Dois artigos e um editorial à respeito da nova droga Ximelagatran, o primeiro novo anticoagulante oral depois do aparecimento do warfarin, são o destaque da revista The New England Journal of Medicine, ocupando boa parte desta publicação. O Ximelagatran é metabolizado em melagatran e não requer monitorização laboratorial, sendo este o seu grande diferencial em relação ao warfarin. Um outro artigo neste mesmo número da revista aborda a fondaparinux, que, como o Ximelagatran não necessita do controle de laboratório. Os links dos três artigos publicados e do editorial estão listados abaixo.
New England Journal of Medicine
||October 30, 2003
Subcutaneous Fondaparinux versus Intravenous Unfractionated Heparin in the Initial Treatment of Pulmonary Embolism
The Matisse Investigators
Background The standard initial treatment of hemodynamically stable patients with pulmonary embolism is intravenous unfractionated heparin, requiring laboratory monitoring and hospitalization.
Methods We conducted a randomized, open-label trial involving 2213 patients with acute symptomatic pulmonary embolism to compare the efficacy and safety of the synthetic antithrombotic agent fondaparinux with those of unfractionated heparin and to document noninferiority in terms of efficacy. Patients received either fondaparinux (5.0, 7.5, or 10.0 mg in patients weighing less than 50, 50 to 100, or more than 100 kg, respectively) subcutaneously once daily or a continuous intravenous infusion of unfractionated heparin (ratio of the activated partial-thromboplastin time to a control value, 1.5 to 2.5), both given for at least five days and until the use of vitamin K antagonists resulted in an international normalized ratio above 2.0. The primary efficacy outcome was the three-month incidence of the composite end point of symptomatic, recurrent pulmonary embolism (nonfatal or fatal) and new or recurrent deep-vein thrombosis.
Results Forty-two of the 1103 patients randomly assigned to receive fondaparinux (3.8 percent) had recurrent thromboembolic events, as compared with 56 of the 1110 patients randomly assigned to receive unfractionated heparin (5.0 percent), for an absolute difference of –1.2 percent in favor of fondaparinux (95 percent confidence interval, –3.0 to 0.5). Major bleeding occurred in 1.3 percent of the patients treated with fondaparinux and 1.1 percent of those treated with unfractionated heparin. Mortality rates at three months were similar in the two groups. Of the patients in the fondaparinux group, 14.5 percent received the drug in part on an outpatient basis.
Conclusions Once-daily, subcutaneous administration of fondaparinux without monitoring is at least as effective and is as safe as adjusted-dose, intravenous administration of unfractionated heparin in the initial treatment of hemodynamically stable patients with pulmonary embolism.
The writing committee of the Matisse Study (H.R. Büller, B.L. Davidson, H. Decousus, A. Gallus, M. Gent, F. Piovella, M.H. Prins, G. Raskob, A.E.M. van den Berg-Segers, R. Cariou, O. Leeuwenkamp, and A.W.A. Lensing) takes responsibility for the content of this article.
Address reprint requests to Dr. Büller at the Academic Medical Center, Department of Vascular Medicine, F4-211, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands, or at firstname.lastname@example.org.
This article has been cited by other articles:
- Shapiro, S. S. (2003). Treating Thrombosis in the 21st Century. N Engl J Med 349: 1762-1764 [Full Text]