The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy

Abstract Background Deep vein thrombosis (DVT) is a common complication in cancer. Although thromboprophylaxis in cancer patients is recommended by the guidelines, clinicians’ use of thromboprophylaxis remains limited due to cost, bleeding complications, and reluctance to give injectable anticoagula...

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Main Authors: Budi Setiawan, Widi Budianto, Tri Wahyu Sukarnowati, Daniel Rizky, Eko Adhi Pangarsa, Damai Santosa, Aru Wisaksono Sudoyo, Tri Indah Winarni, Ignatius Riwanto, Rahajuningsih Dharma Setiabudy, Catharina Suharti
Format: Article
Language:English
Published: BMC 2023-05-01
Series:Thrombosis Journal
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Online Access:https://doi.org/10.1186/s12959-023-00497-0
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author Budi Setiawan
Widi Budianto
Tri Wahyu Sukarnowati
Daniel Rizky
Eko Adhi Pangarsa
Damai Santosa
Aru Wisaksono Sudoyo
Tri Indah Winarni
Ignatius Riwanto
Rahajuningsih Dharma Setiabudy
Catharina Suharti
author_facet Budi Setiawan
Widi Budianto
Tri Wahyu Sukarnowati
Daniel Rizky
Eko Adhi Pangarsa
Damai Santosa
Aru Wisaksono Sudoyo
Tri Indah Winarni
Ignatius Riwanto
Rahajuningsih Dharma Setiabudy
Catharina Suharti
author_sort Budi Setiawan
collection DOAJ
description Abstract Background Deep vein thrombosis (DVT) is a common complication in cancer. Although thromboprophylaxis in cancer patients is recommended by the guidelines, clinicians’ use of thromboprophylaxis remains limited due to cost, bleeding complications, and reluctance to give injectable anticoagulants. Inflammation plays essential roles in the pathogenesis of cancer-associated thrombosis. Owing to its ability to decrease proinflammatory cytokines, statins have anti-inflammatory properties. Thus, statins can be possibly utilized as thromboprophylaxis therapy in cancer patients undergoing chemotherapy. Objective To compare the effectiveness of atorvastatin and rivaroxaban for DVT prevention in high-risk thrombosis patients with cancer undergoing chemotherapy. Methods Double-blind, randomized controlled trial involving cancer patients with high-risk of thrombosis undergoing chemotherapy. We randomly assigned patients without deep-vein thrombosis at screening to receive atorvastatin 20 mg or rivaroxaban 10 mg daily for up to 90 days. Doppler ultrasonography was performed 90 days following chemotherapy to diagnose DVT. Average cost-effectiveness analysis was performed to analyze the cost of atorvastatin compared to rivaroxaban. Results Of the eighty six patients who underwent randomization, primary efficacy end point was observed in 1 of 42 patients (2.3%) in the atorvastatin group and in 1 of 44 (2.2%) in the rivaroxaban group (Odds Ratio [OR], 0.953; 95% confidence interval [CI], 0.240 to 3.971; p = 1.000). There was a significant difference in the incidence of major bleeding, 2 of 42 patients (4.8%) in the atorvastatin group and 12 of 44 (27.3%) in the rivaroxaban group (OR, 0.257; 95% CI, 0.07 to 0.94; p = 0.007). The average cost-effectiveness ratio of using atorvastatin was lower than that of rivaroxaban. Conclusion Atorvastatin did not differ significantly from rivaroxaban in reducing the incidence of DVT, lower bleeding risk, and cost-effectiveness for thromboprophylaxis in high-risk thrombosis patients with cancer undergoing chemotherapy. The presence of limited statistical power and wide confidence intervals in this study needs further study to strengthen the efficacy of atorvastatin as DVT prophylaxis in cancer patients. Trial registration ISRCTN71891829, Registration Date: 17/12/2020.
