New observational study – STAREE’s statement
On September 6, 2018 the BMJ published an observational study which concluded that: "These results do not support the widespread use of statins in old and very old populations, but they do support treatment in those with type 2 diabetes younger than 85 years".
An observational study has a number of limiting factors associated with it. This includes the inability to confirm usage and duration of statin exposure (the study only confirmed usage by filling a script, but this may not mean the patient actually took the drug or took them for long enough); no process of confirming outcomes through a panel of experts who have access to medical histories; and, the population may have been more at risk which is why they were prescribed a statin. There have been other observational studies which have reported different results from the clear beneficial effects reported by clinical trials. As such, the results published from this observational study are of interest and must be considered but not taken as the absolute evidence on statin usage in those 70 and above.
STAREE plans to provide robust evidence to help answer these important questions.
The editorial indicates the need for a randomised controlled trial such as STAREE in the following statement: "These observational findings are exploratory however and should be tested further in randomised trials—to rule out any confounding and to study the effect of statins on CVD death, which were not recorded in the database used for this study." Indeed the authors of this paper have urgently called for a trial like STAREE: "These results, based on observational data, may not provide enough grounds for direct clinical recommendations, but they do show the need for randomised clinical trials to further elucidate this problem. Statins for Reducing Events in the Elderly (STAREE study) is a promising ongoing trial on CVD primary prevention that compares atorvastatin (40mg) with placebo in healthy people older than 70 years."
The high quality clinical trial evidence that will be generated by STAREE will be pivotal to informing future appropriate usage of statins among older people. STAREE will examine disability-free survival and major cardiovascular outcomes including CVD death.
For further information see this article in The Age.