By Bruce Sylvester
SAN DIEGO -- October 28, 2009 -- Naproxen use increases the risk of complicated gastroduodenal ulcers significantly, researchers reported here at the American College of Gastroenterology (ACG) 74th Annual Scientific Meeting.
"Gastroprotective therapy should be considered for all patients, regardless of naproxen dose used, to protect against complicated gastric and duodenal ulcers," said lead investigator Gurkirpal Singh, MD, Stanford University, Palo Alto, California, in his poster presentation on October 25.
As background, the investigators noted that naproxen has been associated in previous clinical trials with less-serious cardiovascular toxicity than COX-2 inhibitors, and this has led to an increase in its use among patients with cardiovascular risks who require nonsteroidal anti-inflammatory (NSAID) drug treatment.
The purpose of the current study was to evaluate and compare the prevalence of upper gastrointestinal (UGI) complications in various doses of naproxen.
Researchers extracted data on 688,424 patients in the MediCal (Medicaid in California) database. They identified eligible study patients aged over 18 years with physician-diagnosed arthritis or joint disorders who had filled 1 or more prescriptions for an NSAID from January 1, 1999, to January 31, 2005.
Eligible patients were also required to have had 12 or more months of health plan coverage before getting their first prescription for an NSAID.
The investigators followed eligible patients from entry date until the end of the study period (January 2005) or until hospitalised for complicated gastric or duodenal ulcer (haemorrhage, perforation, or obstruction).
The investigators identified 11,303 patients, or cases, who had been hospitalised due to complicated gastric or duodenal ulcers (mean age, 70.7 years; 34.8% male), and they matched them for the analysis with 45,212 controls (4 per case; mean age 70.7 years; 34.8% male) based on age, gender, and date of hospitalisation.
Patient characteristics were similar among users of various NSAIDs, except for a higher use of COX-3 inhibitors among older patients with more risk factors.
The investigators found that the multivariate-adjusted rate (of risk for hospitalisation for serious UGI toxicity) ratios for different doses of naproxen compared with "remote" use (>=61 days prior to hospitalisation) were 500 mg/day, 2.51 (1.61-3.92); 750 mg/day, 2.95 (2.34-3.73); and 1,000 mg/day, 3.1 (2.71-3.61).
All rate ratios were significantly higher compared with remote NSAID or COX-2 selective inhibitor use (P < .001).
"The risk of serious UGI toxicity with naproxen is dose-dependent," the authors concluded. They also noted that, even though toxicity is dose-dependent, lower doses showed a significant risk of UGI toxicity and UGI-related hospitalisation.
Funding for this study was provided by AstraZeneca.
[Presentation title: Naproxen Use Increases the Risk for Complicated Gastroduodenal Ulcers in a Dose-Dependent Fashion. Abstract 55]
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