WEDNESDAY, Nov. 2 (HealthDay News) -- For patients with severe hemophilia A, anti-inhibitor coagulant complex (AICC) prophylaxis is safe and significantly reduces bleeding episodes compared with on-demand therapy, according to a study published in the Nov. 3 issue of the New England Journal of Medicine.
Cindy Leissinger, M.D., from Tulane University in New Orleans, and colleagues compared the safety and efficacy of six months of AICC prophylaxis versus on-demand therapy in 34 patients (older than 2 years) with severe hemophilia A, high-titer inhibitors, and prior use of bypassing agents for bleeding. In this cross-over study, AICC was administered at a target dose of 85 U per kilogram (±15 percent) prophylactically on three nonconsecutive days a week or as on-demand treatment for bleeding episodes. A three-month wash-out period separated the two treatment periods wherein patients received on-demand therapy. Of the 34 participants, 26 completed both treatment periods and were analyzed for efficacy, and 33 received at least one study drug dose and were analyzed for safety. The number of bleeding episodes during each six-month treatment period was the primary outcome.
The investigators found that prophylaxis was associated with significant decreases in bleeding episodes, hemarthroses, and target-joint bleeding (≥3 hemarthroses in a single joint during a six-month treatment period) compared with on-demand therapy (62, 61, and 72 percent, respectively). An allergic reaction to the study drug was reported for one patient.
"AICC prophylaxis at the dosage evaluated significantly and safely decreased the frequency of joint and other bleeding events in patients with severe hemophilia A and factor VIII inhibitors," the authors write.
Several authors disclosed financial relationships with pharmaceutical and health care companies, including Baxter Bioscience, which partially funded the study.
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