PMID- 21083590 OWN - NLM STAT- MEDLINE DCOM- 20110506 LR - 20131121 IS - 1365-2036 (Electronic) IS - 0269-2813 (Linking) VI - 33 IP - 1 DP - 2011 Jan TI - Randomised clinical trial: identification of responders to short-term treatment with esomeprazole for dyspepsia in primary care - a randomised, placebo-controlled study. PG - 41-9 LID - 10.1111/j.1365-2036.2010.04501.x [doi] AB - BACKGROUND: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. AIM: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. METHODS: Eight hundred and five uninvestigated, primary care patients with upper GI symptoms that were considered to be acid-related were randomised to 2 weeks' treatment with esomeprazole 40 mg or placebo. The study population was divided into a model sample (N = 484) and a validation sample (N = 321). We developed a therapeutic index to predict PPI response from the model sample and tested this in the validation sample. RESULTS: Response to PPI was found in 68% of patients (44% in placebo arm). Bothersome heartburn and early satiety were associated with increased likelihood of PPI response, whereas dull abdominal pain, pain relieved by bowel movements and nausea in women were associated with a decreased likelihood of PPI response. Patients in the validation sample could be classified as having a 'very high' (n = 55), 'high' (n = 123), 'medium' (n = 78) or 'low' (n = 65) probability of PPI response. The therapeutic gains over placebo were 55%, 31%, 20% and 22%, respectively. CONCLUSIONS: In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). CI - (c) 2010 Blackwell Publishing Ltd. FAU - Meineche-Schmidt, V AU - Meineche-Schmidt V AD - Department of General Practice, The Panum Institute, University of Copenhagen, Denmark. FAU - Christensen, E AU - Christensen E FAU - Bytzer, P AU - Bytzer P LA - eng SI - ClinicalTrials.gov/NCT00318968 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20101029 PL - England TA - Aliment Pharmacol Ther JT - Alimentary pharmacology & therapeutics JID - 8707234 RN - 0 (Anti-Ulcer Agents) RN - 0 (Proton Pump Inhibitors) RN - N3PA6559FT (Esomeprazole) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Anti-Ulcer Agents/*therapeutic use MH - Dyspepsia/*drug therapy MH - Esomeprazole/administration & dosage/*therapeutic use MH - Female MH - Humans MH - Male MH - Middle Aged MH - Primary Health Care MH - Proton Pump Inhibitors/administration & dosage/*therapeutic use MH - Regression Analysis MH - Treatment Outcome MH - Young Adult EDAT- 2010/11/19 06:00 MHDA- 2011/05/07 06:00 CRDT- 2010/11/19 06:00 PHST- 2010/11/19 06:00 [entrez] PHST- 2010/11/19 06:00 [pubmed] PHST- 2011/05/07 06:00 [medline] AID - 10.1111/j.1365-2036.2010.04501.x [doi] PST - ppublish SO - Aliment Pharmacol Ther. 2011 Jan;33(1):41-9. doi: 10.1111/j.1365-2036.2010.04501.x. Epub 2010 Oct 29.