lafutidine and Heartburn

To compare the clinical efficacy of the second-generation H2RA lafutidine with that of lansoprazole in Japanese patients with mild gastroesophageal reflux disease (GERD).. Patients with symptoms of GERD and a diagnosis of grade A reflux esophagitis (according to the Los Angeles classification) were randomized to receive lafutidine (10 mg, twice daily) or lansoprazole (30 mg, once daily) for an initial 8 wk, followed by maintenance treatment comprising half-doses of the assigned drug for 24 wk. The primary endpoint was the frequency and severity of heartburn during initial and maintenance treatment. The secondary endpoints were the sum score of questions 2 and 3 in the Gastrointestinal Symptom Rating Scale (GSRS), and the satisfaction score.. Between April 2012 and March 2013, a total of 53 patients were enrolled, of whom 24 and 29 received lafutidine and lansoprazole, respectively. After 8 wk, the frequency and severity of heartburn was significantly reduced in both groups. However, lafutidine was significantly inferior to lansoprazole with regard to the severity of heartburn during initial and maintenance treatment (P = 0.016). The sum score of questions 2 and 3 in the GSRS, and satisfaction scores were also significantly worse in the lafutidine group than the lansoprazole group (P = 0.0068 and P = 0.0048, respectively).. The clinical efficacy of lafutidine was inferior to that of lansoprazole, even in Japanese patients with mild GERD.

Topics: Acetamides; Adult; Aged; Aged, 80 and over; Esophagitis, Peptic; Female; Gastroesophageal Reflux; Heartburn; Histamine H2 Antagonists; Humans; Japan; Lansoprazole; Male; Middle Aged; Piperidines; Proton Pump Inhibitors; Pyridines; Severity of Illness Index; Treatment Outcome

This randomized, double-blind, controlled study examined whether lafutidine is superior to placebo and non-inferior to famotidine in terms of healing rates as assessed by endoscopy in Japanese patients with mild reflux esophagitis. Safety and improvement in symptoms of heartburn were also assessed.. Patients with an endoscopic diagnosis of grade A or B reflux esophagitis according to the Los Angeles classification were randomly assigned to receive lafutidine (20 mg/day), famotidine (40 mg/day), or placebo for 8 weeks.. Of the 584 patients enrolled in the study, 447 were diagnosed to have grade A or B reflux esophagitis by the Endoscopic Assessment Committee. Healing rates at 8 weeks were 71.0% (115/162) in the lafutidine group, 61.4% (86/140) in the famotidine group, and 9.7% (14/145) in the placebo group. Lafutidine was thus demonstrated to be superior to placebo and non-inferior to famotidine. As compared with placebo, lafutidine significantly improved symptoms of heartburn.. Lafutidine has a high endoscopic healing rate and improves symptoms of heartburn in patients with mild reflux esophagitis. Lafutidine is considered a promising treatment option for mild reflux esophagitis.

Topics: Acetamides; Double-Blind Method; Esophagitis, Peptic; Esophagoscopy; Famotidine; Female; Heartburn; Histamine H2 Antagonists; Humans; Japan; Male; Middle Aged; Piperidines; Pyridines; Treatment Outcome

Medication for the relief of heartburn should have the rapid onset of action required for on-demand use. We studied the inhibition of gastric acid secretion by lafutidine and rabeprazole, given in single doses to fasting and postprandial subjects.. A total of 22 healthy male, Helicobacter pylori-negative volunteers participated in this randomized, two-way crossover study. They were randomly assigned to receive a single oral dose of 10 mg lafutidine or 20 mg rabeprazole after fasting overnight (12 subjects, fasting study) or after eating a test meal (noodles, 364 kcal; protein, 10.1 g; fat, 16 g; carbohydrates, 44.9 g; NaCl, 1.1 g; 10 subjects, postprandial study). Intragastric pH was monitored continuously for 6 h after treatment. The other drug was given after a washout period of at least 7 days, and intragastric pH was similarly monitored.. In the fasting study, lafutidine sustained pH at >3 and >4 during the second, third, fourth, fifth, and sixth hours of the study for significantly longer than rabeprazole. During the first 6 h after treatment, lafutidine sustained pH at more than 2, 3, 3.5, 4, 5, 6, and 7 longer than rabeprazole. In the postprandial study, lafutidine sustained pH >3 and >4 for longer periods than rabeprazole during the third, fourth, fifth, and sixth hours of the study. During the first 6 h after treatment, lafutidine sustained pH at more than 2, 3, 3.5, 4, 5, 6, and 7 longer than rabeprazole.. Lafutidine 10 mg produces a prompter rise in intragastric pH than rabeprazole 20 mg in fasting and postprandial Helicobacter pylori-negative male subjects.

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Acetamides; Administration, Oral; Adult; Benzimidazoles; Cross-Over Studies; Drug Administration Schedule; Gastric Acid; Gastric Acidity Determination; Heartburn; Humans; Hydrogen-Ion Concentration; Male; Monitoring, Physiologic; Omeprazole; Piperidines; Postprandial Period; Pyridines; Rabeprazole; Reference Values; Risk Assessment; Time Factors; Treatment Outcome

Topics: 2-Pyridinylmethylsulfinylbenzimidazoles; Acetamides; Benzimidazoles; Gastric Acid; Gastric Acidity Determination; Heartburn; Helicobacter Infections; Helicobacter pylori; Histamine H2 Antagonists; Humans; Hydrogen-Ion Concentration; Omeprazole; Piperidines; Prognosis; Proton Pump Inhibitors; Pyridines; Rabeprazole; Severity of Illness Index; Treatment Outcome