Review of Side-Effect Profile of Combination Ezetimibe and Statin Therapy in Randomized Clinical Trials

Kashani, Amir; Sallam, Tamer; Bheemreddy, Swarna; Mann, Douglas L.; Wang, Yun; Foody, JoAnne M.

doi:10.1016/j.amjcard.2008.01.041

Cited by 85 publications

(41 citation statements)

References 28 publications

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“…Of the others, based upon a meta-analysis of 18 prospective randomized controlled trials (comprising 71,108 individuals), the highest rate of adverse effects, including greater than 10-fold CK elevations and rhabdomyolysis, was found to be associated with atorvastatin and the lowest risk with fluvastatin, whereas the risks for simvastatin, lovastatin, and pravastatin were intermediate and comparable [15]. Differences in pharmacodynamics and pharmacokinetics may account for these differences and it is noteworthy in this regard that atorvastatin has a much longer plasma elimination half-life (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) …”

Section: Type Of Statinmentioning

confidence: 88%

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Update on Toxic Myopathies

Mastaglia

Needham

2011

Curr Neurol Neurosci Rep

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The toxic myopathies are a clinically and pathologically diverse group of disorders that can be caused by a variety of therapeutic agents used in clinical practice, as well as various venoms and other biological toxins. The most important iatrogenic causes are the statin and fibrate cholesterol-lowering agents that can cause a severe necrotizing myopathy and acute rhabdomyolysis and myoglobinuria. The current update focuses on the mechanisms of statin myotoxicity and the importance of genetic predisposing factors for statin myopathy, as well as the recently described form of necrotizing autoimmune myopathy, which is associated with antibodies to the 3-hydroxy-3-methylglutaryl-coenzyme A reductase enzyme and is responsive to aggressive immunotherapy. Mitochondrial myopathies associated with antiretroviral agents and the pyrimidine nucleoside analogue clevudine, and recent reports of myopathies caused by ingestion of red yeast rice and toxic species of mushrooms are also discussed.

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Section: Type Of Statinmentioning

confidence: 88%

“…However, a recent meta-analysis of 18 randomized controlled trials showed no significant increase in the frequency of raised CK, myalgia, or rhabdomyolysis in patients on combined ezetimibe and statin therapy compared with those taking either drug alone [27].…”

Section: Drug Interactionsmentioning

confidence: 99%

Update on Toxic Myopathies

Mastaglia

Needham

2011

Curr Neurol Neurosci Rep

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“…Adverse events were not observed with combination ezetimibe + statins compared with statin monotherapy in a meta-analysis of 18 randomized clinical trials ( n = 14,497) [72], and in a pooled analysis of 16 studies ( n = 14,471) in patients aged 65-74 and 75 years or older [73].…”

Section: Risks and Precaution Prescribing Informationmentioning

confidence: 97%

Cholesterol Absorption Inhibitor Ezetimibe: Risk–Benefits and Role in Treating Dyslipidemias

2015

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“…A meta-analysis of 18 randomized clinical trials (n ¼ 14,497) showed that the overall safety profile of ezetime plus statin was comparable to that of statin alone [Kashani et al 2008]. There is no evidence that ezetimibe added to any dose of statin increases the risk of adverse effects, including myopathy or hepatic enzyme elevations.…”

Section: Clinical Safetymentioning

confidence: 99%

The ezetimibe controversy: implications for clinical practice

Khanderia

Regal

Rubenfire

et al. 2011

Therapeutic Advances in Cardiovascular Disease

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Low-density lipoprotein cholesterol (LDL-C) remains the primary target of lipidlowering therapy. Achieving LDL-C goals as outlined by the National Cholesterol Education Program Adult Treatment Panel III can be difficult with statins alone; therefore, adjunctive therapy is often indicated to reduce cardiovascular risk. Ezetimibe, a potent inhibitor of intestinal cholesterol absorption, has been shown to be safe, tolerable and effective at lowering LDL-C, non-high-density lipoprotein cholesterol and apolipoprotein B, each of which has been correlated with improved clinical outcomes, alone or in combination with a statin. However, because of randomized trials that demonstrated mixed results about atherosclerotic plaque regression via carotid intima-media thickness and a concern about cancer risk, ezetimibe 0 s role in lipid therapy has been questioned. Currently, a large randomized controlled trial is in progress to answer if ezetimibe improves clinical outcomes in patients with high-risk acute coronary syndrome. A smaller trial in patients with chronic kidney disease demonstrated reduced clinical events, including myocardial infarction, stroke and revascularization for patients taking the combination of ezetimibe and simvastatin versus those taking statin or placebo alone. In this paper, we review the trials that have led to the ezetimibe controversy and then discuss the possible role of ezetimibe in specific patient populations until the results of ongoing clinical trials are known.

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Review of Side-Effect Profile of Combination Ezetimibe and Statin Therapy in Randomized Clinical Trials

Cited by 85 publications

References 28 publications

Update on Toxic Myopathies

Update on Toxic Myopathies

Cholesterol Absorption Inhibitor Ezetimibe: Risk–Benefits and Role in Treating Dyslipidemias

The ezetimibe controversy: implications for clinical practice

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