title: Efficacy and safety of meloxicam in patients with rheumatoid arthritis.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of meloxicam, a new acidic enolic nonsteroidal anti-inflammatory drug, at doses of 7.5 and 15 mg once daily in patients with rheumatoid arthritis (RA).
  
  
  METHODS
  Meloxicam 15 and 7.5 mg daily was administered for 21 days in this double blind, randomized, placebo controlled study. 159 patients received meloxicam 7.5 mg, 162 received meloxicam 15 mg, and 147 received placebo.
  
  
  RESULTS
  Meloxicam 15 mg once daily was significantly superior (p < 0.05) to placebo in 3 of the 4 primary endpoints (disease activity assessed by the investigator, disease activity assessed by the patient, and reduction of the number of tender/painful joints). No difference was observed regarding number of swollen joints. The difference between meloxicam 7.5 mg once daily and placebo reached statistical significance in 2 of the 4 primary endpoints, disease activity assessed by the patient and number of tender/painful joints. A statistically significant difference between meloxicam 1.5 mg and 7.5 mg was not observed for any primary endpoint. The rating of global tolerance by investigators and patients at the end of the study was similar in the 3 treatment groups, indicating that meloxicam and placebo were generally similarly well tolerated. However, there was a slightly higher incidence of gastrointestinal (GI) disturbances reported by patients receiving meloxicam 15 mg. GI adverse events were reported by 11, 11, and 16% of patients in the placebo, meloxicam 7.5 mg, and meloxicam 15 mg groups, respectively. None were serious.
  
  
  CONCLUSIONS
  Meloxicam in daily doses of 7.5 and 15 mg is effective in treating the signs and symptoms of RA.
authors.affiliation: Staatliches Rheumakrankenhaus, Baden-Baden, Germany.
authors.forename: E M
authors.initials: EM
authors.lastname: Lemmel
authors.forename: W
authors.initials: W
authors.lastname: Bolten
authors.forename: R
authors.initials: R
authors.lastname: Burgos-Vargas
authors.forename: P
authors.initials: P
authors.lastname: Platt
authors.forename: M
authors.initials: M
authors.lastname: Nissilä
authors.forename: D
authors.initials: D
authors.lastname: Sahlberg
authors.forename: O
authors.initials: O
authors.lastname: Björneboe
authors.forename: H
authors.initials: H
authors.lastname: Baumgartner
authors.forename: J P
authors.initials: JP
authors.lastname: Valat
authors.forename: P
authors.initials: P
authors.lastname: Franchimont
authors.forename: E
authors.initials: E
authors.lastname: Bluhmki
authors.forename: G
authors.initials: G
authors.lastname: Hanft
authors.forename: M
authors.initials: M
authors.lastname: Distel
mesh_terms: D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000473:pathology; D003710:Demography; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007596:Joints / Q000187:drug effects / Q000473:pathology; D008297:Male; D000077239:Meloxicam; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D012449:Safety; D013843:Thiazines / Q000008:administration & dosage* / Q000009:adverse effects; D013844:Thiazoles / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D013843:Thiazines; D013844:Thiazoles; D000077239:Meloxicam