Safety of venous thromboembolism prophylaxis with fondaparinux in ischemic stroke.

INTRODUCTION: Unfractionated heparin (UFH), low molecular weight heparin or fondaparinux are recommended for venous thromboembolism (VTE) prophylaxis in acutely ill medical patients. There are limited data on the safety of fondaparinux for VTE prophylaxis in ischemic stroke. We examined adverse event frequency in hospitalized patients with ischemic stroke who received VTE prophylaxis with fondaparinux versus UFH. MATERIALS AND METHODS: We performed a propensity score matched analysis on a retrospective cohort of 644 consecutive patients with acute ischemic stroke receiving fondaparinux (n=322) or UFH (n=322) for VTE prophylaxis. Patients who received intravenous tPA and continuous intravenous infusions of UFH were excluded. The primary outcome was major hemorrhage (intracranial or extracranial) and the secondary outcome was total hemorrhage (major and minor hemorrhage) during hospitalization. We also examined the rate of symptomatic VTE. RESULTS: Mean age of the matched cohort was 71.3±14.1 years, median NIHSS score was 4 (IQR 1-11), median duration of anticoagulant exposure was 5 (IQR 3-8) days, and 98.1% received antiplatelet medications. In the matched cohort, there were less observed major hemorrhages in the fondaparinux group 1.2% (4/322) compared to UFH 3.7% (12/322), but this difference was not significant (OR=0.33, 95% CI 0.08-1.10, p=0.08). There were also no significant differences in total hemorrhage (p=0.15), intracranial hemorrhage (p=0.48), major extracranial hemorrhage (p=0.18) and symptomatic VTE (p=1.00) between the groups. CONCLUSIONS: Fondaparinux is not associated with increased hemorrhagic complications compared with UFH in patients with ischemic stroke. There were low rates of symptomatic VTE in both groups.

Low vitamin D level is associated with higher relapse rate in natalizumab treated MS patients.

BACKGROUND: Previous research suggested a relationship between low vitamin D and relapse rate. We examined whether vitamin D levels were associated with: 1) MS severity and 2) recent MS relapse activity, in patients treated with natalizumab. METHODS: All patients (n=118) were treated with natalizumab and were tested for vitamin D levels during the winter of 2009-10. Number of relapses during treatment with natalizumab was determined by retrospective chart review. MS severity was estimated with the Roxburgh's MS Severity Score (MSSS) at the time of the initial blood draw and 1 year preceding and following initial draws. Vitamin D levels of 50 nmol/L or greater were defined as normal. RESULTS: Patients with deficient vitamin D levels (DVD) totaled 45. Sixteen of the 26 patients with relapse in the year prior to the initial blood draw (4 patients had multiple relapses - all were in DVD) and 12 of 17 patients with relapse in the following year were in the DVD group. There was a significant difference between the normal vitamin D group (NVD) and DVD in MS relapse activity in the year prior (p=0.005) and following blood draw (p=0.006). There was no significant between group differences in MSSS at any time. CONCLUSIONS: Natalizumab treated patients with DVD were more likely to experience relapse and may experience more relapses than patients with NVD.