Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study

Clinical Therapeutics
Michael H DavidsonLCP-AtorFen Investigators

Abstract

Coadministration of statin and fenofibrate monotherapies is frequently used to treat patients with dyslipidemia; however, a fixed-dose combination (FDC) tablet is not currently marketed. This study evaluates a new FDC tablet of atorvastatin 40 mg and fenofibrate 100 mg. This was a 12-week, multicenter, double-blind, randomized, parallel-group Phase IIb study. Adults with dyslipidemia (non-HDL-C >130 mg/dL and triglycerides [TG] > or =150 but < or =500 mg/dL) were randomly assigned in a 1:1:1 ratio to receive the FDC, atorvastatin 40 mg, or fenofibrate 145 mg for 12 weeks. Study medication was taken once daily in the evening, without regard to meals. Patients attended follow-up visits after 4, 8, and 12 weeks of the double-blind treatment. The primary efficacy end points were the mean percentage changes from baseline to the final visit (week 12) in non-HDL-C, HDL-C, and TG. Secondary variables were LDL-C, VLDL-C particle concentration, total cholesterol, apolipoprotein B, lipoprotein (a), high-sensitivity C-reactive protein, fibrinogen, homocysteine, creatinine, myeloperoxidase, and lipoprotein-associated phospholipase A2. Tolerability was assessed by adverse events, laboratory parameters, vital signs, physical examinations, and...Continue Reading

References

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Citations

Jan 18, 2013·Clinical and Experimental Pharmacology & Physiology·Qiang GengWenqing Liang
Sep 29, 2011·Drugs·Kate McKeage, Gillian M Keating
Dec 15, 2015·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·Amirhossein SahebkarUNKNOWN Lipid and Blood Pressure Meta-analysis Collaboration (LBPMC) Group
Jan 25, 2011·Cardiology Clinics·Michael H Davidson
Jun 7, 2012·International Journal of Cardiology·Ramprasad GadiVincent M Figueredo
Mar 12, 2015·The Cochrane Database of Systematic Reviews·Stephen P AdamsJames M Wright
Mar 27, 2019·Journal of Cardiovascular Pharmacology and Therapeutics·Eleni PappaMoses S Elisaf
Sep 25, 2019·Nature Reviews. Drug Discovery·Xiao ZhaoFei-Fei Liu
Feb 6, 2017·BMC Medicine·Amirhossein SahebkarUNKNOWN Lipid and Blood Pressure Meta-analysis Collaboration (LBPMC) Group
Jan 1, 2013·Journal of Drug Assessment·Niki KatsikiAsterios Karagiannis
May 17, 2017·Therapeutic Advances in Endocrinology and Metabolism·Kiran JoglekarAmik Sodhi
Sep 15, 2020·Archives of Gerontology and Geriatrics·Adrian ZubrzyckiZbigniew Kmieć

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