Statins for primary prevention in people with a 10% 10-year cardiovascular risk: too much medicine too soon?

Abstract

The National Institute for Health and Care Excellence (NICE) guidelines on lipid modification advise offering statins for primary prevention to patients with over 10% 10-year modelled risk of a cardiovascular event, a change from 20%. This has generated controversy among clinicians, researchers, and journal editors. Patients already taking statins were more likely to stop taking them after the intense media coverage between March and October 2014, though there was no associated change in initiation.1 Clinicians’ worries were crystallised in a letter of concern from leading UK medical figures to NICE concerning the frequency of adverse events and the magnitude of the effectiveness of statins.2 Two sources of evidence were cited regarding risk levels, the meta-analyses by the Cholesterol Collaboration Trialists (CTT) Collaboration and Cochrane.3,4 The CTT Collaboration meta-analysis used individual patient data from 22 randomised controlled trials (RCTs) of statin versus control ( n = 134 537);3 authors were able to stratify individuals into risk categories. The CTT Collaboration is the only group to have been granted access to individual patient data by pharmaceutical companies funding RCTs, but they were not allowed to share data with third parties and were not granted access to individual patient adverse event data.5 For primary prevention, among those at high risk (10–20% risk over 5 years), statins led to a significant relative risk reduction in major vascular events and a non-significant relative risk reduction in vascular mortality. Among intermediate-risk patients (5–10% risk over 5 years), statins were associated with a significant relative risk reduction in major vascular events and major coronary events, but to non-significant reductions in coronary heart disease (CHD) mortality and all-cause mortality. Among those receiving statins for 5 …