The recommendations apply to adults already taking the maximum dose of statins or those who are intolerant to statins and are part of the Rapid Recommendations initiative – to produce rapid and trustworthy guidance based on new evidence to help doctors make better decisions with their patients.
The panel considered the balance of benefits against the burdens and potential harms of starting a new drug according to patients’ level of risk, values, and preferences.
New evidence from 14 trials involving 83,660 patients shows that ezetimibe and PCSK9 inhibitors probably reduce heart attacks and strokes in patients with very high and high cardiovascular risk, but not in patients with moderate and low cardiovascular risk.
These relative benefits were consistent, but their absolute magnitude varied based on cardiovascular risk in individual patients (for example, for 1000 people treated with PCSK9 inhibitors in addition to statins over five years, benefits ranged from 2 fewer strokes in the lowest risk to 21 fewer in the highest risk).
No important side events were found, although PCSK9 inhibitors require injections that sometimes result in injection site reactions, which the experts say is a burden and harm that may matter to patients.
The panel acknowledges some uncertainties in the evidence underlying this guideline and notes that clinicians need to identify patients’ cardiovascular risks to apply these risk-stratified recommendations. Their recommendations may also alter as new evidence emerges.
Source: Medindia
