High use of maintenance therapy after triple therapy regimes in Ireland

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High use of maintenance therapy after triple therapy regimes in Ireland K Bennett, H O Connor, M Barry, C O Morain, J Feely Department of Pharmacology & Therapeutics Department of Gastroenterology Trinity Centre for Health Sciences Dublin

Background Helicobacter pylori is one of the most common bacterial infections. About 20% of under 40 year olds, and 50% of over 60 years have H pylori infection. The major cause of gastric and duodenal ulcers is by H pylori. Guidelines recommending eradication of H. pylori using various regimens have reported success rates of over 90% and recurrence rates as low as 1% per year.

Background Optimal treatment: 2 week course triple therapy involves taking 2 antibiotics plus a H 2 receptor antagonist or proton pump inhibitor (PPI). BNF Sept 2004 states There is normally no need to continue antisecretory treatment (with a PPI or H 2 -receptor antagonist) after eradication unless the ulcer is complicated by haemorrhage or perforation. Prolonged use of PPI may be required for gastro-oesophageal reflux disease (GORD) in a few cases, but at a low maintenance dose.

Background Previously conducted a study of 805 patients, having undergone a hospital-based urea breath test during January 2001-December 2002 (first test). Results of whether the test was positive or negative for H. pylori were communicated to the referring GP. These data were linked to subsequent prescribing by the GP.

Any prescribing of PPI/H2 antagonist in the year after H pylori testing P=0.03 60.00% % of all tested within group 50.00% 40.00% 30.00% 20.00% 10.00% 0.00% P=0.77 P=0.56 P=0.03 Any NSAIDs Any aspirin Any PPI/H2 antagonist Negative Positive-not triple Positive+triple

Aim To examine the use of maintenance proton pump inhibitor (PPI) therapy after a triple therapy regime in a large population-based study.

Methods The General Medical Services (GMS) scheme provides free healthcare (including medicines) to approximately 31% of the population and accounts for approximately 65% of all prescribing. The GMS prescription database provides detailed information on all dispensed prescriptions within the scheme. Data from the largest (Eastern) region of Ireland were used. Chi-square tests and non-parametric analyses were performed. More than 32.3m prescriptions items were paid for by the GMS Payments Board in 2003 with a drug expenditure of approximately 637m.

Methods A cohort of patients dispensed triple therapy on the same prescription claim during 2002 were identified (n=2239). This included: Receipt of amoxicillin with clarithromycin and a PPI PPI one of: esomeprazole, pantoprazole, lansoprazole, rabeprazole, or omeprazole. The cohort was followed for 1 year subsequent to triple therapy to determine whether they were: Asymptomatic (no further treatment) Symptomatic (requiring either second line therapy, in form of PPI+clarithromycin+metronidazole, or a maintenance PPI).

Demographics % 80 60 40 20 0 0-44 45-54 55-64 65-74 75+ Age P<0.0001 % in cohort %maintenance PPI 47.5% of cohort Male, 52.5% Female. No difference in % receiving maintenance PPI.

PPI used in triple therapy regime 5% 13% 30% Lansoprazole Omeprazole Esomeprazole 26% 26% Rabeprazole Pantoprazole

Results PPI in triple therapy Maintenance therapy Lansoprazole 54.6% (371) 44.7% Esomeprazole 52.2% (299) 37.5% Omeprazole 57.5% (329) 38.9% Rabeprazole 52.7% (58) 53.4% Pantoprazole 56.3 (166) 42.8% All PPIs 54.6%(1223) 42% Chi-square, p 0.9 0.09 2.1% second line therapy Switched PPI

Dose of maintenance PPI after triple Maintenance PPI therapy Low/Intermediate (maintenance) dose High dose Lansoprazole 15mg; 12% 30mg; 88% Esomeprazole 20mg; 60% 40mg; 40% Omeprazole 10/20mg; 93% 40mg; 7% Rabeprazole 10mg; 11% 20mg; 89% Pantoprazole 20mg; 24% 40mg; 76% All PPIs 49% 51% Chi square, p<0.001

Duration on maintenance therapy 14 12 10 Duration of maintenance PPi 8 6 4 2 0 N = 307 160 357 51 290 Omeprazole Lansoprazole Esomeprazole Pantoprazole Rabeprazole Triple therapy regime (PPI used) P=0.03

Conclusion H. pylori eradication should not be regarded as a cure for all dyspeptic symptoms, particularly as some patients continue to complain of dyspeptic symptoms after successful treatment. The persistent symptoms may be attributed to the unmasking or development of GORD, or NSAIDinduced peptic ulcer disease.