Interaction study between Org 10172, a low molecular weight heparinoid, and acetylsalicylic acid in healthy male volunteers.
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 greater than 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.
de Boer
A
A
Centre for Human Drug Research, Leiden, The Netherlands.
Danhof
M
M
Cohen
A F
AF
Magnani
H N
HN
Breimer
D D
DD
D000328:Adult; D001241:Aspirin / Q000008:administration & dosage*; D001777:Blood Coagulation / Q000187:drug effects; D002809:Chondroitin Sulfates; D003871:Dermatan Sulfate; D004347:Drug Interactions; D065427:Factor Xa Inhibitors; D006025:Glycosaminoglycans / Q000008:administration & dosage*; D006487:Hemostasis / Q000187:drug effects*; D006496:Heparinoids / Q000008:administration & dosage*; D006497:Heparan Sulfate; D006801:Humans; D008297:Male; D010974:Platelet Aggregation / Q000187:drug effects; D013929:Thromboxane B2 / Q000097:blood
D001241:Aspirin; D002809:Chondroitin Sulfates; D003871:Dermatan Sulfate; D065427:Factor Xa Inhibitors; D006025:Glycosaminoglycans; D006496:Heparinoids; D006497:Heparan Sulfate; D013929:Thromboxane B2; C035838:danaparoid