Randomized, double-blind comparison of immediate-release omeprazole oral suspension versus intravenous cimetidine for the prevention of upper gastrointestinal bleeding in critically ill patients
| Autor: | James A. Rock, Bonnie Hepburn, Andrew A. Quartin, Steven A. Conrad, Andrea Gabrielli, J. Steven Hata, Loren Laine, Robert G. Bagin, William O. Frank, Benjamin D. Margolis |
|---|---|
| Rok vydání: | 2005 |
| Předmět: |
Male
medicine.medical_specialty Gastrointestinal bleeding Critical Care medicine.drug_class Population Administration Oral Proton-pump inhibitor Critical Care and Intensive Care Medicine Bolus (medicine) Double-Blind Method Suspensions Intensive care Humans Medicine Cimetidine Infusions Intravenous education Omeprazole Aged Dosage Forms education.field_of_study business.industry Stomach Hydrogen-Ion Concentration Middle Aged Anti-Ulcer Agents medicine.disease Survival Analysis Surgery Treatment Outcome Anesthesia Female Upper gastrointestinal bleeding Gastrointestinal Hemorrhage business medicine.drug |
| Zdroj: | Critical Care Medicine. 33:760-765 |
| ISSN: | 0090-3493 |
| DOI: | 10.1097/01.ccm.0000157751.92249.32 |
| Popis: | Objective: To demonstrate that a new immediate-release omeprazole oral suspension is effective in preventing upper gastrointestinal bleeding in critically ill patients. Design: A noninferiority analysis was used to compare rates of clinically significant upper gastrointestinal bleeding in a prospective, phase 3, double-blind trial with parallel omeprazole suspension and cimetidine treatment groups. Setting: A total of 47 intensive care units in the United States. Patients: A total of 359 critically ill patients who required mechanical ventilation for ≥48 hrs, had an Acute Physiology and Chronic Health Evaluation score of ≥11 at baseline, had an intact stomach with a nasogastric or orogastric tube in place, and had at least one additional risk factor for upper gastrointestinal bleeding. Interventions: Patients were randomized to treatment with omeprazole suspension (two 40-mg doses on day 1, via orogastric or nasogastric tube, and 40 mg each day thereafter) or intravenous cimetidine (300-mg bolus and 50 mg/hr thereafter) for up to 14 days. Gastric aspirates were sampled for bleeding and pH. Medication doses were doubled for failure of pH control (two successive aspirates with pH ≤ 4). Measurements and Main Results: Clinically significant upper gastrointestinal bleeding (bright red blood not clearing after 5–10 mins of lavage or persistent Gastroccult-positive “coffee-grounds” material for 8 hrs on days 1–2 or for 2–4 hrs on days 3–14 and not clearing with ≥100 mL of lavage) was the primary end point of the trial. The rate of clinically significant bleeding in the per-protocol population was 4.5% with omeprazole suspension and 6.8% with cimetidine, meeting the criteria for the noninferiority of omeprazole suspension. Median gastric pH was ≥6 on all trial days with omeprazole suspension treatment and on 50% of days with cimetidine treatment (p 4 on each trial day in 95% of patients. Conclusions: Immediate-release omeprazole suspension is effective in preventing upper gastrointestinal bleeding and more effective than intravenous cimetidine in maintaining gastric pH of >4 in critically ill patients. |
| Databáze: | OpenAIRE |
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