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Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: A phase 3 study

2008; Elsevier BV; Volume: 204; Issue: 1 Linguagem: Inglês

10.1016/j.atherosclerosis.2008.09.027

1879-1484

Peter H. Jones, Michael H. Davidson, Moti L. Kashyap, Maureen T. Kelly, Susan M. Buttler, Carolyn M. Setze, Darryl J. Sleep, James C. Stolzenbach,

Hyperglycemia and glycemic control in critically ill and hospitalized patients

Objective To evaluate a new formulation of fenofibric acid (ABT-335) co-administered with 2 doses of rosuvastatin in patients with mixed dyslipidemia. Methods In a phase 3, multicenter, randomized, double-blind, active-controlled study, a total of 1445 patients with LDL-C ≥ 130 mg/dL, TG ≥ 150 mg/dL, and HDL-C < 40 mg/dL (<50 mg/dL for women) were randomized to either ABT-335 (135 mg), rosuvastatin (10, 20, or 40 mg), or ABT-335 + rosuvastatin 10 or 20 mg, and treated for 12 weeks. The primary efficacy comparisons were mean percent change in HDL-C and TG (ABT-335 + rosuvastatin vs. corresponding dose of rosuvastatin), and LDL-C (ABT-335 + rosuvastatin vs. ABT-335). Results Combination therapy with ABT-335 + rosuvastatin 10 mg resulted in significantly (p < 0.001) greater improvements in HDL-C (20.3% vs. 8.5%) and TG (−47.1% vs. −24.4%) compared to rosuvastatin 10 mg; and LDL-C (−37.2% vs. −6.5%) compared to ABT-335. Similarly, significantly (p < 0.001) greater improvements were observed with ABT-335 + rosuvastatin 20 mg in HDL-C (19.0% vs. 10.3%) and TG (−42.9% vs. −25.6%) compared to rosuvastatin 20 mg; and LDL-C (−38.8% vs. −6.5%) compared to ABT-335 monotherapy. Greater improvements in multiple secondary endpoints were noted with combination therapy compared to prespecified monotherapies. Both combination therapy doses were generally well tolerated, with a safety profile consistent with ABT-335 and rosuvastatin monotherapies. No rhabdomyolysis or unexpected hepatic, renal, or muscle safety signals were identified. Conclusion In patients with mixed dyslipidemia, combination therapy with ABT-335 + rosuvastatin resulted in more effective control of multiple lipid parameters than either monotherapy alone, with a safety profile similar to both monotherapies. This combination may be an appropriate therapeutic option to treat mixed dyslipidemia.