Dr Steven Nissen on Which Patients Should Be Treated With PCSK9 Inhibitors
Steven Nissen, MD, of Cleveland Clinic discusses two trials that demonstrate what types of patients are eligible to be treated with PCSK9 inhibitors.
Transcript (slightly modified) What does the latest data show about who should be treated with PCSK9 inhibitors?
Of course it's controversial, and the FDA has not acted yet, but there were 2 recent trials—one that we did known as the GLAGOV trial, published last December in JAMA, and then the FOURIER trial, published in the spring in TheNew England Journal of Medicine. In GLAGOV, we took people that had known coronary disease, that were coming for left heart catheterization, for symptoms. The group that got a statin alone had a low-density lipoprotein (LDL) of about 90—they were well treated, mostly with high-intensity statins. The group that got combination therapy with the PCSK9 inhibitor got to an LDL, a median LDL of 36. They had marked regression of coronary disease. So, clearly people that have a lot of coronary plaque, that have come to the catheterization laboratory for symptoms, appear to benefit.
FOURIER, I think was a very good trial—very large, some 27,000 patients. They had very similar baseline LDLs of about 90 and their on-treatment LDLs averaged about 30 and there was a reduction in death, stroke, myocardial infarction; there was a very clear benefit across a broad range of patient types. So, I think that sicker patients in the secondary prevention world are good candidates for LDL lowering to these very low levels.
Now, FDA will have to evaluate FOURIER and whether they choose to give a label or not remains to be seen. Although, I frankly think it’s pretty clear that the data is robust and that there will be a label—how they write the label will be a bit nuanced. My advice to people is that the higher the risk of the patient and the higher the LDL, the more reasonable it is to add a PCSK9 inhibitor to a statin.