cgp-39393 and Renal-Insufficiency--Chronic

Venous thromboembolism (VTE) remains a significant complication of major orthopedic surgery, and chronic kidney disease (CKD) is common among elderly patients undergoing total hip replacement (THR).. The purpose of this study was to evaluate thrombosis and bleeding outcomes in patients with stage 3B CKD treated with either desirudin or enoxaparin after elective THR.. This was a post hoc subgroup analysis of a randomized, multicenter, double-blind study of desirudin vs. enoxaparin in patients undergoing elective THR.. Patients received either subcutaneous desirudin 15 mg twice daily or subcutaneous enoxaparin 40 mg once daily. Of the 2078 randomized patients who received study medication, 577 had stage 3B CKD or worse (27.8%), and the proportion of these patients who experienced a major VTE in the enoxaparin treatment group was found to be much higher than in the desirudin treatment group (11.1% vs. 3.4%, model-adjusted odds ratio 3.52, 95% confidence interval 1.48-8.40, P=0.004). There was no statistically significant difference between treatment groups in terms of rates of major bleeding, regardless of stage of renal function.. CKD has been reported previously to increase the risk of bleeding with anticoagulants, and these findings suggest that CKD may also increase the risk of major VTE for patients treated with enoxaparin, but not for patients treated with desirudin. Clinicians should consider the impact of CKD on the risk of VTE when choosing a prophylaxis agent.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anticoagulants; Arthroplasty, Replacement, Hip; Drug Administration Schedule; Enoxaparin; Female; Hirudins; Humans; Injections, Subcutaneous; Logistic Models; Male; Middle Aged; Multicenter Studies as Topic; Odds Ratio; Patient Selection; Postoperative Hemorrhage; Randomized Controlled Trials as Topic; Recombinant Proteins; Renal Insufficiency, Chronic; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Thrombosis; Time Factors; Treatment Outcome; Young Adult