Novel Proton Pump Inhibitor for GERD with EE
Speaker: Donald O. Castell, MD, Professor of Medicine, Medical University of South Carolina, Charleston, South Carolina
Esomeprazole (Nexium generic, AstraZeneca), the S-isomer of generic omeprazole, when taken in doses of 40 mg daily, is more effective in rapidly achieving sustained resolution of daily and nocturnal heartburn in patients with gastroesophageal reflux disease (GERD) with erosive esophagitis (EE) than lansoprazole (Drug Prevacid, TAP) 30 mg daily.
This conclusion was based on a large-scale, U.S., multicenter, randomized, double-blind trial including 5,241 adult GERD patients with endoscopically confirmed EE to assess the efficacy of esomeprazole compared with lansoprazole for treating daily and nocturnal heartburn in these patients. Patients were randomly assigned to once-daily esomeprazole 40 mg or lansoprazole 30 mg, for up to eight weeks.
Baseline severity of heartburn was balanced between treatment groups. Time to sustained resolution of heartburn, recorded by patient diary data, was achieved significantly faster with esomeprazole (seven days) than with generic lansoprazole (eight days). In addition, faster sustained nocturnal heartburn resolution was recorded with esomeprazole (one day) than with lansoprazole (two days). Finally, more patients treated with esomprazole had complete resolution of investigator-recorded heartburn at the end of week 4 than did those on lansoprazole (62.9% vs. 60.2%). Overall, both canadian esomeprazole and lansoprazole were well-tolerated.
Intravenous PPI for ICU Patients
Speaker: Robert Aris, MD, Associate Professor of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
Intermittent dosing with intravenous (IV) pantoprazole (Generic Protonix IV, Wyeth-Ayerst) a proton pump inhibitor (PPI), rapidly achieves and maintains pH equal to or greater than 4 in critically ill intensive-care unit (ICU) patients at risk for upper gastrointestinal (UGI) bleeding, resulting in the elimination of UGI bleeding events or related symptoms during a recent study.
The multicenter study randomized 86 ICU patients at risk for UGI bleeding to one of four dosing regimens of IV pantoprazole tablet (P)—P 40 mg once daily, P 40 mg twice daily, P 80 mg twice daily, P 80 mg three times daily—or the standard approved regimen of continuous infusion cimetidine (Tagamet, GlaxoSmithKline), to evaluate the potential ability of an IV PPI to rapidly raise intragas-tric pH in ICU patients. Patients were treated with the study drug for at least 48 hours and up to seven days. Gastric aspirations were taken every two hours for the determination of gastric pH and the detection of possible bleeding.
Preliminary results suggested that all IV canadian pantoprazole groups could achieve and maintain gastric pH over 4 within 2.9 to 3.2 hours of the initiation of therapy, with a progressive increase in pH by day 2. Cimetidine reached a pH over 4 in approximately the same time frame (2.5 hours) on day 1, but was unable to maintain control of the percentage of time with pH over 4 by day 2, presumably because of tolerance. The percentage of time that pH was greater than 4 on days 1 and 2, respectively, was 45% and 55% for P 40 mg every 24 hours; 55% and 69% for P 40 mg every 12 hrs; 71% and 82% for P 80 mg every 12 hours; 73% and 83% for P 80 mg every eight hours; and 81% and 73% for cimetidine.
Speaker: Abdullah Rashdan, MD, Senior Fellow, Division of Gastroenterology and Hepatology, St. Louis University School of Medicine, St. Louis, Missouri
Mycophenolate mofetil (MMF) (Cellcept generic, Roche Laboratories, Inc.), a drug indicated for the prophylaxis of organ rejection in patients receiving allogenic renal, cardiac, or hepatic transplants, appears to be a safe and effective steroid-sparing alternative to the standard treatment with azathioprine (Imuran medication, Faro) for the treatment of autoimmune hepatitis (AIH).
Five patients with AIH who were intolerant of or resistant to standard therapy were identified prospectively and treated with MMF. Azathioprine canadian was discontinued in all patients. The initial dose of MMF was 500 mg daily and this was gradually increased in 500-mg daily increments to 2 gm daily or to the highest tolerated dose. Prednisone was subsequently tapered to 5 mg daily or less.
All patients achieved and maintained a biochemical remission over an average follow-up period of 18 months. Two patients had resolution of potentially serious generic azathioprine related complications (cervical dysplasia and skin cancer) when switched to MMF. While on MMF, two patients were able to completely discontinue prednisone; two patients had prednisone doses tapered to 5 mg daily; and one patient had prednisone tapered to 3 mg daily. None of the patients had any adverse effects from MMF. Based on these findings, further larger controlled trials, using histologic endpoint and longer-term follow-up, are strongly suggested to confirm these observations.