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| |  Significant Variation Found in Efficacy of Proton Pump Inhibitor Among Chronic NSAID Users By Bruce Sylvester CHICAGO, IL -- May 17, 2005 -- In patients taking a nonselective or cyclooxygenase 2 (COX-2)-selective, nonsteroidal anti-inflammatory drug (NSAID), esomeprazole (Nexium(R)) appears to provide significantly greater control of intragastric acid at a steady state than lansoprazole (Prevacid(R)) or pantoprazole (Protonix(R)). Results of a head-to-head study of the 3 proton pump inhibitors (PPIs) were presented here on May 15th at Digestive Disease Week (DDW). The researchers evaluated outpatients who were randomized to 1 of 6 treatment sequences, including once-daily doses of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg. "Among NSAID users, acid suppression may reduce the toxicity of the NSAID, and therefore, it is important to understand how and to what extent acid suppression occurs in PPI users who are also taking NSAIDs," said presenter and lead investigator Jay Goldstein, MD, professor of medicine and vice head for clinical affairs, University of Illinois, Chicago, Illinois. "We were able to identify in this study a range and degree of comparative acid suppression, which should prove helpful to clinicians treating these patients," he explained. The study involved 7 US sites and randomized 90 chronic users of COX-2 inhibitors or nonselective NSAIDs in an open-label, 3-way crossover design. Enrollment criteria included a diagnosis of a medical condition requiring prescription-strength nonselective or COX-2-selective NSAIDs for at least 5 days/week for at least 1 month prior to enrollment. The minimum required NSAID daily dose had to be used for the length of the study. Doses of the PPIs were administered 30 minutes before breakfast on 5 consecutive days. The researchers separated treatments by a washout period of at least 10 days. Subjects received all study doses per protocol. Of the 90 enrolled subjects, 77 (86%) were evaluable; 6 patients dropped out of the study, 4 had invalid pH data, 2 were lost to follow-up, and 1 missed a clinical visit. The investigators reported that esomeprazole maintained a pH level of greater than 4.0 for 17.8 hours of the 24-hour period (74.3%) and lansoprazole for 15.9 hours (66.4%, P = .003) and pantoprazole for 14.6 hours (60.7%, P < .0001). All treatments were well tolerated with no serious adverse events and no discontinuations due to adverse events. "We know that long-term NSAID use can increase the risk for stomach ulcers and this can impede extended treatment," Dr. Goldstein said. "So this study takes us another step [further] in refining our ability to use proton pump inhibitor therapy to reduce that risk among the millions of patients who face it." The research was supported by AstraZeneca Pharmaceuticals LP.
[Presentation title: Intragastric Acid Control in Nonsteroidal Anti-Inflammatory Drug (NSAID) Users: Comparison Of Esomeprazole, Lansoprazole, and Pantoprazole. Poster S1714]
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