title: Oxaceprol is a well-tolerated therapy for osteoarthritis with efficacy equivalent to diclofenac.
abstract: The therapeutic equivalence and safety of treatment for 21 days with 400 mg t.i.d. oxaceprol (n = 132) and 50 mg t.i.d. diclofenac (n = 131) were assessed in a multicentre, randomised, double-blind study of a mixed population of patients with osteoarthritis of the knee and/or hip. In a per-protocol analysis of efficacy, the mean Lequesne index decreased by 2.5 points in the oxaceprol group (n = 109) and by 2.8 points in the diclofenac group (n = 109). The 95% confidence interval for the end-point difference revealed therapeutic equivalence. This was confirmed by assessments (visual analogue scale) of pain at rest, weight-bearing pain, pain on standing and pain on movement, all of which decreased to a similar extent under both treatments. The pain-free walking time increased in both groups from 10 min to 25 min by the end of the treatment period. Mobility was also increased to a similar extent by both drugs. The physicians assessed treatment as good or very good in 45-46% of patients in both groups. In all patients who received treatment, 28 and 37 adverse events were reported by 25 out of 132 (18.9%) and 33 out of 131 (25.2%) patients treated with oxaceprol and diclofenac, respectively. In 15 patients (11.4%) with 15 adverse events in the oxaceprol group and 25 patients (19.1%) with 27 adverse events in the diclofenac group, a relation to the medication was considered probable. The difference between the groups was statistically significant (p = 0.04106) for the number of these adverse events. Oxaceprol is therapeutically equivalent to diclofenac, but better tolerated than diclofenac in the treatment of osteoarthritis.
authors.affiliation: Bayerisches Rotes Kreuz, Orthopädische Klinik Lindenlohe, Schwandorf, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Herrmann
authors.forename: D
authors.initials: D
authors.lastname: Steeger
authors.forename: M
authors.initials: M
authors.lastname: Klasser
authors.forename: J
authors.initials: J
authors.lastname: Wirbitzky
authors.forename: M
authors.initials: M
authors.lastname: Fürst
authors.forename: R
authors.initials: R
authors.lastname: Venbrocks
authors.forename: H
authors.initials: H
authors.lastname: Rohde
authors.forename: D
authors.initials: D
authors.lastname: Jungmichel
authors.forename: H D
authors.initials: HD
authors.lastname: Hildebrandt
authors.forename: M J
authors.initials: MJ
authors.lastname: Parnham
authors.forename: W
authors.initials: W
authors.lastname: Gimbel
authors.forename: H
authors.initials: H
authors.lastname: Dirschedl
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018771:Arthralgia / Q000188:drug therapy / Q000503:physiopathology; D004008:Diclofenac / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006909:Hydroxyproline / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000188:drug therapy* / Q000378:metabolism; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000378:metabolism; D010147:Pain Measurement; D012449:Safety; D013810:Therapeutic Equivalency; D016474:Weight-Bearing
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; C012393:oxaceprol; D006909:Hydroxyproline