Apixaban in VTE Patients with High Body Weight and BMI

Pavankumar Kamat

Disclosures

May 14, 2021

Takeaway

  • In patients with venous thromboembolism (VTE) having body weight ≥120 kg or body mass index (BMI) >40 kg/m2, apixaban had similar rates of recurrent VTE or VTE-related death and lower rates of major bleeding and the composite of major or clinically relevant non-major (CRNM) bleeding compared with enoxaparin/warfarin.

  • Results were consistent across different body weight and BMI categories.

Why this matters

  • Findings support the use of apixaban in patients with VTE with body weight ≥120 kg or BMI >40 kg/m2.

  • Future studies are warranted to confirm these findings.

Study design

  • This post hoc analysis of the AMPLIFY trial evaluated the efficacy, safety and exposure of apixaban vs enoxaparin/warfarin in 5395 patients with VTE having body weight ≥120 kg or BMI >40 kg/m2 (safety population of AMPLIFY).

  • Primary efficacy outcome: a composite of recurrent symptomatic VTE or VTE-related death.

  • Primary safety outcome: major bleeding; secondary safety outcome: a composite of major and CRNM bleeding.

  • Funding: Bristol Myers Squibb and Pfizer.

Key results

  • In 5395 patients, 5384 and 5359 patients had recorded body weight (range, 28.9-222.0 kg; ≥120 kg; n=290) and BMI (range, 12.5-71.8 kg/m2; >40 kg/m2; n=263), respectively.

  • The rates of recurrent VTE or VTE-related death were similar between apixaban and enoxaparin/warfarin groups across body weight subgroups (relative risks [RR]; 95% CI):

    • ≤60 kg (0.63; 0.23-1.72);

    • >60 to <100 kg (0.99; 0.65-1.50);

    • ≥100 to <120 kg (0.77; 0.34-1.72); and

    • ≥120 kg (0.20; 0.02-1.72; Pinteraction=.44).

  • Major bleeding rates were lower with apixaban vs enoxaparin/warfarin across body weight subgroups (RR; 95% CI):

    • ≤60 kg (0.15; 0.02-1.15);

    • >60 to <100 kg (0.41; 0.21-0.77) and

    • ≥120 kg (0.34; 0.04-3.22; Pinteraction=not estimable).

  • Major or CRNM bleeding rates were significantly lower with apixaban vs enoxaparin/warfarin across body weight subgroups (RR; 95% CI);

    • ≤60 kg (0.46; 0.24-0.89);

    • >60 to <100 kg (0.49; 0.38-0.63);

    • ≥100 to <120 kg (0.30; 0.16-0.58); and

    • ≥120 kg (0.28; 0.12-0.66; Pinteraction=.36).

  • Similar results were seen in the BMI subgroups.

  • No significant differences were seen in apixaban exposure between patients with high and low body weight.

Limitations

  • Post hoc analysis.

 

Cohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Apr 22 [Epub ahead of print]. doi: 10.1007/s12325-021-01716-8. PMID: 33890242.  View full text

This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.

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