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New research on oesophagitis therapy from University of Connecticut, Health Center summarized
2009 JUN 15 - (NewsRx.com) -- New research, 'The clinical safety of long-term lansoprazole for the maintenance of healed erosive oesophagitis,' is the subject of a report. According to a study from the United States, "The clinical safety of long-term lansoprazole therapy for the maintenance of healed erosive oesophagitis has not been extensively studied in clinical trials. To assess the long-term clinical safety of dose-titrated lansoprazole as maintenance therapy for up to 82 months in subjects with healed erosive oesophagitis." "Clinical safety was assessed by monitoring adverse events (AEs), laboratory data including serum gastrin levels, and endoscopy. Mean duration (±s.d.) of lansoprazole treatment during the titrated open-label period was 56 ±24 months (range <1-82 months). Overall, 189 of 195 (97%) subjects experienced a total of 2825 treatment-emergent AEs. Most AEs occurred during the first year of treatment, were mild-to-moderate in severity and resolved while on treatment. Of 155 serious AEs (in 74 subjects), only two (colitis and rectal haemorrhage in one subject) were considered treatment-related. Sixty-nine of 195 subjects (35%) experienced 187 treatment-related AEs, with diarrhoea (10%), headache (8%) and abdominal pain (6%) being the most common. Gastrin levels >or=400 pg/mL were seen in 9% of subjects; hypergastrinemia was not associated with gastro-intestinal AEs or nodules/polyps," wrote J.W. Freston and colleagues, University of Connecticut, Health Center. The researchers concluded: "Lansoprazole maintenance therapy for up to 6 years is safe and well tolerated in subjects with healed erosive oesophagitis." Freston and colleagues published their study in Alimentary Pharmacology & Therapeutics (The clinical safety of long-term lansoprazole for the maintenance of healed erosive oesophagitis. Alimentary Pharmacology & Therapeutics, 2009;29(12):1249-60). For more information, contact J.W. Freston, University of Connecticut Health Center, Dept. of Medicine, Farmington, CT USA.. Publisher contact information for the journal Alimentary Pharmacology & Therapeutics is: Blackwell Publishing Inc., 350 Main St., Malden, MA 02148, USA. Keywords: United States, Farmington, Oesophagitis Therapy, Adverse Drug Effect, Adverse Drug Event, Adverse Drug Reaction, Clinical Trial Research, Drugs, Endoscopy, Gastroenterology, Lansoprazole, Oesophagitis, Pharmaceuticals, Pharmacology, Surgery, Therapies, Therapy, Treatment. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.
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