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Weight-based, fixed-dose, unmonitored subcutaneous unfractionated heparin administered twice daily found to be equivalent to low molecular weight heparin for treatment of DVT and PE

Henry I. Bussey, Pharm.D.
August, 2006

Reference: Kearon C, Ginsberg JS, Julian JA, et al. Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism. JAMA 2006; 296:935-942.

Investigators in Canada and New Zealand randomized a total of 708 DVT and/or PE patients to twice daily, fixed dose unfractionated heparin (333 U/Kg load followed by 250 U/kg q 12 hrs) or twice daily subcutaneous LMWH (100 U/kg q 12 hrs - approximately 75% received dalteparin and 25% enoxaparin). Most patients (approx. 70% in each group) - including PE patients - were treated as outpatients. The trial was open-label but end points were adjudicated by a board that was blinded to treatment. There was no significant difference in recurrent VTE (3.8% with UFH vs. 3.4% with LMWH), major bleed (1.1% with UFH vs. 1.4% with LMWH), and deaths (18 in UFH vs 22 with LMWH).

Blood samples for aPTT determination were collected at the midpoint of the dosing interval on day 3 of dosing in the UFH group, but the samples were not analyzed until after the study was completed. Subsequently, aPTT values were found to be above the therapeutic range more than within or below the range, but low aPTT values did not correlate with an increase in VTE, and high aPTT values did not correlate with increased bleeding. Platelet counts were not monitored but the mean length of UFH and LMWH treatment was approximately 6 days.

The estimated cost of medication for 6 days of treatment for an 80 kg patient was calculated to be $37 for UFH vs. $712 for LMWH (enoxaparin). It should be noted that the cost of enoxaparin would be about 25% less if the once daily regimen (1.5mg/kg daily) were used, and that other LMWHs may be less expensive in the U.S. An additional consideration could be unpredictable absorption of UFH when given subcutaneously, but this concern did not appear to influence clinical outcomes in this study population. Lastly, whether the choice of LMWH (dalteparin in 75% vs. enoxaparin in 25%) may have influenced results is a potential issue for debate. Interestingly, the recurrent VTE rates at 10 and 30 days of follow-up was 0.7% and 3.3% with dalteparin vs. 0% and 3.2% with enoxaparin. Similarly, major bleeding rates at 10 and 30 days were 1.9% and 3.8% for dalteparin vs. 0% and 2.2% for enoxaparin.

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Sunday, July 14, 2024