Preventive cardiologyMeta-Analysis of Safety of the Coadministration of Statin With Fenofibrate in Patients With Combined Hyperlipidemia
Section snippets
Methods
The search was performed using PubMed. The initial search terms were “statin,” the individual name of all drugs in this class—“rosuvastatin,” “simvastatin,” “pravastatin,” “cerivastatin,” “fluvastatin,” “lovastatin,” and “atorvastatin”—and “fenofibrate.” The search was limited to randomized controlled clinical trials and English-language publications before March 2011. Result sections and tables of these studies were then examined to see whether data on safety during follow-up were reported. We
Results
Our literature search identified 138 potentially relevant studies and 103 of these studies were eliminated because of the abstracts. We retrieved the full text for the remaining 35 studies, 29 of which were subsequently excluded. Therefore, 6 relevant studies were included (Figure 1). Characteristics of the 6 studies are presented in Table 1.4, 5, 6, 7, 8, 9 There were 1,628 subjects with mixed hyperlipidemia in the identified studies. Statins used in the 6 trials included simvastatin,
Discussion
In these patients with combined hyperlipidemia at high risk for coronary heart disease, combination therapy with a statin and fenofibrate showed a safety profile comparable to treatment with a statin alone. Drug discontinuation of coadministration was not significantly greater than with statin monotherapy. Although coadministration may have shown a slight increase of aminotransferase level, adverse events related to study drug and serious adverse events were not significantly different between
References (20)
- et al.
Effects of adding fenofibrate (200 mg/day) to simvastatin (10 mg/day) in patients with combined hyperlipidemia and metabolic syndrome
Am J Cardiol
(2003) - et al.
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
Clin Ther
(2009) - et al.
Targeting vascular risk in patients with metabolic syndrome but without diabetes
Metabolism
(2005) - et al.
Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial)
Am J Cardiol
(2005) - et al.
Comparison of fluvastatin + fenofibrate combination therapy and fluvastatin monotherapy in the treatment of combined hyperlipidemia, type 2 diabetes mellitus, and coronary heart disease: a 12-month, randomized, double-blind, controlled trial
Clin Ther
(2004) - et al.
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) - et al.
The Residual Risk Reduction Initiative: a call to action to reduce residual vascular risk in patients with dyslipidemia
Am J Cardiol
(2008) - et al.
Reporting rate of rhabdomyolysis with fenofibrate + statin versus gemfibrozil + any statin
Am J Cardiol
(2005) - et al.
Statins' dosage in patients with renal failure and cyclosporine drug-drug interactions in transplant recipient patients
Int J Cardiol
(2005) National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)Third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III) final report
Circulation
(2002)
Cited by (45)
Treating Dyslipidemia in Type 2 Diabetes
2018, Cardiology ClinicsCitation Excerpt :Importantly, raising levels of small high-density lipoprotein (HDL) particles is independently associated with cardiovascular benefit, whereas triglyceride lowering is not.43 An elevated rate of myalgia with the combination of gemfibrozil and statin therapy has led to increasing use of fenofibrate as the preferred fibric acid derivative in clinical practice.44 Serial angiographic studies demonstrated that administration of micronized fenofibrate slowed progression of obstructive disease in a cohort of subjects with coronary artery disease and diabetes.45
Managing Dyslipidemia in Type 2 Diabetes
2018, Endocrinology and Metabolism Clinics of North AmericaCitation Excerpt :There was, however, no benefit in those without high TG or reduced HDL levels (n = 9872). These analyses translated to the inclusion of fibrates as add-on therapy for patients with elevated TG (>89 mg/dL) and reduced HDL (<35 mg/dL) with surveillance for rhabdomyolysis, which is observed slightly more with gemfibrozil than other fibrates.53 Niacin, a nicotinic acid derivative and B3 complex vitamin, inhibits lipolysis in adipose tissue thereby reducing supply of free fatty acid to the liver.
The application of atherogenic dyslipidaemia consensus recommendations in the primary care setting. DAT-AP study
2017, Clinica e Investigacion en ArteriosclerosisCitation Excerpt :Indeed, clinical practice guidelines and the European Medicines Agency (EMA) recommend fenofibrate for the treatment of mixed hyperlipidemia together with a statin, when triglycerides and HDL-C are inadequately controlled. The safety of this combination has been demonstrated in several studies,31–33 and there is evidence that fenofibrate confers additional clinical benefit on renal function34,35 and carbohydrate metabolism.36 Some limitations to the interpretation of our results must be taken into account.
Fibrates therapy: Rational use fenofibrate 2016. Executive summary
2016, Clinica e Investigacion en ArteriosclerosisPart II. Combination statin plus fibrate regimens (free and fixed)
2016, Clinica e Investigacion en ArteriosclerosisA novel mouse model of familial combined hyperlipidemia and atherosclerosis
2024, Acta Pharmacologica Sinica
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Drs. Guo and Meng contributed equally to this article.