Efficacy and Tolerability Profile of Etoricoxib in Patients with Osteoarthritis: A Randomized, Double-blind, Placebo and Active-comparator Controlled 12-Week Efficacy Trial

Leung, Albert; Malmström, Kerstin; Gallacher, Alberto; Sarembock, Brian; Poór, Gyula; Beaulieu, André; Castro, Ricardo Sainz; Sanchez, Matilde; DeTora, Lisa; Ng, Jennifer

doi:10.1185/030079902125000282

Cited by 103 publications

(49 citation statements)

References 17 publications

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“…The better understanding of the effectiveness of different existing NSAIDs used in different populations with knee OA-related pain is of great importance because this way we could have more treatment options depending on patients' profile. Short clinical trial have shown that newest NSAIDs, especially coxibs, are effective for knee OA analgesia and have good tolerability, but these have not yet been addressed exclusively to the elderly population 21,22 . In a clinical trial with 3294 Brazilians with symptomatic knee OA 23 , 49% of individuals showed major pain improvement (at rest, initial movement, ambulation and joint compression) with the use of aceclofenac.…”

Section: Discussionmentioning

confidence: 99%

Treatment of pain associated to knee osteoarthritis in the elderly: a randomized double-blind clinical trial with lysine clonixinate

Santos¹,

Souza²,

Neto³

et al. 2011

Rev. dor

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Section: Discussionmentioning

confidence: 99%

Treatment of pain associated to knee osteoarthritis in the elderly: a randomized double-blind clinical trial with lysine clonixinate

Santos¹,

Souza²,

Neto³

et al. 2011

Rev. dor

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“…The COX-2 inhibitors exhibit antiinflammatory and analgesic efficacy similar to that of nonselective NSAIDs, but with better GI tolerability (7,(20)(21)(22)(23)(24). Etoricoxib, a highly selective COX-2 inhibitor, has shown antiinflammatory, analgesic, and antipyretic activity in models of acute and chronic pain and inflammation (25)(26)(27). In a recently reported 8-day active-comparator-controlled study of etoricoxib versus indomethacin in the treatment of acute gout, etoricoxib was shown to be comparable to indomethacin in terms of the patient's assessment of pain, as well as the patient's and investigator's global assessments of response to therapy (28).…”

mentioning

confidence: 99%

Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared with indomethacin 50 mg three times daily in acute gout: A randomized controlled trial

Rubin

Burton

Navarra

et al. 2004

Arthritis & Rheumatism

157

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Objective. To evaluate the efficacy and safety of etoricoxib and indomethacin in the treatment of patients with acute gout.Methods. A randomized, double-blind, activecomparator study was conducted at 42 sites. A total of 189 men and women (>18 years of age) who were experiencing an acute attack (<48 hours) of clinically diagnosed gout were treated for 8 days with etoricoxib, 120 mg/day (n ‫؍‬ 103), or indomethacin, 50 mg 3 times a day (n ‫؍‬ 86). The primary efficacy end point was the patient's assessment of pain in the study joint (0-4-point Likert scale) over days 2-5. Safety was assessed by adverse experiences (AEs) occurring during the trial.Results. Etoricoxib demonstrated clinical efficacy comparable to that of indomethacin in terms of the patient's assessment of pain in the study joint. The difference in the mean change from baseline over days 2-5 was -0.08 (95% confidence interval -0.29, 0.13) (P ‫؍‬ 0.46), which fell within the prespecified comparability bounds of -0.5 to 0.5. Secondary end points over the 8-day study, including the onset of efficacy, reduction in signs of inflammation, and patient's and investigator's global assessments of response to therapy, confirmed the comparable efficacy of the two treatments. The etoricoxib-treated patients had a numerically lower incidence of AEs (43.7%) than did the indomethacintreated patients (57.0%) and a significantly lower incidence of drug-related AEs (16.5% versus 37.2%; P < 0.05).Conclusion. Etoricoxib at a dosage of 120 mg once daily was confirmed to be an effective treatment for acute gout. Etoricoxib was comparable in efficacy to indomethacin at a dosage of 50 mg 3 times daily, and it was generally safe and well tolerated.Acute gouty arthritis is the most common form of inflammatory joint disease in men over the age of 40 years (1,2). It is estimated to affect 0.5-2.8% of men, with a lower rate of occurrence among women, who experience gout primarily after menopause (3). The prevalence is much higher among individuals with a positive family history (3). Monosodium urate monohydrate crystals, which arise from abnormal metabolism of purines, cause an intense inflammatory reaction that

