Summary
Potential interactions between Org 10172 (Lomoparan®; i. v. bolus injection of 3,250
anti-Xa units followed by 750 units twice daily s. c. for 8 days) and acetylsalicylic
acid (ASA) (500 mg orally 14 and 2 h before i. v. Org 10172 administration) were studied
in eight healthy male volunteers using an open, randomised three-way cross-over design.
Except for moderate bruising at venepuncture and s.c. injection sites which were equally
distributed over all three treatments (Org 10172 alone, ASA alone, Org 10172 and ASA
combined), no side effects were observed. The effects of the separate drugs on several
haemostatic parameters were as expected, although the prolongations in bleeding time
after ASA were highly variable and tended to be somewhat more pronounced after the
combination (p >0.05). Org 10172 did not influence the inhibiting effects of ASA on
platelet function nor the functional recovery afterwards, as evaluated by thromboxane
A2 (TXA2) generation and collagen-induced platelet aggregation. Furthermore, no important
interactions were observed with regard to the coagulation tests and plasma anti-Xa
activity. Although this study did not entirely exclude small interactions between
Org 10172 and ASA in this relatively small group of subjects, these effects are probably
without clinical significance.
