ABSTRACT
OBJECTIVE: Assessment of efficacy and safety of meloxicam 7.5 mg and 15 mg once a day (o.a.d.) compared with mefenamic acid 500 mg three times a day (t.i.d.), over a treatment period of 3-5 days, during three menstrual cycles, for primary dysmenorrhea. STUDY DESIGN: Multicenter, multinational, double-blind, double-dummy, three parallel groups, randomized trial, phase IIb, 337 patients. Treatment group comparisons of continuous variables were carried out using the Kruskal-Wallis test and Wilcoxon signed rank tests. Efficacy was analyzed using Fisher and chi(2)-tests. RESULTS: Meloxicam 7.5 mg and 15 mg showed a similar profile in pain reduction and dysmenorrhea symptoms when compared with mefenamic acid. Thirty-five subjects presented with gastrointestinal (GI) adverse events (AEs). Two-thirds of those 35 subjects were in the mefenamic acid group. There were no differences between the safety profiles of the two meloxicam dosages. Laboratory abnormalities did not differ in incidence among the treatment groups. CONCLUSION: Both of the daily doses of meloxicam tested were comparable to 500 mg mefenamic acid t.i.d. in relieving dysmenorrhea symptoms, and meloxicam seems to have a better gastrointestinal tolerability profile.
Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Dysmenorrhea/drug therapy , Mefenamic Acid/therapeutic use , Thiazines/therapeutic use , Thiazoles/therapeutic use , Adolescent , Adult , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Drug Tolerance , Female , Gastrointestinal Diseases/chemically induced , Gastrointestinal Diseases/epidemiology , Humans , Mefenamic Acid/adverse effects , Meloxicam , Thiazines/adverse effects , Thiazoles/adverse effects , Treatment OutcomeABSTRACT
Objetivo:Observação da eficácia e segurança do meloxican ( inibidor seletivo da COX-2) com ácido mefenâmico ( AINE clássico), por um periodo de três a cinco dias, durante três ciclos menstruais, para o tratamento da dismenorréia primária. Materiais e Métodos: Multicêntrico, internacional, duplo cego, paralelo, três grupos, randomizado, fase III b, 337 pacientes. AS variáveis contínuas dos grupos comparados foram analisadas através do teste de Kruskal-Wallis e Wilcoxon. Na avaliação da eficácia se utilizou o teste de Fisher e o qui-quadrado. Resultados : Meloxican 7,5 mg, 15 mg exibiu um perfil semelhante na redução da dor e dos sintomas da dismenorreia primário em comparação ao acido mefenamico. Quarenta e nove indivíduos apresentaram eventos adversos. Quase metade desses 49 pacientes eram do grupo que usou acido mefenamico. Não houve diferenças entre os perfis de segurança entre as duas dosagens de meloxican. As anormalidades laboratoriais não se diferenciaram entre os grupos estudados. Este estudo demonstrou que um AINE inibidor seletivo da COX-2 apresenta a mesma eficiência que um AINDE clássico porém com melhor perfil de tolerabilidade gastrintestinal.
