A double-blind comparison of the efficacy and safety of ketoprofen extended-release (200 mg once daily) and diclofenac (75 mg twice daily) for treatment of osteoarthritis

Kennedy, A. C.; Mullen, Bernard J.; Roth, Sanford H.; Germain, Bernard F.; Bonebrake, Robert A.; Wei, Nathan; Willkens, Robert F.; Lawson, Jeffrey G.; Appelrouth, Daniel J.; White, Raymond

doi:10.1016/s0011-393x(05)80684-8

Cited by 7 publications

(8 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, the observation that liver-and biliary system-related adverse events were observed more frequently in the high dose verum groups than under diclofenac sodium 75 mg dual release capsules and placebo suggests a higher risk for hepatoxicity with increasing doses of the compound. This is consistent with the results of another clinical study on 150 mg diclofenac sodium in osteoarthritis which also reported a considerable frequency of elevated transaminases [14]. In this context, it has to be mentioned additionally that osteoarthritis patients taking diclofenac are already on a higher risk to develop transaminase elevations than patients with rheumatoid arthritis [15].…”

Section: Discussionsupporting

confidence: 89%

Clinical trial on the efficacy and safety of different diclofenac formulations: Multiple-unit formulations compared to enteric coated tablets in patients with activated osteoarthritis

Schmitt

Walter

Kurth³

1999

Inflammopharmacol

View full text Add to dashboard Cite

This double-blind, randomised, multicentre study investigated the efficacy and safety of two different dosages of a diclofenac sodium dual release capsule (150 mg or 75 mg once daily) in comparison to a standard treatment with enteric coated tablets (50 mg t.i.d.) and placebo in patients with activated osteoarthritis. Pain relief as the main efficacy variable was measured through 24 hours by means of a Visual Analogue Scale at baseline and on five assessment days during the 12 weeks of treatment. Efficacy was observed in all treatment groups with a statistically significant difference between the verum groups and placebo. The overall safety and tolerability of the active treatments was good. For the 75 mg group, a lower incidence of liver and biliary system-related side effects was reported. Considering efficacy, safety, and compliance aspects, the once daily administration of diclofenac sodium 75 mg dual release capsule is the appropriate dosage regimen for mid- and long-term treatment of osteoarthritis.

show abstract

Section: Discussionsupporting

confidence: 89%

Clinical trial on the efficacy and safety of different diclofenac formulations: Multiple-unit formulations compared to enteric coated tablets in patients with activated osteoarthritis

Schmitt

Walter

Kurth³

1999

Inflammopharmacol

View full text Add to dashboard Cite

show abstract

“…Clinically significant evidence of hepatotoxicity was found in 8 studies [ 16 , 20 , 23 , 25 , 27 , 28 , 31 , 32 ], which accounted for 44.4%. It was found that almost all studies reported AST or ALT, which indicates hepatotoxicity.…”

Section: Resultsmentioning

confidence: 99%

“…It was found that almost all studies reported AST or ALT, which indicates hepatotoxicity. According to the criteria adopted in this study for hepatotoxicity, 7 of 8 studies (87.5%) demonstrated the elevation of either AST or ALT, or both enzymes, >3 × ULN during the study period [ 16 , 20 , 23 , 25 , 27 , 31 , 32 ] ( Table 3 and supplement 3 ; Table 2 for full information). One study did not report the magnitude of elevated AST or ALT enzymes but reported liver-related discontinuation [ 28 ].…”

Section: Resultsmentioning

confidence: 99%

Hepatotoxicity of Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review of Randomized Controlled Trials

Sriuttha

Sirichanchuen

Permsuwan

2018

International Journal of Hepatology

119

View full text Add to dashboard Cite

Background Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most widely used medication in several countries, including Thailand. NSAIDs have been associated with hepatic side effects; however, the frequency of these side effects is uncertain. Aim of the Review To systematically review published literature on randomized, controlled trials that assessed the risk of clinically significant hepatotoxicity associated with NSAIDs. Methods Searches of bibliographic databases EMBASE, PubMed, and the Cochrane Library were conducted up to July 30, 2016, to identify randomized controlled trials of ibuprofen, naproxen, diclofenac, piroxicam, meloxicam, mefenamic acid, indomethacin, celecoxib, and etoricoxib in adults with any disease that provide information on hepatotoxicity outcomes. Results Among the 698 studies, 18 studies met the selection criteria. However, only 8 studies regarding three NSAIDs (celecoxib, etoricoxib, and diclofenac) demonstrated clinically significant hepatotoxic evidence based on hepatotoxicity justification criteria. Of all the hepatotoxicity events found from the above-mentioned three NSAIDs, diclofenac had the highest proportion, which ranged from 0.015 to 4.3 (×10−2), followed by celecoxib, which ranged from 0.13 to 0.38 (×10−2), and etoricoxib, which ranged from 0.005 to 0.930 (×10−2). Conclusion Diclofenac had higher rates of hepatotoxic evidence compared to other NSAIDs. Hepatotoxic evidence is mostly demonstrated as aminotransferase elevation, while liver-related hospitalization or discontinuation was very low.

