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Efficacy and safety of adding fenofibrate 160 mg in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy.
Am J Cardiol 2010; 106(6):787-92AJ

Abstract

Patients with mixed hyperlipidemia and at high risk of coronary heart disease may not achieve recommended low-density lipoprotein (LDL) and non-high-density lipoprotein (non-HDL) cholesterol goals on statin monotherapy. This study was designed to evaluate the efficacy and safety of a fenofibrate 160 mg/pravastatin 40 mg fixed-dose combination therapy in high-risk patients not at their LDL cholesterol goal on pravastatin 40 mg. In this 12-week, multicenter, randomized, double-blind, double-dummy, parallel-group study, after a run-in on pravastatin 40 mg, 248 patients were randomly assigned to fenofibrate/pravastatin combination therapy or to pravastatin monotherapy. Combination therapy produced significantly greater complementary decreases in non-HDL cholesterol (primary end point) than pravastatin monotherapy (-14.1% vs -6.1%, p = 0.002). Significantly greater improvements were also observed in LDL cholesterol (-11.7% vs -5.9%, p = 0.019), HDL cholesterol (+6.5% vs +2.3%, p = 0.009), triglycerides (-22.6% vs -2.0%, p = 0.006), and apolipoprotein B (-12.6% vs -3.8%, p <0.0001). Significantly more patients receiving the fenofibrate/pravastatin combination therapy than pravastatin alone achieved the LDL cholesterol (<100 mg/dl) and non-HDL cholesterol (<130 mg/dl) goals (p <0.01). Combination therapy was generally well tolerated with incidences of clinical and laboratory adverse experiences similar between the 2 groups. In conclusion, the fenofibrate 160 mg/pravastatin 40 mg fixed-dose combination therapy significantly improved the global atherogenic lipid profile in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy.

Authors+Show Affiliations

Point Medical, Dijon, France.No affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

20816118

Citation

Farnier, Michel, et al. "Efficacy and Safety of Adding Fenofibrate 160 Mg in High-risk Patients With Mixed Hyperlipidemia Not Controlled By Pravastatin 40 Mg Monotherapy." The American Journal of Cardiology, vol. 106, no. 6, 2010, pp. 787-92.
Farnier M, Ducobu J, Bryniarski L. Efficacy and safety of adding fenofibrate 160 mg in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy. Am J Cardiol. 2010;106(6):787-92.
Farnier, M., Ducobu, J., & Bryniarski, L. (2010). Efficacy and safety of adding fenofibrate 160 mg in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy. The American Journal of Cardiology, 106(6), pp. 787-92. doi:10.1016/j.amjcard.2010.05.005.
Farnier M, Ducobu J, Bryniarski L. Efficacy and Safety of Adding Fenofibrate 160 Mg in High-risk Patients With Mixed Hyperlipidemia Not Controlled By Pravastatin 40 Mg Monotherapy. Am J Cardiol. 2010 Sep 15;106(6):787-92. PubMed PMID: 20816118.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of adding fenofibrate 160 mg in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy. AU - Farnier,Michel, AU - Ducobu,Jean, AU - Bryniarski,Leszek, Y1 - 2010/08/02/ PY - 2010/03/03/received PY - 2010/05/06/revised PY - 2010/05/06/accepted PY - 2010/9/7/entrez PY - 2010/9/8/pubmed PY - 2010/9/30/medline SP - 787 EP - 92 JF - The American journal of cardiology JO - Am. J. Cardiol. VL - 106 IS - 6 N2 - Patients with mixed hyperlipidemia and at high risk of coronary heart disease may not achieve recommended low-density lipoprotein (LDL) and non-high-density lipoprotein (non-HDL) cholesterol goals on statin monotherapy. This study was designed to evaluate the efficacy and safety of a fenofibrate 160 mg/pravastatin 40 mg fixed-dose combination therapy in high-risk patients not at their LDL cholesterol goal on pravastatin 40 mg. In this 12-week, multicenter, randomized, double-blind, double-dummy, parallel-group study, after a run-in on pravastatin 40 mg, 248 patients were randomly assigned to fenofibrate/pravastatin combination therapy or to pravastatin monotherapy. Combination therapy produced significantly greater complementary decreases in non-HDL cholesterol (primary end point) than pravastatin monotherapy (-14.1% vs -6.1%, p = 0.002). Significantly greater improvements were also observed in LDL cholesterol (-11.7% vs -5.9%, p = 0.019), HDL cholesterol (+6.5% vs +2.3%, p = 0.009), triglycerides (-22.6% vs -2.0%, p = 0.006), and apolipoprotein B (-12.6% vs -3.8%, p <0.0001). Significantly more patients receiving the fenofibrate/pravastatin combination therapy than pravastatin alone achieved the LDL cholesterol (<100 mg/dl) and non-HDL cholesterol (<130 mg/dl) goals (p <0.01). Combination therapy was generally well tolerated with incidences of clinical and laboratory adverse experiences similar between the 2 groups. In conclusion, the fenofibrate 160 mg/pravastatin 40 mg fixed-dose combination therapy significantly improved the global atherogenic lipid profile in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy. SN - 1879-1913 UR - https://www.unboundmedicine.com/medline/citation/20816118/Efficacy_and_safety_of_adding_fenofibrate_160_mg_in_high_risk_patients_with_mixed_hyperlipidemia_not_controlled_by_pravastatin_40_mg_monotherapy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9149(10)01041-6 DB - PRIME DP - Unbound Medicine ER -