Statins, also known as lipid-lowering drugs, are a popular class of drugs prescribed in the UK. When looking at the most popular drugs in the UK, atorvastatin was the most prescribed drug. Simvastatin also made to the top of most commonly prescribed drugs. Historically, statins have been subject to scrutiny from the press, mostly picking on a negative aspect of stain treatment. In today’s post, I will discuss statins pros and cons (advantages and disadvantages). I will also review other areas of statin treatment, like sid effects, effectiveness and more, to support the most comprehensive list of statins pros and cons.
Table of Contents
What are statins?
Statins are a group of drugs which reduce the level of ‘bad’ cholesterol. Low-density lipoprotein (LDL) cholesterol – ‘bad’ cholesterol contributes over time to narrowing and hardening of the blood vessels (the arteries). Narrowing of arteries can cause serious conditions, including:
- Blockage of the arteries (atherosclerosis)
- Heart attack (supply of the blood the heart is stopped)
- Stroke (supply of the blood to the brain is restricted)
- Angina (chest pains caused by an inadequate supply of blood to the heart)
- Coronary heart disease (restriction of the blood supply to the heart)
Cardiovascular disease (heart attack, angina, heart failure) is one of the leading causes of death in the UK.
The legal classification of statins
In the UK, most statins are classified as prescription-only medicines (POM). POMs need to be prescribed by a doctor or another qualified prescriber.
Can you get simvastatin over the counter?
In 2004, simvastatin 10mg was reclassified from prescription-only medicine to pharmacy-only medicine; however, the first ‘over the counter’ statin called Zocor Heart-Pro was discontinued a few years later. Currently, pharmacy-only simvastatin is not available for sale in the UK, simply because none of the pharmaceutical manufactures produce this drug.
Availability of high dose statins over the counter
In 2019, the availability of high dose statins came into a spotlight again, after the announcement by NHS that statins may be available from pharmacies without a prescription (NHS, 2019). The decision on the availability of high dose statins over the counter has not been made.
Most popular statins in the UK
In the UK five statins are available on prescription:
The above statins may come in generic form or as branded medicines.
Statins are divided into three categories (NICE, 2016), based on their effectiveness to reduce low‑density lipoprotein cholesterol (LDL cholesterol):
- low intensity: expected reduction of LDL is 20% to 30%
- medium intensity: expected reduction of LDL is 31% to 40%
- high intensity: expected reduction of LDL is above 40%.
The table below reflects the popularity of each statin supported with prescribing information for the last 12 months (Openprescribing.net, 2021).
|Rank||Name||Items prescribed (mln)|
Data source: OpenPrescribing.net Period: (Dec ’19—Nov ’20)
Who needs to take statins?
Patients who are considered for statin therapy, need to have a blood sample taken to determine total cholesterol levels, high‑density lipoprotein (HDL) cholesterol, non‑HDL cholesterol, and triglycerides (a type of fat).
Statins can be prescribed for patients as primary or secondary prevention of cardiovascular disease (CVD). Primary prevention describes treatment to prevent a health condition from happening. For example, in terms of CVD, this usually means prevention of heart attack or stroke. Secondary prevention described treatment aiming to prevent further disease progression, for example, reducing future episodes of heart attacks in individuals who have had a heart attack.
Statins are usually recommended as primary prevention in individuals who (NICE, 2020):
- Have estimates risk of developing cardiovascular disease 10% or more in the next 10 years. Risk is based on an assessment called QRISK.
- Type 1 diabetic patients, aged over 40 who have had diabetes for more than 10 years or have other risk factors for developing cardiovascular disease or have diabetic neuropathy.
- Have chronic kidney disease or high cholesterol runs in the family
Secondary prevention with statis is considered in patients who (ibid):
- Patient with cardiovascular disease, for example, patients who have had a heart attack, angina, mini-stroke or peripheral arterial disease.
What are side effects associated with statin therapy?
Side effect profile differs between each statin. Atorvastatin (the most common statin in the UK) can commonly cause the following side effects (BNF, 2021):
- Epistaxis (nose bleeds)
- Hyperglycaemia (increased sugar level)
- Hypersensitivity (allergic reactions)
- Joint disorders
- Laryngeal pain (pain in the larynx)
- Muscle complaints
Additionally, the following common side effects are listed in the licensing information for atorvastatin (eMC, 2019):
- Constipation, diarrhoea, flatulence, dyspepsia, nausea
- Abnormal liver function tests
- Increased blood creatine kinase
Statins – pros and cons
Now let’s talk about statins pros and cons.
Statins – pros
Statins work – reduction of cardiovascular disease and strokes
Statins are the most effective lipid-lowering drugs. Statins lower LDL cholesterol effectively and thus reduce the risk of developing or progressing cardiovascular disease as part of primary and secondary prevention. Lowering of LDL cholesterol reduces the risk of coronary death, ischaemic stroke, myocardial infarction (heart attack) and revascularisation (CCT, 2012).
Statins produce an anti-inflammatory effect
Cardiovascular diseases, for example, atherosclerosis (build-up of fats and cholesterol in arteries) are characterised by chronic inflammation. Many studies confirmed that statins produce anti-inflammatory effect contributing to more beneficial treatment (Jain & Ridker, 2005).
Statins produce an anti-thrombotic effect
Statins may help to prevent a blood clot formation by different means. Statins were also found to help with the destruction of blood clots (Pinal-Fernandez et al., 2018).
Statins produce a pleiotropic effect
the pleiotropic effect is an umbrella term which describes benefits of statins which go beyond a lipid-lowering effect, for example improving endothelial function (endothelium forms inside lining of the arteries), decreasing oxidative stress and inflammation.
