Aceclofenac is a well-tolerated alternative to naproxen in the treatment of osteoarthritis

Abstract

The efficacy and safety of aceclofenac (100 mg bid), a new nonsteroidal anti-inflammatory/anti-rheumatic agent, were compared with those of naproxen (500 mg bid) in a multi-centre, twelve-week, randomized, double-blind, parallel-group clinical trial in outpatients with active osteoarthritis of the knee. 190 patients received aceclofenac, 184 naproxen. The two treatments were compared on the basis of several characteristic clinical features of osteoarthritis of the knee, including various pain measurements. In both groups, the treatment resulted in a significant reduction of the pain at rest, pain on movement and the pain from pressure on the joint, 76-86% of aceclofenac patients reporting reduction in pain after 12 weeks. Three-quarters of the aceclofenac-treated patients had an accompanying reduction in joint swelling and 81.4% in knee function capacity, up to complete freedom of movement. Joint stiffness, which at baseline lasted 20 minutes, was reduced in the aceclofenac group to 10 minutes. A statistically significant difference in the efficacy of the two drugs was not found. The 34 adverse drug effects documented in 24 (12.6%) of the aceclofenac patients were fewer than the 43 events in 30 patients (16.3%) reported for naproxen. The trend towards better tolerability of aceclofenac manifested itself above all in a lower total incidence of gastrointestinal side-effects. Aceclofenac is as effective as naproxen in the symptomatic treatment of osteoarthritis of the knee and is well tolerated in general.

Efficacy and safety of aceclofenac in osteoarthritis: A meta-analysis of randomized controlled trials

“…Table 1 shows the general characteristics of all nine included trials, including study design, total number of randomized participants, gender distribution, trial duration, dose, and number of randomized patients for aceclofenac and control drugs (40)(41)(42)(43)(44)(45)(46)(47)(48). Control drugs were diclofenac in five trials (41-44, 45), piroxicam in two (46, 47), and acetaminophen (48) and naproxen (40) in one trial each. All included trials except one were double blind (44).…”

“…All included trials except one were double blind (44). Finally, two trials did not specify inclusion of primary or secondary osteoarthritis (40,41).…”

Aceclofenac in rheumatology: The golden mean

“…[28], показали, что ацеклофенак 200 мг/сут был столь же эффективен, как напроксен 1000 мг/сут, в отношении выра-женности боли и нарушения функции у больных гонартрозом. При этом на фоне приема ацеклофенака побочные эффекты возникали реже: у 12,6 и 16,3% больных соответственно.…”

Aceclofenac in the treatment of diseases of the locomotor apparatus

“…Показано, что препарат не уступает по эффективности при РЗ высокоэффективным в отношении боли и воспаления н-НПВП: диклофенаку, кетопрофену, индометацину, напроксену, пироксикаму [18][19][20][21][22][23][24][25]. В отече-ственном многоцентровом исследовании сравнивали эф-фективность и безопасность ацеклофенака (n=100) и дик-лофенака (n=100) у больных ОА при 3-месячном непрерыв-ном приеме.…”