Aspirin, Warfarin, or Enoxaparin Thromboprophylaxis in Patients With Multiple Myeloma Treated With Thalidomide: A Phase III, Open-Label, Randomized Trial
| Autor: | Claudia Crippa, Alessandra Romano, Michele Cavo, Francesca Elice, Roberto Marasca, Mario Boccadoro, Massimo Offidani, Renato Zambello, Claudia Cellini, Valeria Magarotto, Vincenzo Callea, Monica Galli, Claudia Polloni, Patrizia Tosi, Angelo Michele Carella, Giulia Benevolo, Elena Zamagni, Andrea Evangelista, Fabiana Gentilini, Stefano Pulini, Antonio Palumbo, Vittorio Montefusco, Sara Bringhen, Chiara Nozzoli, Davide Rossi, Norbert Pescosta, Roberto Ria, Paola Tacchetti, Francesca Patriarca, Luca Baldini, Tommaso Caravita, Fortunato Morabito |
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| Přispěvatelé: | Palumbo A., Cavo M., Bringhen S., Zamagni E., Romano A., Patriarca F., Rossi D., Gentilini F., Crippa C., Galli M., Nozzoli C., Ria R., Marasca R., Montefusco V., Baldini L., Elice F., Callea V., Pulini S., Carella A.M., Zambello R., Benevolo G., Magarotto V., Tacchetti P., Pescosta N., Cellini C., Polloni C., Evangelista A., Caravita T., Morabito F., Offidani M., Tosi P., Boccadoro M. |
| Rok vydání: | 2011 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Time Factors multiple myeloma thrombosis prophylaxis medicine.drug_class Low molecular weight heparin Antineoplastic Agents Hemorrhage Risk Assessment Sudden death Fibrinolytic Agents MULTIPLE MYELOMA Risk Factors Thromboembolism Internal medicine Multicenter trial Antineoplastic Combined Chemotherapy Protocols medicine Humans Enoxaparin THROMBOPROPHYLAXIS Contraindication Aged wafarin Aspirin business.industry Warfarin Anticoagulants Middle Aged Thalidomide Surgery ASPIRIN Treatment Outcome Italy Oncology Cardiovascular Diseases Female business Enoxaparin sodium Platelet Aggregation Inhibitors medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 29:986-993 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | Purpose In patients with myeloma, thalidomide significantly improves outcomes but increases the risk of thromboembolic events. In this randomized, open-label, multicenter trial, we compared aspirin (ASA) or fixed low-dose warfarin (WAR) versus low molecular weight heparin (LMWH) for preventing thromboembolism in patients with myeloma treated with thalidomide-based regimens. Patients and Methods A total of 667 patients with previously untreated myeloma who received thalidomide-containing regimens and had no clinical indication or contraindication for a specific antiplatelet or anticoagulant therapy were randomly assigned to receive ASA (100 mg/d), WAR (1.25 mg/d), or LMWH (enoxaparin 40 mg/d). A composite primary end point included serious thromboembolic events, acute cardiovascular events, or sudden deaths during the first 6 months of treatment. Results Of 659 analyzed patients, 43 (6.5%) had serious thromboembolic events, acute cardiovascular events, or sudden death during the first 6 months (6.4% in the ASA group, 8.2% in the WAR group, and 5.0% in the LMWH group). Compared with LMWH, the absolute differences were +1.3% (95% CI, −3.0% to 5.7%; P = .544) in the ASA group and +3.2% (95% CI, −1.5% to 7.8%; P = .183) in the WAR group. The risk of thromboembolism was 1.38 times higher in patients treated with thalidomide without bortezomib. Three major (0.5%) and 10 minor (1.5%) bleeding episodes were recorded. Conclusion In patients with myeloma treated with thalidomide-based regimens, ASA and WAR showed similar efficacy in reducing serious thromboembolic events, acute cardiovascular events, and sudden deaths compared with LMWH, except in elderly patients where WAR showed less efficacy than LMWH. |
| Databáze: | OpenAIRE |
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