American Journal of Cardiology
Volume 101, Issue 8, Supplement , Pages S3-S8 , 17 April 2008

Safety of Niacin and Simvastatin Combination Therapy

  • Harold Bays, MD

      Affiliations

    • Corresponding Author InformationAddress for reprints: Harold Bays, MD, L-MARC Research Center, 3288 Illinois Avenue, Louisville, Kentucky 40213.

References 

  1. Bays HE. Extended-release niacin/lovastatin: the first combination product for dyslipidemia. Expert Rev Cardiovasc Ther. 2004;2:485–501
  2. Ward S, Lloyd JM, Pandor A, Holmes M, Ara R, Ryan A, et al. A systematic review and economic evaluation of statins for the prevention of coronary events. Health Technol Assess. 2007;11:1–178
  3. McKenney J. New perspectives on the use of niacin in the treatment of lipid disorders. Arch Intern Med. 2004;164:697–705
  4. Abbott Laboratories. Niaspan tablets: niacin extended-release tablets. http://www.rxabbott.com/pdf/niaspan.pdfAccessed October 3, 2007
  5. Merck & Company, Inc.. Zocor (simvastatin). http://www.zocor.com/simvastatin/zocor/consumer/product_information/ppi/index.jspFebruary 26, 2008
  6. Bays H. Statin safety: an overview and assessment of the data—2005. Am J Cardiol. 2006;97(suppl):6C–26C
  7. Ballantyne CM, Corsini A, Davidson MH, Holdaas H, Jacobson TA, Leitersdorf E, et al. Risk for myopathy with statin therapy in high-risk patients. Arch Intern Med. 2003;163:553–564
  8. Guyton JR, Bays HE. Safety considerations with niacin therapy. Am J Cardiol. 2007;99(suppl):22C–31C
  9. Birjmohun RS, Hutten BA, Kastelein JJ, Stroes ES. Efficacy and safety of high-density lipoprotein cholesterol-increasing compounds: a meta-analysis of randomized controlled trials. J Am Coll Cardiol. 2005;45:185–197
  10. Kamal-Bahl S, Burke T, Watson D. Dosage and titration patterns of extended-release niacin in clinical practice. 2006;Paper presented at: American Heart Association 7th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke; May 7–9; Washington, DC
  11. Bays HE, Dujovne CA, McGovern ME, White TE, Kashyap ML, Hutcheson AG, et al. Comparison of once-daily, niacin extended-release/lovastatin with standard doses of atorvastatin and simvastatin (the ADvicor Versus Other Cholesterol-Modulating Agents Trial Evaluation [ADVOCATE]). Am J Cardiol. 2003;91:667–672
  12. Zhao XQ, Morse JS, Dowdy AA, Heise N, DeAngelis D, Frohlich J, et al. Safety and tolerability of simvastatin plus niacin in patients with coronary artery disease and low high-density lipoprotein cholesterol (the HDL Atherosclerosis Treatment Study). Am J Cardiol. 2004;93:307–312
  13. Bays H. Existing and investigational combination drug therapy for high-density lipoprotein cholesterol. Am J Cardiol. 2002;90(suppl):30K–43K
  14. Canner PL, Furberg CD, Terrin ML, McGovern ME. Benefits of niacin by glycemic status in patients with healed myocardial infarction (from the Coronary Drug Project). Am J Cardiol. 2005;95:254–257
  15. Bays H. Commentary: trial finds that simvastatin plus niacin is safe in people with coronary artery disease and low HDL cholesterol. Evid Based Cardiovasc Med. 2004;8:173–176
  16. Kane JP, Malloy MJ, Ports TA, Phillips NR, Diehl JC, Havel RJ. Regression of coronary atherosclerosis during treatment of familial hypercholesterolemia with combined drug regimens. JAMA. 1990;264:3007–3012
  17. Bays HE, Cohen DE. Rationale and design of a prospective clinical trial program to evaluate colesevelam’s glucose-lowering effects in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2007;23:1673–1684
  18. Bays HE, Goldberg RB. The “forgotten” bile acid sequestrants: is now a good time to remember?. Am J Ther. 2007;14:567–580
  19. Bays H, Jones PH. Colesevelam hydrochloride: reducing atherosclerotic coronary heart disease risk factors. Vasc Health Risk Manage. 2007;3:1–10
  20. Nissen SE, Tardif JC, Nicholls SJ, Revkin JH, Shear CL, Duggan WT, et al. Effect of torcetrapib on the progression of coronary atherosclerosis. N Engl J Med. 2007;356:1304–1316
  21. Gadegbeku CA, Dhandayuthapani A, Shrayyef MZ, Egan BM. Hemodynamic effects of nicotinic acid infusion in normotensive and hypertensive subjects. Am J Hypertens. 2003;16:67–71
  22. Canner PL, Berge KG, Wenger NK, Stamler J, Friedman L, Prineas RJ, et al. Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J Am Coll Cardiol. 1986;8:1245–1255
  23. Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, et al Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med. 2001;345:1583–1592
  24. Ballantyne CM, Davidson MH, McKenney J, Keller LH, Bajorunas DR, Karas RH. Comparison of the efficacy and safety of a combination tablet of niacin extended-release and simvastatin and simvastatin monotherapy: the SEACOST I (high-dose) study. Am J Cardiol. In Press.
  25. Ballantyne CM, Davidson MH, McKenney J, Keller LH, Bajorunas DR, Karas RH. Comparison of the efficacy and safety of a combination tablet of niacin extended-release and simvastatin with simvastatin 80 mg monotherapy: the SEACOST II (high-dose) study. J Clin Lipidol. In press.
  26. Karas RH, Kashyap M, Knopp R, Keller LH, Bajorunas DR, Davidson MH. Long-term safety and efficacy of a combination of niacin extended release and simvastatin in patients with dyslipidemia: the OCEANS study. Am J Cardiovasc Drugs. 2008;2:69–81

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

PII: S0002-9149(08)00250-6

doi: 10.1016/j.amjcard.2008.02.026

American Journal of Cardiology
Volume 101, Issue 8, Supplement , Pages S3-S8 , 17 April 2008