The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement

Lassen, Michael R.; Davidson, Bruce L.; Gallus, Alexander; Pineo, Graham F.; Ansell, Jack; Deitchman, David

doi:10.1111/j.1538-7836.2007.02764.x

Cited by 351 publications

(281 citation statements)

References 11 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.…”

mentioning

confidence: 99%

Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome

Alexander

Lopes

James³

et al. 2011

N Engl J Med

915

532

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“…P value is <0.0001. The major bleeding occurred in 2 patients belonging to oral anti-coagulant group and 1 patient from enoxaparin group [9][10][11][12]. Hence the safety outcome is almost similar to both groups and they do not indicate any clinically relevant difference is safety outcome.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Efficacy of Low Molecular Weight Heparin Versus Oral Anticoagulant in Indian Population for Prevention of Deep Vein Thrombosis in Total Knee Replacement

Elumalai¹,

R²,

An³

et al. 2015

Orthop Muscul Syst

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Nearly 50% of patients who undergo TKR develop symptomatic/ asymptomatic DVT without prophylaxis. Since LMWH is costly, subcutaneous injection and inconvenience to patient, Oral anticoagulant is used as alternative. It is a prospective study where patients were observed for 15 days, following TKR. The effectiveness of LMWH Vs Oral anticoagulant in Indian population was done comparing 100 patients who underwent TKR. Inclusion criteria -age more than 18 years, under any anesthesia, Indian origin. Exclusion criteria were head injury, abdominal injury,poly trauma, history of DVT, indwelling epidural catheter. Oral anticoagulant used in the study Dabigatran etexilate 220 mg OD or Apixaban 2.5 mg BD for 15 days. Patient was done colour doppler pre-operatively, POD-(3-5) and (13-15). In 100 patients, 25 patients were given Dabigatran, 25 were given Apixaban and 50 were given LWMH. The absolute risk difference -1.1% in favour of oral anticoagulant. Thus oral anticoagulants was non-inferior to LMWH (P<0.0001). Major bleeding occurred in 2 patients in oral anticoagulant group but none were fatal or required discontinuation of drug. The study showed both oral anticoagulants given for 15 days were as effective as LMWH for prevention of DVT in TKR. Oral anticoagulant proved to be non-inferior to LMWH. Oral anti-coagulant is effective, well tolerated, low rate of bleeding, no evidence of elevated liver enzymes or acute coronary events when compared to LMWH.

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The efficacy and safety of apixaban, an oral, direct factor Xa inhibitor, as thromboprophylaxis in patients following total knee replacement

Abstract: Apixaban in doses of 2.5 mg b.i.d. or 5 mg q.d. has a promising benefit-risk profile compared with the current standards of care following TKR.

Cited by 351 publications

References 11 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

Comparison of Efficacy of Low Molecular Weight Heparin Versus Oral Anticoagulant in Indian Population for Prevention of Deep Vein Thrombosis in Total Knee Replacement

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