Drug products: Arcoxia, Arcoxia®, Coxolin, Etoricoxib Brown, Etoricoxib Krka, Etoricoxib Orion, Etoricoxib Sandoz, Etoricoxib STADA, Etoricoxib Teva, Tauxib, Turox®
ATC code: M01AH05
There are few clinical studies with sex-divided data. Two clinical studies have shown equivalent effect of etoricoxib in men and women with arthrosis. Etoricoxib interacts with contraceptive pills resulting in a higher exposure to etinylestradiol which may increase the risk of thromboembolic adverse events. Coxibs in general have an increased risk of thromboembolic adverse events which needs to be considered. Etoricoxib is contraindicated for use during pregnancy.
According to the original manufacturer, there is no difference between men and women in etoricoxib pharmacokinetics . No studies with a clinically relevant sex analysis regarding the dosing of etoricoxib have been found.
Sex-stratified data on efficacy are scarce in etoricoxib trials . Clinical trials have found no sex differences in treatment response in patients with osteoarthritis (101 men, 415 women, and 133 men, 415 women) [6,7] or in patients with acute gout (171 men, 7 women) . Power analysis of what size of effect difference between men and women these studies could detect are lacking.
Sex-stratified data on adverse effects are scarce in etoricoxib trials . COX-2 inhibitors have an increased risk of cardiovascular adverse events due to the prothrombotic effect caused by the decrease in vasodilatation and antiaggregatory prostacyclin production. Data on sex differences in this risk is lacking [9,10].The incidence of gastrointestinal events in patients taking 120 mg etoricoxib or 2400 mg ibuprofen daily was compared in a randomized, double-blind, placebo-controlled study. One of the risk factors for ulcer development was male sex. However, if this was related to etoricoxib or ibuprofen is unclear .
Co-administration of 60 mg etoricoxib and oral contraceptive (35 µg ethinyl estradiol and 0.5-1 mg norethindrone) for 21 days increased the steady-state AUC of ethinyl estradiol by 37%. A higher exposure to ethinyl estradiol can increase the incidence of adverse events associated with oral contraceptives, such as venous thromboembolic events in women at risk . Use of COX-2 inhibitors in itself is associated with an increased risk of thromboembolic events. Regarding drug-drug interactions aspects, please consult Janusmed Interactions (in Swedish, Janusmed interaktioner).
COX-2 is active in the ovaries during follicular development. COX-2 inhibitors can delay the follicular rupture, which have been associated with transient infertility in some women . The expression of COX is influenced by the change in level of estrogen and progesterone during pregnancy . Celecoxib and etoricoxib are contraindicated for use in all stages of pregnancy and in women of childbearing age. If a woman becomes pregnant during treatment, the COX-2 inhibitor should be discontinued [2,3].Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2015-03-03
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson