Gastroduodenal tolerability of nimesulide and diclofenac in patients with osteoarthritis

Abstract

This l-month, randomized, double-masked, parallel-group study was conducted to compare nimesulide (100 mg twice daily) with diclofenac (50 mg three times daily) with respect to gastroduodenal tolerability and efficacy in patients with osteoarthritis. Results of gastroduodenal endoscopy in 83 patients (42 receiving nimesulide, 41 receiving diclofenac) revealed that, after 30 days, 4 patients (1 nimesulide, 3 diclofenac) had developed ulcers and 6 patients (4 nimesulide, 2 diclofenac) had developed erosions; however, differences between the treatment groups were not statistically significant. Both study drugs were well tolerated. Ten patients (5 in each group) withdrew from the study prematurely because of adverse events. Efficacy was assessed by measuring pain on visual analogue scales, using the functional index of Lequesne, and by scoring spontaneous pain, pain on passive movement, and functional impairment. Nocturnal pain was also checked. All efficacy variables showed a significant improvement during the study, and no statistically signiiicant differences were observed between the treatment groups.

Current status of the therapeutic uses and actions of the preferential cyclo-oxygenase-2 NSAID, nimesulide

“…In these studies nimesulide signifi cantly reduced the signs and symptoms of OA with an effi cacy at least comparable to the reference drugs, including etodolac (Lucker et al, 1994), diclofenac (Estevez et al, 1993;Porto et al, 1998;Huskison et al, 1999;Zgradie, 1999: Omololu et al, 2005, ketoprofen (Dreiser and Riebenfeld, 1993b), naproxen (Fossaluzza and Montagnani, 1989;Quattrini and Paladin, 1995;Kriegel et al, 2001;Fioravanti et al, 2002), piroxicam (Drieser andRiebenfeld, 1993b;Sharma et al, 1999) as well as the coxibs, celecoxib (Bianchi and Broggini, 2003) and rofecoxib (Bianchi and Broggini, 2003;). Of particular importance is that several studies (Blardi et al, 1992;Porto et al, 1998;Wober, 1999) have shown the relative safety of the drug, especially in relation to the gastrointestinal tract (Porto et al, 1998) and economic advantages (Liaropoulos, 1999;Tarricone et al, 2001) of nimesulide in the treatment of osteoarthritis as well as other musculo-skeletal conditions (Wober, 1999;Pohjolainen et al, 2000).…”

“…* * * * * pharmacological rationale there is also a large amount of data on the clinical effectiveness of nimesulide have been obtained from studies in a variety of experimental designs, among them placebo-controlled and double blind studies and large-scale including post-marketing evaluations (Fossaluzza and Montagnani, 1989;Pochobradsky et al, 1991;Blardi et al, 1992;Dreiser and Riebenfeld 1993b;Estevez et al, 1993;Lucker et al, 1994;Quattrini and Paladin, 1995;Porto et al, 1998;Roy et al, 1999;Sharma et al, 1999;Huskisson et al, 1999;Zgradie, 1999;Kriegel et al, 2001;Fioravanti et al, 2002;Bianchi and Broggini, 2003;Herrera and Gonzales, 2003;Omololu et al, 2005;Bianchi et al, 2005).…”

“…Of particular importance is that several studies (Blardi et al, 1992;Porto et al, 1998;Wober, 1999) have shown the relative safety of the drug, especially in relation to the gastrointestinal tract (Porto et al, 1998) and economic advantages (Liaropoulos, 1999;Tarricone et al, 2001) of nimesulide in the treatment of osteoarthritis as well as other musculo-skeletal conditions (Wober, 1999;Pohjolainen et al, 2000).…”

Cyclooxygenase Isozymes: The Biology of Prostaglandin Synthesis and Inhibition

“…Estimates of rate ratios for peptic ulcer, gastrointestinal hemorrhage, or perforation placed the incidence for nimesulide below that for diclofenac and naproxen (Menniti-Ippolito et al, 1998). Other epidemiological analyses (Garcia Rodriguez et al, 1998;Porto et al, 1998) have estimated gastric damage with nimesulide to be equal to or worse than with diclofenac. This surprising result may be due to the small numbers of patients in these studies and the wide range of confidence intervals of the estimates (Rainsford, 1999).…”

A comparison of the cost-effectiveness of five strategies for the prevention of non-steroidal anti-inflammatory drug-induced gastrointestinal toxicity: a systematic review with economic modelling

“…One study only recruited patients with OA for less than 1 year. 131 The maximum mean duration of arthritis (actually AS) reported in any arm was 12 years. 132 The mean age of participants ranged from 38 132 to 72 years.…”