hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with etoricoxib after careful consideration (see section 5.1). Multinational etoricoxib and Diclofenac Arthritis Long-term (MEDAL) ProgrammeThe MEDAL Programme was a prospectively designed Cardiovascular (CV) Safety Outcomes Programme of pooled data from three randomized, double-blind active comparator controlled trials, the MEDAL study, EDGE II and EDGE.
The rate of confirmed thrombotic cardiovascular serious adverse events (consisting of cardiac, cerebrovascular, and peripheral vascular events) was comparable between etoricoxib and diclofenac, and data are summarized in the table below. Across clinical pharmacology studies, etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. The rates of confirmed lower GI clinical events (small or large bowel perforation, obstruction, or haemorrhage, (POBs)) were not significantly different between etoricoxib and diclofenac. No dosage adjustment is necessary for patients with creatinine clearance ≥30 ml/min (see section 5.2). In patients with rheumatoid arthritis (RA), etoricoxib 60 mg and 90 mg once daily both provided significant improvements in pain, inflammation, and mobility. Etoricoxib is administered orally and may be taken with or without food. All active comparators showed an increase relative to placebo with respect to systolic blood pressures; however, etoricoxib was associated with a statistically significant increase at Day 14 when compared to celecoxib and naproxen (mean change from baseline for systolic blood pressure: etoricoxib 7.7 mmHg, celecoxib 2.4 mmHg, naproxen 3.6 mmHg). When suggestions are available use up and down arrows to review and ENTER to select. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with etoricoxib.
Caution should be exercised when co-administering etoricoxib with warfarin or other oral anticoagulants (see section 4.5). However, the rate of these events was higher in patients receiving etoricoxib compared with those receiving naproxen 500 mg twice daily. In clinical studies for acute postoperative dental pain following surgery including 614 patients treated with etoricoxib (90 mg or 120 mg), the adverse experience profile in these studies was generally similar to that reported in the combined OA, RA, and chronic low back pain studies. Etoricoxib is indicated in adults and adolescents 16 years of age and older for the short-term treatment of moderate pain associated with dental surgery. 2005 May;39(5):854-62. doi: 10.1345/aph.1E543. In clinical trials for acute gouty arthritis, etoricoxib was given for 8 days. Divided daily dosage: The recommended starting dose for adult patients who have received no previous treatment is one 100-mg DILANTIN (extended phenytoin sodium capsule, USP) by mouth three times daily. 2003;56(2):65-9. doi: 10.1159/000072735. In rats and rabbits, there was a dose dependent increase in post implantation loss at exposures greater than or equal to 1.5 times the human exposure (see sections 4.3 and 4.6). In patients with ankylosing spondylitis, etoricoxib 90 mg once daily provided significant improvements in spine pain, inflammation, stiffness and function. The incidence of confirmed congestive heart failure adverse events (events that were serious and resulted in hospitalisation or a visit to an emergency department) was non-significantly higher with etoricoxib than diclofenac 150 mg, and this effect was dose-dependent. Renal function should be monitored when etoricoxib and either of these drugs is used in combination. If a woman becomes pregnant during treatment, etoricoxib must be discontinued. Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time INR, particularly in the first few days when therapy with etoricoxib is initiated or the dose of etoricoxib is changed (see section 4.4). However, patients at high risk of digoxin toxicity should be monitored for this when etoricoxib and digoxin are administered concomitantly. A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been demonstrated in long-term clinical trials (see section 5.1). Unable to load your delegates due to an error
No clinical data on exposed pregnancies are available for etoricoxib. In clinical trials, etoricoxib was administered without regard to food intake. The geometric mean area under the curve (AUC0-24hr) was 37.8 µg•hr/ml. The rate for confirmed upper GI events in elderly patients was evaluated and the largest reduction was observed in patients ≥ 75 years of age (1.35 [95% CI 0.94, 1.87] vs. 2.78 [95% CI 2.14, 3.56] events per hundred patient-years for etoricoxib and diclofenac, respectively. Cardiorenal adverse events were observed more frequently with etoricoxib than with diclofenac, and this effect was dose-dependent (see specific results below).
In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
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