The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTNI8054903]

Edward Mills, Jonathan Prousky, Gannady Raskin, Joel Gagnier, Beth Rachlis, Victor Manuel Montori, David Juurlink

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

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. _2003 Mills et al: licensee BioMed Central Ltd.

Original languageEnglish (US)
Article number4
JournalBMC Clinical Pharmacology
Volume3
DOIs
StatePublished - Nov 13 2003

Fingerprint

Niacin
Randomized Controlled Trials
Placebos
Safety
Confidence Intervals
Volunteers
Chills
Pruritus
Aspirin
Counseling
Stomach
Healthy Volunteers
Skin
Incidence

Keywords

  • Niacin
  • Over-the-counter
  • Randomized controlled trial

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Pharmacology

Cite this

The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTNI8054903]. / Mills, Edward; Prousky, Jonathan; Raskin, Gannady; Gagnier, Joel; Rachlis, Beth; Montori, Victor Manuel; Juurlink, David.

In: BMC Clinical Pharmacology, Vol. 3, 4, 13.11.2003.

Research output: Contribution to journalArticle

Mills, Edward ; Prousky, Jonathan ; Raskin, Gannady ; Gagnier, Joel ; Rachlis, Beth ; Montori, Victor Manuel ; Juurlink, David. / The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTNI8054903]. In: BMC Clinical Pharmacology. 2003 ; Vol. 3.
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abstract = "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. _2003 Mills et al: licensee BioMed Central Ltd.",
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AB - 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. _2003 Mills et al: licensee BioMed Central Ltd.

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