Editing Nicotinic acid (section)

===Combined with statins===
Extended release nicotinic acid was combined with [[lovastatin]] (Advicor), and with [[simvastatin]] (Simcor), as prescription drug combinations. The combination niacin/lovastatin was approved by the U.S. [[Food and Drug Administration]] (FDA) in 2001.<ref name=Advicor>{{cite web |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-249_Advicor.cfm |title=Drug Approval Package: Advicor (Niacin Extended-Release & Lovastatin) NDA #21-249 |date=13 September 2002 |website=U.S. [[Food and Drug Administration]] (FDA) |access-date=17 May 2020 |archive-date=4 August 2020 |archive-url=https://web.archive.org/web/20200804174117/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-249_Advicor.cfm |url-status=live }}</ref> The combination niacin/simvastatin was approved by the FDA in 2008.<ref>{{cite web | title=Drug Approval Package: Simcor (Niacin/Simvastatin) NDA #022078 | website=U.S. [[Food and Drug Administration]] (FDA) | date=31 July 2008 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022078s000TOC.cfm | access-date=14 November 2022 | archive-date=14 November 2022 | archive-url=https://web.archive.org/web/20221114011457/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022078s000TOC.cfm | url-status=live }}</ref><ref name=Simcor>{{Cite press release |url=https://www.drugs.com/newdrugs/abbott-receives-fda-approval-simcor-niaspan-simvastatin-novel-combination-medicine-comprehensive-846.html | work = Drugs.com | title = Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management |access-date=2008-03-15 |archive-date=5 August 2020 |archive-url=https://web.archive.org/web/20200805074725/https://www.drugs.com/newdrugs/abbott-receives-fda-approval-simcor-niaspan-simvastatin-novel-combination-medicine-comprehensive-846.html |url-status=live }}</ref> Subsequently, large outcome trials using these nicotinic acid and statin therapies were unable to demonstrate incremental benefit of nicotinic acid beyond statin therapy alone.<ref>{{cite journal |vauthors=Toth PP, Murthy AM, Sidhu MS, Boden WE |title=Is HPS2-THRIVE the death knell for niacin? |journal=J Clin Lipidol |volume=9 |issue=3 |pages=343–50 |date=2015 |pmid=26073392 |doi=10.1016/j.jacl.2015.01.008 }}</ref> The FDA withdrew approval of both drugs in 2016. The reason given: "Based on the collective evidence from several large cardiovascular outcome trials, 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." The drug company discontinued the drugs.<ref name=FDAWithdrawal>{{cite web |url=https://www.federalregister.gov/documents/2016/04/18/2016-08894/abbvie-inc-withdrawal-of-approval-of-new-drug-applications-for-advicor-and-simcor |title=AbbVie Inc.; Withdrawal of Approval of New Drug Applications for Advicor and Simcor |date=18 April 2016 |website=U.S. Federal Register |access-date=17 May 2020 |archive-date=5 August 2020 |archive-url=https://web.archive.org/web/20200805003411/https://www.federalregister.gov/documents/2016/04/18/2016-08894/abbvie-inc-withdrawal-of-approval-of-new-drug-applications-for-advicor-and-simcor |url-status=live }}</ref>