烟酸-ER 的使用、安全性和心血管事件之间的关系。单中心经验。

IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY
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引用次数: 0

摘要

背景/简介研究显示,脂蛋白(a)水平升高的患者心脏病发作和中风等心血管事件的发生率增加。烟酸-ER能将脂蛋白(a)水平降低约30%,但烟酸-ER是否能减少这类人群的心血管事件尚不清楚。这项单中心研究评估了 129 名有过早心血管事件个人或家族史、脂蛋白(a)水平大于 75nmol/L 并处方烟酸-ER 的患者。目标/目的通过病史确定有过早心血管事件个人或家族史的患者,并筛查患者的基线血清脂蛋白(a);将脂蛋白(a)水平大于或等于 75nmol/L 的患者包括在内。该研究旨在确定烟酸-ER 是否能减少心血管事件的发生。虽然目前正在进行 ASO-RNA 和 siRNA 研究,但烟酸-ER 可能是一种成本较低的替代品。方法该研究在 2014-2024 年间跟踪了 129 名由委员会认证的脂质学家/心脏病专家诊治的基线脂蛋白(a)大于 75 nmol/L 的成年患者。患者开始服用 1000 毫克-2000 毫克(平均 1713 毫克)烟酸-ER 和高强度他汀类药物。在这项研究中,118 名患者接受了烟酸-ER 治疗,11 名患者更适合 PCSK-9 治疗。在 118 名患者中,尽管采取了缓解策略,但仍有 36 人无法忍受潮红。结果脂蛋白(a)的平均基线值为221.59 nmol/L,高于AIM-HIGH和HPS2-THRIVE试验中的35-70 nmol/L。目前使用 siRNA 和 ASO-RNA 疗法的试验将纳入标准定为 150 nmol/L。15名患者的实验室检查结果为非抑制性轻度肝功能检查(LFT)升高,开始服用烟酸后,ALT和AST的最高值分别为85 U/L和68 U/L,所有患者均服用高强度他汀类药物。结论烟酸-ER可使脂蛋白(a)水平降低33.68%,与已发表的30%的数据相当。烟酸-ER继续显示出安全性和良好的耐受性,没有中风、感染、胃肠道症状或横纹肌溶解症的发生;低密度脂蛋白胆固醇(LFTs)没有显著升高。由于样本量较少,因此无法观察到烟酸-ER对心血管事件的减少作用。这项研究强调,在继续进行前瞻性治疗试验的同时,有必要进一步评估烟酸-ER对心血管事件的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Association Between Niacin-ER Use, Safety, and Cardiovascular Events. A Single Center Experience.

Background/Synopsis

Studies reveal increased incidences of cardiovascular events such as heart attacks and strokes in patients with elevated lipoprotein(a) levels. Niacin-ER has shown to lower lipoprotein(a) levels by approximately 30% though unknown if niacin-ER reduces cardiovascular events in this population. This single center study evaluates 129 patients with a personal or family history of a premature cardiovascular event whose lipoprotein(a) levels were greater than 75nmol/L and prescribed niacin-ER.

Objective/Purpose

Identify patients with personal or family history of premature cardiovascular events through history and screen patients for baseline serum lipoprotein(a); levels greater than or equal to 75nmol/L were included. Patients were monitored for incidences of cardiovascular events, elevation of liver enzymes, and side-effects of niacin-ER.

The study is an effort to determine if niacin-ER can reduce cardiovascular events. While current ASO-RNA and siRNA studies are undergoing trials, niacin-ER may be a less costly alternative.

Methods

The study followed 129 adult patients seen by a Board Certified Lipidologist/Cardiologist from 2014-2024 with baseline lipoprotein(a) greater than 75 nmol/L. Patients were started on 1000 mg-2000 mg (mean 1713 mg) of niacin-ER and a high intensity statin. In the study, 118 patients were prescribed niacin-ER, while 11 were a better fit for PCSK-9 therapy. Of the 118 patients, 36 could not tolerate the flushing, despite mitigating strategies. Patients’ hospital and outpatient records were reviewed for cardiovascular events.

Results

The average baseline value of lipoprotein(a) was 221.59 nmol/L, higher than 35-70 nmol/L in AIM-HIGH and HPS2-THRIVE trials. Current trials with siRNA and ASO-RNA therapies set inclusion criteria at >150 nmol/L. The average lipoprotein(a) after starting niacin-ER amounted to 157.71 nmol/L, a 33.68% reduction.

Fifteen patients laboratory tests resulted in non-prohibitive mildly elevated liver function tests (LFTs), with maximum ALT and AST of 85 U/L and 68 U/L, respectively, after starting niacin.

All patients were on high-intensity statin.

Conclusions

Niacin-ER reduced lipoprotein(a) levels by 33.68%, comparable to published data of 30%.

Niacin-ER continues to be shown as safe and well-tolerated with no incidences of strokes, infections, gastrointestinal symptoms, or rhabdomyolysis; there was a non-significant elevation in LFTs.

In the 83 patients taking niacin-ER, there were no subsequent cardiovascular events up to ten years follow up.

Reduction in cardiovascular events could not be observed with the low sample size. The study reinforces the need to further assess the effectiveness of niacin-ER on cardiovascular events while prospective therapies continue through trials.

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来源期刊
CiteScore
7.00
自引率
6.80%
发文量
209
审稿时长
49 days
期刊介绍: Because the scope of clinical lipidology is broad, the topics addressed by the Journal are equally diverse. Typical articles explore lipidology as it is practiced in the treatment setting, recent developments in pharmacological research, reports of treatment and trials, case studies, the impact of lifestyle modification, and similar academic material of interest to the practitioner. While preference is given to material of immediate practical concern, the science that underpins lipidology is forwarded by expert contributors so that evidence-based approaches to reducing cardiovascular and coronary heart disease can be made immediately available to our readers. Sections of the Journal will address pioneering studies and the clinicians who conduct them, case studies, ethical standards and conduct, professional guidance such as ATP and NCEP, editorial commentary, letters from readers, National Lipid Association (NLA) news and upcoming event information, as well as abstracts from the NLA annual scientific sessions and the scientific forums held by its chapters, when appropriate.
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