High cholesterol weakens the endothelium, which promotes the process of atherosclerosis, which is characterised by a build-up of fatty materials in arteries, which restrict the blood flow and may result in the clot formation.
The effect of statin on endothelium is a complex topic. By lowering the cholesterol statins improve the function of the endothelium. It is proposed that statins produce an antioxidant effect and increase nitric oxide production, bringing additional benefits in the process (Liao & Laufs, 2005).
Statins – cons
The second part of stains pros and cons may seem to be more lengthy and more detailed. I reviewed certain risk factors with statin therapy more thoroughly to diminish any misunderstandings associated with statin therapy.
Muscle toxicity (including myopathy and rhabdomyolysis)
All statins can cause muscle toxicity. However, the increased risk is observed in individuals taking a higher dose of stains or in certain patients, for example (BNF, 2021):
- a family history of muscle illness
- previous episodes of muscle toxicity
- high alcohol consumption
- reduced performance of kidneys (renal impairment) and
Patients at higher risk of muscle toxicity should typically have a blood test to determine creatine kinase levels (CK). CK indicates muscle injuries and muscular disease. Statin therapy should not be initiated if CK is too high (five times more of the upper limit). Some individuals, for example, ‘muscly’ people, may have high CK, due to increased muscle in the body.
Rhabdomyolysis, destruction of muscle cells, is the most severe side effect of statins, which may cause kidney failure and even death. Rhabdomyolysis is not a common side effect. A large study (252,460 patients) investigated number rhabdomyolysis cases in patients taking lipid-lowering drugs (atorvastatin, pravastatin, or simvastatin). An average incidence of rhabdomyolysis was 0.44 per 10,000 person-years, which means 0.44 of person out of 10,000 people experienced rhabdomyolysis during observation for a year (Graham et al., 2004).
A more recent review of clinical trials estimated that only about 2-3 individuals per 100,000 patients who take statins might develop rhabdomyolysis and acuter renal (kidney) failure (ibid).
The frequency of statin-related myopathy (muscle pain, muscle weakness, cramps and tendon pain) was found to be slightly higher. Another large study which took place in the UK set the incidence of myopathy at 1.2 per 10,000 person-years (Gaist et al., 2001). Taking certain drugs alongside statins increases the risk of myopathy (see the next paragraph).
Statins – interaction with other drugs
Like other drugs, statins can interact with other medicines, when taken at the same time. Taking certain medications with statins at the same time, for example, fibrates increase the risk of rhabdomyolysis (see above).
A common interaction seen in community pharmacy involves statins and some antibiotics, such as erythromycin or clarithromycin. It is usually recommended for simvastatin to avoid the combination of both drugs (BNF, 2021 & Gov.uk, 2014). For atorvastatin, patients are typically asked to suspend taking medicine for the duration of antibiotic treatment.
The list of drugs that interact with statins is much longer. Speak to your GP or pharmacist if you are unsure about the treatment with statins.
Can statin cause diabetes?
Many studies investigated and reported an increased risk of diabetes development in patients on statins. The exact mechanism is not known; multiple factors are proposed. However, the increased risk of diabetes is narrowed to individuals who are already at risk for developing diabetes (Robinson, 2015). Overall the increased risk of statin-related diabetes is most likely unimportant because reducing cardiovascular risk outweighs any potential negative impact of the treatment with statins (ibid).
Can statins cause liver disease?
Liver function tests are usually performed before the initiation with statins and occasionally after the treatment is commenced. Several reasons can impact the level of transaminases, for example, a ‘fatty liver’ or alcoholic liver disease. Use of statins is cautioned in patients who drink alcohol a lot or have a history of liver disease.
Statins can temporarily increase certain chemicals called transaminases without any symptoms present. The frequency of liver damage caused by statins is estimated at 1% (Gillett et al., 2011). However, a liver complication caused by statins varies between studies with some reporting liver complications of very rare frequency. In the US, the Federal Drug Administration (FDA) reported serious, statin-caused liver disease as extremely rare (ibid).
Can statins cause stroke?
Statins may increase the risk of intracerebral haemorrhage (a type of stroke) in patients who previously had a stroke. A large study which investigated the over 500,000 patients over ten years concluded that during the first six months of therapy patients on statins had a similar risk of intracerebral haemorrhage as patients without treatment. However, after the six months of the treatment patients on statins had a lower risk of stroke. Overall this study suggested that statins reduce the risk of intracerebral haemorrhage in patients who had not had this type of stroke before (Ribe et al., 2019).
On the contrary, some reports suggest that statins may increase the risk of haemorrhagic stroke. However, this risk is outweighed by a clear reduction of ischaemic stroke (another type of stroke) together with the decrease of other cardiovascular events and death caused by a blood clot (CTT, 2012).
To a certain degree, statins have a ‘bad’ reputation. Over the years, mainstream media picked on various aspects of statin therapy with tabloids very often being the best in dramatisation or rather the worst in delivery of clear, unbiased information.
Some statins, for example, simvastatin must be taken at night. This is because simvastatin stops cholesterol synthesis, which happens at night. Atorvastatin, the most common statin in the UK can be taken during the day, making this disadvantage less important.
Statins: pros and cons – conclusion
Statins are an effective class of drugs, which reduce cholesterol and any possible cardiovascular events and stroke. Review of around 57000 patients from various clinical trials, which took place between 1994 and 2008 – concluded that statins reduce ‘all-cause’ mortality (death), significant cardiovascular evens (for example a heart attack) and revascularisations with no ‘excess’ of side effects (Taylor et al., 2013).
Although treatment with statins can be associated with muscle problems when treated in the community. Muscle side effects have rarely been reported in clinical trials (Ganga at el., 2014).
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