Efficacy of diclofenac/misoprostol vs diclofenac in the treatment of ankylosing spondylitis.
Patients with active ankylosing spondylitis of at least 6 months' duration were stabilised on diclofenac 50mg, given 2, 3 or 4 times daily in a 4-week open-label run-in. Patients were then randomised to receive a diclofenac 50mg/misoprostol 200 micrograms fixed combination tablet (n = 331) or diclofenac 50mg (n = 339) for 8 weeks at the same dosage frequency as in the open-label phase. For the intent-to-treat cohorts differences between treatment groups in the primary measures of efficacy were statistically significant. This between-group difference was thought to be attributable to the high incidence of 'unknown' outcomes, particularly in the diclofenac/misoprostol recipients. No significant differences were observed in the modified intention-to-treat or evaluable cohorts, which excluded patients with an 'unknown' outcome. No significant between group differences were observed in the change from baseline in the ankylosing spondylitis assessments. A difference was apparent between groups in the incidence of adverse events, particularly abdominal pain and diarrhoea (18.1 and 17.2%, respectively, in diclofenac/misoprostol recipients versus 12.4% each in diclofenac recipients). However, it was thought that the 4-week open-label phase of the study, during which patients received only diclofenac, may have selected for diclofenac-tolerant patients. Thus, in the treatment of ankylosing spondylitis, the diclofenac/misoprostol fixed tablet was as effective as diclofenac. Furthermore, diclofenac/misoprostol was well tolerated.
McKenna
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Rheumatic Diseases Unit, Trafford General Hospital, Davyhulme, Manchester, England.
D000293:Adolescent; D000328:Adult; D000368:Aged; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017060:Patient Satisfaction; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*
D004338:Drug Combinations; D016595:Misoprostol; D004008:Diclofenac