PCSK9 Inhibitors Not Required in Most ASCVD Patients

Most patients with atherosclerotic cardiovascular disease (ASCVD) can achieve target LDL-cholesterol levels (<70 mg/dL) through intensification of statins and ezetimibe, and do not require proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, according to a recent study.

The simulation model study included a cohort of 105,269 patients with ASCVD enrolled in a large administrative US database of medical and pharmacy claims from January 1, 2012 through December 31, 2013 (57.2% male, mean age 65.1 years). Patients were sampled with replacement to match the US epidemiologic distribution and entered into a Monte Carlo simulation (simulation cohort N=1 million; 54.8% male, mean age 66.4 years).
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_________________________________________________________________________________________________________________________________________The simulation applied stepwise treatment intensification algorithms among patients with LDL-C levels of at least 70 mg/dL. Atorvastatin (20 mg) was given to all patients who had not initiated statin therapy. Lipid-lowering therapy (LLT) methods included uptitration to atorvastatin at a dose of 80 mg, adding ezetimibe therapy, adding alirocumab therapy, a PCSK9 inhibitor at a dose of 75 mg, and uptitration to alirocumab at a dose of 150 mg.

Prior to treatment intensification, 51.5% of patients in the simulation cohort received statin monotherapy and 1.7% of patients received statins and ezetimibe. Only 25.5% of patients achieved an LDL-C level below 70 mg/dL before treatment intensification.

LLT intensification simulation models showed that 99.3% of patients could achieve LDL-C levels below 70 mg/dL, including 67.3% of patients receiving statin monotherapy, 18.7% of patients receiving statin and exetimibe, and 14% of patients receiving an add-on PCSK9 inhibitor.

“Large gaps exist between recommendations and current practice regarding LLT in the population with ASCVD,” the researchers concluded. “In our model that assumes no LLT intolerance and full adherence, intensification of oral LLT could achieve an LDL-C level of less than 70 mg/dL in most patients, with only a modest percentage requiring a PCSK9 inhibitor.”

—Melissa Weiss

Reference:

Cannon CP, Khan I, Klimchak AC, Simulation of lipid-lowering therapy intensification in a population with atherosclerotic cardiovascular disease [published online August 2, 2017]. JAMA Cardiol. doi:10.1001/jamacardio.2017.2289.