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Efficacy and safety of rosuvastatin 5 mg in combination with fenofibric acid 135 mg in patients with mixed dyslipidemia - a phase 3 study.
Cardiovasc Drugs Ther. 2010 Dec; 24(5-6):421-8.CD

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.

Authors+Show Affiliations

Sterling Research Group, 2230 Auburn Avenue, Cincinnati, OH 45219, USA. eroth@sterlingresearch.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20953684

Citation

Roth, Eli M., et al. "Efficacy and Safety of Rosuvastatin 5 Mg in Combination With Fenofibric Acid 135 Mg in Patients With Mixed Dyslipidemia - a Phase 3 Study." Cardiovascular Drugs and Therapy, vol. 24, no. 5-6, 2010, pp. 421-8.
Roth EM, Rosenson RS, Carlson DM, et al. Efficacy and safety of rosuvastatin 5 mg in combination with fenofibric acid 135 mg in patients with mixed dyslipidemia - a phase 3 study. Cardiovasc Drugs Ther. 2010;24(5-6):421-8.
Roth, E. M., Rosenson, R. S., Carlson, D. M., Fukumoto, S. M., Setze, C. M., Blasetto, J. W., Khurmi, N. S., Stolzenbach, J. C., & Williams, L. A. (2010). Efficacy and safety of rosuvastatin 5 mg in combination with fenofibric acid 135 mg in patients with mixed dyslipidemia - a phase 3 study. Cardiovascular Drugs and Therapy, 24(5-6), 421-8. https://doi.org/10.1007/s10557-010-6266-4
Roth EM, et al. Efficacy and Safety of Rosuvastatin 5 Mg in Combination With Fenofibric Acid 135 Mg in Patients With Mixed Dyslipidemia - a Phase 3 Study. Cardiovasc Drugs Ther. 2010;24(5-6):421-8. PubMed PMID: 20953684.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of rosuvastatin 5 mg in combination with fenofibric acid 135 mg in patients with mixed dyslipidemia - a phase 3 study. AU - Roth,Eli M, AU - Rosenson,Robert S, AU - Carlson,Dawn M, AU - Fukumoto,Sandra M, AU - Setze,Carolyn M, AU - Blasetto,James W, AU - Khurmi,Nardev S, AU - Stolzenbach,James C, AU - Williams,Laura A, PY - 2010/10/19/entrez PY - 2010/10/19/pubmed PY - 2011/7/8/medline SP - 421 EP - 8 JF - Cardiovascular drugs and therapy JO - Cardiovasc Drugs Ther VL - 24 IS - 5-6 N2 - 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. SN - 1573-7241 UR - https://www.unboundmedicine.com/medline/citation/20953684/Efficacy_and_safety_of_rosuvastatin_5_mg_in_combination_with_fenofibric_acid_135_mg_in_patients_with_mixed_dyslipidemia___a_phase_3_study_ L2 - https://doi.org/10.1007/s10557-010-6266-4 DB - PRIME DP - Unbound Medicine ER -