A new study published today in the British Medical Journal has found statins do not provide any benefit for elderly people, unless they have type 2 diabetes. In order to understand the significance of this study it is useful to first discuss some background and some key important concepts.
Background
Although clinical trials are considered the gold standard in terms of evidence, in reality these trials provide a potential predicted benefit rather than a guarantee of benefit.
Clinical trials and the way they are reported are fraught with issues. Most of these issues relate to the commercial interests. The pharmaceutical company sponsoring the trial believes it owns the data and therefore decides what is published, what is not published, and how and when it is published.
The data can easily be manipulated. The scope or design of the trial can be determined in such a way that might be favorable to the drug being tested. Data about adverse effects can be excluded from the final analysis or not even collected in the first place. The data is also sometimes not made available to other researchers who want to verify the findings. In addition, the results of the trial can be exaggerated in favor of the drug during the writing of the report, by using relative percentages and other misleading calculations.
All of this means it is important to look at post marketing surveillance data and other studies that assess how the medication is actually performing the the real world.
Most of this kind of data for stains has so far failed to show any benefit associated with their widespread use.
For example, researchers collected data from all but one of the municipalities in Sweden and they found that statins had not provided any benefit despite a huge increase in usage.
In 2012 the British Heart Foundation published a report detailing a wide range of heart disease statistics. One of the highlights of this report was the decline in the heart disease death rate that was seen in the UK between 2002 and 2010. This decline was attributable to a reduction in the number of people who smoke and improved emergency treatments within hospitals - statins were not listed in the report since they played no measurable contribution to the decline in heart disease deaths. But much of the mainstream media falsely claimed that statins were responsible for the decline - none of the journalists bothered to check.
The New Study
Now a new study has found no benefit associated with the use of statins in healthy elderly people. But the study did find a benefit for elderly people with type 2 diabetes (more about that later).
This was a large study conducted in Spain and published in the British Medical Journal today. Using data from the Catalan primary care system database (SIDIAP), the researchers identified 46,864 people aged 75 years or more with no history of cardiovascular disease between 2006 and 2015.
Through my contacts I obtained the press release from the British Medical Journal and read the study report prior to official publication.
The press release from the British Medical Journal reads: “New study does not support widespread use of statins in healthy older people to prevent heart disease and stroke”
One thing that makes this study significant is that according to the current clinical guidelines for cardiovascular disease (CVD) prevention, most of the people in this study would be suitable candidates for statin treatment. This should lead to an urgent reassessment of the guidelines, which many doctors already suspect are designed to put more people on statins unnecessarily.
In the study, any benefit was limited to just those people with type 2 diabetes aged between 75 and 84. After age 84, the benefit also disappeared in the type 2 diabetes population.
An important question remains concerning why the diabetic patients benefited when the other patients did not?
It is widely acknowledged that statins cause type 2 diabetes (T2DM). It would be expected that any statin induced diabetes would play out as an increase in heart disease in older age. Since people with diabetes are up to five times more likely to have heart disease.
If the statin benefits were great enough to compensate for this somehow and still produce a benefit, then surely this benefit would also have been seen in the non-diabetic population? I contacted the lead author of the study to ask this specific question and I received the following reply:
"We agree that there exists evidence about the increased risk of T2DM associated with statins, however, we did not observe such increment in our study in people older than 74 years. We have pointed out possible explanations for these results:
The increased risk for T2DM associated with statins is higher in persons with intensive statin regimens, and 85% of statin regimens in our study published in the BMJ were of low to medium potency,
The mean follow-up of the study participants was 7.7 years (which is also the approximate mean duration of statin consumption), thus the possibility that longer duration of statin use might have shown an increased incidence of diabetes cannot be ruled out.
We also speculated with the possibility that the effect of statins on the glucose metabolism may be age-dependent, but this question remains to be elucidated in future independent studies.
We considered that the main explanation to justify the restriction of the benefit from statin therapy to individuals with T2DM was the association of statin effectiveness with the CVD risk of the individuals. In our study, participants with T2DM had a higher prevalence of other cardiovascular risk factors (hypertension, hypercholesterolemia, tobacco use, obesity) than the general population of the same age, and the incidence of cardiovascular disease in those with diabetes was more than 50% higher than in those without diabetes.
Following current guidelines, most of the population older than 74 years would be suitable candidates for statin treatment because the incidence of CVD in this population (i.e. risk) is well above the risk threshold of 10%, but this increased risk is mainly due to age. We think we need specific risk prediction tools for these older people.
Our results do not support these recommendations in the old and very old persons without diabetes, and they raise an important question: whether the current risk threshold for statin indication (10% risk of atherosclerotic CVD at 10 years) is appropriate in this population." Dr. Rafel Ramos, Department of Medical Sciences, School of Medicine, University of Girona, Spain.
I have included Dr. Ramos's reply in its entirety. In my view it is a fairly balanced explanation, which is extremely refreshing. All too often we see reports intent on portraying statins as a wonder drug.
In the report itself the authors do also state that the possibility that a longer duration of statin use might have shown an increased incidence of cancer, or haemorrhagic stroke.
The study has important implications for millions of healthy elderly people who are taking statins.
Finally, it is worth mentioning that any benefit found in this study for elderly diabetic people needs to be considered alongside the huge amount of data showing that higher cholesterol is generally better, particularly in the elderly:
And also, don't let statins break your heart!
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References:
Nilsson, S et al. No connection between the level of exposition to statins in the population and the incidence/ mortality of acute myocardial infarction: An ecological study based on Sweden’s municipalities. Journal of Negative Results in BioMedicine 2011, 10:6 https://jnrbm.biomedcentral.com/articles/10.1186/1477-5751-10-6
British Heart Foundation report: Coronary Heart Disease Statistics 2012. Available from https://www.bhf.org.uk/publications/statistics/coronary-heart-disease-statistics-2012
Link to the new study: http://www.bmj.com/content/362/bmj.k3359