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Questioning statin therapy for older patients
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Download the PDF here
Download the PDF here
Lancet June 12 2020
A far more beneficial public health message is the strong evidence for the cardiovascular benefit of maintaining a healthy lifestyle, especially including routine exercise.
Single clinical trials have not yet determined whether statin therapy provides more benefit than harm to people older than 75 years with or without a history of vascular disease. The Cholesterol Treatment Trialists' Collaboration, which alone has access to patient-level data from most trials, is best able to answer these questions. However, we have several concerns about the Article by the Collaboration1 and the presentation of its results to the media.
First, the collaboration states that “rates of use of statin therapy…are substantially lower in people older than 75 years”,1 but the data in table 2 of one of the two sources cited to support this claim, by Salami and colleagues,2 show just the opposite.
Second, although the collaboration reports that they have data on 14 483 trial participants older than 75 years, approximating the total denominator of all such participants from the figures in the 2019 meta-analysis gives only 9473 participants for figure 1A and 10 513 participants for figure 5A (by dividing the number of events by % per annum ÷100 × median number of years per study). Thus, either the collaborations'calculations are missing 27–35% of the available data or a considerable number of trials had short follow-ups. Although short follow-ups would explain this discrepancy through a difference between the median and mean duration of the studies, we find this explanation untenable because of the magnitude of the difference; it is at least worthy of additional explanation.
Third, the collaboration's data show that annually, 1000 people older than 75 years without a history of vascular disease need treatment to prevent a single major vascular event, and cardiovascular or all-cause mortality data are not presented for this population. These results make informed doctor–patient decisions impossible, especially when the frequency of side-effects that are meaningful to patients is simply not known.
Because most people older than 75 years do not have vascular disease3 and the Collaboration does not present mortality data for this population, we believe the Collaboration was irresponsible in relaying to the media that 8000 deaths could be prevented each year if all UK citizens aged 75 years or older took statins. 4 Given these gaps in the data, we believe it is wrong to recommend statin therapy uniformly for people aged 75 or older who do not have cardiovascular disease. A far more beneficial public health message is the strong evidence for the cardiovascular benefit of maintaining a healthy lifestyle, especially including routine exercise.
Finally, doctors and patients need to be reminded that patient-level data held by the Collaboration remain unavailable for independent analysis and therefore have not been verified.
JA has served as an expert for plaintiffs' attorneys in litigation involving Avandia and Crestor, and is writing a book about the pharmaceutical industry. NJ has served as an expert for the defence attorneys in litigation involving Ferrirprox and Aranesp, and for the plaintiffs' attorneys in litigation involving Neratinib, Loestrin 24 Fe, Suboxone, Doryx, Zoloft, Prozac, Lipitor, and Granuflo. All other authors declare no competing interests.
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