Abstract | BACKGROUND: There are few data on empiric, stepped therapy for heartburn relief or subsequent relapse in primary care. AIMS: To compare heartburn relief produced by a proton pump inhibitor-start or an H(2)-receptor antagonist-start with step-up therapy, as needed, followed by a treatment-free period to assess relapse. METHODS:
Heartburn-dominant uninvestigated dyspepsia patients from 46 primary care centres were randomized to one of two active treatment strategies: omeprazole 20 mg daily ( proton pump inhibitor-start) or ranitidine 150 mg bid (H2-receptor antagonist-start) for the first 4-8 weeks, stepping up to omeprazole 40 or 20 mg daily, respectively, for 4-8 weeks for persistent symptoms. Daily diaries documented heartburn relief (score < or = 3/7 on < or = of 7 prior days) and relapse (score > or = 4 on > or = 2 of 7 prior days). RESULTS: For ' proton pump inhibitor-start' (n = 196) vs. 'H2-receptor antagonist-start' (n = 194), respectively, heartburn relief occurred in 55.1% vs. 27.3% (P < 0.001) at 4 weeks and in 88.3% vs. 87.1% at 16 weeks. After therapy, 308 patients were heartburn-free (159 vs. 149); median times to relapse were 8 vs. 9 days and cumulative relapse rates were 78.6% vs. 75.8%, respectively. CONCLUSIONS: An empiric ' proton pump inhibitor-start' strategy relieves heartburn more effectively than an 'H2-receptor antagonist-start' strategy up to 12 weeks but has no effect on subsequent relapse, which is rapid in most patients.
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Authors | D Armstrong, S J O Veldhuyzen van Zanten, A N Barkun, N Chiba, A B R Thomson, S Smyth, P Sinclair, B Chakraborty, R J White, CADET-HR Study Group |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 21
Issue 10
Pg. 1189-202
(May 15 2005)
ISSN: 0269-2813 [Print] England |
PMID | 15882239
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Ulcer Agents
- Histamine H2 Antagonists
- Proton Pump Inhibitors
- Ranitidine
- Omeprazole
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Anti-Ulcer Agents
(administration & dosage, adverse effects, therapeutic use)
- Double-Blind Method
- Drug Administration Schedule
- Dyspepsia
(drug therapy)
- Female
- Heartburn
(drug therapy)
- Histamine H2 Antagonists
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Male
- Middle Aged
- Omeprazole
(administration & dosage, adverse effects, therapeutic use)
- Proton Pump Inhibitors
- Quality of Life
- Ranitidine
(administration & dosage, adverse effects, therapeutic use)
- Recurrence
- Treatment Outcome
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