Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI.

We compared the efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler, a novel propellant-free inhaler, versus chlorofluorocarbon (CFC)-metered dose inhaler (MDI) and ipratropium Respimat inhaler in patients with COPD. This was a multinational, randomized, double-blind, double-dummy, 12-week, parallel-group, active-controlled study. Patients with moderate to severe COPD were randomized to ipratropium bromide/albuterol (20/100mcg) Respimat inhaler, ipratropium bromide/albuterol MDI [36mcg/206mcg (Combivent Inhalation Aerosol MDI)], or ipratropium bromide (20mcg) Respimat inhaler. Each medication was administered four times daily. Serial spirometry was performed over 6h (0.15min, then hourly) on 4 test days. The primary efficacy variable was forced expiratory volume in 1s (FEV(1)) change from test day baseline at 12 weeks. A total of 1209 of 1480 randomized, treated patients completed the study; the majority were male (65%) with a mean age of 64 yrs and a mean screening pre-bronchodilator FEV(1) (percent predicted) of 41%. Ipratropium bromide/albuterol Respimat inhaler had comparable efficacy to ipratropium bromide/albuterol MDI for FEV(1) area under the curve at 0-6h (AUC(0-6)), superior efficacy to ipratropium Respimat inhaler for FEV(1) AUC(0-4) and comparable efficacy to ipratropium Respimat inhaler for FEV(1) AUC(4-6). All active treatments were well tolerated. This study demonstrates that ipratropium bromide/albuterol 20/100mcg inhaler administered four times daily for 12 weeks had equivalent bronchodilator efficacy and comparable safety to ipratropium bromide/albuterol 36mcg/206mcg MDI, and significantly improved lung function compared with the mono-component ipratropium bromide 20 mcg Respimat inhaler. [Clinical Trial Identifier Number: NCT00400153].

Simple closure or vagotomy and pyloroplasty for the treatment of a perforated duodenal ulcer: comparison of results.

BACKGROUND/AIMS: Treatment of the perforated duodenal ulcer continues to be a controversial subject. The purpose of our study was to compare the results of simple closure of perforated duodenal ulcer versus treatment by truncal vagotomy and pyloroplasty. METHODS: We present a prospective and randomized study of 207 patients who underwent surgical treatment due to perforated duodenal ulcer. In 117 patients the surgical treatment was simple closure and postsurgery medical treatment with proton pump inhibitors for 1 month, and in 90 patients vagotomy and pyloroplasty with no additional medical treatment. RESULTS: We applied the Visick scale in order to compare postsurgery results. The postoperative morbidity and mortality rates were the same with both techniques. Statistically, in both cases, no significant differences were found in postsurgery symptomatology. The different rates of recurrent ulcers and the reinterventions due to recurrent ulcers presented no significant statistical values. CONCLUSION: We conclude that simple closure remains the selected treatment in the majority of patients who present with a perforated duodenal ulcer. The operation is a simple and safe procedure.