Apixaban or Enoxaparin for Thromboprophylaxis after Knee Replacement

Lassen, Michael R.; Raskob, Gary E.; Gallus, Alexander; Pineo, Graham F.; Chen, Dalei; Portman, Ronald J.

doi:10.1056/nejmoa0810773

Cited by 631 publications

(501 citation statements)

References 20 publications

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“…During the development of the oral anticoagulants for prevention of VTE in THR and TKR surgery, multiple phase II dose‐finding trials and phase III trials have typically been conducted for the different types of surgery and comparator dose regimens 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38. The results of the current analyses suggest that the outcome of a single study in one type of surgery with one comparator dose regimen, used in conjunction with the model‐based meta‐analysis, would be sufficient to determine the optimal dose for both types of surgery and compared with both regimens of comparator.…”

Section: Discussionmentioning

confidence: 99%

Direct Oral Anticoagulants Vs. Enoxaparin for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose–Response Meta‐analysis

Boyd

DiCarlo

Mandema³

2017

Clinical Translational Sci

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We carried out a dose–response model‐based meta‐analysis to assess venous thromboembolism (VTE) and bleeding with factor Xa (FXa) inhibitors (apixaban, edoxaban, rivaroxaban) and a thrombin inhibitor (dabigatran) compared with European (EU) (40 mg q.d.) and North American (NA) (30 mg Q12H) dose regimens of a low molecular weight heparin (enoxaparin) following orthopedic surgery. Statistically significant differences in both VTE and bleeding outcomes were found between the NA and EU doses of enoxaparin, with odds ratios (95% confidence interval) for the NA vs. EU dose of 0.73 (0.71–0.76) and 1.20 (1.14–1.29) for total VTE and major bleeding, respectively. At approved doses, estimated odds ratios vs. both doses of enoxaparin for the three FXa inhibitors (range: 0.35–0.75 for VTE; 0.76–1.09 for bleeding) compared with those for dabigatran (range: 0.66–1.21 for VTE; 1.10–1.38 for bleeding) suggested generally greater efficacy and less bleeding for the FXa inhibitors.

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Section: Discussionmentioning

confidence: 99%

Direct Oral Anticoagulants Vs. Enoxaparin for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose–Response Meta‐analysis

Boyd

DiCarlo

Mandema³

2017

Clinical Translational Sci

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“…[4][5][6][7][8][9] Apixaban, an orally active, selective, direct factor Xa inhibitor, has been shown to reduce the incidence of venous thromboembolism in patients undergoing orthopedic surgery and to prevent thromboembolic events in patients with atrial fibrillation who are not candidates for oral vitamin K antagonist therapy. [10][11][12][13][14][15] We previously studied the use of apixaban, at doses of 5 to 20 mg daily, in patients who had had recent acute coronary syndromes and who were receiving aspirin or aspirin plus clopidogrel. 16 Treatment with apixaban resulted in dose-related increases in bleeding events and a trend toward fewer is chemic events.…”

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confidence: 99%

Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome

Alexander

Lopes

James³

et al. 2011

N Engl J Med

910

532

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“…Apixaban is a novel, orally active, selective, direct, reversible inhibitor of the coagulation factor Xa and is approved in a number of countries for multiple indications, including thromboprophylaxis after knee or hip replacement surgery, treatment of deep vein thrombosis (DVT) and PE, prevention of recurrent DVT and PE, and reduction of the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) 1, 2, 3, 4, 5, 6, 7…”

mentioning

confidence: 99%

Population Pharmacokinetics of Apixaban in Subjects With Nonvalvular Atrial Fibrillation

Cirincione

Kowalski²,

Nielsen³

et al. 2018

CPT Pharmacom & Syst Pharma

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This analysis describes the population pharmacokinetics (PPK) of apixaban in nonvalvular atrial fibrillation (NVAF) subjects, and quantifies the impact of intrinsic and extrinsic factors on exposure. The PPK model was developed using data from phase I–III studies. Apixaban exposure was characterized by a two‐compartment PPK model with first‐order absorption and elimination. Predictive covariates on apparent clearance included age, sex, Asian race, renal function, and concomitant strong/moderate cytochrome P450 (CYP)3A4/P‐glycoprotein (P‐gp) inhibitors. Individual covariate effects generally resulted in < 25% change in apixaban exposure vs. the reference NVAF subject (non‐Asian, male, aged 65 years, weighing 70 kg without concomitant CYP3A4/P‐gp inhibitors), except for severe renal impairment, which resulted in 55% higher exposure than the reference subject. The dose‐reduction algorithm resulted in a ~27% lower median exposure, with a large overlap between the 2.5‐mg and 5‐mg groups. The impact of Asian race on apixaban exposure was < 15% and not considered clinically significant.

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Apixaban or Enoxaparin for Thromboprophylaxis after Knee Replacement

Cited by 631 publications

References 20 publications

Direct Oral Anticoagulants Vs. Enoxaparin for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose–Response Meta‐analysis

Direct Oral Anticoagulants Vs. Enoxaparin for Prevention of Venous Thromboembolism Following Orthopedic Surgery: A Dose–Response Meta‐analysis

Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome

Population Pharmacokinetics of Apixaban in Subjects With Nonvalvular Atrial Fibrillation

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