Clinical equivalence between deflazacort oral drops and tablets in active rheumatoid arthritis.

Abstract:

:In order to assess the clinical equivalence between deflazacort oral drops and tablets, 18 patients with active rheumatoid arthritis were enrolled in an open, controlled, randomised ('tablets --> drops' sequence, or vice versa), two-period (21 days each) crossover trial (from tablets to drops, or vice versa). Individual dose titration of deflazacort drops or tablets was made weekly on the basis of clinical need. Primary outcome measures of efficacy were changes in the joint swelling count (JSC), erythrocyte sedimentation rate (ESR), hand-grip strength (HGS), joint pain (JP), duration of morning stiffness (MS), physician's global evaluation and patient's self-assessment. Sixteen patients were available by the end of the study. The formulations were equivalent with respect to HGS and improvement in duration of MS, and close to equivalence with respect to JSC and ESR decrease; the drops seemed to be more effective than tablets with respect to JP reduction. No differences between the two formulations were observed with respect to physician's and patient's assessment. The minimum effective dose of each preparation and the relative potency ratio were also established. Drops and tablets were found to have the same potency.

journal_name

Clin Rheumatol

journal_title

Clinical rheumatology

authors

Di Munno O,Mazzantini M,Milani S,Pasero G

doi

10.1007/s100670050072

subject

Has Abstract

pub_date

1999-01-01 00:00:00

pages

140-4

issue

2

eissn

0770-3198

issn

1434-9949

journal_volume

18

pub_type

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