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

被引：67

作者：

Jones, Peter H. ^{[1
]}

Davidson, Michael H. ^{[2
]}

Kashyap, Moti L. ^{[3
,4
]}

Kelly, Maureen T. ^{[5
]}

Buttler, Susan M. ^{[5
]}

Setze, Carolyn M. ^{[5
]}

Sleep, Darryl J. ^{[5
]}

Stolzenbach, James C. ^{[5
]}

机构：

[1] Baylor Coll Med, Houston, TX 77030 USA

[2] Univ Chicago, Pritzker Sch Med, Chicago, IL 60637 USA

[3] Univ Calif Irvine, Irvine, CA USA

[4] VA Med Ctr, Long Beach, CA USA

[5] Abbott Labs, Abbott Pk, IL 60064 USA

来源：

ATHEROSCLEROSIS | 2009年 / 204卷 / 01期

关键词：

Dyslipidemia; Cholesterol; Fibrates; Hydroxymethylglutaryl-CoA reductase inhibitors; Rosuvastatin; Fenofibric acid; CORONARY-HEART-DISEASE; DENSITY-LIPOPROTEIN CHOLESTEROL; COMBINED HYPERLIPIDEMIA; CARDIOVASCULAR EVENTS; ATORVASTATIN; RISK; TRIGLYCERIDES; MANAGEMENT;

D O I：

10.1016/j.atherosclerosis.2008.09.027

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 10mg 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 10mg; 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 20mg 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. (C) 2008 Elsevier Ireland Ltd. All rights reserved.

引用

页码：208 / 215

页数：8

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