Safety and Efficacy of Fondaparinux in Renal Impairment.

To evaluate the cumulative evidence regarding the efficacy and safety of using fondaparinux in renal impairment, manifested by preventing new or recurrent thrombosis and the incidence of bleeding, respectively. We searched the MEDLINE and Cochrane databases for relevant studies from 1966 until November 2014, using the terms "fondaparinux" and "renal failure" or "dialysis." Additional references were identified from review of literature citations. Inclusion criteria were articles in English language and patients with creatinine clearance (CrCl) less than 50 mL/min. Exclusion criteria were using fondaparinux as an anticoagulant for dialyzer circuit patency, abstracts, case reports, case series, pediatrics (<18 years), and pharmacokinetic studies with no clinical efficacy and safety results. Our search retrieved 4 cohort studies, 1 clinical trial, and 1 randomized clinical trial (RCT) subgroup analysis. A total of 3237 patients received fondaparinux with a dose ranging from 1.25 mg to 2.5 mg daily. Three studies investigated fondaparinux as a prophylactic agent, 2 as a treatment agent, and 1 study investigated both. The only study with control group was the RCT subgroup analysis, which compared fondaparinux to enoxaparin. A total of 470 patients developed thromboembolic complications or death and 169 developed major bleeding. The composite outcome of safety and efficacy in the RCT subgroup analysis was significantly lower in fondaparinux group compared with the enoxaparin group ( = .001). Current evidence regarding the safety and efficacy of fondaparinux in renally impaired patients is limited and does not support its use in such population.