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'Remarkable' benefits for patients taking statins for over a decade

By Emma Wilkinson | 25 Nov 2011

Eligible patients should be started on statins early and keep taking them ‘for life', say researchers who analysed long-term data from those who took part in the Heart Protection Study.

The 23% drop in major cardiovascular events seen in those allocated 40mg simvastatin in the five-year study persisted for years after, the data shows.

Once the study ended most of the high-risk patients in either placebo or treatment group ended up on statins, but the beneficial effect seen in those taking simvastatin since the start continued for up to 11 years, the researchers found.

And the ‘reassuring' long-term data in patients aged 40-80 when the trial started showed no increase in cancer incidence, cancer death or vascular death, the Lancet reported.

Dr Richard Bulbulia, consultant vascular surgeon and research fellow at the Oxford Clinical Trial Service Unit said the persistence of benefit seen in those originally allocated simvastatin was ‘remarkable'.

‘The initial results showed the longer you take statins the bigger the benefits. This shows that people who originally got a statin continued to get that benefit.'

He added: ‘The other key message is we now have really reliable data that there is absolutely no hazard up to 11 years.'

‘This is really important if we continue to lower the threshold at which we prescribe statins so people start them at a younger age and are living longer because of them so are going to be on treatment for longer.'

During the post-trial period, self-reported statin use was similar in both groups, rising from about 59% the first year to 84% by the fifth year.

The similarity in statin use in the 17,500 patients for whom long-term data was available also meant LDL-cholesterol concentrations were comparable between the groups.

Dr Terry McCormack, a GP in Whitby and council member of the Primary Care Cardiovascular Society, said: ‘All the evidence we can get is reassuring because there are still people who have doubts, especially patients who will listen to the scare stories.

‘It is what we expected but it's still good news.'

‘But there is still research that is needed – we need more research in primary prevention and in the very elderly,' he said.

‘The question is how long do you benefit – it you're in your late eighties and taking a statin are you actually benefitting from it?'

The Lancet, published online 23 November 2011.

READERS' COMMENTS

Vinci Ho, GP Partner,
25 Nov 2011
The interesting theory is even though the target of cholesterol level may not be reached , taking statin is still better than not . The effect on endothelial finction is certainly not measured by cholesterols' readings ......
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Justin Smith, Other healthcare professional,
27 Nov 2011
Obviously, the study was no longer comparing a statin against a placebo – it was comparing statins against statins. Just to make it even more confusing; we do not even know which statin people took during the follow-up period and at what dosage.

As far as I am concerned, the fact that just as many people in the placebo group took a statin is enough to nullify this study. However, there are several additional issues.

All of the people included in this study have very high risk. Almost half had already had a heart attack, and everyone else had either other forms of CVD or conditions that would place them at high risk. All of the evidence from statin clinical trials has consistently shown that any 'benefit' varies greatly according to the level of risk the trial participants have. Therefore, if any statin benefits were found during this study, it is simply unthinkable to try and extrapolate this to the general population or the majority of people who take statins.

In addition, the study report and commentary describe the results in terms of relative percentages. This is a very common problem with statin clinical trials. The relative percentage is meaningless to patients and it grossly exaggerates any suggested 'benefit'. For example, in terms of vascular related deaths a risk reduction of 18% is quoted for the initial trial period. However, the real risk reduction in absolute terms was 1.7%.

Incidently, this 1.7% risk reduction in vascular related deaths reduced to 0.1% during the follow-up period. Therefore, there is not any real evidence to support the claim that the 'benefits' of statins increase if a person starts taking the statin earlier in life.

It is also worth mentioning that statins have a wide range of adverse effects (some very serious) that were not included in this study.

http://www.29billion.com/journal/2011/11/24/conclusive-proof-statins-are-safe-and-effective.html
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Terry Mccormack, GP Partner,
28 Nov 2011
In response to Justin Smith. The follow up study compared participants with 11 years statin use against 5.5 or 6 years statin use (the placebo group) and found no difference in safety outcomes. This puts to rest theories that long term use is potentially harmful. The KM curve remained parallel after unblinding (no divergence or convergence). This therefore suggests early use was advantageous and continues benefit was seen. You are right that these are high risk patients and further research is needed, the problem will be to find the funding for such research. Terry McCormack
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Graham Edlin, Sessional/Locum GP,
29 Nov 2011
Given that the original study screened 60,000 patients of whom 36,000 entered pretrial but only 20,000 were prepared to continue on a statin after a 3 month run in and of the 10,000 2,000 were non compliant at one year .That is the triallists were highly selected for non reaction.In J Hippesly cox's paper 16% of statin users were depressed and nearly half were on a nsaid .5% were hypothyroid.The original paper has an increase in skin and neural cancers numbers were small but did reach significance.
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