ORIGINAL ARTICLES   

Gazzetta Medica Italiana Archivio per le Scienze Mediche 1998 April;157(2):31-6

Copyright © 1998 EDIZIONI MINERVA MEDICA

language: English

Clinical effectiveness of a prolonged-release form of oral diclofenac sodium in the treatment of some non-articular rheumatisms

Mattioli P. L. ¹, Palazzini E. ²

¹ University of Reggio Calabria, School of Medicine, Chair of Internal Medicine, Policlinico Mater Domini - Catanzaro; ² Medical Department - Alfa Wassermann SpA, Bologna

Methods. ­Forty ­patients suf­fering ­from radic­u­litis (30 ­cases) and fibro­myo­sitis (10 ­cases) ­were ­treated ­with 150 mg of ­oral diclof­enac ­sodium/day for 30 ­days. Two dif­fering ­posology ­schemes ­were ­applied to ­patients: one ­group (15 ­cases ­with radic­u­litis and 5 ­with fibro­myo­sitis) was admin­is­tered ­daily one con­trolled-­release cap­sule con­taining 150 mg of the ­NSAID ­under ­study; the ­other ­group (15 ­with radic­u­litis and 5 ­with fibro­myo­sitis) was admin­is­tered one ­enteric-­coated ­tablet con­taining 50 mg of diclof­enac ­sodium ­every 8 ­hours. ­Drug effec­tive­ness was mon­i­tored ­during treat­ment reg­is­tering the ­changes in VAS ­values and ­symptom ­scores, as ­well as in ­some labor­a­tory ­tests (ESR, C-reac­tive pro­tein, ­Rheuma ­test); ­drug ­safety was con­trolled ­through the rou­tine labor­a­tory ­tests of ­systemic tol­er­ability and by ­checking ­local tol­er­ance at the gas­troin­tes­tinal ­level.
­Results. The ­same ­dosage reg­imen pro­duced, in the two ­groups, ­very sim­ilar effi­cacy ­results: inten­sity of ­pain and ­severity of the ­other symp­toms and ­signs ­were ­clearly and pro­gres­sively ­reduced ­without sta­tis­ti­cally sig­nif­i­cant dif­fer­ences. ­Systemic tol­er­ability was ­also sim­i­larly ­good in the two ­groups; ­from the gas­tric tol­er­ability ­point of ­view, on the con­trary, the ­once-a-day admin­is­tra­tion ­scheme was decid­edly ­better tol­er­ated, ­since no ­patient com­plained of ­local ­adverse man­i­fes­ta­tions, ­against ­slight and tran­sient epi­sodes (epi­gas­tralgia: 3 ­cases, epi­gas­tralgia and ­nausea: 1 ­case) ­detected in the com­par­ison ­group.