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Etoricoxib

A Review of its Use in the Symptomatic Treatment of Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis and Acute Gouty Arthritis

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Summary

Abstract

Etoricoxib is a selective cyclo-oxygenase (COX)-2 inhibitor, approved in Europe for the symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and acute gouty arthritis. Etoricoxib provided similar symptomatic relief to nonselective NSAIDs in patients with these conditions, and to celecoxib in patients with osteoarthritis. The drug was associated with fewer uncomplicated upper gastrointestinal (GI) adverse events than nonselective NSAIDs, and was noninferior to diclofenac in terms of the rate of thrombotic cardiovascular (CV) events. Etoricoxib may be considered as a treatment option for patients requiring NSAID therapy, particularly those at risk of upper GI events, after careful consideration of significant risk factors for CV events (including uncontrolled hypertension). As with all NSAIDs, the potential GI and CV risks of treatment with etoricoxib should be weighed against the potential benefits in individual patients, and it should be administered at the lowest effective dose for as short a duration as possible.

Pharmacological Properties

Etoricoxib is a selective inhibitor of COX-2. It shows dose-dependent inhibition of COX-2 across the therapeutic dose range, without inhibition of COX-1, does not inhibit gastric prostaglandin synthesis and has no effect on platelet function.

Etoricoxib is absorbed well after oral administration and displays linear pharmacokinetics over the therapeutic dose range. The principal route of elimination is hepatic metabolism, followed by renal excretion, and dosage adjustments may be necessary in patients with hepatic impairment. The elimination half-life of etoricoxib is ≈22 hours, allowing for once-daily administration. Coadministration of CYP3A4 inhibitors or inducers may alter exposure to etoricoxib.

Therapeutic Efficacy

The clinical efficacy of etoricoxib in the symptomatic treatment of various arthritic conditions has been evaluated in a number of well designed trials.

Six to twelve weeks’ treatment with etoricoxib 30 and 60 mg was significantly more effective than placebo, and as effective as treatment with diclofenac, ibuprofen, naproxen or celecoxib, at improving symptoms in patients with osteoarthritis. Reductions in scores for Western Ontario and McMasters Universities’ Osteoarthritis Index (WOMAC) pain, WOMAC physical function, and patient’s global assessment met the criteria for clinical equivalence for etoricoxib 30 mg once daily versus ibuprofen 800 mg three times daily and for etoricoxib 60 mg once daily versus diclofenac 50 mg three times daily and versus naproxen 500 mg twice daily, and met the criteria for noninferiority for etoricoxib 30 mg once daily versus celecoxib 200 mg once daily. Efficacy with etoricoxib was maintained in extension studies of up to 4.5 years.

In patients with rheumatoid arthritis, 8–12 weeks’ treatment with etoricoxib 90 mg once daily was significantly more effective than placebo at improving symptoms, and 12 weeks’ treatment was at least as effective as naproxen 500 mg twice daily (improvements in tender and swollen joint counts and patient and investigator global assessments were similar between etoricoxib and naproxen in one trial and significantly greater with etoricoxib in another trial).

In a single trial, 6 weeks’ treatment with etoricoxib 90 mg once daily led to significantly greater improvements in the symptoms of ankylosing spondylitis than seen with placebo, based on patient assessments of spine pain, global disease activity and the Bath Ankylosing Spondylitis Functional Index. Etoricoxib 90 mg was also significantly more effective than naproxen 1000 mg daily for two of these three endpoints after 6 weeks, and for all three after 52 weeks of treatment.

Eight days’ treatment with etoricoxib 120 mg once daily was as effective as indometacin 50 mg three times daily at improving pain and other symptoms associated with acute gouty arthritis, based on two trials.

Tolerability

Etoricoxib was generally well tolerated in clinical trials in patients with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and acute gouty arthritis. The most commonly reported drug-related adverse events were generally GI (e.g. dyspepsia, upper abdominal pain, diarrhoea, nausea) or CV (e.g. hypertension and peripheral oedema).

Based on two large, well designed trials, the risk of discontinuing treatment because of GI adverse events was significantly lower with etoricoxib 90 mg daily han diclofenac 150 mg daily. Based on several large pooled analyses, etoricoxib was associated with a lower incidence of upper GI events (bleeding, perforation, obstruction, ulcer) than nonselective NSAIDs.

In the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term) programme (a pooled analysis of three large trials in >34 000 patients with osteoarthritis or rheumatoid arthritis) etoricoxib 60–90 mg was noninferior to diclofenac 150 mg daily in terms of the overall rate of arterial and venous thrombotic CV events. In the largest of these trials (n >23 000), the rates of treatment discontinuation for hypertension and oedema were higher with etoricoxib 90 mg (and also 60 mg for hypertension) than with diclofenac. In a pooled analysis of 12 trials, thrombotic events appeared to be numerically (but not statistically) higher with etoricoxib than naproxen, but no difference between etoricoxib and non-naproxen NSAIDs was evident.

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  1. Wolters Kluwer Health | Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand

    Katherine F. Croom & M. Asif A. Siddiqui

  2. Wolters Kluwer Health, Philadelphia, Pennsylvania, USA

    Katherine F. Croom & M. Asif A. Siddiqui

Authors
  1. Katherine F. Croom
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  2. M. Asif A. Siddiqui
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Corresponding author

Correspondence to M. Asif A. Siddiqui.

Additional information

Various sections of the manuscript reviewed by: H. Kokki, Department of Anaesthesiology/Intensive Care, Kuopio University Hospital, Kuopio, Finland; J.S. McLay, Department of Medicine, University of Aberdeen, Aberdeen, UK; P. Patrignani, Department of Medicine and Center of Excellence on Aging, G. d’Annunzio University, Chieti, Italy; V. Phupong, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; A.I. Sebba, Arthritis Associates, Palm Harbor, Florida, USA.

Data Selection

Sources: Medical literature published in any language since 1980 on ‘etoricoxib’, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database of Wolters Kluwer Health | Adis). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: MEDLINE, EMBASE and AdisBase search terms were ‘etoricoxib’ and (‘ankylosing spondylitis’ or ‘rheumatoid arthritis’ or ‘osteoarthritis’ or ‘arthritis’ or ‘gout’). Searches were last updated 20 July 2009.

Selection: Studies in patients with who received etoricoxib. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Ankylosing spondylitis, cyclo-oxygenase 2-inhibitor, etoricoxib, gout, osteoarthritis, pharmacodynamics, pharmacokinetics, rheumatoid arthritis, safety, therapeutic use, tolerability.

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Croom, K.F., Siddiqui, M.A.A. Etoricoxib. Drugs 69, 1513–1532 (2009). https://doi.org/10.2165/00003495-200969110-00008

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  • DOI: https://doi.org/10.2165/00003495-200969110-00008

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