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.

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 Cr  ≥ 30 to Cr 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 max  = 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 A max max  = 0.42 IU/ml). Simulations after 10 therapeutic doses predicted mean A max  = 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 A max  ≤ 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.