“Statins: Adverse Effects”
The present Op-ed identifies adverse effects of statins as presented in the Pubmed literature. Following a detailed description of statins, including an overview of statin side-effects/adverse-effects from myriad database sources, the unique Methodology used for the present statin adverse-effects analysis is presented, the Results are presented and discussed, and finally the study findings are Summarized and Conclusions are drawn.
INTRODUCTION AND BACKGROUND
What are statins, and what is their function in medicine? “Statins (also called HMG-CoA reductase inhibitors) block an enzyme called HMG-CoA reductase (3-hydroxy-3-methylglutaryl coenzyme A reductase) that is involved in the synthesis of mevalonate, a naturally occurring substance that is used by the body to make sterols, including cholesterol.
By inhibiting this enzyme, cholesterol and LDL-cholesterol production is decreased. Statins also increase the number of LDL receptors on liver cells, which enhances the uptake and breakdown of LDL-cholesterol. Most of the effects of statins (including the blocking of the HMG-CoA reductase enzyme), occur in the liver.”
Why is it important to lower serum cholesterol?
What are the side-effects/adverse-effects of statins? According to the following sources, statin side-effects include:
- NHS (National Health Service-UK)
Common side effects
“Side effects can vary between different statins, but common side effects include:
Headache; dizziness; feeling sick; feeling unusually tired or physically weak; digestive system problems, such as constipation, diarrhoea, indigestion or farting; muscle pain; sleep problems; low blood platelet count.”
Uncommon side effects
“Uncommon side effects of statins include:
Being sick; memory problems; hair loss; pins and needles; inflammation of the liver (hepatitis), which can cause flu-like symptoms; inflammation of the pancreas (pancreatitis), which can cause stomach pain; skin problems, such as acne or an itchy red rash; sexual problems, such as loss of libido (reduced sex drive) or erectile dysfunction.”
Rare side effects
“Rare side effects of statins include: Muscle weakness (myopathy); loss of sensation or tingling in the nerve endings of the hands and feet (peripheral neuropathy); tendon problems (tendons are tough cords of tissue that connect muscles to bones)”.
Muscle effects
“It’s rare, but statins can sometimes cause muscle inflammation (swelling) and damage.”
“Statin side effects may be mild to severe, including:
Headache; Nausea; Dizziness; Gas; Diarrhea; Constipation; Achy muscles or joints; Confusion; Memory loss; Damage to your kidneys; Damage to your liver; Muscles breaking down (rhabdomyolysis); Type 2 diabetes or high blood sugar.”
Commonly reported side effects of statins include:
Headaches; Nausea; Mild increase in sugar levels; Muscle and joint aches.
“For people who already have high sugar levels, the mild increase in blood sugar levels may lead to being diagnosed with type 2 diabetes.”
“Rarely, statins can cause more-serious side effects such as:
Muscle cell damage. Very rarely, high-dose statin use can cause muscle cells to break down and release a protein called myoglobin into the bloodstream. This can lead to severe muscle pain and kidney damage.
Liver damage. Occasionally, statin use causes an increase in liver enzymes. If the increase is mild, you can continue to take the medicine. Low to moderate doses of statins don’t appear to raise liver enzyme levels severely.
Some people have reported memory loss and thinking problems after using statins. But a number of studies haven’t been able to find any evidence to prove that statins actually cause these problems.”
“Statin toxicity or intolerance most commonly presents as SAMSs [statin-associated muscle symptoms]……Other side effects of statin therapy, which can be more serious, include new-onset type 2 diabetes mellitus, neurological and neurocognitive effects, hepatotoxicity, renal toxicity, and other conditions…..Observational studies suggest it occurs in 10% to 15% of patients,…..with clinic data putting it as high as 30%…..In randomized controlled trials, the incidence is thought to be 1.5% to 5% of patients, although this is believed to be an underestimation as most studies exclude patients with a history of statin intolerance either before randomization or during the run-in period…..several international organizations have identified statin intolerance to be of major clinical importance that warrants further research and investigation…..Although the only reliably confirmed adverse events caused by statins are said to be muscle-related, type 2 diabetes mellitus, and possibly hemorrhagic stroke,…..it is important to consider all of the clinical manifestations of statin toxicity and intolerance, which can significantly impact adherence to therapy and subsequent cardiovascular risk. Mechanistically, statin toxicity is thought to arise because of HMG-CoA reductase inhibition effects, direct cellular and subcellular effects, or a combination of both…..Other possible causes include genetic factors, drug-drug interactions, vitamin D status, and other metabolic or immune effects…..Regardless of the mechanistic pathway, the end result is a change in drug bioavailability and activity, which can lead to nonadherence and intolerance…..Adverse side effects have generally been shown to be class, dose, time, age, sex, and comorbidity dependent; however, considerable variability exists. Although the mechanisms are varied and likely because of multiple pathways, age is considered the leading predisposing risk factor because of the likely presence of multiple comorbidities (renal or liver dysfunction), concomitant drug use that may interfere, decreased body mass, cognitive impairment, and a decreased resistance to other stressors.”
Statin Side Effects
“Most people who take statin drugs tolerate them very well. But some people have side effects.”
The most common statin side effects include:
“Headache; A hard time sleeping; Flushing of the skin; Muscle aches (myalgia), tenderness, or weakness; Drowsiness; Dizziness; Nausea or vomiting; Belly cramping or pain; Bloating or gas; Diarrhea; Constipation; Rash; Low levels of blood platelets.”
Less common side effects you may have with statins are:
“Nausea; Hair loss; Pins and needles sensations, such as pricking, numbness, or tingling on your skin; Liver inflammation, which can make you feel like you have the flu; Pancreas inflammation, which can cause stomach pain; Skin problems such as rashes or acne; Sexual problems, such as erectile dysfunction or a low sex drive.”
“Statins also carry warnings that memory loss, mental confusion, neuropathy, high blood sugar, and type 2 diabetes are possible side effects. It’s important to remember that statins may also interact with other medications you take.”
“evidence from various studies indicates existence of many statin-induced side effects such as myopathies, rhabdomyolysis, hepatotoxicity, peripheral neuropathy, impaired myocardial contractility, diabetes, autoimmune diseases, and erectile dysfunction (ED).”
“Here we review the statin AE literature, first focusing on muscle AEs as the most reported problem both in the literature and by patients. Evidence regarding the statin muscle AE mechanism, dose effect, drug interactions, and genetic predisposition is examined. We hypothesize, and provide evidence, that the demonstrated mitochondrial mechanisms for muscle AEs have implications to other nonmuscle AEs in patients treated with statins. In meta-analyses of randomized controlled trials (RCTs), muscle AEs are more frequent with statins than with placebo. A number of manifestations of muscle AEs have been reported, with rhabdomyolysis the most feared. AEs are dose dependent, and risk is amplified by drug interactions that functionally increase statin potency, often through inhibition of the cytochrome P450 3A4 system. An array of additional risk factors for statin AEs are those that amplify (or reflect) mitochondrial or metabolic vulnerability, such as metabolic syndrome factors, thyroid disease, and genetic mutations linked to mitochondrial dysfunction. Converging evidence supports a mitochondrial foundation for muscle AEs associated with statins, and both theoretical and empirical considerations suggest that mitochondrial dysfunction may also underlie many nonmuscle statin AEs. Evidence from RCTs and studies of other designs indicates existence of additional statin-associated AEs, such as cognitive loss, neuropathy, pancreatic and hepatic dysfunction, and sexual dysfunction.”
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