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“…During 12 weeks of treatment, the risk of GI events was comparable to that found with other comparators (OR=0.38, 95% CrI=0.03∼4.28, P=0.21 compared with placebo, OR=0.94, 95% CrI=0.04∼20.35, P=0.49 with celecoxib and OR=0.49, 95% CrI=0.03∼7.21, P=0.29 with ibuprofen), while the risk of GI events was significantly lower than that found with naproxen (OR=0.18, 95% CrI=0.03∼1.17, P=0.03) ( Figure 4A). Among studies that included patients with OA of the lower extremities and involved treatment of 12 weeks, etoricoxib showed significantly lower risk of GI events compared with naproxen (OR=0.18, 95% CrI=0.01∼2.73, P=0.06), while there was no significant difference compared with placebo, celecoxib, and ibuprofen (OR=0.24, 95% CrI=0.01∼ 6.07, P=0.18 with placebo, OR=0.99, 95% CrI=0.01∼ 162.70, P=0.50 with celecoxib, OR=0.33, 95% CrI=0.00∼ 20.83, P=0.27 with ibuprofen) ( Figure 4B) [26][27][28][29][30]. In analysis according to dose of etoricoxib, 30 mg of etoricoxib showed comparable risk of GI events with celecoxib, ibuprofen and placebo during 12 weeks.…”

Section: Risks Of Gastrointestinal Adverse Events Of Etoricoxibmentioning

confidence: 91%

“…A final 10 studies were included in our study after further reviewing full texts [21][22][23][24][25][26][27][28][29][30]: eight were excluded because they were not RCTs, three were without peer review, seven involved non-OA patients, one did not involve etoricoxib, 16 reported no outcome of interest, two did not utilize adequate comparators, and one was excluded for other reasons (Figure 1). …”

Section: Study Characteristicsmentioning

confidence: 99%

“…The results were consistent when we included studies of patients with OA of the hip or knee joints over a duration of 12 weeks (OR=0.65, 95% CrI=0.08∼4.91, P=0.33 with placebo, OR=0.99, 95% CrI=0.01∼95.15, P=0.50 with celecoxib, OR=0.84, 95% CrI=0.07∼10.07, P=0.44 with ibuprofen, OR=2.11, 95% CrI=0.14∼31.37, P=0.72 with naproxen) ( Figure 3B) [26][27][28][29][30]. In analysis according to dose of etoricoxib, 30 mg of and 60 mg or higher dose of etoricoxib did not increase the risk of CV events compared with comparators during 12 weeks ( Figure 3C).…”

Section: Risk Of Cardiovascular Adverse Events Of Etoricoxibmentioning

confidence: 99%

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Cardiovascular and Gastrointestinal Effects of Etoricoxib in the Treatment of Osteoarthritis: A Systematic Review and Network Meta-analysis

et al. 2017

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Objective. To estimate the cardiovascular (CV) and gastrointestinal (GI) risks of etoricoxib in the treatment of osteoarthritis (OA) compared to a placebo and other non-steroidal anti-inflammatory drugs (NSAIDs). Methods. A systematic review of randomized, controlled trials (RCTs) of etoricoxib were performed. Bayesian network meta-analysis was used over a duration of 12 weeks. The incidence of CV and GI events for a duration ≥26 weeks were also tabulated and presented using descriptive statistics. Results. From this search, 10 studies were identified. Of these, 6 and 5 RCTs that measured the CV and GI events at 12 weeks were included in meta-analysis. They showed that etoricoxib did not increase the CV events compared to the placebo or NSAIDs during the 12 week period (odds ratio [OR]=0.59 compared to celecoxib, OR=0.89 with ibuprofen, OR=0.70 with placebo, and OR=2.16 with naproxen). The risk of GI events was comparable to that of most comparators, with the exception of naproxen, which had a significantly lower risk of GI events (OR=0.18) during the 12 week period. For a duration ≥26 weeks, the incidence of CV and GI events with etoricoxib increased with increasing duration. Conclusion. Etoricoxib is an alternative short-term treatment option for OA, showing comparable CV and GI complications to other NSAIDs. Nevertheless, further studies will be needed to elucidate the long-term safety of etoricoxib in the treatment of OA. (J Rheum Dis 2017;24:293-302)

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Efficacy and Tolerability Profile of Etoricoxib in Patients with Osteoarthritis: A Randomized, Double-blind, Placebo and Active-comparator Controlled 12-Week Efficacy Trial

Abstract: Etoricoxib showed rapid and durable treatment effects in patients with OA of the knee or hip. Etoricoxib was generally well tolerated.

Cited by 103 publications

References 17 publications

Treatment of pain associated to knee osteoarthritis in the elderly: a randomized double-blind clinical trial with lysine clonixinate

Treatment of pain associated to knee osteoarthritis in the elderly: a randomized double-blind clinical trial with lysine clonixinate

Efficacy and safety profile of treatment with etoricoxib 120 mg once daily compared with indomethacin 50 mg three times daily in acute gout: A randomized controlled trial

Cardiovascular and Gastrointestinal Effects of Etoricoxib in the Treatment of Osteoarthritis: A Systematic Review and Network Meta-analysis

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