Statins are all bad… Myth?

Statin drugs such as Crestor, Lipitor, Zocor and Pravachol have now been used for around 30 years to lower cholesterol levels in people with heart disease. Statins block the main enzyme in cholesterol production but also have significant effects on the metabolism of Coenzyme Q10, Vitamin K2 and selenium within cells.

There have been numerous trials over this time showing a number of benefits for statin drugs in people with pre-existing heart disease. This is known in the medical profession as secondary prevention. I have been saying for a number of years that statins should be part of the management for all people in these groups as long as they are not causing side-effects.

The controversial question, in my opinion, is whether they are indicated in people without a prior history of heart disease, purely because the cholesterol is elevated. This is known as primary prevention. Over the past few decades, we have seen the goal posts shift with more and more people in the community being prescribed statins purely because of the elevated cholesterol levels.

The reality is, when you examine the evidence-based trials, the benefits from long-term statin therapy in the primary prevention group is quite limited, if at all. There is an excellent website, which has various sub categories analysing all the major clinical trials for a variety of different conditions. The specific link which looks at statin therapy given for five years for people without heart disease, really shows marginal benefit at best.

The basic summary from this website demonstrates clearly that being given a statin drug purely for elevated cholesterol over five years, there are no lives saved.

You need to treat 104 people for five years to prevent one heart attack. Statin therapy will only prevent one stroke in 154 people treated for five years. On the other hand they suggest that of 100 people treated for five years, one will develop diabetes as a consequence of statin therapy and one in 10 people will have some degree of muscle damage as a consequence of the statins.

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Three new recent reports, however, may be misinterpreted by the medical profession and many members of the public to suggest statin therapy should be prescribed for more people and that statins have minimal side-effects.

The first report looked at people who are deemed to be at either intermediate or relatively low risk for heart disease. High-risk people have either had established heart disease i.e. secondary prevention or have a high coronary calcium school, which is a CT scan that measures the amount of calcium in the walls of the arteries without dye or injections. This is an indirect measure of fat in the walls, i.e. atherosclerosis.

Intermediate risk people are considered to have somewhere between 10 to 20% ten year risk for heart disease which includes a presence of major risk factors and thankfully something more sophisticated risk analysis equations now include coronary calcium scoring. The five primary risk factors for heart disease include hypertension, cholesterol abnormalities, cigarette smoking, Diabetes and metabolic syndrome, along with a family history of a first-degree relative experiencing some form of cardiovascular disease before age 60. Coronary artery calcium scoring markedly increases the accuracy of this assessment.

Low risk patients are said to have a 7.5–10% ten year risk for heart disease.

This analysis suggested people with an intermediate risk would benefit from low to moderate dose statins and those at low risk may have a small benefit & should probably be offered low to moderate dose statins. The reality is when you examine the absolute benefits in these groups, however, the gains are, in fact, very small.

The second study from Stanford University in the US examines the medical records of just over a half a million people with existing heart disease between the ages of 21 to 84, as part of the VA health care system. These people were only followed for 12 months and they found, unsurprisingly, that people with existing heart disease i.e. secondary prevention, did benefit from being on high-dose statins. High dose statins include 20 to 40 mg of Rosuvastatin (Crestor) daily or 40–80 mg of Atorvastatin (Lipitor) daily. The one year death rates were 4% in those receiving high-intensity statins, 4.8% % in those receiving moderate intensity statins, 5.7% in those receiving low intensity statins and 6.6% in those not receiving statins. But, the major issue here is the very short follow up of one year.

The final study examined just under 3000 patients with ankylosing spondylitis and psoriatic arthritis prescribed statins and compared this to the same number of patients with the same conditions who were not given statins. Over a five year follow-up, there were 271 deaths in the statin group compared with 376 deaths in the group not taking statins. This equated to a 33% reduction in all cause death with statins in this particular high risk group with serious inflammatory disease.

From all the data, I am certainly not suggesting that statins should never be prescribed but unfortunately many members of the medical medical profession takes the data from people at very high risk and then extrapolates this to people at low risk. When you examine the data comparing high-dose statins with moderate intensity statins, the one year data, for example, in the second study shows only a 0.8% benefit over 12 months. The very specific study in people with high level inflammatory conditions such as ankylosing spondylitis and psoriatic arthritis is very important information but purely for people where their inflammatory levels are very high.

The reality is that the vast majority of people in low risk groups can expect substantial longevity and thus talking in 1–5 year blocks is really not relevant. There will almost certainly never be any studies of statin therapy taken on a continual basis which would go for longer than 10 years in low-risk patients.

This is the real world where most of us live and unfortunately, as a cardiologist, I see far too often people at very low risk being prescribed statin drugs, purely for an elevated cholesterol. There is absolutely no scientific data in this group that statins will make much of a difference but with the very significant side-effect profile of these drugs, there is certainly the potential for long term harm. The main message here is to have an accurate assessment of risk, which should include coronary claim scoring for all males aged 50+ and females aged 60+. So, are statins all bad? The answer is no but they are definitely not all good either.