Comparison of aceclofenac with piroxicam in the treatment of osteoarthritis

Abstract

A multicentre, double-blind, randomised, parallel group study was undertaken to investigate the efficacy and safety of aceclofenac (123 patients, 100 mg twice daily) in comparison to piroxicam (117 patients, 20 mg once daily and placebo once daily) in patients with osteoarthritis of the knee. The treatment period of two months was preceded by a washout period of one week duration. On completion of the study, patients in both aceclofenac and piroxicam-treated groups exhibited significant improvement in pain intensity and functional capacity of the affected knee, as represented by the Osteoarthritis Severity Index (OSI) (p < 0.0001 and p < 0.001 respectively). This was further substantiated following the patient's assessment of pain intensity using the Visual Analogue Scale (VAS), in which significant improvements were demonstrated at all time points for each treatment group (p < 0.001). Although both treatment groups showed a significant improvement in all investigator's clinical assessments (functional exploration of the knee, knee flexion and extension (EXT)), there were no significant differences between the groups. There was, however, a more rapid improvement in knee flexion in the aceclofenac group after 15 days of treatment. Both aceclofenac and piroxicam were well tolerated by patients, the most commonly reported adverse events being gastrointestinal, although their incidence was low. Only 24 patients on aceclofenac, as opposed to 33 on piroxicam complained of dyspepsia, epigastralgia and pyrosis. While 7 patients in each group were withdrawn because of adverse events, only one patient with piroxicam was withdrawn because of severe upper gastrointestinal bleeding. Twice as many reports of fecal blood loss were made in the piroxicam group in comparison to the aceclofenac group. In summary, this study confirms the therapeutic efficacy of aceclofenac and suggests that it is a well-tolerated alternative NSAID to piroxicam in the treatment of osteoarthritis.

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

“…As shown in Figure 2, both sequence generation and allocation concealment were adequate in four trials (41)(42)(43)48 (41)(42)(43)(46)(47)(48). No study was deemed adequate with respect to the blinding of outcome assessment.…”

“…Ward et al (41) could not contribute in the efficacy assessment due to dichotomous data of pain and physical function, and we used this trial for the safety assessment only (41). 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.…”

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.…”

Choice of therapeutic tactics after failure of the first tumor necrosis factor-α inhibitor

“…Оценка возможностей адалимумаба (АДА) во второй ли-нии биологической терапии после использования других иФНОα представлена в исследовании Re-ACT [13], церто-лизумаба пэгол (ЦЗП) -в исследованиях REALISTIC, DOSEFLEX [14,15], голимумаба (ГЛМ) -в исследовании GO-AFTER [16,17], тоцилизумаба (ТЦЗ) -в исследовании RADIATE [18], абатацепта (АБЦ) -в исследованиях ATTAIN, ARRIVE [19][20]. Ритуксимаб (РТМ) во всех сов-ременных рекомендациях позиционируется как препарат второй линии, его возможности при неэффективности иФНОα изучены в ряде РКИ (DANGER, MIRROR, REFLEX) [21][22][23].…”