Comparison of effectiveness and safety for low versus full dose of apixaban during extended phase oral anticoagulation in patients with venous thromboembolism

DeRemer, Christina E.; Dietrich, Eric; Kang, Hye‐Rim; Huang, Pei-Lin; Lo‐Ciganic, Wei‐Hsuan; Park, Haesuk

doi:10.1111/joim.13462

Cited by 6 publications

(7 citation statements)

References 28 publications

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“…Fourth, although current guidelines suggest the use of low‐dose anticoagulants when available, 6,54 it was not feasible to stratify the study results by apixaban dose (2.5 mg vs. 5 mg) owing to the small sample size (< 10% of apixaban users were prescribed low dose); therefore, we could not determine whether the low‐dose and the full‐dose apixaban had similar effectiveness and safety as extended treatment. However, it appeared that there were no significant differences in clinical outcomes between patients prescribed low‐dose vs. full‐dose apixaban during extended treatment 55 . Thus, our study results may not be significantly different between the two dosage groups.…”

Section: Discussionmentioning

confidence: 63%

“…However, it appeared that there were no significant differences in clinical outcomes between patients prescribed low-dose vs. full-dose apixaban during extended treatment. 55 Thus, our study results may not be significantly different between the two dosage groups. Fifth, owing to the lack of death information, we could not evaluate the mortality associated with extended treatment.…”

Section: Strengths and Limitationsmentioning

confidence: 62%

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Effectiveness and Safety of Extended Oral Anticoagulant Therapy in Patients with Venous Thromboembolism: A Retrospective Cohort Study

Kang

Lo‐Ciganic

DeRemer

et al. 2022

Clin Pharma and Therapeutics

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Limited real‐world evidence exists for effectiveness and safety of extended oral anticoagulation beyond 6 months of initial treatment in prevention of recurrent venous thromboembolism (VTE) and adverse major bleeding events among patients with VTE. Using MarketScan Commercial and Medicare Supplemental databases (2013–2019), we conducted a retrospective cohort study to compare the risk of recurrent VTE and major bleeding events during extended treatment among patients with VTE who completed the 6‐month initial treatment and received extended oral anticoagulant treatment with apixaban, warfarin, or no extended treatment. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox proportional hazards modeling with inverse probability treatment weighting. We identified 14,818 patients with extended treatment of apixaban (n = 4,338), warfarin (n = 5,298), or no extended treatment (n = 5,182). Compared with no extended treatment, apixaban use was associated with decreased risk of recurrent VTE (HR: 0.10, 95% CI: 0.04–0.26) without increased risk of major bleeding events (HR: 1.06, 95% CI: 0.52–2.17); warfarin use was associated with decreased risk of recurrent VTE (HR: 0.23, 95% CI: 0.12–0.44) but with increased risk of major bleeding events (HR: 2.64, 95% CI: 1.51–4.59). Compared with warfarin, apixaban use was associated with decreased risk of major bleeding events (HR: 0.42, 95% CI: 0.22–0.80) but no difference in risk of recurrent VTE (HR: 0.46, 95% CI: 0.15–1.36). In a real‐world clinical setting, extended anticoagulation with apixaban or warfarin was associated with decreased risk of recurrent VTE compared with no extended treatment, and apixaban had a better safety profile with fewer major bleeding events compared with warfarin among commercially insured patients with VTE.

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Section: Discussionmentioning

confidence: 63%

Section: Strengths and Limitationsmentioning

confidence: 62%

Effectiveness and Safety of Extended Oral Anticoagulant Therapy in Patients with Venous Thromboembolism: A Retrospective Cohort Study

Kang

Lo‐Ciganic

DeRemer

et al. 2022

Clin Pharma and Therapeutics

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“…Therefore, we could not determine whether different doses had similar safety and effectiveness when administered as an extended anticoagulation therapy. A previous study did not find that the clinical outcomes differenced when comparing patients prescribed low‐dose apixaban versus those prescribed the full‐dose of apixaban during extended treatment 42 . Fourth, we had a relatively short follow‐up period, which did not enable full exploration of the long‐term effects of extended phase anticoagulant therapy.…”

Section: Discussionmentioning

confidence: 97%

“…A previous study did not find that the clinical outcomes differenced when comparing patients prescribed low‐dose apixaban versus those prescribed the full‐dose of apixaban during extended treatment. 42 Fourth, we had a relatively short follow‐up period, which did not enable full exploration of the long‐term effects of extended phase anticoagulant therapy. Last, this study is generalizable only to Medicare beneficiaries, who are older or have more comorbidities compared to an average adult population.…”

Section: Discussionmentioning

confidence: 99%

Comparative effectiveness and safety of extended anticoagulant therapy among Medicare beneficiaries with venous thromboembolism

