Meta-Analysis of Safety of the Coadministration of Statin With Fenofibrate in Patients With Combined Hyperlipidemia

Guo, Jinrui; Meng, F.; Ma, Ning; Li, Chunhua; Ding, Zhenjiang; Wang, Hong; Hou, Ruitian; Qin, Yingjie

doi:10.1016/j.amjcard.2012.06.050

Cited by 45 publications

(30 citation statements)

References 18 publications

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“…Myopathy or rhabdomyolysis did not appear in any of the 1,628 subjects included in this meta-analysis. However, a significantly greater incidence of alanine aminotransferase and/or aspartate aminotransferase ≥3 times the upper limit of normal was observed in the combination treatment compared with statin monotherapy (3.1% versus 0.2%, p = 0.0009) [206]. It should be mentioned that the fenofibrate or fenofibric acid plus statin combination is safer compared with gemfibrozil plus statin combination [207,208].…”

Section: Safetymentioning

confidence: 99%

“…A meta-analysis that estimated the safety of statin with fenofibrate combination included 1,628 subjects who participated in a total of 6 studies [206]. The results showed that the rates of serious adverse events (2.0% versus 1.5%, p = 0.71) and adverse events related to study drug (10.9% versus 11.0%, p = 0.95), as well as the rate of discontinuation due to any adverse events (4.5% versus 3.1%, p = 0.20) or any adverse events (42% versus 41%, p = 0.82) were not significantly different between statin and statin/fenofibrate combination.…”

Section: Safetymentioning

confidence: 99%

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Does Combination Therapy with Statins and Fibrates Prevent Cardiovascular Disease in Diabetic Patients with Atherogenic Mixed Dyslipidemia?

et al. 2013

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■ AbstractType 2 diabetes mellitus (T2DM) is associated with the development and progression of cardiovascular disease (CVD). Statins have an established efficacy in the management of dyslipidemia primarily by decreasing the levels of lowdensity lipoprotein cholesterol and thus decreasing CVD risk. They also have a favorable safety profile. Despite the statin-mediated benefit of CVD risk reduction a residual CVD risk remains, especially in T2DM patients with high triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) values. Fibrates decrease TG levels, increase HDL-C concentrations, and improve many other atherosclerosis-related variables. Fibrate/statin co-administration improves the overall lipoprotein profile in patients with mixed dyslipidemia and may reduce the residual CVD risk during statin therapy. However, limited data exists regarding the effects of statin/fibrate combination on CVD outcomes in patients with T2DM. In the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study the statin/fibrate combination did not significantly reduce the rate of CVD events compared with simvastatin/placebo in patients with T2DM. However, it did show a possible benefit in a pre-specified analysis in the subgroup of patients with high TG and low HDL-C levels. Furthermore, in the ACCORD study the simvastatin/fenofibrate combination significantly reduced the rate of progression of retinopathy compared with statin/placebo administration in patients with T2DM. The present review presents the available data regarding the effects of statin/fibrate combination in patients with T2DM and atherogenic mixed dyslipidemia.

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Section: Safetymentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

Does Combination Therapy with Statins and Fibrates Prevent Cardiovascular Disease in Diabetic Patients with Atherogenic Mixed Dyslipidemia?

et al. 2013

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“…There is no identifiable risk of rhabdomyolysis with the addition of fenofibrate to statins (as opposed to gemfibrozil) (68). Co-administration of ezetimibe 10 mg and fenofibrate 160 mg produced significantly greater reductions in LDL-C compared with fenofibrate alone (22% vs. 9%, respectively; p < 0.001) (68).…”

Section: -Addition Of Non-statinmentioning

confidence: 97%

Expert opinion: the therapeutic challenges faced by statin intolerance

Patel

Martin²,

Banach

2016

Expert Opinion on Pharmacotherapy

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When initiating statin therapy, attention to risk factors for statin intolerance is strongly recommended. Most patients will tolerate some degree of statin therapy; thus statin re-challenge is advisable. If alternative dosing regimens are not tolerated, non-statin medications are acceptable alternatives. To limit errors in the diagnosis of statin intolerance, improvements in clinician-patient communication about the side effects and benefits of statins should be attempted.

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“…56 It is important to emphasise that PCSK9 inhibitors are approved only as adjuncts to statins unless the patient is completely intolerant. 48,53,54 Conclusion Cardiovascular benefits are strongly linked to reductions in LDL-C levels, as long as proven and safe LDL-C-lowering agents are used. While most SaMAEs are mild and reversible, a subgroup of patients treated with statins may develop autoimmune inflammatory myositis or necrotising myopathy which does not resolve with statin discontinuation and requires immunosuppressive therapy.…”

Section: Management Of Dyslipidaemiamentioning

confidence: 99%

“…52 On the other hand, the coadministration of statin with fenofibrate among patients with combined hyperlipidaemia is safe, although attention to factors predisposing to statin toxicity is always warranted when statins are used as either a monotherapy or in combination with other drugs. 10,53 Monoclonal antibodies against PCSK9 have shown good efficacy and tolerability in patients with statin intolerance. At 12 weeks, evolocumab was found to reduce LDL-C levels by 53-56% compared to 15-18% with ezetimibe.…”

Section: Management Of Dyslipidaemiamentioning

confidence: 99%

Statin-Associated Muscle Adverse Events: Update for clinicians

Al-Mohaissen¹,

Ignaszewski²,

Fröhlich³

et al. 2016

SQUMJ

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Statins are potent medications which reduce low-density lipoprotein cholesterol (LDL-C) levels. Their efficacy in cardiovascular risk reduction is well established and indications for their use are expanding. While statins are generally well tolerated and safe, adverse events are relatively common, particularly statinassociated muscle adverse events (SaMAEs), which are the most frequently encountered type of adverse event. Recent guidelines and guideline updates on SaMAEs and statin intolerance have included revised definitions of SaMAEs, incorporating new evidence on their pathogenesis and management. As SaMAEs emerge as a therapeutic challenge, it is important for physicians to be aware of updates on management strategies to ensure better patient outcomes. The majority of patients who are considered statin-intolerant can nevertheless tolerate some forms of statin therapy and successfully achieve optimal LDL-C levels. This review article discusses the recent classification of SaMAEs with emphasis on pathogenesis and management strategies.

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Meta-Analysis of Safety of the Coadministration of Statin With Fenofibrate in Patients With Combined Hyperlipidemia

Cited by 45 publications

References 18 publications

Does Combination Therapy with Statins and Fibrates Prevent Cardiovascular Disease in Diabetic Patients with Atherogenic Mixed Dyslipidemia?

Does Combination Therapy with Statins and Fibrates Prevent Cardiovascular Disease in Diabetic Patients with Atherogenic Mixed Dyslipidemia?

Expert opinion: the therapeutic challenges faced by statin intolerance

Statin-Associated Muscle Adverse Events: Update for clinicians

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