The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903]

BMC Clinical Pharmacology

David Juurlink⁶  Victor M Montori⁴  Beth Rachlis¹  Joel Gagnier²  Gannady Raskin⁵  Jonathan Prousky¹  Edward Mills³ 

[1] Department of Research, Canadian College of Naturopathic Medicine, North York, Canada;Department of Clinical Epidemiology, University of Toronto, Toronto, Canada;Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada;Division of Endocrinology, Diabetes, Metabolism, Nutrition, and Internal Medicine, Mayo Clinic, Rochester, USA;Department of Academics, Bastyr University, Seattle, USA;Department of Medicine, University of Toronto, Toronto, Canada

关键词: Niacin;    Randomized controlled trial;    Over-the-counter;   

Others  :  1085480
DOI  :  10.1186/1472-6904-3-4

 received in 2003-07-31, accepted in 2003-11-13,  发布年份 2003

【 摘 要 】

Background

Niacin is widely available over the counter (OTC). We sought to determine the safety of 500 mg immediate release niacin, when healthy individuals use them as directed.

Methods

51 female and 17 male healthy volunteers (mean age 27 years SD 4.4) participated in a randomized placebo-controlled blinded trial of a single dose of an OTC, immediate-release niacin 500 mg (n = 33), or a single dose of placebo (n = 35) on an empty stomach. The outcomes measured were self-reported incidence of flushing and other adverse effects.

Results

33 volunteers on niacin (100%) and 1 volunteer on placebo (3%) flushed (relative risk 35, 95% confidence interval (CI) 6.8–194.7). Mean time to flushing on niacin was 18.2 min (95% CI: 12.7–23.6); mean duration of flushing was 75.4 min (95% CI: 62.5–88.2). Other adverse effects occurred commonly in the niacin group: chills (51.5% vs. 0%, P < .0001), generalized pruritus (75% vs. 0%, P = <.001), gastrointestinal upset (30% vs. 3%, P = .005), and cutaneous tingling (30% vs. 0%, P = <.001). Six participants did not tolerate the adverse effects of niacin and 3 required medical attention.

Conclusion

Clinicians counseling patients about niacin should alert patients not only about flushing but also about gastrointestinal symptoms, the most severe in this study. They should not trust that patients would receive information about these side effects or their prevention (with aspirin) from the OTC packet insert.

【 授权许可】

   
2003 Mills et al; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.

【 图 表 】

Figure 1.

Figure 2.

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