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      Fenofibrate/simvastatin fixed-dose combination in the treatment of mixed dyslipidemia: safety, efficacy, and place in therapy

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          Abstract

          Lipids disorder is the principal cause of atherosclerosis and may present with several forms, according to blood lipoprotein prevalence. One of the most common forms is combined dyslipidemia, characterized by high levels of triglycerides and low level of high-density lipoprotein. Single lipid-lowering drugs may have very selective effect on lipoproteins; hence, the need to use multiple therapy against dyslipidemia. However, the risk of toxicity is a concerning issue. In this review, the effect and safety of an approved combination therapy with simvastatin plus fenofibrate are described, with an analysis of pros and cons resulting from randomized multicenter trials, meta-analyses, animal models, and case reports as well.

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          2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults

          Neil J Stone, Jennifer G Robinson, Alice H. Lichtenstein … (2014)
          Supplemental Digital Content is available in the text.
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            Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S)

            A.G. Olsson, J McMurray, G Thorgeirsson … (1994)
            Drug therapy for hypercholesterolaemia has remained controversial mainly because of insufficient clinical trial evidence for improved survival. The present trial was designed to evaluate the effect of cholesterol lowering with simvastatin on mortality and morbidity in patients with coronary heart disease (CHD). 4444 patients with angina pectoris or previous myocardial infarction and serum cholesterol 5.5-8.0 mmol/L on a lipid-lowering diet were randomised to double-blind treatment with simvastatin or placebo. Over the 5.4 years median follow-up period, simvastatin produced mean changes in total cholesterol, low-density-lipoprotein cholesterol, and high-density-lipoprotein cholesterol of -25%, -35%, and +8%, respectively, with few adverse effects. 256 patients (12%) in the placebo group died, compared with 182 (8%) in the simvastatin group. The relative risk of death in the simvastatin group was 0.70 (95% CI 0.58-0.85, p = 0.0003). The 6-year probabilities of survival in the placebo and simvastatin groups were 87.6% and 91.3%, respectively. There were 189 coronary deaths in the placebo group and 111 in the simvastatin group (relative risk 0.58, 95% CI 0.46-0.73), while noncardiovascular causes accounted for 49 and 46 deaths, respectively. 622 patients (28%) in the placebo group and 431 (19%) in the simvastatin group had one or more major coronary events. The relative risk was 0.66 (95% CI 0.59-0.75, p < 0.00001), and the respective probabilities of escaping such events were 70.5% and 79.6%. This risk was also significantly reduced in subgroups consisting of women and patients of both sexes aged 60 or more. Other benefits of treatment included a 37% reduction (p < 0.00001) in the risk of undergoing myocardial revascularisation procedures. This study shows that long-term treatment with simvastatin is safe and improves survival in CHD patients.
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              ESC/EAS Guidelines for the management of dyslipidaemias The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS).

              David Wood, Ian Graham, Serap Erdine … (2011)
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                Author and article information

                Journal
                Journal ID (nlm-ta): Vasc Health Risk Manag
                Journal ID (iso-abbrev): Vasc Health Risk Manag
                Journal ID (publisher-id): Vascular Health and Risk Management
                Title: Vascular Health and Risk Management
                Publisher: Dove Medical Press
                ISSN (Print): 1176-6344
                ISSN (Electronic): 1178-2048
                Publication date Collection: 2017
                Publication date (Electronic): 16 February 2017
                Volume: 13
                Pages: 29-41
                Affiliations
                [1 ]University of Foggia, Foggia, Italy
                [2 ]Asklepios Klinik – St Georg, Hamburg, Germany
                [3 ]Ospedale San Paolo, Bari, Italy
                Author notes
                Correspondence: Natale Daniele Brunetti, Department of Cardiology, University of Foggia, Viale Pinto n.1, 71122 Foggia, Italy, Tel +39 3389 112 358, Fax +39 0881 745 424, Email natale.brunetti@ 123456unifg.it
                Article
                Publisher ID: vhrm-13-029
                DOI: 10.2147/VHRM.S95044
                PMC ID: 5317328
                PubMed ID: 28243111
                SO-VID: 635fdfc4-84a6-4063-a137-7a6dbf1a7974
                Copyright © © 2017 Tarantino et al. This work is published and licensed by Dove Medical Press Limited
                License:

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Subject: Review

                ScienceOpen disciplines: Cardiovascular Medicine
                Keywords: fibrates,simvastatin,fixed-dose combination,combined dyslipidemia,review
                Data availability:
                ScienceOpen disciplines: Cardiovascular Medicine
                Keywords: fibrates, simvastatin, fixed-dose combination, combined dyslipidemia, review

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