Sociedad Americana de Hirudoterapia

Dabigatran: new drug. Continue to use heparin, a better-known option

Research article published in Prescrire international (2009)

Última actualización: June 18, 2026Revisado por: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Research reportDesarrollo de fármacosPrescrire International et al. · Prescrire international, 2009

Abstract

(1) The standard anticoagulant for preventing thromboembolic events after hip or knee replacement surgery is a subcutaneous low-molecular-weight heparin such as enoxaparin; (2) Dabigatran, a specific thrombin inhibitor, was recently licensed for oral prophylaxis in this setting, as dabigatran etexilate (mesilate), a prodrug; (3) The clinical evaluation of dabigatran in this indication is based on two comparative double-blind trials with similar protocols, comparing dabigatran 150 mg or 220 mg/day versus enoxaparin in 3494 patients undergoing hip replacement surgery and 2101 patients undergoing knee replacement surgery. The results were virtually identical: compared with enoxaparin, dabigatran did not reduce overall mortality (almost zero in the different groups), the frequency of symptomatic pulmonary embolism (almost zero in the different groups), or the frequency of symptomatic deep venous thrombosis (0.1% to 1.2%); (4) There was no difference between the groups with respect to the frequency of severe bleeding (about 1.5%), hepatic disorders (about 4%), or acute coronary events (a few cases). But dabigatran was associated with surgical wound seepage in 7% of patients, versus 4.7% with enoxaparin; (5) The anticoagulant effect of dabigatran, and therefore the frequency of haemorrhage, increases with age and in cases of renal failure. However, clinical trials included relatively few elderly patients and/or patients with renal failure, who nonetheless represent a large proportion of the candidates for hip or knee replacement; (6) Dabigatran becomes more potent when combined with P-glycoprotein inhibitors or with drugs that impair renal function. Combination with other antithrombotic drugs should be avoided. (7) Dabigatran is administered orally, while enoxaparin requires daily subcutaneous injections. Dabigatran therapy does not necessitate laboratory monitoring, while the platelet count must be monitored with enoxaparin. There is no known antidote for dabigatran overdose; (8) In summary, for the prevention of venous thromboembolic events after orthopaedic surgery, it is better to continue to use heparins, at least pending more thorough evaluation of dabigatran.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeJournal Article
Indexed MeSH termsAnticoagulantsArthroplasty, Replacement, HipArthroplasty, Replacement, KneeBenzimidazolesDabigatranDrug ApprovalEnoxaparinFactor Xa InhibitorsFibrinolytic AgentsFranceHemorrhageHeparin

Resumen

Dabigatran: new drug. Continue to use heparin, a better-known option.

Por qué esto importa para la hirudoterapia

This article evaluates dabigatran etexilate, an oral direct thrombin inhibitor, for venous thromboembolism prophylaxis after hip or knee replacement surgery, based on two double-blind comparative trials involving over 5,500 patients. The abstract reports that dabigatran offered no advantage over enoxaparin in mortality, symptomatic pulmonary embolism, or symptomatic deep vein thrombosis, while being associated with more frequent surgical wound seepage (7% vs. 4.7%); the author concludes that heparins remain the preferred, better-characterized option. For ASH, the relevance is only indirect: although dabigatran is a direct thrombin inhibitor—the same mechanistic class as leech-derived hirudin—the abstract makes no mention of hirudin, leeches, or hirudotherapy. The article provides no data on leech-based therapeutics and should not be cited as evidence for or against hirudotherapy.

Citación

Dabigatran: new drug. Continue to use heparin, a better-known option

Prescrire International et al. · Prescrire international, 2009

Contexto clínico relacionado

Añadido a la biblioteca ASH: May 27, 2026 · Última actualización del sitio: June 18, 2026

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