Multizonal observational study conducted by clinical practitioners on Repatha® use in patients with hyperlipidemia (ZERBINI): Colombian results

IF 1.9 Q3 PERIPHERAL VASCULAR DISEASE Clinica e Investigacion en Arteriosclerosis Pub Date : 2024-01-01 DOI:10.1016/j.arteri.2023.06.001
Heidy M. Roncancio , Julián R. Lugo-Peña , Ángel A. García , Janeth Leal , Carlos A. Hoyos , Johnny A. Beltrán , César L. Cruz , Carol Paez-Cano , Mariana Pineda-Posada , Eduardo Contreras
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Abstract

Background

Cardiovascular disease (CVD) represents the primary cause of death and disability globally, with elevated cholesterol as one of the leading risk factors for CVD. We describe the clinical characteristics, treatment patterns, and effectiveness of evolocumab in treating hyperlipidemia.

Methods

Observational study conducted through a chart review of patients with hyperlipidemia receiving evolocumab as part of clinical management in Colombia.

Results

This study included 115 patients treated with evolocumab. A total of 101 patients (87.8%) had a history of CVD, 13 (11.3%) familial hypercholesterolemia (FH), and 23 (20%) type 2 diabetes. Thirty-nine patients reported intolerance to any statin (33.9%). The median value of LDL-C before initiation of evolocumab was 147 mg/dL (IQR: 122.5–183.7 mg/dL). Within the first 3 months of treatment, LDL-C value dropped to a median value of 53 mg/dL (IQR: 34.0–95.5 mg/dL), showing a reduction of 63.9%. The median LDL-C values remained below 45 mg/dL until the end of follow-up. Among the patients with available data, up to 61% achieved an LDL-C level below 55 mg/dL at the 10–12-month follow-up. A total of 72% of patients were persistent with treatment. Safety results showed a low frequency of hospitalizations (≤2%) and treatment-emergent adverse drug reactions (5.2%). No serious adverse events were reported.

Conclusions

Evolocumab was associated with reductions in LDL-C levels, with a relative decrease of 63.9% within the first 3 months of treatment. Low rates of interruptions due to adverse events and adequate medication persistence was reported.

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由临床医师开展的关于高脂血症患者使用 Repatha® 的多区域观察研究(ZERBINI):哥伦比亚的结果
背景心血管疾病(CVD)是导致全球死亡和残疾的主要原因,而胆固醇升高是导致心血管疾病的主要危险因素之一。我们描述了 evolocumab 治疗高脂血症的临床特征、治疗模式和有效性。方法通过对哥伦比亚接受 evolocumab 作为临床治疗一部分的高脂血症患者进行病历回顾,开展了一项观察性研究。共有 101 名患者(87.8%)有心血管疾病史,13 名患者(11.3%)有家族性高胆固醇血症(FH),23 名患者(20%)有 2 型糖尿病。39名患者(33.9%)表示对任何他汀类药物不耐受。开始使用 evolocumab 前,低密度脂蛋白胆固醇的中位值为 147 mg/dL(IQR:122.5-183.7 mg/dL)。在治疗的前 3 个月,低密度脂蛋白胆固醇的中位值降至 53 毫克/分升(IQR:34.0-95.5 毫克/分升),降幅达 63.9%。直到随访结束,低密度脂蛋白胆固醇的中位值一直保持在 45 毫克/分升以下。在有数据可查的患者中,高达61%的患者在10-12个月的随访中将低密度脂蛋白胆固醇水平降至55毫克/分升以下。共有72%的患者坚持治疗。安全性结果显示,住院率(≤2%)和治疗引发的药物不良反应发生率(5.2%)较低。结论Evolocumab可降低LDL-C水平,在治疗的前3个月内相对降幅达63.9%。因不良事件而中断治疗的比例较低,且有足够的用药持续性。
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来源期刊
Clinica e Investigacion en Arteriosclerosis
Clinica e Investigacion en Arteriosclerosis PERIPHERAL VASCULAR DISEASE-
CiteScore
3.20
自引率
6.20%
发文量
44
审稿时长
40 days
期刊介绍: La publicación idónea para acceder tanto a los últimos originales de investigación como a formación médica continuada sobre la arteriosclerosis y su etiología, epidemiología, fisiopatología, diagnóstico y tratamiento. Además, es la publicación oficial de la Sociedad Española de Arteriosclerosis.
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