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Cardiovascular: The cardiovascular safety of etoricoxib has been assessed in the MEDAL program which pooled data from 3 studies involving over 30,000 patients with either osteoarthritis or rheumatoid arthritis. Patients with osteoarthritis were given etoricoxib 60 or 90 mg daily; those with rheumatoid arthritis received 90 mg daily. In all studies, diclofenac 150 mg daily was given as the comparator. After an average treatment duration of 18 months, the rate of thrombotic events such as myocardial infarction, stroke, and sudden or unexplained death with etoricoxib were similar to those for diclofenac. One of the 3 studies showed that there was a non-significant increase in the rate of heart failure with etoricoxib 90 mg daily compared to diclofenac.
In another study that pooled pre-licensing data, the risk of thrombotic events with etoricoxib, given at a dose of at least 60 mg daily, was also found to be similar to that for placebo treatment, ibuprofen 2.4 g daily, diclofenac 150 mg daily and naproxen 1 g daily, although there was a trend towards more events with etoricoxib than with naproxen. The EMEA's Committee for Medicinal Product for Human Use (CHMP) has recommended the inclusion of a warning in the labelling of etoricoxib that it must not be given to patients whose blood pressure is persistently above 140/90 mmHg and inadequately controlled; in addition, high blood pressure should be controlled before starting treatment and monitored for 2 weeks afterwards then regularly thereafter. Etoricoxib should be used the shortest duration possible and lowest effective daily dose. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.
Hepatic: NSAIDs should be used with caution in patients with hepatic impairment; NSAIDs should be avoided in severe liver disease (Child-Pugh 10 or more), maximum 60 mg daily in mild hepatic impairment (Child-Pugh score 5 to 6), maximum 60 mg on alternate days or 30 mg once daily in moderate hepatic impairment (Child-Pugh score 7 to 9).
Renal: NSAIDs should be avoided if possible or used with caution in patients with renal impairment; the lowest effective dose should be used for the shortest possible duration, and renal function should be monitored. Sodium and water retention may occur and renal function may deteriorate, possibly leading to renal failure; deterioration in renal function has also been reported after topical use. Avoid if eGFR less than 30 ml/minute/1.73 m2.
Gastro-intestinal: It is generally accepted that the inhibition of cyclo-oxygenase-1 (COX-1) plays a role in the adverse gastrointestinal effects of the NSAIDs, and COX-2 by NSAIDs such as etoricoxib may cause less gastrotoxicity than that seen with the non-selective inhibition of the traditional NSAIDs. In addition, etoricoxib should not be used in patients with active gastrointestinal ulceration or bleeding. In a study of the pooled data from 3 randomised clinical studies, etoricoxib (in doses of 60 or 90 mg daily) was associated with significantly less frequent upper gastrointestinal clinical events than diclofenac (150 mg daily). But the adverse gastrointestinal effects may be increased, if used in the elderly patients and have a history of gastrointestinal reaction.
