Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; 2.5 mg, 5 mg) |
| Drug Class | Factor Xa inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
- Indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
- Indicated for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy.
Latest News
Summary
- Eliquis (apixaban) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; and for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy.
- This summary is based on the review of 51 systematic reviews/meta-analyses. [1-51]
- Stroke/Systemic Embolism Prevention in Nonvalvular Atrial Fibrillation (NVAF): Apixaban was more effective in reducing the risk of stroke or systemic embolism compared to warfarin (RR 0.85; 95% CI 0.75-0.97) and significantly outperformed aspirin or placebo (RR 0.33; 95% CI 0.19-0.58). It was particularly effective in elderly patients and those with renal impairment, where it ranked highest for efficacy.
- Venous Thromboembolism (VTE) Prophylaxis Post-Surgery: Apixaban 5 mg provided an optimal balance between preventing VTE and controlling hemorrhage following total hip arthroplasty (THA), showing superior outcomes compared to enoxaparin and rivaroxaban. Although rivaroxaban was highly effective in preventing VTE, it had a higher associated bleeding risk compared to apixaban.
- Treatment of VTE in Severe Renal Failure: Apixaban significantly reduced VTE recurrence compared to warfarin (RR 0.65; 95% CI 0.43-0.98) and exhibited a lower rate of major and minor bleeding events, making it a safer option for patients with severe renal failure.
- Cancer-Associated VTE: In patients with cancer-associated thrombosis, apixaban demonstrated a lower risk of recurrent VTE compared to dalteparin (RR 0.49; 95% CI 0.15-1.58), although the difference in major bleeding rates was not statistically significant. This positions apixaban as a potentially preferred option in this high-risk population.
- Major Bleeding Risks in NVAF: Apixaban was associated with significantly lower risks of major bleeding, including gastrointestinal bleeding and intracranial hemorrhage, compared to warfarin and rivaroxaban. In elderly patients, apixaban had the highest safety ranking for reducing major bleeding, with a rank probability of 71.4%.
- Safety in Chronic Kidney Disease (CKD) Patients: Apixaban demonstrated a lower risk of major bleeding compared to warfarin in patients with severe renal impairment (hazard ratio [HR]: 0.53; 95% CI: 0.33-0.84), while maintaining comparable efficacy for stroke prevention in this high-risk population.
- Intracranial Hemorrhage: Apixaban significantly reduced the risk of intracranial hemorrhage compared to vitamin K antagonists (VKAs), with a relative risk (RR) of 0.43 (95% CI: 0.31-0.58). This benefit was consistent across different patient subgroups, including those at a high risk of intracranial hemorrhage.
- Bleeding Risks in Cancer-Associated Thrombosis (CAT): In patients with cancer-associated thrombosis, apixaban showed a lower risk of bleeding events compared to low-molecular-weight heparins (LMWHs) like dalteparin, making it a favorable option for this population.
- Elderly Patients and Stroke Prevention: Apixaban demonstrated superior efficacy and safety in stroke prevention among elderly patients (aged ≥75 years) with nonvalvular atrial fibrillation (NVAF), showing a lower risk of stroke/systemic embolism compared to warfarin (RR 0.85; 95% CI 0.75-0.97), and a significantly reduced risk of major bleeding events, including intracranial hemorrhage, making it the most favorable option for this population.
- Chronic Kidney Disease (CKD) and Cancer-Associated Thrombosis (CAT): Apixaban was particularly effective in patients with CKD stages 3-5D, showing a lower risk of major bleeding (HR 0.53; 95% CI 0.33-0.84) compared to warfarin, while also maintaining efficacy in stroke prevention. Additionally, in patients with cancer-associated thrombosis (CAT), apixaban was preferred due to its lower risk of recurrent VTE and bleeding events compared to low-molecular-weight heparins (LMWHs) like dalteparin.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Eliquis (apixaban) Prescribing Information. | 2021 | Bristol-Myers Squibb Company., Princeton, NJ |