Therapeutic Action


In patients with osteoarthritis, Aceclofenac decreases pain, reduces disease severity and improves the functional capacity of the knee. In contrast to some other NSAIDs, Aceclofenac has shown stimulatory effects on cartilage matrix synthesis [9].

Treatment of osteoarthritis with NSAIDs diminishes inflammation along with mediators of cartilage destruction. However, NSAIDs may exert adverse direct effects on cartilage, particularly if treatment is prolonged. OA cartilage exhibited characteristic proteoglycan turnover. Aceclofenac has beneficial effects on OA cartilage. Aceclofenac is associated with increased proteoglycan synthesis and normalized release. Importantly, it improved proteoglycan content [4].

A multicentre, double-blind, randomised, parallel group study has confirmed the therapeutic efficacy of Aceclofenac and suggests that it is a well-tolerated alternative to piroxicam in the treatment of osteoarthritis. According to this study both treatment groups showed a significant improvement in functional exploration of the knee, knee flexion and extension, there were no significant differences between them but there was, however, a more rapid improvement in knee flexion in the Aceclofenac group after 15 days of treatment. Aceclofenac is better tolerated as compared with piroxicam [18].

Aceclofenac reduces joint inflammation, pain intensity and the duration of morning stiffness in patients with rheumatoid arthritis [9]. 4′-hydroxy Aceclofenac may contribute to the therapeutic effect of Aceclofenac on rheumatoid arthritis and osteoarthritis. It down-regulated both basal and IL-1beta-induced production of proMMP-1 and proMMP-3 at a concentration sufficient to suppress PGE2 production without modulating proMMP-2 or TIMP-1, whereas Aceclofenac itself had no marked effect on the production of proMMPs.

The anti-inflammatory and analgesic efficacy of Aceclofenac is similar to that of ketoprofen, indomethacin and Tenoxicam in patients with rheumatoid arthritis. In randomized, double blind trials in 169 to 261 patients, Aceclofenac (100 mg twice daily for 3 or 6 months) significantly reduced relative to baseline joint inflammation, pain intensity and the duration of morning stiffness and improved hand grip strength.

A multicentre, double blind, randomised, parallel group, placebo controlled study over a period of 4 weeks has confirm the efficacy and safety of 100mg Aceclofenac twice daily in 73 patients with active rheumatoid arthritis. The results showed that treatment with Aceclofenac is effective in improving the Ritchie articular index (predetermined primary end point), duration of morning stiffness, joint swelling, ARA functional class, patient’s and physician’s global assessments, and pain [19].

A multicentric parallel, randomized, double-blind trial of three months duration is demonstrated that Aceclofenac is a suitable alternative of Tenoxicam in the treatment of rheumatoid arthritis as Aceclofenac has similar efficacy and better safety profile than Tenoxicam, mainly regarding gastrointestinal tolerability. This trail was completed by 237 patients. Both treatment groups showed amelioration of clinical parameters monitored at 15 days, and this improvement continued until the end of the trial, no statistically significant differences being observed between both drugs [20].

Ankylosing spondylitis (AS) is a chronic inflammatory disease. In contrast to other inflammatory rheumatic diseases, like RA, the therapeutic options are limited and confined the role of NSAIDs in the management of AS. Disease-modifying anti-rheumatic drugs (DMARDs) and glucocorticoids have only a limited role for peripheral arthritis but are not effective for the axial manifestations. Consequently, recently reported recommendations for the management of AS suggested NSAIDs as a first-line drug treatment for patients with symptomatic disease [10].

The duration of morning stiffness and pain intensity are reduced and spinal mobility improved, by Aceclofenac in patients with ankylosing spondylitis, with improvements being similar to those observed with indomethacin, naproxen or Tenoxicam. These effects were observed after Aceclofenac 100 mg twice daily for 3 months in randomized, double blind trials involving 104 to 308 patients [9].

Aceclofenac (150 mg intramuscularly for 2 days, then 100 mg orally, both twice daily) was superior to Diclofenac in alleviating functional impairment in a 7 days study in 100 patients with acute lumbago. Aceclofenac 100 mg twice daily was associated with symptomatic relief of acute low back pain in a non-comparative study in 67 patients.

The analgesic efficacy of Aceclofenac has been shown in comparisons with paracetamol in women undergoing episiotomy. Aceclofenac 100 mg was superior to paracetamol 650 mg in providing relief from post-episiotomy pain, particularly 3 to 5 hours after ingestion.

Aceclofenac in ACHNIL is also effective in other painful conditions like dental and gynecological painful conditions [9]. In a more recent non-comparative study in 1338 women with dysmenorrohea treated for first 3 days of 2 consecutive cycles.

The analgesic efficacy as single doses of Aceclofenac has been assessed in patients with moderate to severe tooth pain and in extraction of impacted third molars. The analgesic efficacy of single doses of Aceclofenac 50, 100 and 150 mg was greater than that of placebo in patients with moderate to severe tooth pain or pain caused by extraction of impacted third molars.