After demonstrating initial safety of Ibuprofen administered to hemophiliacs, a 16-wk double-blind individual crossover trial was designed to test the safety and, to a more limited extent, the efficacy of 1600 mg of Ibuprofen or placebo given daily to 20 hemophiliacs with hemophiliac arthropathy. The trial was completed with no evidence of increased frequency or severity of hemophiliac bleeding episodes or clinical or laboratory evidence of bleeding secondary to Ibuprofen. There were five treatment failures, none associated with hemorrhage or lack of compliance. A benefit was obtained in reduction of early morning stiffness and pain. Ibuprofen should be considered as a safe and potentially beneficial antiinflammatory agent in the treatment of carefully monitored hemophiliacs eligible for such therapy.

Most anti-inflammatory analgesics, particularly ASA, are considered contraindicated in the treatment of hemophiliacs because of inhibition of in vitro hemostatic function. Nevertheless, it would appear reasonable to use such agents in the therapy of chronic or acute hemophiliac arthropathy, provided that the anti-inflammatory drug did not increase the incidence of hemorrhage. Using moderately and severely affected factor VIII and IX deficient hemophiliacs, Ibuprofen was given, using a short (24 hrs) and long term (21 days) trial in order to assess the effect on in vitro hemostasis and the incidence of hemorrhagic symptoms compared to a comparable period prior to the ingestion of drug. An initial safety trial used 24 normal subjects and 12 moderately to severely affected factor VIII and factor IX deficient hemophiliacs. Within each group 600 mgs of Ibuprofen or lactose placebo was given in a random double-blind study. Over 24 hours no changes were seen in the bleeding time, peripheral blood counts or spontaneous bleeding patterns. Subsequently a 21 day trial was initiated with 15 moderately to severely affected hemophiliacs, using a dose of 2400 mg per os Ibuprofen per day. At 0,7,14 and 21 days, factor assays, bleeding times, platelet function and cell studies were performed. No clinically significant changes were found in any of the experimental variables, including pattern of spontaneous hemorrhages. Four of the 15 subjects experienced intermittent dyspepsia, controlled by antacids. 7 of 11 individuals with hemophilic arthropathy had a subjective decrease in symptoms from arthropathy. It is concluded that Ibuprofen is not associated with clinically significant changes in vitro or in vivo hemostatic function in factor VIII or IX deficient hemophiliacs, and should be considered in the treatment of hemophilic arthropathy.