Stress Ulcer Agents

Some patients may prefer the oral route. Some agents can be given in solution or suspension and administered via a nasogastric tube—but be aware of drug interactions. There are limited comparative data for preventing SRMD with these classes. The H2RA and PPI classes of agents are available in intravenous forms, which may be preferable in critically ill patients. However, none of the PPIs are FDA-approved for SRMD prophylaxis.

In the general patient population, SRMD prophylaxis with H2RAs or PPIs is common in 30% to 50% of patients without clear evidence of benefit. Qadeer, et al., identified a 0.4% bleeding rate in their retrospective case-control study of nearly 18,000 patients over a four-year period. In their study, the key risk factor for development of nosocomial GI bleeding was treatment with full-dose anticoagulation or clopidogrel.

Another concern they identified is that when a patient commences an SRMD prophylaxis agent in the hospital, they continue on it post-discharge when it is not needed. This creates an unnecessary cost burden and risks adverse drug interactions.

Todd Janicki, MD, and Scott Stewart, MD, both with the department of medicine at the State University of New York at Buffalo, this year reported on a review of evidence for SRMD prophylaxis in general medicine patients from the peer-reviewed literature.5 They found limited data, identifying only five citations meeting their evaluation criteria. Two of these studies noted only a 3% to 6% reduction in clinically significant bleeding utilizing SRMD prophylaxis. TH

Michele Kaufman is a clinical/managed care consultant and medical writer based in New York City.

New Indications

The two oldest low molecular heparin (LMWH) injection products, Fragmin (dalteparin, Pfizer) and Lovenox (enoxaparin, Sanofi-Aventis) have each added new indications to their U.S. labels. Fragmin is now indicated for extended treatment of symptomatic venous thromboembolism (VTE) including both proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) to reduce VTE recurrence in patients with cancer.

Its other FDA-approved uses:

• Prophylaxis of DVT (which may lead to PE) in patients undergoing hip replacement surgery;
• Prophylaxis of DVT in patients undergoing abdominal surgery who are at risk for thromboembolic (TE) complications;
• Prophylaxis of DVT in patients who are at-risk for TE complications due to severely restricted mobility during acute illness; and
• Prophylaxis of ischemic complications due to unstable angina and non-Q-wave myocardial infarction (MI) when used along with aspirin.

Lovenox is now also indicated for treatment of patients with acute ST-segment elevation MI (STEMI), managed medically or with subsequent percutaneous coronary intervention (PCI).

Its other FDA-approved uses:

• Prophylaxis of DVT in abdominal surgery;
• Prophylaxis of DVT in hip replacement surgery;
• Prophylaxis of DVT in knee replacement surgery;
• Prophylaxis of DVT in medical patients with severely restricted mobility during acute illness;
• Inpatient treatment of acute DVT with or without PE;
• Outpatient treatment of acute DVT without PE; and
• Prophylaxis of ischemic complication of unstable angina and non-Q-wave STEMI managed medically or with subsequent PCI.

References

1. Grube RRA, May DB. Stress ulcer prophylaxis in hospitalized patients not in intensive care units. Am J Health-Syst Pharm. 2007;64:1396-400.
2. ASHP Commission on Therapeutics. ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health-Syst Pharm. 1999;56:347-379.
3. Qadeer MA, Richter JE, Brotman DJ. Hospital-acquired gastrointestinal bleeding outside the critical care unit: risk factors, role of acid suppression, and endoscopy findings. J Hosp Med. 2006;1(1):13-20.
4. Weinhouse GL, Manaker S. Stress ulcer prophylaxis in the intensive care unit. In: UpToDate, Rose, BD (Ed), UpToDate, Waltham, Mass. 2007.
5. Janicki T, Stewart S. Stress-ulcer prophylaxis for general medical patients: a review of the evidence. J Hosp Med. 2007;2(2):86-92.