Controlled-release indomethacin and sustained-release diclofenac sodium in the treatment of rheumatoid arthritis: A comparative controlled clinical trial

Abstract

The efficacy and tolerability of a new, controlled-release indomethacin (75 mg) tablet was compared to that of a sustained-release diclofenac sodium (100 mg) tablet in 84 patients with rheumatoid arthritis. The study was designed as a double-blind, double-dummy crossover trial, patients being allocated at random to receive 1 active tablet and 1 placebo tablet of the alternative medication at night for 4 weeks before being crossed over to the alternative treatment for a further 4 weeks. Patient and clinical assessments on entry and at the end of each treatment period showed that pain scores for day and night, duration of morning stiffness, requirement for escape analgesia (paracetamol) and treatment preference were similar for both treatments. Both preparations also significantly improved the degree of joint tenderness compared to baseline (p less than 0.001), as measured by a modified Ritchie Articular Index. Incidence and severity of side-effects were comparable, with a significant improvement in degree of constipation reported for both treatments compared to baseline (p less than 0.05). The incidence and severity of headache was statistically significantly worse (p less than 0.05) for controlled-release indomethacin; however, there was no difference in any other parameter of tolerability. It was concluded that controlled-release indomethacin tablets (75 mg) given as a single night-time dose were as efficacious and well tolerated as sustained-release diclofenac sodium (100 mg).

Application of multivariate optimization to electrochemical determination of methyldopa drug in the presence of diclofenac at a nanostructured electrochemical sensor

“…Diclofenac (DCF) is a non-steroidal anti-inflammatory drug (NSAID) with strong antirheumatic, anti-inflammatory, analgesic and anti-pyretic properties [22], which is widely used in the treatment of rheumatoid arthritis, osteoarthritis, non-articular rheumatism and sport injuries [23][24][25]. It is used to relieve the symptoms of many diseases such as ankylosing spondylitis and acute muscle pain conditions [26].…”

Therapeutic coordination polymers: tailoring drug release through metal–ligand interactions

“…To give a particular example, sodium Diclofenac is currently prescribed in 100 mg oral doses for chronic conditions, such as Rheumatoid Arthritis. 55,56 However, in extreme cases, larger doses can be prescribed, but only if the therapeutic benet outweighs the known adverse effects. The same amount of Diclofenac released from MgDiclo6 offers a slower release rate and only contains a small fraction of ∼3 mg of the daily recommended dose of Mg 2+ (∼300-400 mg).…”

Controlled Drug Delivery Approaches for Rheumatoid Arthritis

“…Slow release formulations like indomethacin micro granules, Sustain release capsules prepared by the centrifugation (Crowley et al, 2001). Clinical studies indicated comparable safety and efficacy profiles.…”