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What are the efficacy and safety profiles of NOACs?

For initial and continued treatment and prevention of recurrent VTE

The efficacy and safety of NOACs for the treatment and prevention of recurrent VTE have been assessed in randomised controlled trials. The meta-analysis results shown below provide an overview of the efficacy and safety profiles of NOACs vs. LMWH/warfarin in the treatment of VTE.1 It should be noted that there are no head-to-head randomised clinical trials comparing the NOACs, and comparisons cannot be made between individual NOACs based on meta-analysis data, as the different trials have unique designs and can vary greatly in terms of key parameters, as can be seen in the study designs below. Please refer to individual SmPCs for further information.



* Duration of treatment was determined by the treating physician before randomisation. Most patients received 6 or 12 months of therapy.
† Patients with body weight ≤60 kg or CrCl 30–50 mL/min, or patients receiving concomitant potent P-gp inhibitors received edoxaban 30 mg OD.4

[References for image: 2. Agnelli G, et al. N Engl J Med 2013;369:799–808; 3. Schulman S, et al. Circulation 2014;129:764–772; 4. The Hokusai-VTE Investigators. N Engl J Med 2013;369:1406–1415; 5. Prins MH, et al. Thromb J 2013;11:21; 6. Raskob G, et al. J Thromb Haemost 2013;11:1287–1294.]

Meta-analysis: Efficacy of NOACs vs warfarin for recurrent VTE/VTE-related death prevention in patients with VTE
Meta analysis Efficacy

There are no head-to-head randomised clinical trials comparing the NOACs. Comparisons cannot be made between individual NOACs based on these data. Adapted from Van Es N et al., 2014. *For Hokusai-VTE, event data for the on-treatment period was used. Heterogeneity: I2=0%; p=0.53

Meta-analysis: Bleeding profiles for NOACs versus warfarin in patients with VTE
Major bleeding profiles NOACs

There are no head-to-head randomised clinical trials comparing the NOACs. Comparisons cannot be made between individual NOACs based on these data. Adapted from Van Es N et al., 2014. *Sums of numbers of events from RE-COVER and RE-COVER II with respect to major bleeding slightly differ from those in pooled analysis. Data from pooled analysis used because these were most accurate. Heterogeneity: I2=51%; p=0.07

[Reference for images: 1. Van Es et al. Blood 2014; 124: 1968–1975.]

For extended therapy (prevention of recurrent VTE)

The randomised controlled trials assessing the efficacy and safety of NOACs for extended therapy (prevention of recurrent VTE) are summarised below.

NOACs in extended VTE treatment

*Only the 2.5 mg BD dose of apixaban is licensed for prevention of recurrent DVT / PE.
†Edoxaban is approved for the treatment and prevention of VTE.

[References for image: 7. Apixaban Summary of Product Characteristics. Accessed August 2019. Available at: www.medicines.org.uk/emc/product/2878/smpc. 8. Schulman S, et al. N Engl J Med 2013;368:709–18. 9. Bauersachs R, et al. N Engl J Med 2010;363:2499–5101. 10. Agnelli G, et al. N Engl J Med 2013;368:699–708. 11. Weitz JI, et al. N Engl J Med 2017;376:1211–22.]

An overview of the results from these trials can be found in this guide.

Key clinical trials VTE




In VTE treatments: VTE treatments | NOACs for the treatment and prevention of recurrent VTE | What are the characteristics of the different NOAC? | What are the efficacy and safety profiles of NOACs?

Click here to view ELIQUIS (apixaban) prescribing and adverse event reporting information.

Abbreviations

BD = Twice Daily CI = Confidence Interval INR = International Normalised Ratio LMWH = Low Molecular Weight Heparin
NOAC = Non-vitamin K antagonist Oral Anticoagulant OD = Once Daily VKA = Vitamin K Antagonist
VTE = Venous Thromboembolism

References
  1. Van Es N et al. Blood 2014; 124: 1968–1975.
  2. Agnelli G, et al. N Engl J Med 2013;369:799–808.
  3. Schulman S, et al. Circulation 2014;129:764–772.
  4. The Hokusai-VTE Investigators. N Engl J Med 2013;369:1406–1415.
  5. Prins MH, et al. Thromb J 2013;11:21.
  6. Raskob G, et al. J Thromb Haemost 2013;11:1287–1294.
  7. Apixaban Summary of Product Characteristics. Available at: www.medicines.org.uk/emc/product/2878/smpc.
    August 2019.
  8. Schulman S, et al. N Engl J Med 2013;368:709–18.
  9. Bauersachs R, et al. N Engl J Med 2010;363:2499–5101.
  10. Agnelli G, et al. N Engl J Med 2013;368:699–708.
  11. Weitz JI, et al. N Engl J Med 2017;376:1211–22.

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Job code: 432UK1900506-01
Date of preparation: September 2019

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