Dalteparin treatment produced equivalent peak steady-state antifactor Xa levels in patients with renal impairment compared to controls (0.47 vs 0.55 U/ml; p=0.0001 for equivalency).
Observational (n=22)
Open-label
No
Does renal impairment alter peak antifactor Xa activity in patients receiving dalteparin compared to controls with normal renal function?
Peak antifactor Xa activity is equivalent in patients with and without renal impairment receiving dalteparin, suggesting dose adjustments may not be necessary for non-dialysis patients.
Absolute Event Rate: 0.47% vs 0.55%
p-value: p=0.0001
STUDY OBJECTIVE: To evaluate the relationship between impaired renal function and antifactor Xa activity in patients receiving dalteparin. DESIGN: Open-label prospective study. SETTING: Inpatient and outpatient units of a large teaching hospital. SUBJECTS: Eleven patients with renal impairment and 11 control subjects with normal renal function. INTERVENTION: Subjects were administered dalteparin at a dosage of approximately 100 U/kg subcutaneously every 12 hours. MEASUREMENTS AND MAIN RESULTS: Peak steady-state antifactor Xa levels were compared between the groups. Mean +/- SD levels were similar for patients with and without renal impairment: 0.47 +/- 0.25 and 0.55 +/- 0.20 U/ml, respectively. A test of equivalency showed statistical significance (p=0.0001). CONCLUSION: No meaningful difference in peak antifactor Xa activity was found between patients with renal impairment and control subjects. To the extent that peak antifactor Xa levels can be used as markers for adjusting doses of dalteparin, these data suggest that such adjustments are not necessary for patients with renal impairment who are not receiving dialysis.
Shprecher et al. (2005) conducted an observational in Renal impairment (n=22). Dalteparin vs. Control subjects with normal renal function was evaluated on Peak steady-state antifactor Xa levels (p=0.0001). Dalteparin treatment produced equivalent peak steady-state antifactor Xa levels in patients with renal impairment compared to controls (0.47 vs 0.55 U/ml; p=0.0001 for equivalency).