Clinical trial: lansoprazole 15 or 30 mg once daily vs. placebo for treatment of frequent nighttime heartburn in self-treating subjects.

BACKGROUND: Frequent nighttime heartburn is common. Lansoprazole 15 mg is indicated for treatment of heartburn and other gastro-oesophageal reflux disease-related symptoms. AIM: To evaluate the efficacy and safety of lansoprazole in self-treating subjects with frequent nocturnal heartburn. METHODS: A total of 864 subjects with heartburn on >or=2 days/week over the past month were randomized to double-blind treatment with lansoprazole 15 or 30 mg or placebo each morning. Endpoints were percentage of night times without heartburn (primary), percentage of 24-h days without heartburn and percentage of subjects without heartburn on day 1. RESULTS: Mean percentage of night times without heartburn was significantly greater with lansoprazole 15 mg (61.3%) or lansoprazole 30 mg (61.7%) vs. placebo (47.8%) over 14 days (P < 0.0001 vs. placebo for both doses). Percentage of 24-h days without heartburn and percentage of subjects without heartburn on day 1 were significantly greater with lansoprazole 15 or 30 mg vs. placebo. CONCLUSIONS: Both lansoprazole 15 and 30 mg were highly effective and well tolerated in reducing symptoms in subjects with frequent nighttime heartburn. The benefit of therapy on 24-h heartburn and nighttime heartburn on day 1 of treatment was also evident. Lansoprazole 15 mg is a suitable choice for management of frequent nighttime heartburn.

Double-blind placebo-controlled multicentre studies of rebamipide, a gastroprotective drug, in the treatment of functional dyspepsia with or without Helicobacter pylori infection.

BACKGROUND: Functional dyspepsia is a problem that is difficult to treat in clinical practice. AIM: To evaluate the efficacy and safety of rebamipide (a cytoprotective drug) in functional dyspepsia. METHODS: Patients with functional dyspepsia (n=557) were divided a priori into two studies by Helicobacter pylori status, and enrolled in a 2-week baseline evaluation period. Ninety-nine patients with Helicobacter pylori and 173 patients without Helicobacter pylori, continuing to have at least moderate upper abdominal pain or discomfort, were randomly assigned to rebamipide 100 mg, rebamipide 200 mg or placebo, three times a day, in a double-blind design for 8 weeks. RESULTS: There was significant improvement of individual symptom scores from baseline in all the treatment arms. No significant improvement of individual symptom scores was observed in either rebamipide group at the end of the studies compared to placebo, although the belching score was significantly reduced in the rebamipide 100 mg and 200 mg groups at week 2 (P=0.017 and P=0.012, respectively) in the Helicobacter pylori-positive patients. The ratio of patients who requested usage of the study medication again was greater in the rebamipide 100 mg (85%) and 200 mg (96%, P=0.020) groups compared with the placebo group (72%) among Helicobacter pylori-positive patients. There were no serious study medication related adverse events. CONCLUSIONS: Rebamipide was not superior to placebo in terms of individual symptoms at the end of treatment.

Laparoscopic repair of a colonoscopic perforation.

We report a case of laparoscopic repair of a diagnostic colonoscopic perforation. No other such reports were noted in the literature. The management of colonoscopic perforations has become controversial. Operative vs nonoperative treatment is continually debated. The morbidity of operative management is significant. Colostomy is often performed. Laparoscopy should allow early evaluation of operative patients and primary repair of those with minimal contamination and no residual pathology. The benefits of minimally invasive surgery, such as shortened hospitalization and rapid return to full activities, including work, were realized in our patient. Laparoscopy should be considered in the selective management of colonoscopic perforations.

Triple therapy with lansoprazole, clarithromycin, and amoxicillin for the cure of Helicobacter pylori infection: a short report.

BACKGROUND: Given the therapeutic potential of proton pump inhibitor-based triple therapy for successful cure of Helicobacter pylori infection, we evaluated the efficacy and safety of lansoprazole with clarithromycin and amoxicillin in an open-label, single-center study. MATERIALS AND METHODS: H. pylori-positive patients self-administered lansoprazole, 30 mg; clarithromycin, 500 mg; and amoxicillin, 1 gm bid for 14 days. Patients were assessed pretreatment, at which time the presence of H. pylori was documented by rapid urease test, culture, or histology, following study drug administration (week 2) for a brief evaluation only, and at least 4 weeks posttreatment (week 6), which included endoscopy with collection of biopsy specimens for culture and histology testing. RESULTS: Primary clarithromycin and metronidazole resistance were observed in 6% (2 of 30) and 43% (13 of 30) of study patients, respectively. One month after the end of therapy, H. pylori infection was cured in 23 of 25 patients (92%; 95% confidence interval, 74%-99%). The triple-therapy regimen was well-tolerated; 17% of patients (5 of 30) reported mild to moderate adverse effects during the treatment period. CONCLUSION: A 2-week, triple-drug combination of lansoprazole, clarithoromycin, and amoxicillin is highly effective for cure of H. pylori infection. Additionally, the triple-drug combination was well-tolerated by patients infected with H. pylori.