Once daily enoxaparin for outpatient treatment of acute venous thromboembolism: a case-control study.
We studied the efficacy and safety of an investigational enoxaparin regimen, 1.5 mg/kg once daily, as a bridge to warfarin for the outpatient treatment of acute venous thromboembolism. We undertook a case-control design. We enrolled 40 acute venous thromboembolism cases prospectively and matched them by age, gender, and location of venous thromboembolism to 80 previously treated controls. All controls had received enoxaparin 1 mg/kg twice daily. The primary end point was recurrent venous thromboembolism. We followed the cases for 30 days. We discontinued enoxaparin after we achieved the target international normalized ratio between 2.0 and 3.0. One case (2.9%) and three controls (3.8%) had recurrent venous thromboembolic events (P = 1.00). There were no major bleeding complications in the case group, compared to 3 (3.8%) in the control group (P = .55). Once daily enoxaparin, 1.5 mg/kg, as a bridge to warfarin was as effective with a similar safety profile as twice daily enoxaparin, 1mg/kg, for initial treatment of acute venous thromboembolism in the outpatient setting. This case-control study provides the rationale for undertaking a randomized controlled trial comparing enoxaparin 1.5 mg/kg once daily versus enoxaparin 1.0 mg/kg twice daily as a bridge to warfarin in outpatients with acute venous thromboembolism.
Hacobian
Melkon
M
Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
Shetty
Ranjith
R
Niles
Clyde Matthew
CM
Gerhard-Herman
Marie
M
Vallurupalli
Neelima
N
Baroletti
Steven
S
McKean
Sylvia C
SC
Sonis
Jonathan
J
Parasuraman
Sudha
S
Kosowsky
Joshua M
JM
Goldhaber
Samuel Z
SZ
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D016022:Case-Control Studies; D017984:Enoxaparin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011446:Prospective Studies; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000188:drug therapy*
D000925:Anticoagulants; D017984:Enoxaparin