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4CPS-027 Real-world effectiveness of evolocumab and alirocumab at 12 months of treatment
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  1. M Gomez Zamora1,
  2. P Rovira Torres1,
  3. A Jimenez Portilla2,
  4. M Ortiz1,
  5. A Gomez Lobon1,
  6. MM Santandreu Esterlich1,
  7. E Rodriguez Campos1,
  8. O Delgado Sanchez1,
  9. JR Urgeles Planella2
  1. 1Hospital Universitario Son Espases, Pharmacy, Palma de Mallorca, Spain
  2. 2Hospital Universitario Son Espases, Endocrinology, Palma de Mallorca, Spain

Abstract

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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