When are statins recommended?

People who have a high risk of cardiovascular disease are usually advised to take statins because then the advantages outweigh the disadvantages. This is particularly true of

• people who have (had) a heart or blood vessel disease – for example, coronary artery disease, blood circulation problems in the legs (PAD), or a stroke.
• people with other risk factors such as diabetes, high blood pressure, smoking or being very overweight.
• people who have very high cholesterol due to their genes (familial hypercholesterolemia).

If you've never had any of these diseases and only have a slightly increased risk of developing one, the protective effect of statins will be smaller. It is then particularly worth considering the pros and cons of the medication together with your doctor.

People who have a low risk often try to improve their cardiovascular health themselves at first – for example, by doing more exercise or stopping smoking. Others decide to take statins because the benefits – however small – are important to them. You can also change your mind later if, for example, new risk factors develop or your personal situation changes.

Your personal risk of cardiovascular disease can be determined together with your doctor using computer programs. These programs are based on data from long-term studies that monitored the health of thousands of people.

The following information is needed in order to calculate your risk:

• Age: The risk of cardiovascular disease increases with age.
• Biological sex: Men are at higher risk than women.
• Family history of heart disease: The risk is higher if a brother or your father had a heart attack or stroke before the age of 55, or if a sister or your mother had a heart attack or stroke before the age of 65.
• Smoking: The toxins in tobacco smoke can lead to inflammation and damage the blood vessel walls, among other things.
• Blood pressure: The higher your blood pressure, the higher the risk of cardiovascular disease.
• Type 2 diabetes: People who have type 2 diabetes are at greater risk of developing cardiovascular disease.
• Cholesterol levels: High non-HDL cholesterol levels are particularly unfavorable. This is a measure of the total cholesterol without HDL cholesterol. It includes all harmful lipoproteins – like LDL cholesterol, for instance.

Once calculated, your personal risk is expressed as a percentage. It reflects how likely you are to have a stroke or heart attack in the next ten years.

Statins lower the risk of cardiovascular disease by about 30%. This will mean different things for people with different initial risks. In a 50-year-old woman with no risk factors, the natural risk of a heart attack or stroke within ten years is less than 1%. In a 50-year-old man, it is 3%.

The influence of other heart attack risk factors can be shown in the following examples involving two women (Olga and Veronica) and two men (Peter and Yusuf).

They are all 50 years old and have the same cholesterol levels. Their total cholesterol is 260 milligrams per deciliter (mg/dl), which is the same as 6.2 millimoles per liter (mmol/l). 44 mg/dl (1.1 mmol/l) of their total cholesterol is HDL cholesterol. But there are differences between the four people's other risk factors, which affect their risk of a heart attack:

• Olga's blood pressure (145/90 mmHg) is slightly higher than the normal level but she doesn't have any other risk factors. Without treatment, her risk of a heart attack over the next ten years is 4%.
• Veronica also has slightly high blood pressure. But she smokes and her father had a heart attack at the early age of 50. Without treatment, her risk of a heart attack over the next ten years is 18%.
• Peter's cholesterol levels are slightly higher than normal but he has no other risk factors. Without treatment, his risk is 11%.
• Yusuf has very high blood pressure (162/96 mmHg). He also smokes. Without treatment, his risk of having a heart attack within the next ten years is 33%.

Statins can reduce the risk by 30% for each of these people. That means that the medication can reduce

• Olga's risk of a heart attack from 4% to 3%,
• Veronica's risk from 18% to 13%,
• Peter's risk from 11% to 8% and
• Yusuf's risk from 33% to 23%.

The ten-year risk of a heart attack with or without statins is shown again in the following illustrations. As we can see, statins wouldn't make a big difference for Olga because she doesn't have any other risk factors. Yusuf would clearly benefit more from the medication because of the higher risk for men and due to his other risk factors.

Statins are usually well tolerated. One possible side effect is muscle pain or muscle weakness. This is very uncommon, though. In large-scale comparative studies over a period of five years,

• 95 out of 1,000 people who took a placebo (dummy drug) said they had muscle pain, and
• 101 out of 1,000 people who took statins said they had muscle pain.

The studies also found that muscle pain is common in people who don't take statins. Some people who take statins mistakenly believe that the medication is causing this pain. So it's not a good idea to stop the treatment right away if you think it is causing a side effect. Instead, talk to your doctor first. Trying a different drug or reducing the dose might help.

Sometimes you hear that statins increase the risk of cataracts. But only one of several good-quality studies found this to be a side effect. Fewer than 1 out of 100 people were reported to have this side effect there. So experts think it's unlikely that statins lead to cataracts. There may be a small risk, though.

Statins can also lead to a slight increase in blood sugar levels, but this is very rare and doesn't usually affect the person's health.

Because the risk of serious side effects from statins is very low, experts agree that the advantages of taking them significantly outweigh any disadvantages.

In very rare cases, statins lead to muscle damage. This results in pain, weakness and swelling in the muscles – typically in the shoulders, legs or back. Muscle damage increases the amount of an enzyme called creatine kinase in the blood, so this sign of muscle damage can be detected in a blood test.

In the most severe form of muscle damage (known as rhabdomyolysis), cells of the skeletal muscles break down and enter the bloodstream in large quantities. This releases substances that can damage the kidneys. The possible signs of rhabdomyolysis include painful or rapidly tiring muscles as well as reddish or dark-colored urine. If you notice this, it's important to stop taking the statins and seek medical advice immediately.

In studies, muscle damage occurred in about 1 out of 10,000 people who took statins for more than 1 year. The severe form (rhabdomyolysis) was even rarer. It is more common if high doses are taken.

Some people are worried that the medication will build up in their body if they take it regularly over the long term. But these worries are unfounded: Our bodies continuously break down medications and get rid of them with the help of various mechanisms.

Statins might interact with certain other medications (like the antibiotic clarithromycin) so they shouldn't be taken together. Because of this, it's always important to tell your doctor what medications you are already taking. Anyone who takes statins should also avoid grapefruits because this fruit can prevent the drug from being broken down properly in the liver.

Statins have been very well studied in research involving a lot of people. But hardly any of the participants were already over 75 years old and had no previous heart or blood vessel diseases. The risk of side effects and drug interactions can increase in older age, though.

So it's not clear whether older people without previous cardiovascular disease also benefit from starting treatment with statins. In order to find that out, two large studies are currently being carried out in the U.S. and Australia.