title: Comparison of aceclofenac with piroxicam in the treatment of osteoarthritis.
abstract: A multicentre, double-blind, randomised, parallel group study was undertaken to investigate the efficacy and safety of aceclofenac (123 patients, 100 mg twice daily) in comparison to piroxicam (117 patients, 20 mg once daily and placebo once daily) in patients with osteoarthritis of the knee. The treatment period of two months was preceded by a washout period of one week duration. On completion of the study, patients in both aceclofenac and piroxicam-treated groups exhibited significant improvement in pain intensity and functional capacity of the affected knee, as represented by the Osteoarthritis Severity Index (OSI) (p < 0.0001 and p < 0.001 respectively). This was further substantiated following the patient's assessment of pain intensity using the Visual Analogue Scale (VAS), in which significant improvements were demonstrated at all time points for each treatment group (p < 0.001). Although both treatment groups showed a significant improvement in all investigator's clinical assessments (functional exploration of the knee, knee flexion and extension (EXT)), there were no significant differences between the groups. There was, however, a more rapid improvement in knee flexion in the aceclofenac group after 15 days of treatment. Both aceclofenac and piroxicam were well tolerated by patients, the most commonly reported adverse events being gastrointestinal, although their incidence was low. Only 24 patients on aceclofenac, as opposed to 33 on piroxicam complained of dyspepsia, epigastralgia and pyrosis. While 7 patients in each group were withdrawn because of adverse events, only one patient with piroxicam was withdrawn because of severe upper gastrointestinal bleeding. Twice as many reports of fecal blood loss were made in the piroxicam group in comparison to the aceclofenac group. In summary, this study confirms the therapeutic efficacy of aceclofenac and suggests that it is a well-tolerated alternative NSAID to piroxicam in the treatment of osteoarthritis.
authors.affiliation: Hospital Carlos Haya, Malaga, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Peréz Busquier
authors.forename: E
authors.initials: E
authors.lastname: Calero
authors.forename: M
authors.initials: M
authors.lastname: Rodríguez
authors.forename: P
authors.initials: P
authors.lastname: Castellon Arce
authors.forename: A
authors.initials: A
authors.lastname: Bermudez
authors.forename: L F
authors.initials: LF
authors.lastname: Linares
authors.forename: J
authors.initials: J
authors.lastname: Mesa
authors.forename: C
authors.initials: C
authors.lastname: Ffernandez Crisostomos
authors.forename: C
authors.initials: C
authors.lastname: Garcia
authors.forename: A
authors.initials: A
authors.lastname: Garcia Lopez
authors.forename: A
authors.initials: A
authors.lastname: Valenzuela
authors.forename: A
authors.initials: A
authors.lastname: Povedano
authors.forename: S
authors.initials: S
authors.lastname: Garcia Perez
authors.forename: M A
authors.initials: MA
authors.lastname: Lopez
authors.forename: R
authors.initials: R
authors.lastname: Caliz
authors.forename: F
authors.initials: F
authors.lastname: Garcia Villalba
authors.forename: M
authors.initials: M
authors.lastname: Cano
authors.forename: F
authors.initials: F
authors.lastname: Gines Martinez
authors.forename: J
authors.initials: J
authors.lastname: Gonzalez
authors.forename: M A
authors.initials: MA
authors.lastname: Caracuel
authors.forename: R
authors.initials: R
authors.lastname: Roldan
authors.forename: M
authors.initials: M
authors.lastname: Guzman Ubeda
authors.forename: A
authors.initials: A
authors.lastname: Gonzalez
authors.forename: I L
authors.initials: IL
authors.lastname: Marenco de la Fuente
authors.forename: M
authors.initials: M
authors.lastname: Alepuz Pou
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004008:Diclofenac / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D010147:Pain Measurement; D010894:Piroxicam / Q000627:therapeutic use*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010894:Piroxicam; D004008:Diclofenac; C056498:aceclofenac