Fondaparinux Pre-, Peri-, and/or Postpartum for the Prophylaxis/Treatment of Venous Thromboembolism (FondaPPP)

Carl-Erik Dempfle, Jürgen Koscielny, Edelgard Lindhoff-Last, Birgit Linnemann, Irene Bux-Gewehr, Günther Kappert, Ute Scholz, Stefan Kropff, Sonja Eberle, Peter Bramlage, Andreas Heinken, Carl-Erik Dempfle, Jürgen Koscielny, Edelgard Lindhoff-Last, Birgit Linnemann, Irene Bux-Gewehr, Günther Kappert, Ute Scholz, Stefan Kropff, Sonja Eberle, Peter Bramlage, Andreas Heinken

Abstract

We analyzed data for women who received fondaparinux for ≥7 days during pregnancy. The study retrospectively included women who received fondaparinux pre-, peri- and/or postpartum for ≥7 days for prophylaxis/venous thromboembolism (VTE) treatment at German specialist centers (2004-2010). Data on pregnancy, VTE risk factors, anticoagulant treatment, pregnancy outcome and adverse events were extracted from medical records. 120 women (mean age 31.5 years) were included. Among 84 women with prior pregnancies, 41.0% had ≥1 abortion. Anticoagulation was indicated for prophylaxis in 92.5% cases, including 82.5% women with an elevated VTE risk (82.8% thrombophilia, 34.2% VTE history). All women received low-molecular-weight heparin (LMWH) as first-line therapy; 3 also unfractionated heparin. Treatment changed to fondaparinux, due to heparin allergy (41.7%) or heparin-induced thrombocytopenia (10.0%). Fondaparinux was generally well tolerated. Adverse events included bleeding events (n = 5), abortion (n = 2), premature births (n = 2), stillbirth (n = 1), arrested labors (n = 2), injection site erythema (n = 4) and unspecified drug hypersensitivity (n = 6). No VTE events or increased liver enzymes occurred during treatment. In this retrospective study, fondaparinux was effective and well tolerated. Trial registration: ClinicalTrials.gov NCT01004939.

Keywords: fondaparinux; pregnancy; venous thromboembolism.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: CED discloses speaker honoraria from Aspen, Sanofi-Aventis, Mitsubishi Pharma, ITF Pharma, Bayer Vital Pharma, Bayer Healthcare, Daiichi Pharma, CSL Behring, Pfizer, BMS. JK discloses speaker honoraria from Aspen, Bayer Health Care Pharmaceuticals, Daiichi Sankyo, Boehringer Ingelheim, CSL Behring, Sanofi-Aventis, Pfizer, BMS, Mitsubishi Pharma, Ferring GmbH, Mylan Healthcare GmbH and Novo Nordisk. JK is also a medical advisor for CSL Behring International, Bayer HealthCare Pharmaceuticals (national and international) and Novo Nordisk (national) during the last 3 years. IBG, GK, and BL declare to have no conflicts of interest. ELL discloses speaker honoraria from Aspen, Mitsubishi Pharma, Bayer Healthcare, Daiichi Pharma, CSL Behring, Pfizer, BMS. US discloses speaker honoraria from Bayer Healthcare, CSL Behring, Pfizer, Roche. SK was previously employed by GlaxoSmithKline and owns GSK stock. SE was previously employed by GlaxoSmithKline and owns/owned no GSK stock. PB reports to have received consultancy honoraria from Aspen. AH was previously employed by GlaxoSmithKline and owns/owned no GSK stock. He is now employee of Aspen.

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