Comparison of gastrointestinal safety and tolerability of aceclofenac with diclofenac: a multicenter, randomized, double-blind study in patients with knee osteoarthritis

Abstract

Aceclofenac was better tolerated in terms of incidence and severity of GI AEs and GPA requirement and was as efficacious as diclofenac. The need for GPAs increased with the increase in duration of treatment with NSAIDs. Hence, it could be concluded that usual practice of co-prescription of GPAs with aceclofenac could be avoided to improve patient compliance and reduce cost of treatment. However, long term trials with endoscopic evaluation in the wider population are required to assess the GI tolerability of aceclofenac and diclofenac in detail.

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.…”

Novel elastic membrane vesicles (EMVs) and ethosomes-mediated effective topical delivery of aceclofenac: a new therapeutic approach for pain and inflammation

“…Orally administered non-steroidal anti-inflammatory drugs (NSAIDs) play a significant role in the symptomatic management of OA and are regarded as firstline treatment for the same (Raza et al, 2014a). Aceclofenac (ACE) is an effective NSAID, frequently prescribed by the oral route for the management of OA owing to its analgesic and anti-inflammatory properties (Dooley et al, 2001;Pareek & Chandurkar, 2013). ACE inhibits the synthesis of inflammatory cytokines including interleukin (IL)-1b, tumor necrosis factor (TNF) and prostaglandin E2 (PGE2).…”

Comparison of pharmacokinetics and safety of fixed-dose combination of SKI306X and aceclofenac versus separate tablets in healthy subjects

“…[14] In vivo, aceclofenac blocked prostaglandin E2 production via COX-1 and COX-2 inhibition after being metabolized to 4'-hydroxyaceclofenac, diclofenac, and 4'-hydroxydiclofenac in human inflammatory cells. [10,15] Aceclofenac is absorbed rapidly after oral administration and is effective within 30 minutes of ingestion. [10] The C max is reached after approximately 1 to 3 hours and the t 1/2 is approximately 4 hours.…”