Details

Autor(en) / Beteiligte

• van Marrewijk, Corine J, MSc
• Mujakovic, Suhreta, PhD
• Fransen, Gerdine AJ, PhD
• Numans, Mattijs E, MD
• de Wit, Niek J, MD
• Muris, Jean WM, MD
• van Oijen, Martijn GH, MSc
• Jansen, Jan BMJ, Prof
• Grobbee, Diederik E, Prof
• Knottnerus, J André, Prof
• Laheij, Robert JF, MD

Titel

Effect and cost-effectiveness of step-up versus step-down treatment with antacids, H2 -receptor antagonists, and proton pump inhibitors in patients with new onset dyspepsia (DIAMOND study): a primary-care-based randomised controlled trial

Ist Teil von

• The Lancet (British edition), 2009-01, Vol.373 (9659), p.215-225

Ort / Verlag

England

Erscheinungsjahr

2009

Link zum Volltext

Quelle

Access via ScienceDirect (Elsevier)

Beschreibungen/Notizen

• Summary Background Substantial physician workload and high costs are associated with the treatment of dyspepsia in primary health care. Despite the availability of consensus statements and guidelines, the most cost-effective empirical strategy for initial management of the condition remains to be determined. We compared step-up and step-down treatment strategies for initial management of patients with new onset dyspepsia in primary care. Methods Patients aged 18 years and older who consulted with their family doctor for new onset dyspepsia in the Netherlands were eligible for enrolment in this double-blind, randomised controlled trial. Between October, 2003, and January, 2006, 664 patients were randomly assigned to receive stepwise treatment with antacid, H2 -receptor antagonist, and proton pump inhibitor (step-up; n=341), or these drugs in the reverse order (step-down; n=323), by use of a computer-generated sequence with blocks of six. Each step lasted 4 weeks and treatment only continued with the next step if symptoms persisted or relapsed within 4 weeks. Primary outcomes were symptom relief and cost-effectiveness of initial management at 6 months. Analysis was by intention to treat (ITT); the ITT population consisted of all patients with data for the primary outcome at 6 months. This trial is registered with ClinicalTrials.gov , number NCT00247715. Findings 332 patients in the step-up, and 313 in the step-down group reached an endpoint with sufficient data for evaluation; the main reason for dropout was loss to follow-up. Treatment success after 6 months was achieved in 238 (72%) patients in the step-up group and 219 (70%) patients in the step-down group (odds ratio 0·92, 95% CI 0·7–1·3). The average medical costs were lower for patients in the step-up group than for those in the step-down group (€228 vs €245; p=0·0008), which was mainly because of costs of medication. One or more adverse drug events were reported by 94 (28%) patients in the step-up and 93 (29%) patients in the step-down group. All were minor events, including (other) dyspeptic symptoms, diarrhoea, constipation, and bad/dry taste. Interpretation Although treatment success with either step-up or step-down treatment is similar, the step-up strategy is more cost effective at 6 months for initial treatment of patients with new onset dyspeptic symptoms in primary care. Funding The Netherlands Organisation for Health Research and Development.