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Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release.
Clin Gastroenterol Hepatol. 2012 Mar; 10(3):247-53.CG

Abstract

BACKGROUND & AIMS

Many patients with gastroesophageal reflux disease (GERD) take a proton pump inhibitor (PPI) twice daily to control symptoms. Once-daily dexlansoprazole modified release (MR) has a dual-delayed release formulation, making it attractive for step-down management of patients whose symptoms are well controlled on twice-daily PPIs. We investigated whether step-down to once-daily dexlansoprazole controls heartburn in patients with GERD who were receiving twice-daily PPI therapy.

METHODS

Patients 18 years and older taking a twice-daily PPI for symptom control were enrolled (n = 178) in a single-blind, multicenter study; 163 patients completed the study and 142 patients met criteria for the efficacy analysis. During the 6-week screening and treatment periods, patients recorded the presence of heartburn symptoms twice daily in electronic diaries. Patients' heartburn was considered well controlled if they had an average of 1 symptom or fewer per week during the last 4 weeks of screening and treatment. After screening, qualified patients were switched to masked dexlansoprazole MR 30 mg and placebo for 6 weeks. The primary efficacy end point was the proportion of patients whose heartburn remained well controlled after step-down. GERD-related symptoms and quality of life (QOL) also were evaluated using the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) and the PAGI-QOL questionnaires, respectively.

RESULTS

After step-down to once-daily dexlansoprazole MR 30 mg, heartburn remained well controlled in 88% of patients (125 of 142). These patients were able to maintain their GERD-related symptom severity and QOL, indicated by marginal changes in the PAGI-SYM and PAGI-QOL total and subscale scores, respectively.

CONCLUSIONS

Most patients with GERD who take twice-daily PPI to control heartburn are able to successfully step down to once-daily dexlansoprazole 30 mg.

Authors+Show Affiliations

Section of Gastroenterology, Southern Arizona VA Healthcare System, Tucson, Arizona 85723, USA. ronnie.fass@med.va.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22155561

Citation

Fass, Ronnie, et al. "Maintenance of Heartburn Relief After Step-down From Twice-daily Proton Pump Inhibitor to Once-daily Dexlansoprazole Modified Release." Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, vol. 10, no. 3, 2012, pp. 247-53.
Fass R, Inadomi J, Han C, et al. Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. Clin Gastroenterol Hepatol. 2012;10(3):247-53.
Fass, R., Inadomi, J., Han, C., Mody, R., O'Neil, J., & Perez, M. C. (2012). Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, 10(3), 247-53. https://doi.org/10.1016/j.cgh.2011.11.021
Fass R, et al. Maintenance of Heartburn Relief After Step-down From Twice-daily Proton Pump Inhibitor to Once-daily Dexlansoprazole Modified Release. Clin Gastroenterol Hepatol. 2012;10(3):247-53. PubMed PMID: 22155561.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. AU - Fass,Ronnie, AU - Inadomi,John, AU - Han,Cong, AU - Mody,Reema, AU - O'Neil,Janet, AU - Perez,M Claudia, Y1 - 2011/12/07/ PY - 2011/08/17/received PY - 2011/11/14/revised PY - 2011/11/28/accepted PY - 2011/12/14/entrez PY - 2011/12/14/pubmed PY - 2012/6/14/medline SP - 247 EP - 53 JF - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association JO - Clin. Gastroenterol. Hepatol. VL - 10 IS - 3 N2 - BACKGROUND & AIMS: Many patients with gastroesophageal reflux disease (GERD) take a proton pump inhibitor (PPI) twice daily to control symptoms. Once-daily dexlansoprazole modified release (MR) has a dual-delayed release formulation, making it attractive for step-down management of patients whose symptoms are well controlled on twice-daily PPIs. We investigated whether step-down to once-daily dexlansoprazole controls heartburn in patients with GERD who were receiving twice-daily PPI therapy. METHODS: Patients 18 years and older taking a twice-daily PPI for symptom control were enrolled (n = 178) in a single-blind, multicenter study; 163 patients completed the study and 142 patients met criteria for the efficacy analysis. During the 6-week screening and treatment periods, patients recorded the presence of heartburn symptoms twice daily in electronic diaries. Patients' heartburn was considered well controlled if they had an average of 1 symptom or fewer per week during the last 4 weeks of screening and treatment. After screening, qualified patients were switched to masked dexlansoprazole MR 30 mg and placebo for 6 weeks. The primary efficacy end point was the proportion of patients whose heartburn remained well controlled after step-down. GERD-related symptoms and quality of life (QOL) also were evaluated using the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) and the PAGI-QOL questionnaires, respectively. RESULTS: After step-down to once-daily dexlansoprazole MR 30 mg, heartburn remained well controlled in 88% of patients (125 of 142). These patients were able to maintain their GERD-related symptom severity and QOL, indicated by marginal changes in the PAGI-SYM and PAGI-QOL total and subscale scores, respectively. CONCLUSIONS: Most patients with GERD who take twice-daily PPI to control heartburn are able to successfully step down to once-daily dexlansoprazole 30 mg. SN - 1542-7714 UR - https://www.unboundmedicine.com/medline/citation/22155561/Maintenance_of_heartburn_relief_after_step_down_from_twice_daily_proton_pump_inhibitor_to_once_daily_dexlansoprazole_modified_release_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1542-3565(11)01279-1 DB - PRIME DP - Unbound Medicine ER -