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spelling doaj.art-ef7b9a5055b5464985904e859e4305122023-05-14T11:24:55ZengBMCThrombosis Journal1477-95602023-05-0121111510.1186/s12959-023-00497-0The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapyBudi Setiawan0Widi Budianto1Tri Wahyu Sukarnowati2Daniel Rizky3Eko Adhi Pangarsa4Damai Santosa5Aru Wisaksono Sudoyo6Tri Indah Winarni7Ignatius Riwanto8Rahajuningsih Dharma Setiabudy9Catharina Suharti10Hematology-Medical Oncology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Diponegoro/Dr. Kariadi HospitalHematology-Medical Oncology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Diponegoro/Dr. Kariadi HospitalHematology-Medical Oncology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Diponegoro/Dr. Kariadi HospitalHematology-Medical Oncology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Diponegoro/Dr. Kariadi HospitalHematology-Medical Oncology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Diponegoro/Dr. Kariadi HospitalHematology-Medical Oncology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Diponegoro/Dr. Kariadi HospitalHematology-Medical Oncology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo HospitalDepartment of Anatomy, Faculty of Medicine, Universitas Diponegoro/Center for Biomedical Research (CEBIOR), Faculty of Medicine, Universitas DiponegoroDigestive Surgery Division, Department of Surgery, Faculty of Medicine, Universitas Diponegoro/Dr. Kariadi HospitalDepartment of Clinical Pathology, Faculty of Medicine, Universitas IndonesiaHematology-Medical Oncology Division, Department of Internal Medicine, Faculty of Medicine, Universitas Diponegoro/Dr. Kariadi HospitalAbstract Background Deep vein thrombosis (DVT) is a common complication in cancer. Although thromboprophylaxis in cancer patients is recommended by the guidelines, clinicians’ use of thromboprophylaxis remains limited due to cost, bleeding complications, and reluctance to give injectable anticoagulants. Inflammation plays essential roles in the pathogenesis of cancer-associated thrombosis. Owing to its ability to decrease proinflammatory cytokines, statins have anti-inflammatory properties. Thus, statins can be possibly utilized as thromboprophylaxis therapy in cancer patients undergoing chemotherapy. Objective To compare the effectiveness of atorvastatin and rivaroxaban for DVT prevention in high-risk thrombosis patients with cancer undergoing chemotherapy. Methods Double-blind, randomized controlled trial involving cancer patients with high-risk of thrombosis undergoing chemotherapy. We randomly assigned patients without deep-vein thrombosis at screening to receive atorvastatin 20 mg or rivaroxaban 10 mg daily for up to 90 days. Doppler ultrasonography was performed 90 days following chemotherapy to diagnose DVT. Average cost-effectiveness analysis was performed to analyze the cost of atorvastatin compared to rivaroxaban. Results Of the eighty six patients who underwent randomization, primary efficacy end point was observed in 1 of 42 patients (2.3%) in the atorvastatin group and in 1 of 44 (2.2%) in the rivaroxaban group (Odds Ratio [OR], 0.953; 95% confidence interval [CI], 0.240 to 3.971; p = 1.000). There was a significant difference in the incidence of major bleeding, 2 of 42 patients (4.8%) in the atorvastatin group and 12 of 44 (27.3%) in the rivaroxaban group (OR, 0.257; 95% CI, 0.07 to 0.94; p = 0.007). The average cost-effectiveness ratio of using atorvastatin was lower than that of rivaroxaban. Conclusion Atorvastatin did not differ significantly from rivaroxaban in reducing the incidence of DVT, lower bleeding risk, and cost-effectiveness for thromboprophylaxis in high-risk thrombosis patients with cancer undergoing chemotherapy. The presence of limited statistical power and wide confidence intervals in this study needs further study to strengthen the efficacy of atorvastatin as DVT prophylaxis in cancer patients. Trial registration ISRCTN71891829, Registration Date: 17/12/2020.https://doi.org/10.1186/s12959-023-00497-0CancerChemotherapyDVTThromboprophylaxisAtorvastatin
spellingShingle Budi Setiawan
Widi Budianto
Tri Wahyu Sukarnowati
Daniel Rizky
Eko Adhi Pangarsa
Damai Santosa
Aru Wisaksono Sudoyo
Tri Indah Winarni
Ignatius Riwanto
Rahajuningsih Dharma Setiabudy
Catharina Suharti
The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy
Thrombosis Journal
Cancer
Chemotherapy
DVT
Thromboprophylaxis
Atorvastatin
title The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy
title_full The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy
title_fullStr The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy
title_full_unstemmed The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy
title_short The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy
title_sort effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy
topic Cancer
Chemotherapy
DVT
Thromboprophylaxis
Atorvastatin
url https://doi.org/10.1186/s12959-023-00497-0
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