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Effects of combination therapy with rosuvastatin and fenofibric acid in patients with mixed dyslipidemia and high-sensitivity C-reactive protein (≥ 2 mg/L). cmb@bcm.tmc.edu.
J Clin Lipidol. 2011 Sep-Oct; 5(5):401-7.JC

Abstract

BACKGROUND

Elevated levels of high-sensitivity C-reactive protein (hsCRP) correlate with an increased risk for cardiovascular events. Combination therapy with a statin and a fibrate may be more effective than statin monotherapy for reducing hsCRP, especially in patients with mixed dyslipidemia.

OBJECTIVE

To characterize the treatment effects of rosuvastatin and fenofibric acid combination therapy compared with individual monotherapies in mixed dyslipidemic patients with baseline hsCRP ≥2 mg/L versus <2 mg/L and to determine the effects of long-term treatment with rosuvastatin and fenofibric acid combination therapy on hsCRP and other lipids for patients with hsCRP ≥2 mg/L after treatment with rosuvastatin monotherapy.

METHODS

Data for the post hoc analysis were derived from two 12-week controlled studies and a 52-week extension study. Patients were treated with fenofibric acid 135 mg; rosuvastatin 5, 10, 20, or 40 mg; or rosuvastatin 5, 10, or 20 mg and fenofibric acid 135 mg in the controlled studies; and with rosuvastatin 20 mg and fenofibric acid 135 mg in the extension study.

RESULTS

In this analysis, 65% (1416/2182) of patients had pretreatment baseline hsCRP ≥2 mg/L. Among all treatment groups, larger decreases in hsCRP were observed in patients with greater baseline hsCRP; however, improvements in other lipids/apolipoprotein were comparable between the baseline hsCRP categories. Among patients with high hsCRP (≥2 mg/L) remaining after 12 weeks of rosuvastatin 10, 20, or 40 mg monotherapy, hsCRP was reduced by ∼36% after switching to rosuvastatin 20 mg and fenofibric acid 135 mg for up to 52 weeks, and ∼36% of patients shifted from hsCRP ≥2 mg/L to <2 mg/L.

CONCLUSIONS

Combination therapy with rosuvastatin and fenofibric acid may be effective for improving the inflammatory biomarker, hsCRP as well as other lipid abnormalities in patients with mixed dyslipidemia and high hsCRP.

Authors+Show Affiliations

Section of Atherosclerosis and Vascular Medicine, Baylor College of Medicine, and Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart and Vascular Center, Houston, TX 70030, USA. cmb@bcm.tmc.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21981842

Citation

Ballantyne, Christie M., et al. "Effects of Combination Therapy With Rosuvastatin and Fenofibric Acid in Patients With Mixed Dyslipidemia and High-sensitivity C-reactive Protein (≥ 2 mg/L). Cmb@bcm.tmc.edu." Journal of Clinical Lipidology, vol. 5, no. 5, 2011, pp. 401-7.
Ballantyne CM, Davidson MH, Setze CM, et al. Effects of combination therapy with rosuvastatin and fenofibric acid in patients with mixed dyslipidemia and high-sensitivity C-reactive protein (≥ 2 mg/L). cmb@bcm.tmc.edu. J Clin Lipidol. 2011;5(5):401-7.
Ballantyne, C. M., Davidson, M. H., Setze, C. M., & Kelly, M. T. (2011). Effects of combination therapy with rosuvastatin and fenofibric acid in patients with mixed dyslipidemia and high-sensitivity C-reactive protein (≥ 2 mg/L). cmb@bcm.tmc.edu. Journal of Clinical Lipidology, 5(5), 401-7. https://doi.org/10.1016/j.jacl.2011.06.010
Ballantyne CM, et al. Effects of Combination Therapy With Rosuvastatin and Fenofibric Acid in Patients With Mixed Dyslipidemia and High-sensitivity C-reactive Protein (≥ 2 mg/L). Cmb@bcm.tmc.edu. J Clin Lipidol. 2011 Sep-Oct;5(5):401-7. PubMed PMID: 21981842.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of combination therapy with rosuvastatin and fenofibric acid in patients with mixed dyslipidemia and high-sensitivity C-reactive protein (≥ 2 mg/L). cmb@bcm.tmc.edu. AU - Ballantyne,Christie M, AU - Davidson,Michael H, AU - Setze,Carolyn M, AU - Kelly,Maureen T, Y1 - 2011/06/28/ PY - 2011/03/01/received PY - 2011/06/09/revised PY - 2011/06/19/accepted PY - 2011/10/11/entrez PY - 2011/10/11/pubmed PY - 2012/2/4/medline SP - 401 EP - 7 JF - Journal of clinical lipidology JO - J Clin Lipidol VL - 5 IS - 5 N2 - BACKGROUND: Elevated levels of high-sensitivity C-reactive protein (hsCRP) correlate with an increased risk for cardiovascular events. Combination therapy with a statin and a fibrate may be more effective than statin monotherapy for reducing hsCRP, especially in patients with mixed dyslipidemia. OBJECTIVE: To characterize the treatment effects of rosuvastatin and fenofibric acid combination therapy compared with individual monotherapies in mixed dyslipidemic patients with baseline hsCRP ≥2 mg/L versus <2 mg/L and to determine the effects of long-term treatment with rosuvastatin and fenofibric acid combination therapy on hsCRP and other lipids for patients with hsCRP ≥2 mg/L after treatment with rosuvastatin monotherapy. METHODS: Data for the post hoc analysis were derived from two 12-week controlled studies and a 52-week extension study. Patients were treated with fenofibric acid 135 mg; rosuvastatin 5, 10, 20, or 40 mg; or rosuvastatin 5, 10, or 20 mg and fenofibric acid 135 mg in the controlled studies; and with rosuvastatin 20 mg and fenofibric acid 135 mg in the extension study. RESULTS: In this analysis, 65% (1416/2182) of patients had pretreatment baseline hsCRP ≥2 mg/L. Among all treatment groups, larger decreases in hsCRP were observed in patients with greater baseline hsCRP; however, improvements in other lipids/apolipoprotein were comparable between the baseline hsCRP categories. Among patients with high hsCRP (≥2 mg/L) remaining after 12 weeks of rosuvastatin 10, 20, or 40 mg monotherapy, hsCRP was reduced by ∼36% after switching to rosuvastatin 20 mg and fenofibric acid 135 mg for up to 52 weeks, and ∼36% of patients shifted from hsCRP ≥2 mg/L to <2 mg/L. CONCLUSIONS: Combination therapy with rosuvastatin and fenofibric acid may be effective for improving the inflammatory biomarker, hsCRP as well as other lipid abnormalities in patients with mixed dyslipidemia and high hsCRP. SN - 1933-2874 UR - https://www.unboundmedicine.com/medline/citation/21981842/Effects_of_combination_therapy_with_rosuvastatin_and_fenofibric_acid_in_patients_with_mixed_dyslipidemia_and_high_sensitivity_C_reactive_protein__≥_2_mg/L___cmb@bcm_tmc_edu_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1933-2874(11)00617-9 DB - PRIME DP - Unbound Medicine ER -