Apixaban in VTE Patients with High Body Weight and BMI

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; P_interaction=.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; P_interaction=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; P_interaction=.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.

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