Acta Ortopédica Brasileira (Mar 2001)
Eficácia e tolerabilidade da nimesulida versus celecoxib na osteoartrite Efficacy and tolerability of nimesulide versus celecoxib in osteoarthritis
Abstract
O objetivo do estudo foi comparar a eficácia e a tolerabilidade da nimesulida versus o celecoxib no tratamento da osteoartrite. A casuística envolveu 57 pacientes com idade entre 40 e 80 anos, que foram randomizados em dois grupos, recebendo as medicações do estudo durante 30 dias de forma simples-cega na dosagem de um comprimido de 100mg de nimesulida duas vezes ao dia e uma cápsula de 100mg de celecoxib duas vezes ao dia. Após a inclusão no estudo na visita basal, foram realizadas três visitas com intervalo de dez dias entre elas. Os aspectos analisados foram: dor em repouso, dor em movimento e dor noturna, através de uma escala analógica da dor, duração da rigidez matinal, capacidade funcional (HAQ), classe funcional ACR-1991 e o índice de gravidade para osteoartrite de joelhos em todas as visitas. Foi também avaliado o tempo para andar 15 metros naqueles pacientes com acometimento de joelhos ou quadril. A avaliação da eficácia e tolerabilidade foi realizada pelo investigador e pelo paciente nas três visitas após o início do tratamento. Os eventos adversos foram registrados durante todo o período do estudo. Houve diminuição significativa e semelhante nas médias da escala para dor ao movimento e dor em repouso para ambos medicamentos em todas as visitas. Houve diminuição da dor noturna ao longo do tratamento no grupo celecoxib e a partir da visita 3 no grupo nimesulida, e ao final do estudo, as médias dos dois grupos foram semelhantes ( p = 0,152). As médias da duração da rigidez matinal diminuíram significativamente no grupo tratado com nimesulida durante todo o seguimento, e no grupo celecoxib a partir da visita 3, sendo semelhantes ao final do estudo ( p= 0,993). O tempo médio para andar 15 metros diminuiu significativamente no grupo nimesulida na visita 4 (p The aim of the present study was to compare the efficacy and tolerability of nimesulide versus celecoxib in the treatment of osteoarthritis. Fifty seven patients aged between 40 and 80 years old were randomly allocated in a single-blind fashion to one of two treatment groups, which consisted in a 30-day treatment with nimesulide (tablets) or celecoxib (capsules), 100 mg twice a day of either one. After the baseline period, there were three visits with a 10-day interval between each. At each visit, the severity of pain (at rest, movement and night), morning stiffness, the degree of functional impairment (HAQ), functional classification (ACR-1991) and severity index for knee osteoarthritis were evaluated. For those with osteoarthritis of the knee or hip, the time that was necessary to walk fifteen meters was measured. The efficacy and tolerability were assessed separately by physicians and patients at all visits except during the baseline visit. All adverse events were reported throughout the whole study period. There was a significant and similar decrease in the averages of the pain scale at movement and rest for both groups at all visits. The nocturnal pain decreased throughout the treatment for the celecoxib group and at the third visit for the nimesulide group. At the end of the study period these averages were statistically similar (p = 0,152). The mean duration of morning stiffness decreased significantly in the nimesulide group throughout the whole study, and began only from the third visit on for the celecoxib group, becoming statistically similar at the end (p = 0,993). The mean time to walk the fifteen meters decreased significantly for the nimesulide group only at visit 4 (p < 0,001*), and all the means from the second visit on were lower than those for the celecoxib group. There was a significant decrease in the means of functional impairment (HAQ scale) for the nimesulide group during the whole study period, while in the celecoxib group this decrease appeared on visit 4, where the means became similar (p = 0,517). The severity index of The Lesquesne & Samson's (1991) for osteoarthritis of the knee for the nimesulide group decreased significantly from the third visit on, what did not happen with the celecoxib group. Both groups developed similarly in the functional classification (ACR-1991) throughout the whole study. Both groups had a similar efficacy and tolerability when evaluated by patients and of efficacy, when evaluated by physicians. During the study period, 21% of the patients of nimesulide group and 25% of celecoxib group complained of adverse events. In conclusion, nimesulide demonstrated efficacy and tolerability similar to celecoxib in the treatment of osteoarthritis. Pain during the night decreased earlier in the celecoxib group, while patients of the nimesulide group showed a quicker regression of the parameters morning stiffness, functional capability and the severity index.
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