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IRIS substudy: No accumulation of anti-Xa activity in elderly patients with renal failure taking tinzaparin
51st ASH Annual Meeting
There was no accumulation of anti-Xa activity in patients aged 75 to 99 years with moderate to severe renal impairment who were receiving unadjusted recommended full dose of tinzaparin, 175 IU/kg per day for the treatment of venous thromboembolism, according to the findings from the Innohep in Renal Insufficiency Study (IRIS) substudy.
IRIS is an international, multicenter trial that compared the safety of tinzaparin (Innohep, Celgene) and unfractionated heparin. In this substudy, researchers examined if there was an accumulation of anti-Xa and whether a relationship existed between anti-Xa activity and age, weight, creatinine clearance or clinical outcomes in patients treated with tinzaparin for VTE.
Virginie Siguret, PhD, of the Université Paris Descartes, in Paris, presented the findings at the 51st ASH Annual Meeting.
Researchers enrolled 268 patients of which data from 32% were analyzed. Levels were analyzed on day two and day three, or on day five and the visit at the end of treatment.
No correlation was noted between anti-Xa activity and age, weight or creatinine clearance or between anti-Xa levels for patients with or without severe renal impairment.
The mean accumulation ratio was 1.06 (90% CI, 1.01-1.11); no significant accumulation was detected. The mean anti-Xa activity did not differ significantly between eight patients with clinically relevant bleeding during treatment and 79 patients without bleeding. One patient with clinically relevant bleeding had anti-Xa activity <2.0 IU/mL and seven patients without bleeding had anti-Xa <1.5 IU/mL.
The mean anti-Xa activity was significantly lower among patients with infectious disease at baseline vs. patients without infectious disease on day-two/three (P=0.007) and day-five/day of visit at end of treatment (P=0.002). There was no statistically significant difference in anti-Xa levels between patients with and without ongoing malignancy.
For more information:
- Siguret V. #172. Presented at: 51st ASH Annual Meeting and Exposition; Dec. 5-8, 2009; New Orleans.
