?We agree with Cordero et al. that, in absolute numbers, patients with CVD form the largest subgroup eligible for treatment with proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i). In our study, 84% of PCSK9i-eligible patients had CVD.1 Treatment optimization in Spain would likely reduce the number of PCSK9i-eligible patients by roughly 50%. The REPAR study has shown the effectiveness of combination lipid-lowering therapy. Nevertheless, in our study, only between 1.9% and 6.6% of patients with CVD received this therapy.1
The studies by Fourier2 and Odissey3 demonstrate that the addition of PCSK9i reduces primary or secondary endpoints by 15% to 20% among CVD patients on optimal lipid-lowering therapy. The CVD patient groups that would benefit most from PCSK9i therapy include those with recurrent events (number needed to treat [NNT]=38), an event in the last 2 years (NNT=35), multivessel disease (NNT=29), concomitant peripheral aterial disease (NNT=29), or recent ischemic heart disease concomitant with low-density lipoprotein cholesterol>100 mg/dL (NNT=16).4 Even in the setting of statin therapy, patients with familial hypercholesterolemia have a 3-fold higher prevalence of CVD than unaffected relatives.4
Data from the Departament de Salut de Catalunya indicate that 560 patients were treated with PCSK9i from their commercial launch until March 2018. This number corresponds to between 1.05% and 3.4% of eligible patients, indicating that many patients who could benefit from PCSK9i therapy are not receiving it.
It is incumbent upon all stakeholders to work to redefine shared criteria for the indication of PCSK9i therapy.
FUNDINGThis study received funding from the Spanish Ministry of the Economy through the Instituto de Salud Carlos III (Red de Investigación Cardiovascular Programa HERACLES RD12/0042 and Red RedIAPP RD12/0007 and the CIBERCV), the European Regional Development Fund (ERDF-FEDER), and the Generalitat de Catalunya through the Agència de Gestió Ajuts Universitaris de Recerca (2014 SGR 240 and 2014 SGR 902) and the Agència de Qualitat i Avaluació Sanitàries de Catalunya, Pla Estratègic de Recerca i Innovació en Salut (PERIS) (SLT002/16/00145).
CONFLICTS OF INTERESTL. Masana has received fees from Amgen, Sanofi, Daichii, and Mylan for activities unrelated to the present study.