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01.12.2010

Efficacy and Safety of Rosuvastatin 5 mg in Combination with Fenofibric Acid 135 mg in Patients with Mixed Dyslipidemia – A Phase 3 Study

verfasst von: Eli M. Roth, Robert S. Rosenson, Dawn M. Carlson, Sandra M. Fukumoto, Carolyn M. Setze, James W. Blasetto, Nardev S. Khurmi, James C. Stolzenbach, Laura A. Williams

Erschienen in: Cardiovascular Drugs and Therapy | Ausgabe 5-6/2010

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Abstract

Background

Patients with mixed dyslipidemia characterized by elevated low-density lipoprotein cholesterol (LDL-C), elevated triglycerides (TG), and reduced high-density lipoprotein cholesterol (HDL-C) often require combination therapy to improve multiple lipid and nonlipid parameters. This phase 3, multicenter, randomized, double-blind study evaluated the efficacy and safety of rosuvastatin 5 mg coadministered with fenofibric acid 135 mg in patients with mixed dyslipidemia.

Methods

A total of 760 patients with TG ≥ 150 mg/dL, HDL-C <40 mg/dL (<50 mg/dL for women), and LDL-C ≥ 130 mg/dL were randomized for a 12-week treatment period to rosuvastatin 5 mg, fenofibric acid 135 mg, or rosuvastatin 5 mg + fenofibric acid 135 mg. The primary efficacy comparisons were mean percentage changes in HDL-C and TG (rosuvastatin + fenofibric acid vs. rosuvastatin monotherapy), and LDL-C (rosuvastatin + fenofibric acid vs. fenofibric acid monotherapy).

Results

Treatment with rosuvastatin + fenofibric acid resulted in statistically significant greater improvements in HDL-C (23.0% vs. 12.4%; P < 0.001) and TG (–40.3% vs. –17.5%; P < 0.001), compared with rosuvastatin monotherapy; and LDL-C (–28.7% vs. –4.1%; P < 0.001), compared with fenofibric acid monotherapy. All secondary efficacy variables improved with combination therapy. Combination therapy was generally well tolerated with a safety profile consistent with individual monotherapies. No unexpected muscle, hepatic, or renal safety signals were identified with combination therapy versus individual monotherapies.

Conclusion

In conclusion, rosuvastatin 5 mg + fenofibric acid 135 mg resulted in comprehensive improvements in the lipid profile of patients with mixed dyslipidemia without unanticipated adverse events.
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Metadaten
Titel
Efficacy and Safety of Rosuvastatin 5 mg in Combination with Fenofibric Acid 135 mg in Patients with Mixed Dyslipidemia – A Phase 3 Study
verfasst von
Eli M. Roth
Robert S. Rosenson
Dawn M. Carlson
Sandra M. Fukumoto
Carolyn M. Setze
James W. Blasetto
Nardev S. Khurmi
James C. Stolzenbach
Laura A. Williams
Publikationsdatum
01.12.2010
Verlag
Springer US
Erschienen in
Cardiovascular Drugs and Therapy / Ausgabe 5-6/2010
Print ISSN: 0920-3206
Elektronische ISSN: 1573-7241
DOI
https://doi.org/10.1007/s10557-010-6266-4

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