PPI in secondary hemochromatosis.

Authors
Category Primary study
JournalOverview of Medical Research in the Netherlands
Year 2017
INTERVENTION: 12 months treatment with esomeprazole 40 mg twice daily or 12 months treatment with placebo twice daily. CONDITION: Secondary hemochromatosis , Hereditary anemia , Proton pump inhibitor ; ; PRIMARY OUTCOME: The change in LIC measured by MRI of the liver expressed in milgram Fe/gram dry weight after one year of treatment with esomeprazole compared to one year treatment with placebo. SECONDARY OUTCOME: 1. Tolerability of esomeprazole: the incidence of side effect / adverse events will be monitored every 3 months during study visits. ; ; 2. Quality of life: this will be assessed with EQ5D‐forms, with time intervals of 3 months. ; ; 3. Cost‐effectiveness analysis of esomeprazole in treatment of iron overload in hereditary anemia. This will be assessed by a prospective cost‐effectiveness analysis. IMCQ and iPCQ questionnaires will be filled in with time intervals of 3 months. ; ; 4. Related changes in markers of iron metabolism: plasma hepcidin, serum ferritin. ; ; 5. Compliance to study drug. ; ; 6. Need for chelation therapy. ; INCLUSION CRITERIA: o diagnosis of hereditary anemia: hemoglobinopathy (including all sickle cell syndromes and beta‐thalassemia), sideroblastic anemia, congenital dyserythropoietic anemia or an erythrocyte enzyme deficiency. o hemoglobin level at baseline <7.0 mmol/L o clinically stable and relevant iron overload defined as either one of: ‐ a baseline LIC measurement by MRI between 3 and 15 mg Fe/g without having received iron chelation 6 months prior to entering the study. ‐ OR a baseline LIC measurement by MRI between 3 and 15 mg Fe/g on stable chelation therapy (deferasirox, deferoxamine or deferiprone), with documented stable dosage the preceding 6 months and no expected dose reductions or increases the next two years. o aged more than 18 years and able to sign informed consent. o serum transferrin saturation higher than 0.45 once during the preceding 24 months. o received less than 10 units of blood during the preced
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First added on: Aug 23, 2024