Impact of Recombinant Activated Factor VII on Health-Related Quality of Life after Intracerebral HemorrhageDiringer M.N.a · Ferran J.-M.b · Broderick J.c · Davis S.d · Mayer S.A.e · Steiner T.f · Brun N.C.b · Skolnick B.E.g · Christensen M.C.b
aDepartments of Neurology and Neurosurgery, Washington University School of Medicine, St. Louis, Mo., USA; bNovo Nordisk, Global Development, Bagsvaerd, Denmark; cUniversity of Cincinnati Medical Center, Cincinnati, Ohio, USA; dRoyal Melbourne Hospital, University of Melbourne, Melbourne, Australia; eColumbia University College of Physicians and Surgeons, New York, N.Y., USA; fUniversity of Heidelberg, Heidelberg, Germany and gNovo Nordisk Inc., Princeton, N.J., USA
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Background: We recently demonstrated that recombinant activated factor VII (rFVIIa) given to patients presenting within 3 h of acute spontaneous intracerebral hemorrhage (ICH) reduces mortality (18% vs. 29%) and poor outcome (modified Rankin Scale, mRS, 4–6, 53 vs. 69%). This analysis was performed to determine the impact of rFVIIa on health-related quality of life (HRQoL) in those patients. Methods: In a prospective, randomized controlled trial, 399 patients (mean age, 66 years) received placebo, 40, 80 or 160 µg/kg of rFVIIa within 4 h of acute ICH. At 90 days, HRQoL was assessed with the EuroQoL (EQ-5D), a 5-dimensional measure of health which also includes the Visual Analogue Scale. Additionally, each level of the 90-day mRS was adjusted, using 4 different previously published utility values, to obtain a clearer picture of perceived HRQoL. Results: Among the 5 dimensions of EQ-5D, only mobility rating was significantly better for rFVIIa-treated patients (serious problems, 34 vs. 54%; p = 0.01). Yet, the utility value (scaled 1.0 = perfect health and 0.0 = dead) associated with the composite EQ-5D demonstrated significantly better HRQoL (0.48 vs. 0.36; p = 0.01). This was also true for the EQ-5D Visual Analogue Scale score (44 vs. 36; p = 0.04). Finally, all 4 algorithms for applying utility scores to the mRS indicated that rFVIIa was associated with significantly better perceived HRQoL (all p < 0.006). Conclusions: Treatment with rFVIIa within 4 h of acute spontaneous ICH improves HRQoL.
© 2007 S. Karger AG, Basel
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