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Disclaimer: CME certification for these activities has expired. All information is pertinent to the timeframe in which it was released.


Does an Aspirin a Day Take the Benefit Away? Preventing NSAID-Related Adverse Events in the Coxib Era


GOAL
To provide a guide for the selection of gastroprotective strategies for the patient requiring continued inflammatory pain management.

TARGET AUDIENCE
This activity is designed for medical directors and pharmacy directors of managed care plans, pharmacy and therapeutic committee members, and all hospital-based managed care decision makers. No prerequisites required.

LEARNING OBJECTIVES
The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity. At the conclusion of this activity, participants should be able to:

  • Review the clinical and economic impact of gastrointestinal events related to the use of nonsteroidal anti-inflammatory drugs (NSAIDs).
  • Identify patient risk factors for NSAID-related adverse gastrointestinal events.
  • Discuss the impact of aspirin on NSAID-related adverse gastrointestinal events and its importance when choosing regimens to prevent their occurrence.
  • Discuss available treatments aimed at decreasing gastrointestinal toxicity in chronic NSAID users.

ACCREDITATION STATEMENT
The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to sponsor continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
The Johns Hopkins University School of Medicine designates this educational activity for a maximum of 2 category 1 credits toward the AMA Physician's Recognition Award. Each physician should claim only those credits that he/she actually spent in the activity.

The estimated time to complete this educational activity: 2 hours.

Release date: June 15, 2003. Expiration date: June 15, 2005.

This program is approved for 2 hours (0.2 CEUs) and is cosponsored by the University of Tennessee College of Pharmacy, which is approved by the American Council on Pharmaceutical Education as a provider of continuing pharmaceutical education. A statement of CE credit will be mailed within 4 weeks of successful completion and evaluation of the program. ACPE Program# 064-999-03-203-H01.

DISCLAIMER STATEMENT
The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of Johns Hopkins University School of Medicine name implies review of educational format design and approach. Please review the complete prescribing information of specific drugs or combinations of drugs, including indications, contraindications, warnings, and adverse effects, before administering pharmacologic therapy to patients.

This program is supported by an educational grant from TAP Pharmaceutical Products, Inc.

Advanced Studies in Medicine (ISSN-1530-3004) is published by Galen Publishing, a division of Advanced Studies in Medicine, an HMG Company. PO Box 340, Somerville, NJ 08876. (908) 253-9001. Copyright ©2003 by Galen Publishing. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from the publisher. Advanced Studies in Medicine is a registered trademark of The Healthcare Media Group, LLC.

Full Disclosure Policy Affecting CME Activities:
As a sponsor accredited by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of Johns Hopkins University School of Medicine to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer(s) of any commercial product(s) discussed in an educational presentation. Program Directors and Participating Faculty reported the following:

PROGRAM DIRECTORS

    A. Mark Fendrick, MD
    Associate Professor of Medicine and Health Management and Policy
    Schools of Medicine and Public Health
    University of Michigan
    Ann Arbor, Michigan
    • Dr Fendrick reports receiving grants and/or research support from Merck & Co, Inc; serving as a consultant to AstraZeneca LP, Merck & Co, Inc, Proctor & Gamble Pharmaceuticals, and TAP Pharmaceutical Products, Inc; and receiving honoraria from Proctor & Gamble Pharmaceuticals and TAP Pharmaceutical Products, Inc.

    Linda A. Lee, MD
    Assistant Professor of Medicine
    Division of Gastroenterology
    Johns Hopkins University School of Medicine
    Baltimore, Maryland
    • Dr Lee reports having no financial or advisory relationships with corporate organizations related to this activity.

PARTICIPATING FACULTY

    Uri Ladabaum, MD
    Assistant Clinical Professor of Medicine
    University of California, San Francisco School of Medicine
    San Francisco, California
    • Dr Ladabaum reports receiving grants and/or research support from AstraZeneca LP, and honoraria from GlaxoSmithKline and Novartis corporation.

    James M. Scheiman, MD
    Associate Professor of Medicine
    Division of Gastroenterology
    University of Michigan Medical Center
    Ann Arbor, Michigan
    • Dr Scheiman reports receiving grants and/or research support from AstraZeneca LP, Merck & Co, Inc, and Pfizer, Inc; serving as a consultant to AstraZeneca LP, Merck & Co, Inc, NitroMed, Inc, Novartis Corporation, Ortho-McNeil Pharmaceutical, Inc, and TAP Pharmaceutical Products, Inc; and serving on the speakers' bureau for AstraZeneca LP, Boehringer Ingelheim, Merck & Co, Inc, Pfizer, Inc, TAP Pharmaceutical Products, Inc, and Wyeth.

Notice:
In accordance with the ACCME Standards for Commercial Support, the audience is advised that one or more articles in this continuing medical education activity contains reference(s) to unlabeled or unapproved uses of drugs or devices. The following faculty member has disclosed that his article has referenced the following unlabeled/unapproved uses of drugs or products:

Dr Scheiman - Proton pump inhibitors.
All other faculty have indicated that they have not referenced unlabeled/unapproved uses of drugs or devices.

Advanced Studies in Medicine provides disclosure information from contributing authors, lead presenters, and participating faculty. Advanced Studies in Medicine does not provide disclosure information from authors of abstracts and poster presentations. The reader shall be advised that these contributors may or may not maintain financial relationships with pharmaceutical companies.

This issue of Advanced Studies in Medicine presents highlights from a series of symposia on the prevention of adverse gastrointestinal (GI) events related to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The series, which was accredited for continuing medical education by the Johns Hopkins University School of Medicine, was specifically developed to address the concerns of decision makers in managed care organizations.

