Statins Side Effects And Safety Concerns

It is easy to be wondered by such an apparently exceptionable pharmacological profile. But let’s not forget that the target population for statins is comprised of patients that typically need lifelong therapy to maintain their lipid levels balanced. As such, it is important not to undermine the potential risk of adverse effects from continued statin use. 

In 2001, the first statin, cerivastatin was withdrawn from the market worldwide after the confirmed reports of serious myopathy (a condition in which muscle fiber do not work and patients suffer from muscle weakness) and rhabdomyolysis (a condition in which damaged muscles break down rapidly) have been published. The withdrawal sent a wave of panic among drug manufacturers and clinicians given the fact that statins by that time had already established itself as first-line medicine for reduction of CVD risk.

Evidence from various studies suggests that taking statins can result in many other adverse events. The following list summarizes the most significant ones:

• Liver toxicity: liver toxicity induced by statins appears to be rare, but nonetheless serious, since it can range from asymptomatic elevation of liver enzymes in the blood to hepatitis and even acute liver failure. The mechanisms behind this type of statin-induced toxicity are still elusive.
• Renal toxicity: evidence of renal toxicity is conflicting. Most clinical trials reported statins to protect kidney function and only a few reported the presence of blood or proteins in the urine (which normally indicated problems with the kidneys) of patients treated with statins.
• Diabetes mellitus: a recently published large scale study including 1,235,671 participants observed an 18 % increased risk of type 2 diabetes with statin therapy compared to non-treated subjects. Another study investigated the association between different statins and new-onset diabetes. The study concluded that patients on fluvastatin, lovastatin, and rosuvastatin were at lower risk of new-onset diabetes, whereas patients who took pravastatin were at greater risk.
• Neurologic effects: statins, unlike the vast majority of drugs, possesses chemical properties that allow it to diffuse into the brain with relative ease. Data published by the FDA admitted that statins may cause memory loss, forgetfulness, and confusion span. However, these symptoms are typically reversible within a few weeks after the discontinuation of the drug.

Need for balanced approach

Just like the beneficial effects of statins must be analyzed with a critical eye, the data supporting their potential side effects must be carefully considered and the circumstances under which said data were collected must be taken into account. As a very recent study, published in the European Journal of Preventive Cardiology, points out: “the benefit of statin therapy on death, stroke, and heart attack is quantified against placebo control [i.e. the effects of statins are compared to the effects of taking nothing whatsoever], but side effect information is not. Adverse events listed for statins come from many sources, most unable to differentiate between events caused by the drug and spontaneous events.”

The authors analyzed the results of clinical trials comparing statins and placebo and came to the astonishing conclusion that only a small minority of symptoms reported on statins are genuinely due to the statins. Almost all reported symptoms occurred just as frequently when patients were taking placebo. 

See Also: Statin: Drug for Heart Disease

So, similarly to what happens in other fields of medicine, evidence can be confusing or conflicting. Two things, however, are for certain. First, statins are effective lipid-lowering medications and they most definitely help in preventing the mortality and morbidity arising from cardiovascular complications. In most patients, statins are safe and well tolerated. However, patients and doctors need accurate and unbiased information, collected in clinical trials, regarding the actual relationship between the occurrence of the adverse events and the action of the statin they are taking, so that they can make the right therapeutic decisions. This is actually essential, as statins are now among the most frequently prescribed medications and their use is likely to increase significantly in the near future.