This new review, recently published in BMJ, questions the benefit of statins in low-risk primary prevention patients. Authors argue that statins should be more cautiously indicated in primary prevention, considering that their absolute benefit is almost marginal in low-risk patients.
Changes in the European guidelines have translated into a wide expansion of patients eligible for this therapy. In 1987, about 8% of patients older than 50 years had an indication for statins, while now, based on the new guidelines, such indication reaches 60% of the same population. As a result of this wide expansion, the number needed to treat (NNT) has also increased. The reduction of one major cardiovascular event in the low-risk population required treating 40 patients in 1987, while (based on the new guidelines) the same outcome required treating 400 patients in 2016. This has a huge cost for healthcare systems, even though the cost of statins has dropped drastically in recent years.
This debate has been present in both sides of the Atlantic Ocean. In 2018, the American College of Cardiology/American Heart Association (ACC/AHA) guidelines emphasized the need to “discuss” with the patient the pros and cons of statins for primary prevention, particularly in the low-risk population. This decision, made jointly with the patient, should include a review of major risk factors, the benefits of lifestyle modifications, the potential for drug-drug interactions, and, of course, financial costs. Patient preferences have been permanently included in the decision algorithm.
For this review published in BMJ, researchers included all randomized studies published since 1995. Overall, statins reduced the risk of all-cause mortality (risk ratio [RR]: 0.91; 95% confidence interval [CI]: 0.85-0.97), cardiovascular death (odds ratio [OR]: 0.85; 95% CI: 0.77-0.95), and major cardiovascular events (RR: 0.75; 95% CI: 0.70-0.80). Such benefit for the general population varies depending on the baseline risk of patients.
In low-risk patients, statins have no impact on mortality; however, they are still able to reduce coronary events by about 40%.
When the analysis includes only women, statins do not reduce the risk of all-cause mortality.
Such spectacular relative reduction in events may hide a very small absolute reduction among low-risk patients, particularly young women.
In a practical example, for a patient with a 10-year cardiovascular risk lower than 5% (very low), statins may reduce the risk of dying from cardiovascular disease by 20%, but the confidence interval is very wide, suggesting that the risk could be reduced by up to 57% or increased by 47%.
Original title: Statins for primary prevention of cardiovascular disease.
Reference: Byrne P et al. BMJ. 2019;367:l5674.
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