Statin Safety: A Systematic Review

Law, Malcolm; Rudnicka, Alicja R.

doi:10.1016/j.amjcard.2005.12.010

Cited by 715 publications

(521 citation statements)

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“…31,217 It usually resolves rapidly when statin therapy is stopped. 141 The underlying mechanisms for statin-related myopathy are not well understood.…”

Section: Increases In Rates Of Myopathymentioning

confidence: 99%

“…222 The rates of reports of myopathy in regulatory databases are also higher with higher doses of atorvastatin, although such spontaneous reports may be biased and the absolute risks are still small even with the highest approved dose. 216 The rate of myopathy can be increased substantially when statins are used in combination with other drugs that affect their metabolism (in particular, inhibitors of cytochrome P450 or the P-glycoprotein, such as cyclosporine and azole antifungals) 141,174,217 and in certain types of patient (e.g. people of Asian origin and those who have functional variation in the SLCO1B1 gene).…”

Section: Increases In Rates Of Myopathymentioning

confidence: 99%

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Interpretation of the evidence for the efficacy and safety of statin therapy

et al. 2016

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General rightsThis document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms SummaryThis review is intended to help clinicians, patients and the public make informed decisions about statin therapy for the prevention of heart attacks and strokes. It explains how the evidence that is available from randomized controlled trials yields reliable information about both the efficacy and safety of statin therapy. In addition, it discusses how claims that statins commonly cause adverse effects reflect a failure to recognise the limitations of other sources of evidence about the effects of treatment.Large-scale randomized trial evidence shows that statin therapy reduces the risk of heart attacks, ischaemic strokes and coronary revascularization procedures ("major vascular events") by about one quarter for each mmol/L reduction in low density lipoprotein (LDL) cholesterol during each year (after the first) that it continues to be taken. The absolute benefits of statin therapy depend on an individual's absolute risk of occlusive vascular events and the absolute reduction in LDL cholesterol that is achieved. For example, lowering LDL cholesterol by 2 mmol/L (77 mg/dL) with an effective low-cost statin regimen (e.g. atorvastatin 40 mg daily, costing about £2 per

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“…31,217 It usually resolves rapidly when statin therapy is stopped. 141 The underlying mechanisms for statin-related myopathy are not well understood.…”

Section: Increases In Rates Of Myopathymentioning

confidence: 99%

Section: Increases In Rates Of Myopathymentioning

confidence: 99%

Interpretation of the evidence for the efficacy and safety of statin therapy

et al. 2016

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“…Statins are considered relatively safe; however, they can cause life-threatening rhabdomyolysis with acute kidney insufficiency (AKI). These effects may be aggravated by high doses and interactions with other drugs that result in high systemic exposure, measured by the area under the plasma drug concentration-time curve (AUC) [1,2]. Therefore, it is important to be proactive and intervene when necessary by changing the interacting drugs, doses, and/or monitoring the patient more closely.…”

Section: Introductionmentioning

confidence: 99%

“…Nonetheless, the AUC of most statins increases considerably despite not being metabolized by CYP450. Rhabdomyolysis incidence with the use of statins metabolized by CYP3A4 is approximately 5 times higher than with the use of the non-CYP3A4metabolized statins [1,2].Patients receiving statins should be closely monitored for symptoms of skeletal muscle toxicity and increases in serum creatinine kinase (CK) concentrations. In addition, statin package inserts occasionally give clear recommendations on how to respond to a statin-antimicrobial interaction; these recommendations are summarized in Table 1.…”

Section: Introductionmentioning

confidence: 99%

An updated review of interactions of statins with antibacterial and antifungal agents

Eljaaly¹,

Alshehri²

2017

J Transl Sci

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Numerous antimicrobial agents interact with statins. It is important to prevent these drug interactions and resulting statin toxicity and/or reduced efficacy. We review and highlight major drug-drug interactions between statins and antibacterial and antifungal agents; interactions with antiviral agents were not considered. Daptomycin interacts with statins via additive skeletal muscle toxicity. One possibility is to discontinue statins during daptomycin therapy, though no retrospective studies to date have shown a statistically significant elevation of adverse outcome risk. Multiple doses of rifampin induce cytochrome P450 (CYP), particularly 3A4 and 2C9, resulting in reduced systemic exposures to all statins, except rosuvastatin, for which the response was variable. Macrolide antibiotics are inhibitors of CYP3A4 and organic anion-transporting polypeptide-1B1. Azithromycin has the fewest drug interactions, while clarithromycin and erythromycin increase systemic exposure to all statins except rosuvastatin and fluvastatin. Azole antifungals are CYP450 inhibitors. Itraconazole and posaconazole are strong CYP3A4 inhibitors and mainly affect simvastatin, lovastatin, and atorvastatin, while fluconazole is an inhibitor of CYP2C9 and potentially CYP2C19 and mainly affects fluvastatin; however, risk cannot be ruled out with rosuvastatin.

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“…In the first decade of statin use, myopathy emerged as the only substantial safety concern with statins, and the incidence of severe myopathy in randomized trials is about 0.01% [1].…”

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confidence: 99%