title: Effect of body weight on efficacy and safety of direct oral anticoagulants in the treatment of patients with acute venous thromboembolism: a meta-analysis of randomized controlled trials.
abstract: OBJECTIVE
  To evaluate the effect of body weight (BW) on safety and efficacy of direct oral anticoagulants (DOACs).
  
  
  METHODS
  We performed a meta-analysis of randomized controlled trials (RCTs) comparing DOACs with vitamin K antagonists (VKA) in patients with venous thromboembolism (VTE). Efficacy (prevention of recurrent VTE or VTE-related death) and safety (occurrence of major or clinically relevant non-major bleeding) outcomes were stratified according to patients' BW (low, normal, and high).
  
  
  RESULTS
  Six RCTs with a total of 27,023 patients were included. DOACs showed a similar efficacy to VKA in patients with high BW, normal BW, and low BW (RR 0.98, 95% CI 0.72, 1.35; RR 0.91, 95% CI 0.75, 1.09; and RR 0.84, 95% CI 0.57, 1.24, respectively). Safety was comparable among DOACs and VKA in patients with high BW and low BW (RR 0.93, 95% CI 0.65, 1.32; and RR 0.80, 95% CI 0.54, 1.20), whereas DOACs were marginally safer than VKA in normal-BW subjects (RR 0.82, 95% CI 0.67, 1.00). However, the difference among DOACs and VKA in the rate of bleeding episodes appeared similar in the three BW groups.
  
  
  CONCLUSIONS
  Results of our meta-analysis suggested that DOACs might be a safe and effective therapeutic option for the treatment of acute VTE even in the patients with extreme body weights. However, other studies with larger study populations are warranted to confirm our findings.
authors: Department of Clinical Medicine and Surgery, Federico II University , Naples , Italy.
authors: Matteo Nicola Dario
authors: MN
authors: Di Minno
authors: Roberta
authors: R
authors: Lupoli
authors: Alessandro
authors: A
authors: Di Minno
authors: Pasquale
authors: P
authors: Ambrosino
authors: Antonella
authors: A
authors: Scalera
authors: Francesco
authors: F
authors: Dentali
mesh_terms: D015110:4-Hydroxycoumarins / Q000627:therapeutic use; D000208:Acute Disease; D000284:Administration, Oral; D000925:Anticoagulants / Q000627:therapeutic use*; D001835:Body Weight; D005260:Female; D006801:Humans; D007192:Indenes / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000188:drug therapy*; D014812:Vitamin K / Q000037:antagonists & inhibitors / Q000627:therapeutic use
chemical_list: D015110:4-Hydroxycoumarins; D000925:Anticoagulants; D007192:Indenes; C011664:antivitamins K; D014812:Vitamin K
keywords: Direct oral anticoagulants; obesity; venous thrombosis