BACKGROUND/RATIONALE:
This proposal addresses the need for outcomes research related to the most commonly prescribed medication in the United States, non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are associated with serious upper gastrointestinal events (UGIE) defined as perforation, obstruction or bleeding. The annual incidence of NSAID-related UGIE is 2.0-4.5%. NSAIDs contribute to 10-20/1000 hospitalizations per year and a 4-fold increased risk of death. At present, the primary strategies for reducing UGIE include: the use of NSAIDs with misoprostol or a proton pump inhibitor, or prescription of a selective Cox-2 inhibiting NSAID (coxib). Current guidelines advocate the use of these strategies in individuals at high risk of UGIE (old age, prior UGIE, concomitant anticoagulant/steroid use or high dose NSAID). However, when we examined national VA provider adherence to recommended guidelines for safe NSAID prescription, we discovered low adherence (27.4 %), even in the presence of multiple risk factors. Furthermore, recent evidence has suggested an increase in NSAID-related cardiovascular morbidity (myocardial infarction and stroke) associated with some of the recommended strategies for safer NSAID prescription. It remains unknown whether this observed low provider adherence is associated with worse patient outcomes. Do these "recommended guidelines" really make a difference? Do current recommended guidelines result in a reduction of GI adverse events and GI healthcare resource utilization? These are the questions we plan to address in this Merit Review Grant.
OBJECTIVE(S):
Specific Aim #1: To determine if provider adherence to recommended NSAID prescription improves GI clinical outcomes among high-risk patients (patients >65 years, patients co-prescribed anticoagulants or steroids, patients on a high average daily dose of NSAID or patients with a prior history of UGIE).
Specific Aim #2: To determine if an adherent strategy using a coxib (versus NSAID with proton pump inhibitor or misoprostol) is associated with a higher risk of cardiovascular events defined as non-fatal acute myocardial infarction and non-hemorrhagic stroke.
Specific Aim #3: To assess the cost-effectiveness of provider adherence to recommended NSAID prescription among high-risk patients. Cost-effectiveness will be assessed by examining the health resource utilization associated with the care of UGIE among patients who had been prescribed a PPI and those who had not been prescribed a PPI.
METHODS:
We propose a retrospective cohort study using medical and pharmacy data from the VA and claims data from a linked dataset of VA and Medicare, spanning the period from 01/01/00-09/30/05. In the first aim, we will use a time-dependent analysis to assess the extent to which provider adherence to clinical guidelines for safe NSAID prescription affects the clinical outcomes of UGIE, NSAID associated GI health resource utilization. In the second aim, we will assess the incidence of NSAID-related myocardial infarction and stroke. In the third aim, we will use the clinical outcome probabilities obtained (in aims #1 and #2) and the associated VA costs (pharmacy and resource utilization) to assess the cost-effectiveness of an adherent NSAID prescription strategy versus non-adherent strategy. The cost-benefit and budget impact analysis performed will assess the extent to which the VA would find it in its best interest to pay (willingness to pay) for its providers' adherence to recommended guidelines, should such a practice be associated with superior patient outcomes and lower resource consumption.
FINDINGS/RESULTS:
The cohort has been created for this project. The cohort was truncated at the end of 12/31/04, as 2005 Medicare data was not available. Data analysis of the third specific aim is ongoing. The results of the first two specific aims have been presented at national gastroenterology meetings, have received research awards from the American College of Gastroenterology and the American Gastroenterological Association, and the results of specific aims 1 and 2 have been published as full manuscripts (citations are available through the ART Website).
IMPACT:
Currently, the VA does endorse the use of safer NSAID prescription strategies among high-risk users, but lacks evidence that this adherent strategy results in a reduction of healthcare utilization or is cost-effective. Our data will be valuable to VA decision makers regarding formulary choices and in shaping prescription policy. First, we must ascertain whether or not these "recommended guidelines" actually reduce GI adverse events in real-life. Once clinical effectiveness has been demonstrated, we can then interpret current VA policies with regard to their cost-effectiveness. We believe that our analysis will assist VA policy makers in deciding whether or not they should embrace current recommended guidelines for the safer prescription of NSAIDs.
PUBLICATIONS:
Journal Articles
- Abraham NS, Hartman C, Castillo D, Richardson P, Smalley W. Effectiveness of national provider prescription of PPI gastroprotection among elderly NSAID users. American Journal of Gastroenterology. 2008; 103(2): 323-32.
- Abraham NS, El-Serag HB, Hartman C, Richardson P, Deswal A. Cyclooxygenase-2 selectivity of non-steroidal anti-inflammatory drugs and the risk of myocardial infarction and cerebrovascular accident. Alimentary Pharmacology and Therapeutics. 2007; 25(8): 913-24.
- Abraham NS, Hartman C, Smalley W. Mortality following NSAID-related gastrointestinal or cardiovascular event. Gastroenterology. 2007; 132(4 Suppl 2): AB 918.
