STAREE eyed about statins?

Mrs Fernandes is an active and health conscious 77 year-old. She enjoys walking holidays in the mountains and goes to weekly pilates and spin classes at her local gym. She takes medication for hypertension and osteoporosis but has never wanted to start a statin, feeling that she could manage her cholesterol through a healthy diet. However, her latest non-HDL cholesterol is 3.7mmol/L and this hasn’t shifted between three readings over the past decade. Would you recommend a statin to her?

One of the longstanding criticisms of statins has been the fact that the randomised trials that underpin their use were conducted among younger people with a mean age typically in the mid-60s. This has left us with some uncertainty as to whether statins have the same treatment effect and safety profile among older people, like Mrs Fernandes. 

A large Australian trial called STAREE set out to address this question. They recruited almost 10,000 people from primary care, excluding people who were already eligible for a statin for secondary prevention and including equal numbers of men and women. Importantly, the mean age of participants was 74.7, with over 40% aged >75 years, making it the first large statin trial among older people. People were randomised to 40mg of atorvastatin or a placebo and followed-up for 5.9 years. 

Statins reduced mean LDL cholesterol by 0.8mmol/L and reduced the cardiovascular primary outcome by 30% compared to placebo, including cardiovascular death, non-fatal MI stroke, or a revascularisation procedure (hazard ratio 0.70, 95%CI 0.61 to 0.82). The number needed to treat was 37. 

STAREE was also designed to look at wider impact of statins in terms of disability-free survival. However, statin-use did not lead to a reduction in the second primary outcome, which was a combination of death from any cause, dementia or physical disability (HR 0.94, 95%CI 0.84 to 1.05). This may be because around 80% of deaths were from non-cardiovascular causes, where statins are likely to have limited impact. New cases of dementia and physical disability were relatively uncommon. 

What was noticeable was how many people stopped treatment across the trial period; only around half of participants were still taking the medication after 5 years. 

The most common reason for stopping treatment in both groups was that participants were ‘unwilling’ to continue – around 1 in 6 people stopped treatment for this reason. In fact, more people stopped the placebo than the statin and the safety data were reassuring, with no difference in major adverse events between the two groups (2.7% in each) and only a small increased risk of musculoskeletal (32.0% v 29.4%) and hepatobiliary events (3.3% v 0.9%) with statins.

This seems to get to the heart of the issue with statins – it is impressive that statins still produced a 30% reduction in cardiovascular events when half of people had stopped treatment over the study period. However, although statins are safe, many people in this age group seem simply unwilling to continue taking statins in the longer-term and this may reflect other treatment priorities or concerns around medication burden and side-effects. 

So, while STAREE helps to provide important and reliable evidence that statins are safe and effective at protecting against cardiovascular disease in older people, the debate around the relative benefits of statins for primary prevention will continue. There are opportunities for large population health benefits from statins but only a relatively small reduction in risk for each individual. The number needed to treat of 37 will not convince everyone that population-wide use of statins is merited in older people. Will the results of STAREE be enough to persuade Mrs Fernandes of the need for a statin? Will it persuade you?