show abstract

“… Network diagram for mixed treatment comparison analysis of dyspepsia. 37 , 44 – 47 , 49 , 50 , 53 , 58 , 60 – 62 , 64 , 69 – 78 , 80 , 81 , 83 , 84 , 86 , 88 – 119 …”

Section: Figurementioning

confidence: 99%

“… Summary plot of naproxen/esomeprazole magnesium versus comparators for the outcomes of ( A ) dyspepsia 37 , 44 – 47 , 49 , 50 , 53 , 58 , 60 – 62 , 64 , 69 – 78 , 80 , 81 , 83 , 84 , 86 , 88 – 119 and ( B ) any gastrointestinal event. 43 , 45 , 47 , 49 , 53 – 55 , 58 – 60 , 64 , 66 , 68 , 71 – 74 , 77 , 81 , 82 , 86 , 87 , 89 , 91 , 93 , 95 – 99 , 102 , 103 , 105 – 110 , 112 , 119 – 137 …”

Section: Figurementioning

confidence: 99%

Efficacy and tolerability of naproxen/esomeprazole magnesium tablets compared with non-specific NSAIDs and COX-2 inhibitors: a systematic review and network analyses

Wolkin¹,

Datto²,

Hellmund³

et al. 2013

OARRR

View full text Add to dashboard Cite

Non-steroidal anti-inflammatory drugs (NSAIDs), such as non-selective NSAIDs (nsNSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors, are commonly prescribed for arthritic pain relief in patients with osteoarthritis (OA), rheumatoid arthritis (RA), or ankylosing spondylitis (AS). Treatment guidelines for chronic NSAID therapy include the consideration for gastroprotection for those at risk of gastric ulcers (GUs) associated with the chronic NSAID therapy. The United States Food and Drug Administration has approved naproxen/esomeprazole magnesium tablets for the relief of signs and symptoms of OA, RA, and AS, and to decrease the risk of developing GUs in patients at risk of developing NSAID-associated GUs. The European Medical Association has approved this therapy for the symptomatic treatment of OA, RA, and AS in patients who are at risk of developing NSAID-associated GUs and/or duodenal ulcers, for whom treatment with lower doses of naproxen or other NSAIDs is not considered sufficient. Naproxen/esomeprazole magnesium tablets have been compared with naproxen and celecoxib for these indications in head-to-head trials. This systematic literature review and network meta-analyses of data from randomized controlled trials was performed to compare naproxen/esomeprazole magnesium tablets with a number of additional relevant comparators. For this study, an original review examined MEDLINE®, Embase®, and the Cochrane Controlled Trials Register from database start to April 14, 2009. Using the same methodology, a review update was conducted to December 21, 2009. The systematic review and network analyses showed naproxen/esomeprazole magnesium tablets have an improved upper gastrointestinal tolerability profile (dyspepsia and gastric or gastroduodenal ulcers) over several active comparators (naproxen, ibuprofen, diclofenac, ketoprofen, etoricoxib, and fixed-dose diclofenac sodium plus misoprostol), and are equally effective as all active comparators in treating arthritic symptoms in patients with OA, RA, and AS. Naproxen/esomeprazole magnesium tablets are therefore a valuable option for treating arthritic symptoms in eligible patients with OA, RA, and AS.

show abstract

A double-blind comparison of the efficacy and safety of ketoprofen extended-release (200 mg once daily) and diclofenac (75 mg twice daily) for treatment of osteoarthritis

Cited by 7 publications

References 15 publications

Clinical trial on the efficacy and safety of different diclofenac formulations: Multiple-unit formulations compared to enteric coated tablets in patients with activated osteoarthritis

Clinical trial on the efficacy and safety of different diclofenac formulations: Multiple-unit formulations compared to enteric coated tablets in patients with activated osteoarthritis

Hepatotoxicity of Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review of Randomized Controlled Trials

Efficacy and tolerability of naproxen/esomeprazole magnesium tablets compared with non-specific NSAIDs and COX-2 inhibitors: a systematic review and network analyses

Contact Info

Product

Resources

About