American Journal of Cardiology
Volume 101, Issue 8, Supplement , Pages S9-S13 , 17 April 2008

The Safety of Niacin in the US Food and Drug Administration Adverse Event Reporting Database

  • Alawi A. Alsheikh-Ali, MD
    • ,
  • Richard H. Karas, MD, PhD

      Affiliations

    • Corresponding Author InformationAddress for reprints: Richard H. Karas, MD, PhD, Molecular Cardiology Research Institute, Box #80, Tufts-New England Medical Center, 750 Washington Street, Boston, Massachusetts 02111.

References 

  1. Kuvin JT, Alsheikh-Ali AA, Karas RH. High-density lipoprotein cholesterol-raising strategies. J Cardiovasc Pharmacol. 2006;47:196–204
  2. McKenney J. New perspectives on the use of niacin in the treatment of lipid disorders. Arch Intern Med. 2004;164:697–705
  3. Alsheikh-Ali A, Abourjaily HM, Karas RH. Relative safety of extended-release niacin versus other niacin formulations. [abstract 3754] Circulation. 2004;110:III-813
  4. Alsheikh-Ali AA, Karas RH. Relative safety of lipid altering drugs in the general population. [abstract] Circulation. 2005;112:II-798
  5. Alsheikh-Ali AA, Kuvin JT, Karas RH. Risk of adverse events with fibrates. Am J Cardiol. 2004;94:935–938
  6. Holoshitz N, Alsheikh-Ali AA, Karas RH. Relative safety of gemfibrozil and fenofibrate in the absence of concomitant cerivastatin use. Am J Cardiol. 2008;101:95–97
  7. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in AdultsExecutive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on DetectionEvaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001;285:2486–2497.
  8. Grundy SM, Cleeman JI, Merz CN, Brewer HB, Clark LT, Hunninghake DB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110:227–239
  9. Mosca L, Banka CL, Benjamin EJ, Berra K, Bushnell C, Dolor RJ, et al Evidence-based guidelines for cardiovascular disease prevention in women: 2007 update. Circulation. 2007;115:1481–1501
  10. Alsheikh-Ali AA, Kuvin JT, Karas RH. High-density lipoprotein cholesterol in the cardiovascular equation: does the “good” still count?. Atherosclerosis. 2005;180:217–223
  11. Barter P, Gotto AM, LaRosa JC, Maroni J, Szarek M, Grundy SM, et al. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. N Engl J Med. 2007;357:1301–1310
  12. Alsheikh-Ali AA, Lin JL, Abourjaily P, Ahearn D, Kuvin JT, Karas RH. Prevalence of low high-density lipoprotein cholesterol in patients with documented coronary heart disease or risk equivalent and controlled low-density lipoprotein cholesterol. Am J Cardiol. 2007;100:1499–1501
  13. Niaspan [package insert]. Cranbury, NJ: Kos Pharmaceuticals, Inc; 2005;
  14. Zocor [package insert]. Whitehouse Station, NJ: Merck & Co; 2005;
  15. Davidson MH, Armani A, McKenney JM, Jacobson TA. Safety considerations with fibrate therapy. Am J Cardiol. 2007;99(suppl):3C–18C
  16. Corsini A, Bellosta S, Davidson MH. Pharmacokinetic interactions between statins and fibrates. Am J Cardiol. 2005;96(suppl):44K–49K
  17. Alsheikh-Ali AA, Karas RH. Safety of lovastatin/extended release niacin compared with lovastatin alone, atorvastatin alone, pravastatin alone, and simvastatin alone (from the United States Food and Drug Administration Adverse Event Reporting System). Am J Cardiol. 2007;99:379–381
  18. Begaud B, Martin K, Haramburu F, Moore N. Rates of spontaneous reporting of adverse drug reactions in France. JAMA. 2002;288:1588
  19. Rossi AC, Knapp DE, Anello C, O’Neill RT, Graham CF, Mendelis PS, et al. Discovery of adverse drug reactions (A comparison of selected phase IV studies with spontaneous reporting methods). JAMA. 1983;249:2226–2228
  20. Staffa JA, Chang J, Green L. Cerivastatin and reports of fatal rhabdomyolysis. N Engl J Med. 2002;346:539–540

 Statement of author disclosure: Please see the Author Disclosures section at the end of this article.

PII: S0002-9149(08)00251-8

doi: 10.1016/j.amjcard.2008.02.027

American Journal of Cardiology
Volume 101, Issue 8, Supplement , Pages S9-S13 , 17 April 2008

Article Tools

* Image Usage & Resolution