Dataset Information

The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy : A randomised controlled trial: open label.

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.

SUBMITTER: Setiawan B

PROVIDER: S-EPMC10164452 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy : A randomised controlled trial: open label.

Setiawan Budi B Budianto Widi W Sukarnowati Tri Wahyu TW Rizky Daniel D Pangarsa Eko Adhi EA Santosa Damai D Sudoyo Aru Wisaksono AW Winarni Tri Indah TI Riwanto Ignatius I Setiabudy Rahajuningsih Dharma RD Suharti Catharina C

Thrombosis journal 20230508 1

<h4>Background</h4>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, ...[more]

PMID: 37150824

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Project description:BackgroundEven with adherence to thromboprophylaxis recommended by guidelines, the incidence of deep vein thrombosis (DVT) remains high among patients with severe community-acquired pneumonia (SCAP). There is an urgent need to identify the risk factors for DVT in these patients to optimize preventive strategies.Study design and methodsWe retrospectively enrolled 309 adults with SCAP admitted to Beijing Chao-Yang Hospital between 1 January 2015 and 30 June 2023. All patients received guideline-recommended thromboprophylaxis and lower extremity venous compression ultrasound scanning. Clinical characteristics, including demographic information, clinical history, vital signs, laboratory findings, treatments, complications, and outcomes, were analyzed for patients with and without DVT in these two cohorts.ResultsOf the 309 patients, 110 (35.6%) developed 1ower extremity DVT. There was no significant difference in the incidence of DVT among the different prophylactic measures (P = 0.393). Multivariate logistic regression analysis showed an association between a history of VTE (OR, 13.388, 95% CI: 2.179 ~ 82.257; P = 0.005), bedridden time > 3 days (OR, 17.672, 95% CI: 5.686 ~ 54.929; P < 0.001), D-dimer levels ≥ 1.0 µg/mL (OR, 2.109, 95% CI: 1.018 ~ 4.372; P = 0.045), LDH levels ≥ 400 U/L (OR, 2.548, 95% CI: 1.308 ~ 4.965; P = 0.006), IMV (OR, 2.479, 95% CI: 1.233 ~ 4.986; P = 0.011) and the occurrence of DVT. A new prediction model, including history of VTE, bedridden time, D-dimer levels, LDH levels and IMV, showed a better performance in predicting DVT (AUC = 0.856; 95% CI: 0.766 ~ 0.921; sensitivity: 80.6%; specificity: 81.4%) than Padua prediction score (AUC = 0.666) and Caprini prediction score (AUC = 0.688) for patients with SCAP. The 30-day mortality and in-hospital mortality in the DVT group were significantly higher than those in the non-DVT group.ConclusionsEven received guideline-recommended thromboprophylaxis, the prevalence of DVT among patients with SCAP remains unexpectedly high which is also associated with a poor prognosis. It is necessary to identify people at high risk of DVT early and refine the preventive strategies accordingly to improve patient outcomes.

Dataset Information

The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy : A randomised controlled trial: open label.

Background

Objective

Methods

Results

Conclusion

Trial registration

Publications

The effectiveness of atorvastatin for the prevention of deep vein thrombosis in cancer patients undergoing chemotherapy : A randomised controlled trial: open label.

Similar Datasets

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