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Editorial
. 2018 Aug;33(8):1213-1214.
doi: 10.1007/s11606-018-4498-3. Epub 2018 Jun 4.

If the IMPROVE-IT Trial Was Positive, as Reported, Why Did the FDA Denied Expanded Approval for Ezetimibe and Simvastatin? An Explanation of the Tipping Point Analysis

Emma P Deloughery  1 , Vinay Prasad  2
Affiliations
Editorial

If the IMPROVE-IT Trial Was Positive, as Reported, Why Did the FDA Denied Expanded Approval for Ezetimibe and Simvastatin? An Explanation of the Tipping Point Analysis

Emma P Deloughery et al. J Gen Intern Med. 2018 Aug.
No abstract available

PubMed Disclaimer

Conflict of interest statement

Dr Prasad is the author of Ending Medical Reversal, and receives royalties.

Comment on

  • Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.
    Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Cannon CP, et al. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3. N Engl J Med. 2015. PMID: 26039521 Clinical Trial.

References

    1. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015;372(25):2387–2397. doi: 10.1056/NEJMoa1410489. - DOI - PubMed
    1. Brauser D. FDA advisors: reject secondary-prevention ezetimibe indication. News 2015. https://www.medscape.com/viewarticle/855958. Accessed Aug. 05, 2017.
    1. Correia LC. Ezetimibe: Clinical and Scientific Meaning of the IMPROVE-IT Study. Arq Bras Cardiol. 2016;106(3):247–249. - PMC - PubMed
    1. FDA Briefing Document. Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). In: Committees A, ed. [Online]: U. S. Food & Drug Administration; 2015.
    1. FDA Briefing Document. Oncologic Drugs Advisory Committee Meeting (BLA:125646): Tisagenlecleucel Novartis Pharmaceuticals Corporation. In: Committee ODA, ed: U.S. Food and Drug Administration 2017;39:46.

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