Health & body · 2009
Can fixed-dose injections treat with fewer serious adverse reactions than adjusted intravenous heparin?
Yes—in this randomized trial of 90 outpatients with acute deep-vein thrombosis, major adverse reactions occurred in 4.5% of those receiving fixed-dose subcutaneous CY216 versus 22% receiving adjusted intravenous unfractionated heparin (p = 0.01). Pulmonary embolism occurred once in each group, and longer-term recurrence and post-thrombotic manifestations did not differ.
Details
A prospective randomized trial enrolled 90 consecutive outpatients with acute proximal and/or distal deep-vein thrombosis (DVT), confirmed by phlebography. It compared 10 days of adjusted-dose intravenous unfractionated heparin (UFH) with fixed-dose subcutaneous low-molecular-weight heparin, CY216, at 225 IC anti-Xa U/kg every 12 hours.
The incidence of pulmonary embolism did not differ between the groups: there was one episode in each group.
Comparisons of pretreatment and posttreatment venograms and perfusion lung scans showed statistically significant improvement only in the CY216 group (p < 0.01 for venograms and p < 0.05 for perfusion lung scans).
Major adverse reactions—major hemorrhages, a relevant fall in hemoglobin, and serious thrombocytopenia—were significantly more frequent in the UFH group: 22% versus 4.5% in the CY216 group (p = 0.01).
After a mean follow-up of 2 years, the incidence of thromboembolic recurrences and that of post-thrombotic manifestations did not differ between the groups.
The authors concluded that fixed-dose subcutaneous CY216 was more effective and safer than adjusted-dose intravenous UFH for treating acute DVT.
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