KFMMC Cardiac Center, Interventional Cardiologist, King Fahd Military Medical Complex, Dharan, Saudi Arabia.
Cardiology Unit, Sabah Hospital, Kuwait City, Kuwait.
PLoS One. 2023 Jan 20;18(1):e0278821. doi: 10.1371/journal.pone.0278821. eCollection 2023.
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.
目的:血脂异常是一种普遍存在的疾病,在全球范围内具有显著的发病率和死亡率,包括在阿拉伯海湾地区。本研究旨在描述在临床实践中接受依洛尤单抗治疗的患者的特征。
方法:ZERBINI 是一项多国家、观察性、回顾性/前瞻性研究,研究对象为接受依洛尤单抗治疗的患者,这些患者的血脂异常是在常规临床管理中接受治疗的。本地区出版物报告了来自沙特阿拉伯和科威特的成年参与者的数据,这些参与者在入组前至少接受了 1 剂依洛尤单抗,并且在接受依洛尤单抗治疗前 6 个月内接受过依洛尤单抗治疗。除了基线和随访数据外,还收集了患者特征和治疗持续时间的数据,随访时间最长为依洛尤单抗治疗开始后 12 个月。
结果:来自两个地点(沙特阿拉伯[ n = 155]和科威特[ n = 70])的共 225 名患者入组。两个地点的平均年龄相当,大多数患者有基线冠心病和/或高血压。依洛尤单抗治疗开始后 6 个月内,基线 LDL-C 水平(沙特阿拉伯的平均值 ± 标准差为 3.6 ± 1.4mmol/L,科威特为 3.1 ± 1.4mmol/L)降低了约 57%-62%(沙特阿拉伯的 63 名患者为 1.5 ± 1.2mmol/L,科威特的 28 名患者为 1.2 ± 0.8mmol/L)。在 12 个月的随访期间,这种降低得以维持。依洛尤单抗治疗开始后 6 个月内,大多数患者达到了 ACC 2018 LDL-C 目标(<1.8mmol/L;沙特阿拉伯的 74.6%,科威特的 93.1%)和 ESC 2019 LDL-C 目标(<1.4mmol/L;沙特阿拉伯的 66.7%,科威特的 75.9%)。依洛尤单抗的药物治疗持续率较高(高达 90.7%)。依洛尤单抗具有良好的安全性,在两个地点均未观察到治疗相关不良事件。
结论:依洛尤单抗是一种有效的降脂治疗药物。当依洛尤单抗与背景降脂治疗联合使用时,可增加 LDL-C 达标率,具有较高的耐受性和持续率。需要长期随访和大规模数据进一步支持这些观察结果。
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