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Statins - are they worth it?

Ami Banerjee
Last edited 7th July 2009

Last week, the press reported that relatives of people with familial hypercholesteraemia are not being adequately screened in the UK, despite their increased risk of heart attacks, which could be prevented by early treatment with statins. However, the more important story was about statins themselves.

Statins are the blockbuster drugs of the past two decades. After their cholesterol-lowering effect proved to be effective in preventing further heart attacks and death in coronary heart disease (CHD) patients (secondary prevention), several studies have broadened the definition of who should get statins. However, the role for statins in people with risk factors (e.g. diabetes) but no CHD (primary prevention) is far from clear, even though some people are talking about putting statins in the water. A recent study combined data from randomised controlled trials of statins to look at over 70 000 patients without CHD, but with risk factors. They report that statin use led to a 12% reduction in death, a 30% reduction in heart attacks, a 20% reduction in stroke, and no increased risk of cancer. The effects were regardless of age, sex or diabetes. Can we now say that all patients with risk factors for CHD should get statins?

The answer is unfortunately no because we are not told properly about risks, safety and cost-effectiveness. Although the death rate dropped by 12% (relative risk reduction or RRR), it actually only fell from 5.7% to 5.1% with statin therapy (a 0.6% absolute risk reduction or ARR). Bottom line- you need to treat 170 people with statins for 4 years to prevent 1 death. For heart attacks, there is a 1.2% ARR, and this means that we would have to treat 80 people with statins for 4 years to prevent 1 heart attack. For strokes, there was a 0.4% ARR, and 240 people have to be treated to prevent 1 stroke. These numbers look less impressive than the relative risk reductions and tell us more about how costly it would be to treat everybody with risk factors (but no CHD) in the population.

The study showed no increased risk of cancer with statins. The problem is that this study did not include all the trials of statins which measured cancer outcomes, such as breast cancer, and also trials have tended not to measure rates of melanoma, which is increasing worldwide. With an average of only 2 years of follow-up, it is hard for this study to make strong conclusions about the safety of stating with regard to cancer.

So interestingly, just like aspirin, it appears that primary prevention with statins is not for everybody and the risks of long-term therapy have to be weighed against the benefits. However, the benefits for people with established heart disease are beyond doubt for statins and aspirin.

worth it at a price

Statin drugs really lowered my cholesterol. I went completely vegetarian and couldn't get the same results. However the pain and side effects were killers. I took nine supplements that helped with the muscle pain. I finally switched to statinhelp that combined them. I'm afraid to stop the statins since I can't control it with diet since both parents had heart problems.

RRR vs ARR

As always, the headline-grabbing RRR gives you "significantly improved survival and large reductions in ... cardiovascular events"

While I agree that statins are not for all, some of these "primary prevention" patients receive similar ARR with statins as those post-stroke. Current guidance recommends considering your pre-treatment 10-year absolute risk before prescribing, since those with multiple risk factors have the greatest benefit (i.e. same RRR but greater ARR).

While a 4-year mean follow-up may be insufficient to determine strong safety conclusions with regard to malignancy, it is equally likely to be insufficient to show the full mortality benefit of statin treatment, which may well increase with duration of treatment (up to a threshold), and potentially persist following discontinuation. Unfortunately, this is simply a reflection of how clinical evidence is collected.

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