A pharmacist-run proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor clinic: short-term results and practical strategies

Introduction:  Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors represent the newest class of lipid-lowering therapies designed to reduce LDL-C; alirocumab and evolocumab are the only agents currently approved within the United States. Inhibition of the PCSK9 chaperone protein allows for continued LDL receptor recycling and increased cholesterol removal from circulation.

Objectives:  The goal of this research is to report the real-world safety and efficacy of these medications in a pharmacist-run PCSK9 inhibitor clinic.

Study Design:  This is a prospective, observational, IRB-approved study from an endocrinology practice involving patients referred to a pharmacist-managed PCSK9 inhibitor clinic.

Methods:  This study will assess the efficacy (percent change in LDL-C, TC, non-HDL-C, TG, and HDL-C from baseline) and tolerability of alirocumab and evolocumab in approximately 60 patients with cardiovascular disease and/or diabetes mellitus. Collected data will include: patient demographic information, indication for referral and history of prior antilipemic therapy. A description of pharmacist activities will also be provided.

Results: To date, 55 patients (55% alirocumab, 45% evolocumab) have been referred to the clinic and received at least one dose of a PCSK9 inhibitor. Twenty-two patients have completed at least one month of therapy and of these patients, 56% were receiving statin therapy when a PCSK9 inhibitor was initiated and the mean baseline LDL-C was 133 mg/dL ± 70. From these twenty-two patients, the following observations were observed [mean percent change ± standard deviation]: -51.4% ± 18.1 in LDL-C; -31.3% ± 10.1 in TC; -45.2% ± 13.0 in non-HDL-C; -26.1% ± 27.4 in TG, and +9.6% ± 15.3 in HDL-C.

Conclusions:  These real-world interim data reinforce results observed from clinical trials of alirocumab and evolocumab. PCSK9 inhibitors are a unique class of antilipemics associated with intensive and consistent reductions in LDL-C.