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Etoricoxib

Classification: C

Drug products: Arcoxia, Arcoxia®, Coxolin, Etoricoxib Brown, Etoricoxib Krka, Etoricoxib Orion, Etoricoxib Sandoz, Etoricoxib STADA, Etoricoxib Teva, Tauxib, Turox®

ATC code: M01AH05

Substances: etoricoxib

Summary

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.

Additional information

Pharmacokinetics and dosing

According to the original manufacturer, there is no difference between men and women in etoricoxib pharmacokinetics [4]. No studies with a clinically relevant sex analysis regarding the dosing of etoricoxib have been found.

Effects

Sex-stratified data on efficacy are scarce in etoricoxib trials [5]. 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) [8]. Power analysis of what size of effect difference between men and women these studies could detect are lacking.

Adverse effects

Sex-stratified data on adverse effects are scarce in etoricoxib trials [5]. 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 [11].

Reproductive health issues

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 [12]. 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 [1]. The expression of COX is influenced by the change in level of estrogen and progesterone during pregnancy [2]. 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).

Updated: 2017-03-28

Date of litterature search: 2015-03-03

References

  1. Stone S, Khamashta MA, Nelson-Piercy C. Nonsteroidal anti-inflammatory drugs and reversible female infertility: is there a link?. Drug Saf. 2002;25:545-51. PubMed
  2. Chan VS. A mechanistic perspective on the specificity and extent of COX-2 inhibition in pregnancy. Drug Saf. 2004;27:421-6. PubMed
  3. ONENSAL (celecoxib). Summary of Product Characteristics. European Medicines Agency (EMA); 2011.
  4. ARCOXIA (etoricoxib). Summary of Product Characteristics. Medical Products Agency - Sweden; 2013.
  5. Chilet-Rosell E, Ruiz-Cantero MT, Horga JF. Women's health and gender-based clinical trials on etoricoxib: methodological gender bias. J Public Health (Oxf). 2009;31:434-45. PubMed
  6. Zacher J, Feldman D, Gerli R, Scott D, Hou SM, Uebelhart D et al. A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis. Curr Med Res Opin. 2003;19:725-36. PubMed
  7. Puopolo A, Boice JA, Fidelholtz JL, Littlejohn TW, Miranda P, Berrocal A et al. A randomized placebo-controlled trial comparing the efficacy of etoricoxib 30 mg and ibuprofen 2400 mg for the treatment of patients with osteoarthritis. Osteoarthritis Cartilage. 2007;15:1348-56. PubMed
  8. Navarra S, Rubin BR, Yu Q, Smugar SS, Tershakovec AM. Association of baseline disease and patient characteristics with response to etoricoxib and indomethacin for acute gout. Curr Med Res Opin. 2007;23:1685-91. PubMed
  9. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA. 2001;286:954-9. PubMed
  10. Coxib and traditional NSAID Trialists' (CNT) Collaboration, Bhala N, Emberson J, Merhi A, Abramson S, Arber N et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013;382:769-79. PubMed
  11. Hunt RH, Harper S, Watson DJ, Yu C, Quan H, Lee M et al. The gastrointestinal safety of the COX-2 selective inhibitor etoricoxib assessed by both endoscopy and analysis of upper gastrointestinal events. Am J Gastroenterol. 2003;98:1725-33. PubMed
  12. Schwartz J, Hunt T, Smith WB, Wong P, Larson P, Crumley T et al. The effect of etoricoxib on the pharmacokinetics of oral contraceptives in healthy participants. J Clin Pharmacol. 2009;49:807-15. PubMed
  13. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson

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