A randomized, double-blind, multicenter trial of nimesulide-beta-cyclodextrin versus naproxen in patients with osteoarthritis

Fioravanti, Antonella; Storri, Lara; Martino, S; Bisogno, Stefania; Oldani, Virginio; Scotti, Aurelio; Marcolongo, Roberto

doi:10.1016/s0149-2918(02)85127-x

Cited by 9 publications

(5 citation statements)

References 13 publications

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“…After 20 days of treatment, pain was reduced for 32.9% and 42.3% in the Tenaprost and Nimulid group respectively. Similar percentage of pain reduction (40.5%) was obtained when nimesulide was applied in the treatment of knee osteoarthritis in the study of Fioravanti et al (16). None of these two nimesulide formulations had an effect on knee circumference.…”

Section: Discussionsupporting

confidence: 64%

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Efficacy and safety of two generic copies of nimesulide in patients with low back pain or knee osteoarthritis

Ilic¹,

Sefik-Bukilica²,

Janković³

et al. 2011

Reumatismo

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Low back pain and knee osteoarthritis are the most common causes of rheumatic troubles among all the nonspecific joint diseases. In the United States, low back pain (LBP) accounts for almost $ 20 billion in lost productivity annually (1), and more than $ 80 billion is spent each year in the management of the disorder (2). Currently, there is no currative treatment for both low back pain and knee osteoarthritis. Nonsteroid antiinflammatory drugs (NSAIDs) are widely used for symptomatic relief (3) due to their analgetic and anti-inflamatory effect..

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Section: Discussionsupporting

confidence: 64%

“…Determination of sample size was based on a nomogram for calculating the sample size for studies using continuous variables (14), on the studies investigating efficacy of nimesulide in patients with ostheoarticular pain (15,16) and assuming an error of 0.05 and a β error of 0.20.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of two generic copies of nimesulide in patients with low back pain or knee osteoarthritis

Ilic¹,

Sefik-Bukilica²,

Janković³

et al. 2011

Reumatismo

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“…* * * * * 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).…”

Section: Osteoarthritis Of the Knee By Nimesulidementioning

confidence: 99%

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

Rainsford

2006

Inflammopharmacol

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This review summarizes the principal therapeutic responses to the preferential COX-2 NSAID, nimesulide, in treating musculo-skeletal joint symptoms and various acute and chronic pain conditions and the mode of action in relation to therapy in these states. In extensive studies in laboratory animal models and clinical trails in patients nimesulide has been found to have potent analgesic, anti-inflammatory and anti-pyretic activities. It is approved for use in over 50 countries worldwide (including those in the EU, South and Central America, China, India and some other South-East Asia) for the treatment of acute pain, the symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea. Its mode of action in these states is related to the preferential inhibition of the production of cyclo-oxygenase-2 (COX-2) and other inflammatory mediators whose production is controlled by stimulation of cyclic-3 ,5'-adenosine monophosphate (cAMP); this means that nimesulide is a multi-factorial drug in controlling inflammation and pain. The adverse reaction profile of nimesulide is, in general, like that of other NSAIDs. It does, however, have relatively low occurrence of gastro-intestinal (GI) side effects which is related to its low propensity to inhibit the physiologically important COX-1 in the GI mucosa and important physicochemical properties (high pKa of 6.5 and lipophilicity) as well as inhibiting of mast cell derived histamine and acid secretion in the stomach. In contrast with the coxibs, nimesulide has not been found to have appreciable cardiovascular toxicity.

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“…24 Another study compared nimesulide/beta-cyclodextrin and naproxen for 2 weeks in patients with osteoarthritis; the drugs were shown to be equivalent in terms of pain control and functional capacity. 23 Quattrini et al also demonstrated similar efficacy between nimesulide and naproxen for pain control in 120 patients with hip osteoarthritis. 21 Similar results were described by Lecomte et al after 14 days of treatment for osteoarticular pain secondary to tendinitis and bursitis 22 and by Calligaris et al in 660 patients with minor traumatic injuries related to sports practice.…”

Section: Discussionmentioning

confidence: 88%

Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms

Scheinberg

Júnior²,

Macedo³

et al. 2018

DDDT

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PurposeThis study investigated the safety and efficacy of fixed-dose combination tablets of naproxen/esomeprazole magnesium and nimesulide/pantoprazole to determine if both regimens are equally suited to relieve pain in patients with osteoarticular diseases and dyspeptic symptoms.MethodsPatients were randomly assigned to receive either nimesulide/pantoprazole (100 mg/20 mg) twice daily or naproxen/esomeprazole magnesium (500 mg/20 mg) twice daily for 14 days. The primary endpoint was defined as the mean change in modified Western Ontario and McMaster Universities Osteoarthritis Index pain subscale. Secondary endpoints were mean visual analog scale score of dyspeptic symptoms (nausea, abdominal discomfort/pain, epigastric burning, postprandial fullness), mean visual analog scale score of individual dyspeptic symptoms, and individual score of dyspeptic symptoms according to patient diary. This study is registered at ClinicalTrials.gov: NCT01670552.ResultsA total of 490 patients were enrolled and randomized, and 399 completed treatment (naproxen/esomeprazole, n=201; nimesulide/pantoprazole, n=198). The difference in mean change in the modified Western Ontario and McMaster Universities Osteoarthritis Index pain score after 7 days of treatment between the two treatment groups was 2.33 mm (95% CI, −1.22 to 5.89 mm). After 14 days of therapy, the difference was 0.45 mm (95% CI, −3.29 to 4.19 mm). The most common adverse events in the pooled group were abdominal discomfort, abdominal distention, dyspepsia, and nausea, but none of these was deemed to be clinically meaningful.ConclusionThe present study demonstrated noninferiority of a 14-day regimen with a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for the treatment of osteoarticular pain.

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A randomized, double-blind, multicenter trial of nimesulide-beta-cyclodextrin versus naproxen in patients with osteoarthritis

Cited by 9 publications

References 13 publications

Efficacy and safety of two generic copies of nimesulide in patients with low back pain or knee osteoarthritis

Efficacy and safety of two generic copies of nimesulide in patients with low back pain or knee osteoarthritis

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

Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms

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