Vaezi, Michael F.;
Richter, Joel E.;
Stasney, C Richard;
Spiegel, Joseph R.;
Iannuzzi, Ralph A.;
Crawley, Joseph A.;
Hwang, Clara;
Sostek, Mark B.;
Shaker, Reza
Treatment of Chronic Posterior Laryngitis With Esomeprazole
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Media type:
E-Article
Title:
Treatment of Chronic Posterior Laryngitis With Esomeprazole
Contributor:
Vaezi, Michael F.;
Richter, Joel E.;
Stasney, C Richard;
Spiegel, Joseph R.;
Iannuzzi, Ralph A.;
Crawley, Joseph A.;
Hwang, Clara;
Sostek, Mark B.;
Shaker, Reza
imprint:
Wiley, 2006
Published in:The Laryngoscope
Language:
English
DOI:
10.1097/01.mlg.0000192173.00498.ba
ISSN:
0023-852X;
1531-4995
Origination:
Footnote:
Description:
<jats:title>Abstract</jats:title><jats:p><jats:bold>Objective:</jats:bold> To evaluate the efficacy of acid‐suppressive therapy with the proton pump inhibitor esomeprazole on the signs and symptoms of chronic posterior laryngitis (CPL) in patients with suspected reflux laryngitis.</jats:p><jats:p><jats:bold>Study Design:</jats:bold> Prospective, multicenter, randomized, parallel‐group trial that compared twice‐daily esomeprazole 40 mg with placebo for 16 weeks.</jats:p><jats:p><jats:bold>Methods:</jats:bold> Eligible patients had a history of one or more CPL symptoms (throat clearing, cough, globus, sore throat, or hoarseness) and laryngoscopic signs indicating reflux laryngitis based on CPL index (CPLI) scores measured during a screening laryngoscopy. Patients were randomized to treatment if their 7‐day screening diary‐card recordings showed a cumulative primary symptom score of 9 or higher and they had 3 or more days with moderately severe symptoms based on a 7‐point scale. Efficacy was assessed by changes in symptoms as recorded by patients and investigators and by changes in CPLI scores based on laryngoscopic examinations.</jats:p><jats:p><jats:bold>Results:</jats:bold> The patients' primary CPL symptom at final visit (primary efficacy end point) was resolved in 14.7% (14/95) and 16.0% (8/50) of patients in the esomeprazole and placebo groups, respectively (<jats:italic>P</jats:italic> = .799). Esomeprazole and placebo were not significantly different for change from baseline to the final visit in mean total CPLI (–1.66 ± 2.13 vs. –2.0 ± 2.55, respectively; <jats:italic>P</jats:italic> = .446) or any other secondary efficacy end points based on patient diary card or investigator assessments.</jats:p><jats:p><jats:bold>Conclusion:</jats:bold> This study provides no evidence of a therapeutic benefit of treatment with esomeprazole 40 mg twice daily for 16 weeks compared with placebo for signs and symptoms associated with CPL.</jats:p>