Multizonal observational study conducted by clinical practitioners on evolocumab use in subjects with hyperlipidemia in Saudi Arabia and Kuwait: Results from the ZERBINI study

Khalid Al Faraidy 1, Mousa Akbar 2, Mohamed Shehri 3, Mohammad Aljarallah 4, Gamal Abdin Hussein 5, Raja Dashti 6, Ahmad Al Qudaimi 7, Fahad Al Nouri 8, Zuhier Awan 9, Ahmed Essam 10, Alaa Emara 11

Affiliations

01 January 2023

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doi: 10.1371/journal.pone.0278821

Abstract

Objectives: Dyslipidemia is a prevalent condition with significant morbidity and mortality across the world, including in the Arabian Gulf. The present study aimed to describe the characteristics of patients receiving evolocumab in clinical practice.

Methods: ZERBINI was a multi-country, observational, retrospective/prospective study of subjects receiving evolocumab as part of routine clinical management of their hyperlipidemia. This regional publication reports on adult participants from Saudi Arabia and Kuwait who have had ≥1 dose of evolocumab before enrollment and ≤6 months' prior exposure to evolocumab. Patient characteristics and treatment persistence data were collected in addition to baseline and follow-up data up to 12 months post-evolocumab initiation.

Results: Overall, 225 patients were included from two sites, Saudi Arabia (N = 155) and Kuwait (N = 70). Mean age was comparable across sites and most patients had baseline coronary artery disease and/or hypertension. Baseline LDL-C levels (mean ± SD 3.6 ± 1.4 mmol/L in Saudi Arabia, 3.1 ± 1.4 mmol/L in Kuwait) were reduced by approximately 57%-62% in the first 6 months after evolocumab initiation (1.5 ± 1.2 mmol/L in Saudi Arabia [n = 63], 1.2 ± 0.8 mmol/L in Kuwait [n = 28]). This decrease was maintained over the 12-month follow-up period. Most patients achieved ACC 2018 LDL-C goals (<1.8 mmol/L; 74.6% in Saudi Arabia, 93.1% in Kuwait) and ESC 2019 LDL-C goals (<1.4 mmol/L; 66.7% in Saudi Arabia, 75.9% in Kuwait) in the first 6 months after evolocumab initiation. Medication persistence with evolocumab was high (up to 90.7%). Evolocumab had a favorable safety profile and no treatment-emergent adverse events were observed at either site.

Conclusion: Evolocumab is an effective lipid-lowering treatment in local populations. LDL-C goal achievement is increased when evolocumab is added to background lipid-lowering therapy with high tolerability and persistence. Long-term follow-up and large-scale data are needed to further support these observations.

Copyright: © 2023 Al Faraidy et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Conflict of interest statement

The authors MS, MAJ and RD have declared that no competing interests exist KF: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Consultancies from: Saudi Heart Association; Saudi Council for Health Specialties Commission; Gulf Intervention Society; Amgen; Novartis; Sanofi; Medtronic; Boehringer Ingelheim; Lectures from: Amgen; Novartis; Sanofi; Medtronic; Boehringer Ingelheim; Clinical studies from: Amgen MA: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Lectures from: Amgen, Sanofi, AstraZeneca, Bayer,Boehringer Ingelheim, MSD, Novartis, Pfizer, Novonordisk, Servier, Abbott, Algorithm GAH: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Lectures from Amgen; Boehringer Ingelhein; Novartis. Clinical studies from: Amgen. AAQ: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Lectures from Amgen; Novartis. Clinical studies and research grants from Amgen; Other: GHA FAN: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Consultancies, lectures and Clinical studies from Amgen ZA: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Consultancies from: AlBorg Diagnostic; Lectures from: Amgen; Sanofi; Pfizer. Clinical studies from: Amgen. Research grants from: King Abdulaziz University A. Essam: I have read the journal’s policy and the authors of this manuscript have the following competing interests: employed by the funder of the study, Amgen. A. Emara: I have read the journal’s policy and the authors of this manuscript have the following competing interests: employed by the funder of the study, Amgen. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Flow diagram of study design.

Fig 1. Flow diagram of study design.

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