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Scientists publishing in JAMA Internal Medicine examine statin treatment among adults aged 65 to 74 years and 75 years and older when used for primary prevention in the Lipid-Lowering Trial (LLT) component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). A Before the Headlines analysis accompanied these comments.
Prof. Jeremy Pearson, Associate Medical Director, British Heart Foundation, said:
“Statins are proven to prevent heart attacks and strokes in people with high cholesterol, but this study calls in to question whether they work in older people with moderate cholesterol levels. However, the statin used in the study, pravastatin, is no longer prescribed to lower cholesterol and has since been replaced by stronger statins. This could have an impact on the results so more research is needed to confirm the findings, based on current best practice.
“Age is a major risk factor for heart disease, and there are a number steps people can take to reduce their risk of having a heart attack or stroke. This includes having a healthy diet, being physically active, stopping smoking and where necessary, lowering their cholesterol levels and managing blood pressure through diet and medication.”
Dr Tim Chico, Reader in Cardiovascular Medicine & consultant cardiologist, University of Sheffield, said:
“This paper is a new analysis of a previous study, and doesn’t really add much to our understanding of who should get statins because of important flaws the authors themselves point out. If you measure anything in two groups of people (like rates of death or heart attack) there will always be some difference between groups caused by random variation, even if the groups are identical. To work out if the differences are real, we use statistical tests to see how likely the differences are just a result of this variation. This current study finds that any differences between the groups of people on statins and those not taking these are probably just random chance. Although if they were able to include more people in the groups they might find true differences, equally it is possible that the “non-significant” differences they find would become less or disappear entirely. Despite this, the authors seem to make more of the non-significant increase in death in patients taking statins than the non-significant reduction in heart disease seen in the statin group, which seems biased towards hoping to find a harmful effect, but prone to dismissing a beneficial one.
“So why didn’t statins make older people live longer in this study? There are a number of possible explanations. Although this study was attempting to compare people taking statins against those not taking them, by the end of the study many people had “crossed over”; patients in the treatment group had stopped their statin, while people not supposed to be taking them had been started on them! This makes it even harder to see an effect of the drug. In addition, the older you are, the more likely you are to develop other problems or die of these before any effect of drug treatment can be detected. Also, this study was of “primary prevention” where we know studies need many thousands of people to detect effects, as most people will not suffer heart disease during the study irrespective of which group they are in, and this study almost certainly did not include enough people. It is worth highlighting that elderly patients do still register a cholesterol-lowing effect when taking statins.
“The average life expectancy in the UK is around 85 years old. When I see older patients in my clinic, I discuss the implications that some treatments are less likely to prolong their life than if started at a younger age, but that some may improve quality of life by reducing risk of admission to hospital with a heart attack or other conditions. The higher someone’s risk of heart disease (based on whether they smoke, have previous heart problems, are diabetic, etc) the more likely they are to benefit from statin treatment and I don’t have an age cut-off above which I won’t suggest treatment. However, the decision to start statins has to come from a discussion about what we know, and what we don’t, between the individual patient and doctor.”
Dr Amitava Banerjee, Senior Clinical Lecturer in Clinical Data Science and Honorary Consultant Cardiologist, UCL, said:
“The question of whether to use statins to stop heart attacks in older individuals (≥75 years) with no prior history of cardiovascular disease (known as “primary prevention”) illustrates two problems with clinical research. First, we do not have all the information we need from existing clinical trials. Second, trials do not always reflect the population in the real world. For example, a 2013 Cochrane review of statin trials in primary prevention showed that the average age of participants was 57, whereas the patient population is much older. This is borne out by variable guidelines between countries and variable clinical practice.
“We already know that there is limited, if any, benefit in using statins for prevention in elderly individuals with no history of cardiovascular disease, mostly from subgroup or post-hoc analyses of trials. These new published data broadly represent “old wine in new bottles” in that they also suggest that there is no benefit of statins in the over 75 age group. However, this is a post-hoc analysis from a trial which stopped recruiting in 2003 using an old statin which is now far less commonly prescribed (pravastatin) than others (e.g. simvastatin, atorvastatin, rosuvastatin). Therefore, I would want to see similar data for the newer statins as well. In the absence of comparative trials of different statins, we will need to rely on real world evidence from routinely collected data. There is a trial (STAREE) specifically looking at statin use for primary prevention in older people in Australia which is due to report in 2020, which will give a more definitive answer. Overall, in the absence of strong evidence, the decision to start a statin is still a balance of risks, benefits and patient preferences, which is consistent with current NICE guidelines. In my own practice, the balance is probably against the use of statins in older individuals for primary prevention, especially in the context of multiple comorbidities, poly-pharmacy and frailty.”
* ‘Effect of Statin Treatment vs Usual Care on Primary Cardiovascular Prevention Among Older Adults’ by Han et al. be published in JAMA Internal Medicine on Monday 22nd May.
All our previous output on this subject can be seen at this weblink: http://www.sciencemediacentre.org/?s=statins&cat
Declared interests
Dr Tim Chico: No conflicts of interest.
Dr Amitava Banerjee: No conflicts of interest.