Adverse Effects of Statins - Myths and Reality

Abstract

Statins reduce cardiovascular mortality and morbidity as well as cardiovascular events in patients with a very high risk of cardiovascular disease (CVD) and also in subjects with high or moderate risk by reducing the levels of low-density lipoprotein cholesterol (LDL-C). Although they are considered to be drugs with a very good safety profile, because of their wide use there are many concerns that their adverse effects might compromise their proven beneficial effects. Therefore this article reviews all the data and provides an evidence- based insight what are the proven adverse effects of statins and what are the "myths" about them. The most important side effects include myopathy and rhabdomyolysis. Another side effect is increased activity of liver tests which occurs occasionally and is reversible. However, recent studies even suggest that statin therapy can improve hepatic steatosis. It is beyond any doubt that statins do slightly increase the incidence of type 2 diabetes mellitus in people with two or more components of metabolic syndrome but the cardiovascular benefits of such a treatment by far exceed this risk. Statin therapy has also been associated with some adverse renal effects, eg. acute renal failure, but recent data suggest even a possible protective effect of these drugs on renal dysfunction. Concerns that statins might increase cancer have not been proven. On the contrary, several studies have indicated a possible benefit of these drugs in patients with different types of cancer. Early concerns about cognitive dysfunction and memory loss associated with statins use could not be proven and most recent data even suggest a possible beneficial effect of statins in the prevention of dementia. Systematic reviews and clinical guidelines suggest that the cardiovascular benefits of statins by far out-weight non-cardiovascular harms in patients with cardiovascular risk.

Association of Hydroxylmethyl Glutaryl Coenzyme A Reductase Inhibitors, L-Type Calcium Channel Antagonists, and Biguanides With Rates of Psychiatric Hospitalization and Self-Harm in Individuals With Serious Mental Illness

“… 28 All 3 classes have relatively good adverse event profiles. 31 , 32 , 33 Ideally, further RCTs of these drugs will be conducted that are appropriately powered, with meaningful clinical end points.…”

Lipid lowering drug therapy in patients with coronary heart disease from 24 European countries – Findings from the EUROASPIRE IV survey

“…It is also worrying that 6e36 months after a CHD event the number of patients without any statin therapy did not decrease and that the number of patients on high-intensity statin treatment did not increase. The reasons why the physicians often prescribe lowintensity statin treatment instead of high-intensity therapy when needed are different and complex but quite often it is the fear of adverse effects of statins [12,13] Even more feared are the patients who are frequently confused with the information from the media suggesting that statins have many serious adverse effects so they stop taking the statins after some time or do not adhere to the prescribed dose [12,14,15]. Although high levels of adherence are undoubtedly associated with reductions in adverse clinical CHD outcomes, including all-cause mortality and fatal and nonfatal cardiovascular events (the most consistent benefits being at adherence levels 80% or greater) while poor statin adherence is associated with increased risk of adverse CHD outcomes, taken in general non-adherence to statin therapy is a big problem [16,17].…”

One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: prospective follow-up of SAILS randomised trial

“…Importantly, in addition to their hypothesised beneficial pleiotropic effects, statins have known toxicity to liver and skeletal muscle, even when administered for a short time 6. In the SAILS trial, patients randomised to rosuvastatin had significantly fewer hepatic and renal failure-free days, and higher serum levels of aspartate aminotransferase, with some having concurrent elevations of creatine kinase and alanine aminotransferase indicating potential muscle and/or liver toxicity 1.…”