A Call to Test for H. Pylori Before Starting NSAIDs in High Risk Patients

BIRMINGHAM, Ala., Sept. 22 -- The American Gastroenterology Association has issued recommendations aimed at balancing the gastrointestinal and cardiovascular pluses and minuses when using nonsteroidal anti-inflammatory drugs (NSAIDs).

In the first such AGA recommendations to gastroenterologists, a consensus panel called for consideration of routine screening for Helicobacter pylori infection for all patients at high risk of GI complications about to initiate NSAID therapy.

Other factors involved in the GI risk associated with NSAID treatment should also be reduced while balancing cardiovascular risks, wrote C. Mel Wilcox, M.D., of the University of Alabama at Birmingham, and colleagues, in the September issue of Clinical Gastroenterology and Hepatology.

Overall, the GI risk can be modified, but not eliminated, through careful use of Cox-2 inhibitors and gastroprotective therapies, the panel wrote. GI complications are the most common adverse events associated with NSAID use, said the panel. Serious GI complications, such as symptomatic or complicated ulcers with bleeding, perforation, or obstruction, occur in 1% to 4% of NSAID users annually, the panel added.

Short-term studies have shown that eradicating H. pylori infection prophylactically decreases the incidence of peptic ulcers in patients who then initiate NSAID therapy. Recommendations in 1998 on H. pylori by the American College of Gastroenterology suggested that screening is not necessary for all patients but did not define the need for it in high-risk patients.

While previous peptic ulcer is the most significant risk factor for GI complications, other factors include a history of NSAID-related GI complications, advanced age, concomitant use of corticosteroids or anticoagulants with high-dose NSAID medication, and combination NSAID use.

The AGA recommendations for these high risk patients are to:

• Routinely assess for H. pylori, particularly among those with a history of a previous ulcer or ulcer complication,
• Treat H. pylori when present and strongly consider cotherapy with gastroprotective treatment, and
• Strongly consider instituting gastroprotection with Cytotec (misoprostol, at 600 mg/day or more, or proton pump inhibitors.

The recommendations for all patients receiving NSAID medication include:

• Carefully review NSAID-treatment indications and risk factors for both GI and cardiovascular complications,
• Prescribe lower-risk agents,
• Limit duration and dosage,
• Ask about and avoid combination NSAID therapy, such as patient-initiated aspirin use,
• Treat known H. pylori infection, but do not routinely test for H. pylori in average-risk patients starting NSAID therapy, and
• Monitor patients taking both nonselective NSAIDs and coxibs for cardiovascular side effects.

These recommendations generally follow the American Heart Association and FDA recommendations to stick to lower-risk NSAIDs when possible and to assess risks and benefits for each patient.

Short-term, low-dose NSAID use have not been associated with an increased risk of serious cardiovascular events and nonprescription forms have "very favorable" overall benefit versus risk profiles when used according to the labeled instructions, according to the FDA.

The AGA's statement suggests that for patients with a higher risk of life-threatening gastrointestinal bleeding than of cardiovascular events, nonselective NSAIDs (ibuprofen, etodolac, and diclofenac, and Cox-2 inhibitors) are a better choice. Buffered or coated aspirin does not significantly reduce the GI risk for these patients, the authors noted.

For patients with a higher risk of cardiovascular events than of gastrointestinal bleeding, Cox-2 inhibitors should be avoided, they wrote.

Patients with known cardiovascular disease or at a high risk of a cardiovascular event should receive low-dose aspirin, the panel recommended. They noted that ibuprofen and other nonselective NSAIDS may interfere with the cardiovascular benefit of aspirin.

Adding aspirin to a coxib regimen may help reduce the increased cardiovascular risk from coxib use but is unproven in this role and eliminates the gastrointestinal-sparing effects of coxibs.

The combination of nonselective NSAIDs plus proton pump inhibitors or coxib therapy alone as gastroprotection are significantly safer than nonselective NSAID use alone, the panel noted. However, antisecretory H₂-receptor antagonist therapy is inadequate and coxib therapy could increase cardiovascular risk.

Modifying cardiovascular risk factors like tobacco cessation, blood pressure and cholesterol reduction, and glucose control in diabetic patients is warranted in general, although unproven to specifically reduce NSAID- and Cox-2-associated cardiovascular risks, the panel wrote.

Further research is needed, particularly for the nonselective NSAIDs, to clarify the best way to reduce both cardiovascular and gastrointestinal risk, the authors concluded.

Some of the authors reported being consultants to pharmaceutical companies that make NSAIDs. The conference at which this consensus statement was developed was supported by an unrestricted educational grant from TAP Pharmaceuticals.