4CPS-026 Adherence and effectiveness of PCSK9 inhibitors in routine clinical practice

BackgroundAlirocumab and evolocumab are monoclonal antibodies that belong to a new class of cholesterol-lowering drugs by inhibiting the proprotein convertase subtilisin/kexin type-9 (PCSK9) enzyme.PurposeThe main objective of this study was to evaluate the adherence to alirocumab and evolocumab therapies and its relation to drug effectiveness.Material and methodsObservational, descriptive and retrospective study conducted in a tertiary hospital. All patients that initiated treatment with alirocumab and evolocumab from October 2016 to February 2018 were included.Data sources were patients’ electronic medical records and outpatients’ electronic prescription and dispensation programme. Main variables collected were: gender, age, indication, prescriber’s medical departments and low-density lipoprotein (LDL-C).Adherence was calculated indirectly by consulting dispensing data in the outpatient prescription tool.Effectiveness was defined as the percentage decrease in LDL-C from baseline to week 24.ResultsForty patients were included: 22 men (55%) and 18 women (45%), with median age 57 years (19–85). Nine patients (22.5%) had heterozygous primary hypercholesterolaemia, seven (17.5%) heterozygous primary hypercholesterolaemia and severe cardiovascular disease, 11 (27.5%) severe cardiovascular disease, 10 (25%) severe cardiovascular disease and statin intolerance, and three (7.5%) statin intolerance. Alirocumab was prescribed in 19 patients (47.5%) and evolocumab in 21 (52.5%).Mean adherence index was 1.03 (SD 0.13). Mean basal LDL-C and LDL-C after 24 weeks were 125, 42 mg/dl (SD 43.34) and 61, 22 mg/dl (SD 44.17), respectively. The percentage decrease in LDL-C from baseline to week 24 was 43%, 31% in the alirocumab group and 54% in the evolocumab group. The adherence index in both groups was similar.Twenty-eight patients (70%) had a percentage decrease in LDL-C >40% with an adherence index of 1.04 (SD 0.12), while 12 patients (30%) had a percentage decrease in LDL-C