Double-blind study to evaluate efficacy and safety of meloxicam 7.5 mg and 15 mg versus mefenamic acid 1500 mg in the treatment of primary dysmenorrhea.
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.


METHODS
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.


CONCLUSIONS
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.
de Mello
Nilson Roberto
NR
University of São Paulo, São Paulo City, Brazil.
Baracat
Edmund Chada
EC
Tomaz
Geraldez
G
Bedone
Aloísio José
AJ
Camargos
Aroldo
A
Barbosa
Ione Cristina
IC
de Souza
Rosival Nassar
RN
Rumi
Demetrio Ortega
DO
Martinez Alcala
Felix Octavio
FO
Velasco
Jorge Antonio Aldrete
JA
Cortes
Roberto Jose Risco
RJ
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D004412:Dysmenorrhea / Q000188:drug therapy*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D008528:Mefenamic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D000077239:Meloxicam; D013843:Thiazines / Q000009:adverse effects / Q000627:therapeutic use*; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013843:Thiazines; D013844:Thiazoles; D008528:Mefenamic Acid; D000077239:Meloxicam