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与烟酸缓释剂治疗相关的潮红和其他皮肤不良事件。

Flushing and other dermatologic adverse events associated with extended-release niacin therapy.

机构信息

Duke University Medical Center, Durham, PO Box 3510, Baker House, Room 281, Trent Drive, NC 27710 USA.

出版信息

J Clin Lipidol. 2009 Apr;3(2):101-8. doi: 10.1016/j.jacl.2009.02.003. Epub 2009 Feb 11.

DOI:10.1016/j.jacl.2009.02.003
PMID:21291799
Abstract

BACKGROUND

Niacin lowers levels of atherogenic apolipoprotein-B-containing lipoproteins, including lipoprotein(a), and raises levels of atheroprotective high-density lipoproteins. However, cutaneous flushing has been a major impediment to the clinical use of niacin.

OBJECTIVE

Extended-release niacin (niacin ER) is a once-daily prescription niacin formulated to limit flushing. An analysis of flushing events with niacin ER should facilitate its clinical use.

METHODS

The analysis pools previously unpublished data on flushing and related side effects from four randomized, double-blind studies of niacin ER, and also reviews long-term data on flushing from a 96-week open label, uncontrolled study.

RESULTS

Among 333 patients treated with niacin ER (once daily at bedtime) for 3 to 6 months, 83% reported at least one flushing episode, compared to 18% of patients treated with placebo or gemfibrozil. Approximately 50% had ≤5 flushing events, and only 5% reported >20 flushing events. The majority (76%) of patients treated with niacin ER rated flushing events as mild to moderate in intensity; 6% of patients withdrew due to flushing. In an 8-week comparison of niacin ER once daily at bedtime with immediate-release niacin three times daily at equivalent total daily doses, the total number of flushing events was 76% lower in the niacin ER group.

CONCLUSION

Niacin ER can help control flushing events while providing favorable effects on lipids and lipoproteins. The generalizability of this analysis may be limited by self-selection and motivation of research subjects, and further studies of flushing in the clinical practice setting are warranted.

摘要

背景

烟酸可降低载脂蛋白 B 含脂蛋白(包括脂蛋白(a))等致动脉粥样硬化脂蛋白的水平,并升高有益的高密度脂蛋白水平。然而,皮肤潮红一直是烟酸临床应用的主要障碍。

目的

烟酸缓释剂(niacin ER)是一种每日一次的处方烟酸制剂,旨在限制潮红反应。对烟酸 ER 潮红事件的分析有助于其临床应用。

方法

对四项烟酸 ER 随机、双盲研究中未发表的潮红和相关不良反应数据进行了汇总分析,并对为期 96 周的开放标签、非对照研究中的长期潮红数据进行了综述。

结果

在 333 例接受烟酸 ER(每晚一次,睡前服用)治疗 3 至 6 个月的患者中,83%报告至少发生了一次潮红事件,而安慰剂或吉非贝齐组的这一比例为 18%。约 50%的患者发生≤5 次潮红事件,只有 5%的患者报告发生>20 次潮红事件。大多数(76%)接受烟酸 ER 治疗的患者将潮红事件评为轻度至中度;有 6%的患者因潮红而退出研究。在每晚一次的烟酸 ER 与每日三次、等效总日剂量的烟酸速释剂的 8 周比较中,烟酸 ER 组的潮红事件总数减少了 76%。

结论

烟酸 ER 可帮助控制潮红事件,同时对血脂和脂蛋白产生有利影响。该分析的普遍性可能受到研究对象的自我选择和动机的限制,有必要在临床实践环境中进一步研究潮红问题。

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