Pain management in osteoarthritis: A focus on onset of efficacy—a comparison of rofecoxib, celecoxib, acetaminophen, and nabumetone across four clinical trials

Battisti, Wendy P.; Katz, Nathaniel; Weaver, Arthur L.; Matsumoto, Alan K.; Kivitz, Alan; Polis, Adam B.; Geba, Gregory P.

doi:10.1016/j.jpain.2004.09.004

Cited by 31 publications

(28 citation statements)

References 31 publications

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“…After evaluation of the abstracts according to the predefined selection criteria, 28 citations (=30 studies) were identified as potential relevant and full text reports were obtained [15-42] in addition to 8 studies from the etoricoxib development program [43-48]. After evaluation of the full reports, 9 publications were excluded since they reported different outcomes [15,16], did not consider the appropriate doses of the treatment under study [17], were shorter than 2 weeks [18,19], reported the outcomes of pain and physical function not according to the WOMAC scales or subscales [20,21] and did not report the results per intervention [22]. Since the trials from Zhao et al, [23] and Bensen et al, [24] were duplicate reports of one trial, only Bensen et al, [24] was included.…”

Section: Resultsmentioning

confidence: 99%

Efficacy of Etoricoxib, Celecoxib, Lumiracoxib, Non-Selective NSAIDs, and Acetaminophen in Osteoarthritis: A Mixed Treatment Comparison

Stam¹

2012

TORJ

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Objective:To compare the efficacy of etoricoxib, lumiracoxib, celecoxib, non-selective (ns) NSAIDs and acetaminophen in the treatment of osteoarthritis (OA)Methods:Randomized placebo controlled trials investigating the effects of acetaminophen 4000mg, diclofenac 150mg, naproxen 1000mg, ibuprofen 2400mg, celecoxib 100-400mg, lumiracoxib 100-400mg, and etoricoxib 30-60mg with treatment duration of at least two weeks were identified with a systematic literature search. The endpoints of interest were pain, physical function and patient global assessment of disease status (PGADS). Pain and physical function reported on different scales (VAS or LIKERT) were translated into effect sizes (ES). An ES 0.2 - 0.5 was defined as a “small” treatment effect, whereas ES of 0.5 – 0.8 and > 0.8 were defined as “moderate” and “large”, respectively. A negative effect indicated superior effects of the treatment group compared to the control group. Results of all trials were analyzed simultaneously with a Bayesian mixed treatment comparison.Results:There is a >95% probability that etoricoxib (30 or 60mg) shows the greatest improvement in pain and physical function of all interventions compared. ESs of etoricoxib 30mg relative to placebo, celecoxib 200mg, ibuprofen 2400mg, and diclofenac 150mg were -0.66 (95% Credible Interval -0.83; -0.49), -0.32 (-0.50; -0.14), -0.25 (-0.53; 0.03), and -0.17 (-0.41; 0.08), respectively. Regarding physical functioning, ESs of etoricoxib 30mg relative to placebo, celecoxib 200mg, ibuprofen 2400mg, and diclofenac 150mg were -0.61 (-0.76; -0.46), -0.27 (-0.43; -0.10), -0.20 (-0.47; 0.07), and -0.09 (- 0.33; 0.14) respectively. The greatest improvements in PGADS were expected with either etoricoxib or diclofenac.Conclusion:The current study estimated the efficacy of acetaminophen, nsNSAIDs, and COX-2 selective NSAIDs in OA and found that etoricoxib 30 mg is likely to result in the greatest improvements in pain and physical function. Differences in PGADS between interventions were smaller.

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Section: Resultsmentioning

confidence: 99%

Efficacy of Etoricoxib, Celecoxib, Lumiracoxib, Non-Selective NSAIDs, and Acetaminophen in Osteoarthritis: A Mixed Treatment Comparison

Stam¹

2012

TORJ

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“…Thirty-six RCTs were excluded as they gave insufficient information about the occurrence of MIs 51 – 86. The remaining 14 RCTs allowed comparisons of MI with serious upper GI adverse events 3 10 87 – 98.…”

Section: Resultsmentioning

confidence: 99%

Non-steroidal anti-inflammatory drugs and myocardial infarctions: comparative systematic review of evidence from observational studies and randomised controlled trials

