期刊论文详细信息
BMC Clinical Pharmacology
The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903]
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
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【 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.

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【 参考文献 】
  • [1]FDA: . [http://vm.cfsan.fda.gov/~dms/supplmnt.html] webciteCenter for Food Safety & Applied Nutrition. Dietary SupplementsDec.10, 2002
  • [2]HealthCanada.: Dept of Justice. Food and Drugs Act. ( R.S. 1985, c. F-27 )
  • [3]Barnes J, Mills SY, Abbot NC, Willoughby M, Ernst E: Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies. Br J Clin Pharmacol 1998, 45:496-500.
  • [4]Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH: Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999, 48:623-627.
  • [5]Improving ADR reporting Lancet 2002, 360:1435.
  • [6]Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, Friedewald W: Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol 1986, 8:1245-1255.
  • [7]Kashyap ML, McGovern ME, Berra K, Guyton JR, Kwiterovich PO, Harper WL, Toth PD, Favrot LK, Kerzner B, Nash SD, Bays HE, Simmons PD: Long-term safety and efficacy of a once-daily niacin/lovastatin formulation for patients with dyslipidemia. Am J Cardiol 2002, 89:672-678.
  • [8]Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, Dowdy AA, Marino EK, Bolson EL, Alaupovic P, Frohlich J, Albers JJ: Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med 2001, 345:1583-1592.
  • [9]SoRelle R: Niacin-simvastatin combination benefits patients with coronary artery disease. Circulation 2001, 104:E9050-60.
  • [10]Morrow JD, Parsons W. G., 3rd, Roberts L. J., 2nd: Release of markedly increased quantities of prostaglandin D2 in vivo in humans following the administration of nicotinic acid. Prostaglandins 1989, 38:263-274.
  • [11]Morrow JD, Awad JA, Oates JA, Roberts L. J., 2nd: Identification of skin as a major site of prostaglandin D2 release following oral administration of niacin in humans. J Invest Dermatol 1992, 98:812-815.
  • [12]Jungnickel PW, Maloley PA, Vander Tuin EL, Peddicord TE, Campbell JR: Effect of two aspirin pretreatment regimens on niacin-induced cutaneous reactions. J Gen Intern Med 1997, 12:591-596.
  • [13]Dunn RT, Ford MA, Rindone JP, Kwiecinski FA: Low-Dose Aspirin and Ibuprofen Reduce the Cutaneous Reactions Following Niacin Administration. Am J Ther 1995, 2:478-480.
  • [14]McKenney JM, Proctor JD, Harris S, Chinchili VM: A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients. Jama 1994, 271:672-677.
  • [15]Clementz GL, Holmes AW: Nicotinic acid-induced fulminant hepatic failure. J Clin Gastroenterol 1987, 9:582-584.
  • [16]Ernst E, Pittler MH: Risks associated with herbal medicinal products. Wien Med Wochenschr 2002, 152:183-189.
  • [17]Aronson JK, Derry S, Loke YK: Adverse drug reactions: keeping up to date. Fundam Clin Pharmacol 2002, 16:49-56.
  • [18]Bracchi R: Drug companies should report side effects in terms of frequency. Bmj 1996, 312:442.
  • [19]Edwards JE, McQuay HJ, Moore RA, Collins SL: Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain. J Pain Symptom Manage 1999, 18:427-437.
  • [20]Derry S, Kong Loke Y, Aronson JK: Incomplete evidence: the inadequacy of databases in tracing published adverse drug reactions in clinical trials. BMC Med Res Methodol 2001, 1:7. BioMed Central Full Text
  • [21]Figueiras A, Tato F, Fontainas J, Takkouche B, Gestal-Otero JJ: Physicians' attitudes towards voluntary reporting of adverse drug events. J Eval Clin Pract 2001, 7:347-354.
  • [22]Yim BT, Chong PH: Niacin-ER and lovastatin treatment of hypercholesterolemia and mixed dyslipidemia. Ann Pharmacother 2003, 37:106-115.
  • [23]Capuzzi DM, Morgan JM, Weiss RJ, Chitra RR, Hutchinson HG, Cressman MD: Beneficial effects of rosuvastatin alone and in combination with extended-release niacin in patients with a combined hyperlipidemia and low high-density lipoprotein cholesterol levels. Am J Cardiol 2003, 91:1304-1310.
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