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      In-office Placement of Mometasone Furoate Sinus Implants for Recurrent Nasal Polyps: A Pooled Analysis

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          Abstract

          Background

          A mometasone furoate (MF) sinus implant (1350 mcg) was evaluated in 2 randomized controlled trials (RCTs) in 400 adults with nasal polyps (NP) who were candidates for revision endoscopic sinus surgery (RESS). We conducted a pooled analysis to evaluate the efficacy of MF implant in specific subgroups of NP patients.

          Methods

          Pooled data from 2 RCTs for 375 patients were analyzed across prespecified subjective and objective end points through day 90.

          Results

          At day 90, patients receiving implants and MF nasal spray (MFNS) experienced significant improvements in nasal obstruction/congestion (NO/C) score ( P = .0095), bilateral polyp grade (BPG, P = .0008), and ethmoid sinus obstruction ( P < .0001) compared to control using MFNS alone. Fewer treatment than control patients remained candidates for RESS (41.0% vs 69.3%, P < .0001). All subgroups experienced significant treatment effects, except NO/C in smokers ( P = .0509) and patients without altered smell ( P = .1873). Subgroups without asthma and with only 1 prior ESS experienced largest treatment effect on NO/C, and those with recent surgery <24 months and BPG >5 showed largest effect on endoscopic end points and RESS. Control patients with ESS <24 months were at 7 times highest risk for RESS ( P < .0001). One (0.4%) patient experienced implant-related serious adverse event (epistaxis).

          Conclusion

          On pooled analysis, MF implants with MFNS showed more favorable results than MFNS alone across several subjective and objective end points at day 90 and may play an important role in management of NP patients, especially those who have allergic rhinitis, expanded polyposis, altered smell, or had most recent ESS < 24 months.

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          Most cited references28

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          Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial.

          Dupilumab has demonstrated efficacy in patients with asthma and atopic dermatitis, which are both type 2 helper T-cell-mediated diseases.
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            International Consensus Statement on Allergy and Rhinology: Rhinosinusitis.

            The body of knowledge regarding rhinosinusitis(RS) continues to expand, with rapid growth in number of publications, yet substantial variability in the quality of those presentations. In an effort to both consolidate and critically appraise this information, rhinologic experts from around the world have produced the International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR:RS).
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              Summary health statistics for U.S. adults: national health interview survey, 2012.

              This report presents detailed tables from the 2012 National Health Interview Survey (NHIS) for the civilian noninstitutionalized adult population, classified by sex, age, race and Hispanic origin, education, current employment status, family income, poverty status, health insurance coverage, marital status, and place and region of residence. Estimates (frequencies and percentages) are presented for selected chronic conditions and mental health characteristics, functional limitations, health status, health behaviors, health care access and utilization, and human immunodeficiency virus testing. Percentages and percent distributions are presented in both age-adjusted and unadjusted versions.
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                Author and article information

                Journal
                Am J Rhinol Allergy
                Am J Rhinol Allergy
                AJR
                spajr
                American Journal of Rhinology & Allergy
                SAGE Publications (Sage CA: Los Angeles, CA )
                1945-8924
                1945-8932
                23 May 2019
                September 2019
                : 33
                : 5
                : 545-558
                Affiliations
                [1 ]ENT of Georgia, Atlanta, Georgia
                [2 ]Department of Otolaryngology – Head and Neck Surgery at Northwestern University, Feinberg School of Medicine, Chicago, Illinois
                [3 ]Divisions of Rhinology and Endoscopic Sinus – Skull Base Surgery and Allergy, Eastern Virginia Medical School, Norfolk, Virginia
                [4 ]Advanced ENT and Allergy, Louisville, Kentucky
                [5 ]Sacramento ENT, Roseville, California
                [6 ]Iowa ENT Center, Des Moines, Iowa
                [7 ]Collin County Ear Nose and Throat, Frisco, Texas
                [8 ]Ohio Sinus Institute, Dublin, Ohio
                [9 ]Palo Alto, California
                [10 ]Intersect ENT, Inc., Menlo Park, California
                Author notes
                [*]J. Pablo Stolovitzky, ENT of Georgia, 5673 Peachtree Dunwoody Road, Atlanta, GA 30342, USA. Email: stol@ 123456entofga.com
                Author information
                https://orcid.org/0000-0002-8370-4884
                Article
                10.1177_1945892419850924
                10.1177/1945892419850924
                6728749
                31117809
                0b11687a-5960-4cd2-b29c-ef09e1532765
                © The Author(s) 2019

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                Categories
                Original Articles

                Immunology
                bioabsorbable,chronic sinusitis,corticosteroid,ethmoid,endoscopic sinus surgery,polyposis,sinus surgery,stent

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