Niacin/lovastatin

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Niacin/lovastatin
Niacin2DCSD.svg
Lovastatin2DCSD.svg
Combination of
Nicotinic acid Lipid-lowering agent
Lovastatin Statin
Clinical data
Routes of
administration
Oral
ATC code
Legal status
Legal status
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CAS Number
KEGG
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Niacin/lovastatin (trade names Advicor) was a drug combination used for the treatment of dyslipidemia. It was a combination of the lipid-modifying drug/vitamin niacin in extended release form and the statin drug lovastatin (trade name Mevacor). [1] The combination preparation was developed by Kos Pharmaceuticals, Inc., which was acquired by Abbott Laboratories in 2006, subsequently transferred to AbbVie Inc. when that company was spun off from Abbott in January 2013.

Advicor was approved by the U.S. Food and Drug Administration (FDA) on December 17, 2001. [2] The FDA withdrew approval on 18 April 2016. The reason given: "Based on the collective evidence from several large cardiovascular outcome trials (Refs. 1-3.), the Agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events." AbbVie Inc. agreed to voluntarily discontinue marketing Advicor. [3] The same FDA action also applied to Simcor, a niacin-extended release combination with simvastatin. [3]

Dosage

The combination was available as tablets containing niacin/lovastatin:

Related Research Articles

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Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes was a randomized control trial designed to assess the efficacy of niacin (extended-release) added to statin therapy in reducing cardiovascular events in patients with established atherosclerotic cardiovascular disease (ASCVD). These patients had well-controlled low-density lipoprotein (LDL) cholesterol but persistently low high-density lipoprotein (HDL) cholesterol and elevated triglycerides. 3,414 patients with established ASCVD were enrolled. The mean follow-up period was three years. The trial was stopped early due to a lack of efficacy and a trend towards an increase in the incidence of ischemic stroke.

References

  1. Bays HE (July 2004). "Extended-release niacin/lovastatin: the first combination product for dyslipidemia". Expert Review of Cardiovascular Therapy. 2 (4): 485–501. doi:10.1586/14779072.2.4.485. PMID   15225109.
  2. "Advicor (Niacin Extended-Release & Lovastatin) Tablets". U.S. Food and Drug Administration; Drug Approval Package. 13 September 2002. Retrieved 17 May 2020.
  3. 1 2 "AbbVie Inc.; Withdrawal of Approval of New Drug Applications for ADVICOR and SIMCOR". U.S. Federal Register. 18 April 2016. Retrieved 17 May 2020.