D004008:Diclofenac / Q000009:adverse effects* / Q000627:therapeutic use; D016145:Endoscopy, Digestive System; D005753:Gastric Mucosa / Q000187:drug effects* / Q000473:pathology; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000175:diagnosis; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects* / Q000473:pathology; D008875:Middle Aged; D000077430:Nabumetone; D015207:Osteoarthritis, Hip / Q000150:complications / Q000188:drug therapy; D020370:Osteoarthritis, Knee / Q000150:complications / Q000188:drug therapy; D010147:Pain Measurement; D012449:Safety; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D002074:Butanones; D004008:Diclofenac; D000077430:Nabumetone