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

Edward J. Mills1,2, Jonathan E. Prousky2, Gannady Raskin3, Joel Gagnier4, Beth Rachlis2, Víctor M. Montori5, David N. Juurlink6
1Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada
2Department of Research, Canadian College of Naturopathic Medicine, North York, Canada
3Department of Academics, Bastyr University, Seattle, USA
4Department of Clinical Epidemiology, University of Toronto, Toronto, Canada
5Division of Endocrinology, Diabetes, Metabolism, Nutrition, and Internal Medicine, Mayo Clinic, Rochester, USA
6Department of Medicine, University of Toronto, Toronto, Canada

Tóm tắt

Từ khóa


Tài liệu tham khảo

FDA: . Center for Food Safety & Applied Nutrition. Dietary Supplements. Dec.10, 2002, [ http://vm.cfsan.fda.gov/~dms/supplmnt.html ]

HealthCanada.: Dept of Justice. Food and Drugs Act. ( R.S. 1985, c. F-27 ).

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. 10.1046/j.1365-2125.1998.00715.x.

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. 10.1046/j.1365-2125.1999.00060.x.

Improving ADR reporting. Lancet. 2002, 360: 1435-10.1016/S0140-6736(02)11485-1.

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.

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. 10.1016/S0002-9149(01)02338-4.

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. 10.1056/NEJMoa011090.

SoRelle R: Niacin-simvastatin combination benefits patients with coronary artery disease. Circulation. 2001, 104: E9050-60.

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. 10.1016/0090-6980(89)90088-9.

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.

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. 10.1046/j.1525-1497.1997.07118.x.

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.

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. 10.1001/jama.271.9.672.

Clementz GL, Holmes AW: Nicotinic acid-induced fulminant hepatic failure. J Clin Gastroenterol. 1987, 9: 582-584.

Ernst E, Pittler MH: Risks associated with herbal medicinal products. Wien Med Wochenschr. 2002, 152: 183-189. 10.1046/j.1563-258X.2002.01112.x.

Aronson JK, Derry S, Loke YK: Adverse drug reactions: keeping up to date. Fundam Clin Pharmacol. 2002, 16: 49-56. 10.1046/j.1472-8206.2002.00066.x.

Bracchi R: Drug companies should report side effects in terms of frequency. Bmj. 1996, 312: 442-

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. 10.1016/S0885-3924(99)00093-7.

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: 7-10.1186/1471-2288-1-7.

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. 10.1046/j.1365-2753.2001.00295.x.

Yim BT, Chong PH: Niacin-ER and lovastatin treatment of hypercholesterolemia and mixed dyslipidemia. Ann Pharmacother. 2003, 37: 106-115. 10.1345/aph.1C161.

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. 10.1016/S0002-9149(03)00318-7.