کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
6002484 1182969 2014 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Regular articlePharmacodynamics assessment of Bemiparin after multiple prophylactic and single therapeutic doses in adult and elderly healthy volunteers and in subjects with varying degrees of renal impairment
ترجمه فارسی عنوان
ارزیابی منظم در مورد داروهای ضد بارداری بمبیرین پس از دوزهای مختلف پروفیلاکتیک و تک درمانی در افراد سالم و داوطلب سالم و افراد مبتلا به اختلالات کلیوی
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی کاردیولوژی و پزشکی قلب و عروق
چکیده انگلیسی

IntroductionAging and renal impairment may prolong the half-life and lead to accumulation of low molecular weight heparins. Correct dosing is critical to prevent bleeding or thrombosis.Materials and MethodsOpen, parallel study. Healthy adult [n = 13] and elderly (> 65 yrs) [n = 12] volunteers; and subjects with mild (ClCr ≥ 50 to ≤ 80 mL/min, n = 8), moderate (ClCr ≥ 30 to < 50 mL/min, n = 7), and severe (ClCr < 30 mL/min, n = 8) renal impairment received four prophylactic doses (3,500 IU/24 h) and a single therapeutic dose (115 IU/kg) of bemiparin with an interim washout period. Anti-FXa activity and the potential need for dose adjustment were evaluated.ResultsThere were statistically significant differences in the severe renal impairment group vs. adult volunteers in all anti-FXa related parameters, but no significant differences in any of the anti-FXa related parameters between the adult and the elderly. Anti-FXa simulations after 10 prophylactic doses predicted mean Amax = 0.59 IU/mL in subjects with severe renal impairment and 0.33-0.39 IU/mL in the rest. Simulations in the severe renal impairment group with dose adjustment (2,500 IU/24 h) predicted all individual Amax < 0.60 IU/mL (mean Amax = 0.42 IU/ml). Simulations after 10 therapeutic doses predicted mean Amax = 1.22 IU/mL in severe renal impairment group and 0.89-0.98 IU/mL in the rest. Simulations in the severe renal impairment group with 75% dose adjustment predicted individual Amax ≤ 1.60 IU/mL (mean Amax = 0.91 IU/mL).ConclusionsNo dose adjustments are required in elderly with preserved renal function. A dose adjustment of bemiparin is only advisable in patients with severe renal impairment when using prophylactic or therapeutic doses.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Thrombosis Research - Volume 133, Issue 6, June 2014, Pages 1029-1038
نویسندگان
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