Scott

Kingsley

Smith

et al. 2007

Annals of the Rheumatic Diseases

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Objective: The comparative risk of myocardial infarction (MI) with cyclo-oxygenase-2-specific drugs and traditional non-steroidal anti-inflammatory drugs (NSAIDs) was determined. Methods:The results of studies of a suitable size in colonic adenoma and arthritis-that had been published in English and from which crude data about MIs could be extracted-were evaluated. Medline, Embase and Cinahl (2000-2006) databases, as well as published bibliographies, were used as data sources. Systematic reviews examined MI risks in case-control and cohort studies, as well as in randomised controlled trials (RCTs). Results: 14 case-control studies (74 673 MI patients, 368 968 controls) showed no significant association of NSAIDs with MI in a random-effects model (OR 1.17; 95% CI 0.99 to 1.37) and a small risk of MI in a fixedeffects model (OR 1.32; 95% CI 1.29 to 1.35). Sensitivity analyses showed higher risks of MI in large European studies involving matched controls. Six cohort studies (387 983 patient years, 1 120 812 control years) showed no significant risk of MI with NSAIDs (RR 1.03; 95% CI 1.00 to 1.07); the risk was higher with rofecoxib (RR 1.25; 95% CI 1.17 to 1.34) but not with any other NSAIDs. Four RCTs of NSAIDs in colonic adenoma (6000 patients) showed an increased risk of MI (RR 2.68; 95% CI 1.43 to 5.01). Fourteen RCTs in arthritis (45 425 patients) showed more MIs with cyclo-oxygenase-2-specific drugs (Peto OR 1.6; 95% CI 1.1 to 2.4), but fewer serious upper gastrointestinal events (Peto OR 0.40; 95% CI 0.31 to 0.53). Conclusion:The overall risk of MI with NSAIDs and cyclo-oxygenase-2-specific drugs was small; rofecoxib showed the highest risk. There was an increased MI risk with cyclo-oxygenase-2-specific drugs compared with NSAIDs, but less serious upper gastrointestinal toxicity. E mphasis on the adverse effects of non-steroidal antiinflammatory drugs (NSAIDs) has moved from their upper gastrointestinal (GI) to their cardiovascular toxicity.1 This reflects widespread concern that cyclo-oxygenase-2-specific drugs in general, and rofecoxib in particular, increase the risk of myocardial infarction (MI) compared with traditional NSAIDs.2 Like other cyclo-oxygenase-2-specific drugs, rofecoxib minimises serious GI toxicity whilst retaining anti-inflammatory efficacy. Although these benefits have been established experimentally in randomised controlled trials (RCTs), a large trial by Bombardier et al 3 (the Vigor trial) showed an excess of MIs with rofecoxib. When a second RCT in colonic adenoma also reported an excess of MIs, rofecoxib was withdrawn worldwide. 4 Since then, there has been substantial debate about the risk of MI with cyclo-oxygenase-2-specific drugs in particular and with NSAIDs in general.In addition to the debate amongst clinicians and patients on the cardiovascular toxicity of NSAIDs, regulators have also taken different views. The US Food and Drug Administration (FDA) 5 has concluded that there are significant cardiovascular risks with all NSAIDs, while the European Medicines Agency has con...

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“…However, nabumetone has poor solubility in water. This poor solubility and the consequent reduction in absorption rate is claimed to be responsible for the slow onset of action of nabumetone in humans (25). It was hypothesized that the absorption rate of nabumetone could be improved by reducing the particle size.…”

Section: Electrospinning Of Drugs Using a Semi-crystalline Polymermentioning

confidence: 99%

Electrospun Nanofibers in Oral Drug Delivery

et al. 2010

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In order to enhance the delivery of drugs with limited absorption due to poor solubility/dissolution, approaches are being developed to improve the dissolution rates and solubility of drug molecules. These approaches include identification of water-soluble salts of parent drugs, preparation of stable amorphous drug formulations, inclusion of solubility-enhancing agents in the dosage form, and particle size reduction. Technologies to reduce drug particle size to sub-micrometer range are being applied to product development more frequently. Electrospinning is being considered as one of the technologies which can produce nanosized drugs incorporated in polymeric nanofibers. In vitro and in vivo studies have demonstrated that the release rates of drugs from these nanofiber formulations are enhanced compared to those from original drug substance. This technology has the potential to be used for enhancing the oral delivery of poorly soluble drugs.

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Pain management in osteoarthritis: A focus on onset of efficacy—a comparison of rofecoxib, celecoxib, acetaminophen, and nabumetone across four clinical trials

Cited by 31 publications

References 31 publications

Efficacy of Etoricoxib, Celecoxib, Lumiracoxib, Non-Selective NSAIDs, and Acetaminophen in Osteoarthritis: A Mixed Treatment Comparison

Efficacy of Etoricoxib, Celecoxib, Lumiracoxib, Non-Selective NSAIDs, and Acetaminophen in Osteoarthritis: A Mixed Treatment Comparison

Non-steroidal anti-inflammatory drugs and myocardial infarctions: comparative systematic review of evidence from observational studies and randomised controlled trials

Electrospun Nanofibers in Oral Drug Delivery

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