Etoricoxib (Arcoxia): be aware of hypertension risk
Published in NPS RADAR
Date published: About this date
Etoricoxib (Arcoxia) is a new COX-2 selective NSAID that became available in Australia on private prescription in August 2009. It is not listed on the Pharmaceutical Benefits Scheme (PBS). In July 2008 the Pharmaceutical Benefits Advisory Committee rejected an application to list etoricoxib on the PBS for osteoarthritis, concluding that there was no demonstrated need to list another COX-2 selective NSAID and that etoricoxib appears to cause more episodes of hypertension than celecoxib.1
In most other respects the efficacy and safety of etoricoxib are similar to those of celecoxib. In 2 trials comparing celecoxib 200 mg once daily with etoricoxib 30 mg once daily in people with osteoarthritis, over 26 weeks etoricoxib was no worse than celecoxib at reducing pain and improving function.2 The 2 drugs are likely to have similar gastrointestinal safety, although only imprecise estimates of the comparative rates of serious gastrointestinal injury (e.g. perforations, obstructions and bleeding) are available.3
For more information about the efficacy and safety of etoricoxib, refer to the Australian Prescriber October 2009 New Drugs article.
Etoricoxib is contraindicated for people with uncontrolled hypertension
Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses. It is contraindicated for patients with existing hypertension whose blood pressure is persistently above 140/90 mm Hg.4
Over 26 weeks of treatment in trials the incidence of any recorded hypertension-related adverse event was higher with etoricoxib 30 mg than with celecoxib 200 mg (5.7% vs 2.3%, 95% CI of difference 0.97–6.10).5 Compared with diclofenac, etoricoxib was also associated with a significantly higher risk of hypertension, oedema and heart failure (pooled data for etoricoxib 60 mg and 90 mg doses).5
For symptomatic treatment of osteoarthritis, the recommended dose is etoricoxib 30 mg once daily, increased to 60 mg once daily for patients with insufficient relief from symptoms. Etoricoxib 120 mg once daily is approved for a maximum 8 days for acute flares of gouty arthritism, and for acute analgesia including dental pain and primary dysmenorrhoea.4
Assess the risk of new or continuing NSAID use
When assessing the need for NSAID therapy, weigh the risk of cardiovascular, renal and gastrointestinal effects against the potential benefits of treatment for each patient. Elevated cardiovascular risk has been associated with COX-2 selective NSAIDs in some studies. A pooled analysis comparing etoricoxib 30 mg daily or higher with naproxen 1000 mg daily found a significantly higher rate of serious thrombotic cardiovascular events with etoricoxib.4 Evidence for the long-term cardiovascular safety of conventional NSAIDs is limited and does not provide strong evidence of a lower risk than for COX-2 selective NSAIDs.
Using a COX-2 selective NSAID is most justified in people at higher risk of gastrointestinal adverse effects (see NPS RADAR August 2005: Elevated cardiovascular risk with NSAIDs?). In the general NSAID-using population, the incidence of serious ulcer complications is low, so the absolute reduction in the risk of complications when using a COX-2 selective NSAID rather than a conventional NSAID is small for most people. An alternative gastroprotective strategy for people at high risk is to co-prescribe a conventional NSAID with a proton-pump inhibitor, double-dose H2 antagonist, or misoprostol (see NPS News 46: Proton pump inhibitors).
- Australian Government Department of Health and Ageing. Public summary document for etoricoxib, tablet, 30 milligrams, 60 milligrams Arcoxia July 2008. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-etoricoxib-july08 (accessed 1 October 2009).
- Bingham CO, 3rd, et al. Rheumatology (Oxford) 2007;46:496–507.
- Australian Government Department of Health and Ageing. Public summary document for etoricoxib, tablet, 60 milligrams, Arcoxia, July 2007. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbac-psd-etoricoxib-july07 (accessed 1 October 2009).
- Merck Sharp & Dohme (Australia) Pty. Limited. Arcoxia product information. 17 July 2009.
- US Food and Drug Administration and Merck & Co. I. Briefing Information for the April 12, 2007 Arthritis Drugs Advisory Committee. 2007. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4290b1-00-index.htm (accessed 1 October 2009).