Background Alirocumab and Evolocumab are proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9-I) that have been authorised by the Autonomous Health Service under the following conditions: uncontrolled familial hypercholesterolaemia (FH) with low-density lipoprotein (LDL-C) >130 mg/dL, uncontrolled stable atherosclerotic cardiovascular disease (ASCVD) with LDL-C >130 mg/dL or unstable ASCVD with LDL-C >100 mg/dL in combination with a statin and ezetimibe at maximum tolerated doses.
Purpose We aim is to analyse the effectiveness of PCSK9-I in patients treated at a tertiary care hospital
Material and methods Retrospective study of all patients treated with PCSK9-I from April 2016 to June 2017 and follow-up at 12 months of treatment. The variable of effectiveness analysed was the percentage of reduction in LDL-C.
Data were collected at the beginning and after the first annual visit from medical records (Millennium-Cerner), and were analysed by the IBM SPSS Statistics program.
Results Thirty-eight patients were included, median age of 56 years (35–80), 53% women. In 19 (50.0%) cases, PCSK9-I were indicated for ASCVD, in 15 (39.5%) for FH and in four (10.5%) for both indications: 15 (39.5%) patients were intolerant to statins and seven (18.4%) to ezetimibe. The mean level of initial LDL-C was 180.5±49.4 mg/dL. PCSK9-I were prescribed in combination with statins in 25 (65.8%) patients and ezetimibe 24 (63.2%). Evolocumab was indicated in 27 (71.1%) cases and alirocumab in 11 (28.9%). The recommended target for LDL-C was 100 mg/dl for 14 patients and 70 mg/dl for 24.1 After 12 months, median 53 weeks (42–76), data were collected from 25 (65.8%) patients, in 11 cases (28.9%) the blood test was not done and two (5.3%) discontinued treatment. The mean LDL-C was 84.6±43.8 mg/dl, with a relative percentage reduction of 50.8%±34.8%. There was no significant difference in effectiveness between evolocumab and alirocumab (−55.2% vs −40.8%, p=0.408). The therapeutic goal was achieved in 15 (60%) patients.
Conclusion PCSK9-I showed similar LDL-C reductions to those described in clinical trials (50%–70%), although only 60% of patients achieved the recommended goal after 1 year of treatment.
References and/or acknowledgements 1. 2016European Guidelines on cardiovascular disease prevention in clinical practice.
No conflict of interest.
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