The use of statins – a class of drugs taken to combat high cholesterol, heart disease and stroke – in patients without prior history of heart disease are only of modest benefit in preventing deaths when taken in the short-term. These are the findings of the largest study of its type to date.

Statins are one of the most widely used drugs for the treatment and prevention of heart disease, both among people who already have it and among high-risk but healthy people. They are among the most successful drugs of all time and have been credited with preventing millions of heart attacks and strokes.

 



But in a meta analysis – a study which reviews all previous published scientific evidence on a specific area – scientists from St George’s, University of London and Cambridge University found scant evidence that statins saved lives in the short term in groups with no history of heart disease.

The researchers investigated over 65,000 patient records from 11 existing statin studies that took place all around the world between 1970 and 2009.

They analysed death from all causes, rather than those related to heart disease, to weigh up the overall value of the drugs in saving lives as a primary prevention strategy – that is, in people with no prior history of heart disease, but who are considered at risk because of other factors such as old age and diabetes. This analysis considers the impact of any unknown, fatal side effects of statins as well as their known life saving benefits.

Contrary to previous reports based on more limited data, the study found that when taken in the short term, statins only have a borderline impact on preventing death rates amongst this group, when all causes of mortality are considered – the equivalent of seven people in every 10,000 people treated for one year. 

The findings are published in the 28 June issue of the Archives of Internal Medicine.

“There have been many conflicting reports about the potential benefits and risk of statins and those who are taking them to lower their cholesterol may well be confused about whether it is worth it and how safe they are,” explains Professor Kausik Ray from St George’s, University of London, who led the study in his former role at Cambridge University. “It’s clear cut they save lives amongst people who have already had a cardiovascular disease. This study aims to provide the most comprehensive, unbiased information to date on the potential of statins as a life-extending drug for the rest of the population, by taking into account deaths from all causes.”

The trial participants, who took the statins for an average of 3.7 years, were split into two groups – those who received statin treatment and those who took a placebo. The researchers found that of those 32,606 participants who took the placebo there were 1,447 deaths. In the statin treatment group, there were 1,346 deaths out of 32,623 participants. In the report, the scientists state that the small reduction in the statin group was not statistically significant.

“We believe the data confirms the overall safety profile of statins in healthy people. But it also shows that, in the short term at least, the large mortality benefits of statin in those who have already had a heart disease can not be extrapolated into lower risk groups. These findings may be useful in informing health economic considerations before extending the present guidance on primary prevention to lower risk settings,” Prof Ray continues.

No patients involved in the study had a history of stroke or heart attack, but all were considered at high risk of the disease.

“The methodology used ‘cleans up’ the findings of other studies by isolating the effect of statins when taken as a primary prevention strategy and using in some cases unpublished data. It does it on a large scale whilst using a random effects model which provides a more conservative estimate among diverse populations studied – this ensures an unbiased analysis and presents the truest picture,” concludes Prof Ray.