The clinician interview, 4 case studies, and abstracts of 6 recently published articles included in this issue bring the clinical and economic impact of NSAID-related GI events into focus and suggest strategies to prevent these events. These 3 editorial formats encompass many of the issues involved in choosing NSAID therapy and preventing GI events, which include the following:

  • The need to recognize NSAID-related GI events as a serious and common medical problem;
  • The need to recognize that many adverse GI events related to aspirin and NSAID use can be prevented;
  • The need to identify patient risk factors for NSAID-related GI events;
  • The impact of aspirin on NSAID-related GI events and its critical role in choosing regimens to prevent their occurrence; and
  • The impact of gastroprotective agents on decreasing GI toxicity in chronic NSAID users.

NSAID Use and GI Complications
An estimated 13 million Americans, or 5.4% of the population, take an NSAID on a regular basis.1 Among those older than 65 years of age, 79% take NSAIDs weekly, and 34% take at least 1 tablet daily.2 However, NSAIDs have long been associated with adverse GI complications. Recent reports indicate that NSAID-related complications account for more than 100 000 hospitalizations and an estimated 16 500 deaths annually, making these complications the 15th most common cause of death in the United States.3

Prevention Strategies
The first strategy for preventing NSAID-related GI events is to know which factors increase the risk for these events and to assess each patient accordingly. Risk is generally greatest within the first month of NSAID use; however, complications beyond this initial period are common. What is often forgotten is the increased risk in those patients who require aspirin for cardioprotection in addition to NSAIDs for relief of pain and inflammation. This underappreciated risk factor has been referred to as a prime example of "when two rights make a wrong."

Although a history of ulcer complications is a strong risk factor for future NSAID-related complications, most patients who develop GI complications have no previous symptoms.3,4 It is therefore crucial to consider prevention of GI complications in patients taking NSAIDs before symptoms develop.

Other preventive strategies include discontinuation of NSAIDs or use of non-NSAID analgesics, decreasing the NSAID dose, switching from a traditional NSAID to a cyclooxygenase-2 (COX-2) selective inhibitor, prescribing misoprostol to protect the GI tract, and prescribing antisecretory therapy with agents such as H2-receptor antagonists or proton pump inhibitors (PPIs).

In This Publication
The clinician interview featured in this issue of Advanced Studies in Medicine addresses several of the clinical and economic issues involved in preventing NSAID-related GI events. It emphasizes a strategy to stratify patients on the basis of GI risk and the need for aspirin prophylaxis (based on cardiovascular risk) and to choose NSAID therapy and concomitant GI therapy accordingly (Figure).5

The 4 case studies illustrate the use of the 2 x 2 matrix in the clinical setting, with each case focusing on a different quadrant of risk with the matrix.

The 6 abstracts chosen for inclusion in this publication add to the body of evidence in favor of using safer NSAIDs (ie, the COX-2 selective inhibitors) and concomitant therapy to prevent NSAID-related GI events. The first abstract is devoted to the 2 x 2 matrix; the second compares the efficacy of 2 gastroprotective agents for ulcer prevention in long-term NSAID users; the third reviews the major controversies in COX-2 selective inhibition; the fourth compares a COX-2 inhibitor with a traditional NSAID plus a PPI; the fifth evaluates the efficacy of a PPI in the prevention of ulcer complications in patients using long-term low-dose aspirin; and the last describes the complementary roles of COX-2 inhibitors and PPIs.

Rounding out this publication is the continuing education test, which is also available online. We hope you find the material presented herein to be valuable to your health plan.

Figure. A Clinician's Guide to the Selection of NSAID Therapy

No/Low NSAID GI Risk NSAID GI Risk
No Aspirin Traditional NSAID COX-2 Inhibitor
OR
If on PPI, add traditional NSAID
Aspirin* Traditional NSAID plus gastroprotective agent Gastroprotective agent Irrespective of NSAID used

REFERENCES
1. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs. N Engl J Med. 1999;340:1888-1899.
2. Johnson RE, Hornbrook M, Hooker RS, Woodson GT, Shneidman R. Analysis of the costs of NSAID-associated gastropathy. Experience in a US health maintenance organization. Pharmacoeconomics. 1997;12:76-88.
3. Singh G, Ramey DR, Morfeld D, Shi H, Hatoum HT, Fries JF. Gastrointestinal tract complications of nonsteroidal anti-
inflammatory drug treatment in rheumatoid arthritis. A prospective observational cohort study. Arch Intern Med. 1996;156:1530-1536.
4. Armstrong CP, Blower AL. Nonsteroidal anti-inflammatory drugs and life threatening complications of peptic ulceration. Gut. 1987;28:527-532.
5. Fendrick AM, Garabedian-Ruffalo SM. A clinicianÕs guide to the selection of NSAID therapy. Pharm Ther. 2002; 27:579-580,582.

*Associate Professor of Medicine and Health Management and Policy, Schools of Medicine and Public Health, University of Michigan, Ann Arbor;  Assistant Professor of Medicine, Division of Gastroenterology, Johns Hopkins University School of Medicine, Baltimore, Maryland.





Johns Hopkins Advanced Studies in Medicine (ISSN-1558-0334), is published by Galen Publishing, LLC, d/b/a ASiM, PO Box 340, Somerville, NJ 08876. (908) 253-9001. Copyright ©2012 by Galen Publishing. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from the publisher. ASiM is a registered trademark of The Healthcare Media Group, LLC.