Angiotensin Receptor Blockers (ARBs), Hydrochlorothiazide, Atenolol, Amlodipine Use and Celiac Disease

    Basic Details
    Date Posted
    Friday, June 7, 2013
    Status
    Complete
    Medical Product
    amlodipine
    angiotensin II receptor blocker (ARB)
    atenolol
    candesartan
    eprosartan
    hydrochlorothiazide (HCTZ)
    irbesartan
    losartan
    olmesartan
    telmisartan
    valsartan
    Health Outcome(s)
    celiac disease
    Description

    Modular program-based one-time assessment of incident celiac disease events among new users of specific Angiotensin Receptor Blockers (ARBS) including olmesartan, candesartan, eprosartan, irbesartan, losartan, telmisartan, and valsartan and new users of hydrochlorothiazide, atenolol, and amlodipine.Two main categories of counts were generated: 1) incident counts with respect to each of the medications, and 2) incident Celiac Disease events for each exposure group per 1000 person-days at risk [January 2007 – December 2011]. Modular programs are adaptable standardized programs. Results were generated using Modular Program 3; click here for more information. Programs were executed in August 2012.

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    Additional Details
    FDA Center
    CDER
    Time Period
    2007 - 2011
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)