Pharmacodynamics 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

Salvador Rico, Rosa María Antonijoan, Maria Rosa Ballester, Ibon Gutierro, Ignacio Ayani, Javier Martinez-Gonzalez, Montserrat Borrell, Jordi Fontcuberta, Ignasi Gich

Research output: Contribution to journalArticleResearchpeer-review

3 Citations (Scopus)

Abstract

Introduction Aging 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 Methods Open, parallel study. Healthy adult [n = 13] and elderly (> 65 yrs) [n = 12] volunteers; and subjects with mild (Cl Cr ≥ 50 to ≤ 80 mL/min, n = 8), moderate (Cl-rfis1 ≥ 30 to < 50 mL/min, n = 7), and severe (Cl Cr < 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. Results There 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 A;b = 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 A max = 0.91 IU/mL). Conclusions No 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. © 2014 Elsevier Ltd. All rights reserved.
Original languageEnglish
Pages (from-to)1029-1038
JournalThrombosis Research
Volume133
Issue number6
DOIs
Publication statusPublished - 1 Jan 2014

Keywords

  • Anti-Factor Xa
  • Bemiparin
  • Elderly
  • Low molecular weight heparins
  • Pharmacodynamics
  • Renal impairment

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