Arixtra® (fondaparinuksnatrij)
Sigurnost i podnošljivost
Sigurnost i podnošljivost
Sigurnosni podaci prevencije i liječenja venske tromboembolije (VTE) iz kliničkih studija1-6
Fondaparinux je pokazao sličan sigurnosni profil kao i usporedne terapije, s niskim stopama velikog krvarenja u svim studijama VTE (Tablica 2.)
Pripremljeno prema 1-6.
U bolesnika s UA/NSTEMI, fondaparinuks je bio sličan enoksaparinu u smanjenju rizika od ishemijskih događaja, ali je značajno smanjio stopu velikih krvarenja te poboljšao dugoročni mortalitet i morbiditet (Tablica 3.).7
U bolesnika sa STEMI-jem, osobito onih koji nisu podvrgnuti primarnoj perkutanoj koronarnoj intervenciji, fondaparinuks značajno smanjuje smrtnost iponovni infarkt bez povećanja krvarenja (Tablica 3.)8
Pripremljeno prema 7,8.
Slika 10. Sigurnosni podaci OASIS-5 studije: veliko krvarenje (definirano kao smrtonosno krvarenje, intrakranijalno, retroperitonealno ili intraokularno, što dovodi do smanjenja hemoglobina za ≥ 3,0 g/dl ili je potrebna transfuzija ≥ 2 jedinice crvenih krvnih zrnaca) na dan 97
Pripremljeno prema 7.
Literatura:
- Turpie AG, Bauer KA, et al. Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: a meta-analysis of 4 randomized double-blind studies. Arch Intern Med. 2002;162(16):1833-1840.
- Agnelli G, Bergqvist D et al. investigators P. Randomized clinical trial of postoperative fondaparinux versus perioperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery. Br J Surg. 2005;92(10):1212-1220.
- Cohen AT, Davidson BL et al. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006;332(7537):325-329.
- Buller HR, Davidson BL et al. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med. 2004;140(11):867-873.
- Buller HR, Davidson BL et al. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med. 2003;349(18):1695-1702.
- Decousus H, Prandoni P et al. Fondaparinux for the treatment of superficial-vein thrombosis in the legs. N Engl J Med. 2010;363(13):1222-1232.
- Fifth Organization to Assess Strategies in Acute Ischemic Syndromes I, Yusuf S, Mehta SR, et al. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006;354(14):1464-1476.
- Yusuf S, Mehta SR et al. Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: the OASIS-6 randomized trial. JAMA. 2006;295(13):1519-1530.
- Fox KA, Bassand JP et al. Influence of renal function on the efficacy and safety of fondaparinux relative to enoxaparin in non ST-segment elevation acute coronary syndromes. Ann Intern Med. 2007;147(5):304-310.
