Safety profile of six months lansoprozole treatment in children

Abstract

Proton pump inhibitors (PPIs) block acid production through H/K ATPase inhibition which is the final pump in the acid secretion pathway. They are generally well tolerated in the short term both in adults and children. However, prolonged suppression of acid secretion may interfere with absorption of various minerals, vitamins, and hematinic factors [1]. Although parietal cells are the major site for PPI activation, H/K ATPase pumps which are found in leukocytes and osteoclasts may also be a target for PPIs, which may therefore have some other deleterious effects beside gastric acid inhibition. We evaluated the impact of six months’ lansoprazole treatment on hemoglobin (Hb), serum iron (Fe), ferritin, total iron binding capacity (TIBC), vitamin B12, calcium (Ca), phosphate (P), alkaline phosphatase (ALP) level, urine Ca/Cr, bone turnover, bone mineralization, community acquired pneumonia, and acute gastroenteritis in children. Forty-five children (22 female), aged between 4–17 years (mean 12), who were diagnosed as GERD and had received lansoprozole (1–1.4 mg/kg/day, max 60 mg), and sodium alginate (0.25 mg/kg/dose three times a day) for six months during November 2007 to May 2009, were eligible for the study. None of these children had any systemic illness. GERD was diagnosed by 24 hours esophageal pH monitoring. Patients with symptoms suggestive of gastritis or peptic ulcer underwent gastroduodenoscopy. In each visit (2 months interval), parents were asked for signs of acute gastroenteritis and pneumonia in the preceding 2 months and encouraged to get in touch with the clinic in any kind of infectious or adverse event. Endoscopy was performed in 27 patients, and revealed antral gastritis in 19 and mild duodenitis in 14. Among them, 8 patients had also corpus gastritis and 16 had H. pylori infection. H. pylori-infected children were included in the study 8 weeks after H. pylori eradication was achieved. The mean levels of hemoglobin, serum iron, ferritin, total iron binding capacity, Ca, P, alkaline phosphatase, vitamin B12, urine calcium/creatinine ratio, mean L1-4 bone mineral density, and Z score at baseline were similar to those at six months of lansoprazole treatment (Table 1). L1–L4 total bone mineral content increased significantly (55.9%, p=0.021). One patient developed two episodes of pneumonia. None of the patient developed acute gastroenteritis. Gastric acidity reduces ferric iron to the more soluble ferrous form and facilitates iron absorption [2]. Studies indicating the potential of iron deficiency anemia development, with long term PPI treatment in the clinical practice are restricted with only few case reports in adults [3]. We did not detect an association between iron deficiency anemia and lansoprozole treatment in children. Vitamin B12 requires gastric acidity in order to be released from foods [2]. It has been proposed that reduction of M. Eren (*) Department of Pediatrics, Section of Gastroenterology and Hepatology, Eskisehir Osmangazi University, Faculty of Medicine, Eskisehir, Turkey e-mail: makbule99@yahoo.com