Total hip replacement is a bloody business. Orthopedicsurgeons worry that somewhere in the many transfusionspatients require may lurk a contaminating HIV or hepatitisvirus. Recombinant erythropoietin (EPO) looks like a sanguineanswer to their anxiety.

Saturday's Lancet reported a large-scale Canadian clinical trial,under the title "Effectiveness of perioperative recombinanthuman erythropoietin in elective hip replacement."

Two hundred and eight evenly matched patients took part inthe Canada-wide, multicenter, double-blind, randomized,placebo-controlled study. Its bottom line: Of 77 patients whoreceived daily injections of 300 units of EPO per kilogramduring 14 days before surgery, only 23 percent requiredtransfusions. Of 78 subjects who got 14 pre-operative days ofplacebo, 44 percent needed blood supplements. In between, of53 on placebo for six days followed by nine on EPO, 30 percentgot transfused.

As for cost factors, the Lancet paper reported that one 14-dayregimen came to C$3,938 (U.S.$3,072) and that each 10,000-unit vial cost C$134 (U.S.$104). The report commented that"costs of other methods of avoiding homologous transfusion,including autologous transfusion, are also likely to beconsiderable."

To mount their trial, the Canadians organized The CanadianOrthopedic Perioperative EPO Study Group. A member of thisbody's steering committee, epidemiologist Brian Feagan of theUniversity of Western Ontario, told BioWorld that "discussionsare under way to follow up on our initial study. The issues areformidable, especially cost and mode of application."

In the Lancet report, EPO was administered by dailysubcutaneous injection. Alternative dosing schedules, saidFeagan, need to be explored, such as a single depot injection orpatient self-administration device.

Feagan's "takeaway message" on the future of EPO's usefulnessin surgery: "Like most biotechnology products, we have to findout what is the best way of getting the most bang for the buck."

Lancet's press release states: "... The use of a geneticallyengineered form of hormone erythropoietin, which stimulatesred-blood-cell production, can now be added to the list ofalternative strategies."

U.S. TRIAL OF EPO AS BLOOD SUPPLEMENT

In the U.S., recombinant EPO is marketed by its discoverer,Amgen Inc. of Thousand Oaks, Calif., as Epogen, for anemia ofkidney-failure dialysis. It is also FDA-approved for treatingcancer chemotherapy and the anemias of AIDS. Johnson &Johnson's Ortho Biotech subsidiary is licensed by Amgen to sellEPO for all indications other than dialysis.

Ortho recently conducted its own trial of EPO as a bloodsupplement in 200 elective, orthopedic major-surgery patientsat 20 U.S. centers. Its final report, said company spokeswomanSara Colomarino, is still in manuscript. Following on this initialstudy, plans are in discussion for a new Phase III trial,enrolling 300 patients at 25 centers.

-- David N. Leff Science Editor

(c) 1997 American Health Consultants. All rights reserved.

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