Park

Kang

Huang

et al. 2022

Clinical Translational Sci

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Guidelines recommend an extended course of anticoagulation therapy for patients who experienced venous thromboembolism (VTE) without transient provocation, however, optimal duration remains uncertain. We assessed effectiveness and safety of extended use of apixaban and warfarin greater than 6 months of initial treatment in patients with VTE. We conducted a retrospective cohort study of Medicare beneficiaries aged greater than or equal to 18 years with deep vein thrombosis or pulmonary embolism. Patients were required to have initiated anticoagulants within 30 days of their first VTE diagnosis, completed 6 months of initial anticoagulant treatment, and received extended phase treatment with apixaban (the apixaban group) or warfarin (the warfarin group) or no extended therapy. Multivariable Cox proportional hazards modeling with inverse probability treatment weighting was used to compare recurrent VTE, mortality, and major bleeding risks among the three groups. Mean extended‐treatment duration was up to 10 months and 14 months in apixaban and warfarin groups, respectively. Compared with no extended treatment, apixaban use was associated with decreased risks of recurrent VTE (hazard ratio [HR] = 0.08, [95% confidence interval [CI]: 0.01–0.41]) and mortality (HR = 0.37, [95% CI: 0.27–0.51]) without increased major bleeding risk (HR = 1.29, [95% CI: 0.68–2.45]); warfarin use was associated not with recurrent VTE risk change but with increased major bleeding risk (HR = 2.14, [95% CI: 1.26–3.65]) and decreased mortality risk (HR = 0.39, [95% CI: 0.29–0.51]). Compared with warfarin, apixaban use was associated with decreased recurrent VTE (HR = 0.13, [95% CI: 0.03–0.63]) and major bleeding (HR = 0.56, [95% CI: 0.32–0.98]) risks. Subgroup and sensitivity analyses (e.g., intention‐to‐treat) findings remained consistent. Compared with warfarin or no extended therapy, extended‐apixaban use was associated with reduced risk of recurrent VTE without increased major bleeding risk. Continuing anticoagulant therapy with apixaban greater than 6 months may be effective and safe.

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“…In Denmark, less than 5% of the patients initiated an extended treatment with 10 mg rivaroxaban or 2.5 mg apixaban which was administered twice daily after an initial treatment period of at least 3 months between 2017 and 2018 [ 45 ]. Using US claims data, DeRemer et al investigated the extended treatment with 2.5 mg vs. 5 mg apixaban among more than 6000 patients with venous thromboembolism who had completed 6 months of an initial treatment [ 46 ]. The authors concluded that 2.5 mg apixaban was associated with similar outcomes as those which were seen with the higher dose, but this study highlights limitations such as confounding by indication, given the nature of the observational study design.…”

Section: Anticoagulation For Acute and Extended Treatmentmentioning

confidence: 99%

Long-Term Management of Pulmonary Embolism: A Review of Consequences, Treatment, and Rehabilitation

Højen

Nielsen

Overvad

et al. 2022

JCM

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The concept of pulmonary embolism is evolving. Recent and emerging evidence on the treatment of specific patient populations, its secondary prevention, long-term complications, and the unmet need for rehabilitation has the potential to change clinical practice for the benefit of the patients. This review discusses the recent evidence from clinical trials, observational studies, and guidelines focusing on anticoagulation treatment, rehabilitation, emotional stress, quality of life, and the associated outcomes for patients with pulmonary embolism. Guidelines suggest that the type and duration of treatment with anticoagulation should be based on prevalent risk factors. Recent studies demonstrate that an anticoagulant treatment that is longer than two years may be effective and safe for some patients. The evidence for extended treatment in cancer patients is limited. Careful consideration is particularly necessary for pulmonary embolisms in pregnancy, cancer, and at the end of life. The rehabilitation and prevention of unnecessary deconditioning, emotional distress, and a reduced quality of life is an important, but currently they are unmet priorities for many patients with a pulmonary embolism. Future research could demonstrate optimal anticoagulant therapy durations, follow-ups, and rehabilitation, and effective patient-centered decision making at the end of life. A patient preferences and shared decision making should be incorporated in their routine care when weighing the benefits and risks with primary treatment and secondary prevention.

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Comparison of effectiveness and safety for low versus full dose of apixaban during extended phase oral anticoagulation in patients with venous thromboembolism

Cited by 6 publications

References 28 publications

Effectiveness and Safety of Extended Oral Anticoagulant Therapy in Patients with Venous Thromboembolism: A Retrospective Cohort Study

Effectiveness and Safety of Extended Oral Anticoagulant Therapy in Patients with Venous Thromboembolism: A Retrospective Cohort Study

Comparative effectiveness and safety of extended anticoagulant therapy among Medicare beneficiaries with venous thromboembolism

Long-Term Management of Pulmonary Embolism: A Review of Consequences, Treatment, and Rehabilitation

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