Alert Center: NSAIDs and Cardiovascular Effects
Whether the benefits of COX-2 inhibitors ("coxibs") and even some NSAIDs outweigh their cardiovascular risks is an ongoing debate. Physicians as well as patients are uncertain about the optimal use of these agents. This Alert Center provides links to articles and/or policy statements that update the evidence in this important therapeutic area. This Center is not intended to be a definitive source on the subject.
Medscape News
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CME
Naproxen and Celecoxib Do Not Improve Cognitive Function in Elderly Patients
In the Alzheimer's Disease Anti-inflammatory Prevention Trial, use of naproxen or celecoxib did not improve cognitive function, and there was weak evidence for a detrimental effect of naproxen.
Medscape Medical News, May 2008
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COX-2 Inhibitor Plus PPI Best for Preventing NSAID-Related Gastropathy
Although all of the common gastroprotective strategies reduce the risk of upper gastrointestinal (GI) complications in users of nonsteroidal anti-inflammatory drugs (NSAIDs), the combination of a COX-2 inhibitor with a proton pump inhibitor (PPI) is associated with the largest risk reduction, according to a Canadian study reported in the April issue of Gastroenterology.
Reuters Health Information, May 2008
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What Your Patients Are Reading: Long-Term NSAID Use Protective Against Alzheimer's
Long-term use of NSAIDs (particularly ibuprofen) may ward off dementia, hypertension is responsible for a large percentage of disease burden worldwide, chocolate may lower the risk for preeclampsia, exclusively breast-fed children are smarter than their classmates, and cosmetic filler injections may cause acute renal failure.
Medscape Medical News, May 2008
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CME/CE
Long-Term Use of Ibuprofen Lowers Alzheimer's Disease Risk
Long-term use of nonsteroidal anti-inflammatory drugs, specifically ibuprofen, lowers the risk for Alzheimer's disease.
Medscape Medical News, May 2008
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Vioxx Documents Offer Glimpse Into Ghostwritten Manuscripts, "Hire-A-PI," and Data Manipulation
One study documents how Merck hired medical writing companies to conduct reviews or conducted clinical-trial research in-house, then shopped around for an academic author/principal investigator. A second study evaluates mortality reporting in internal documents vs published papers and FDA communications.
Heartwire, April 2008
Featured Articles and Columns
Comparative Effectiveness and Safety of Analgesics for Osteoarthritis: Executive Summary From AHRQ
Review the best evidence on the comparative effectiveness of NSAIDs and other analgesics for osteoarthritis.
Risks versus Benefits of Cyclooxygenase-2-selective Nonsteroidal Antiinflammatory Drugs
This article provides a summary of the basic science underlying the controversies over COX-2-selective NSAIDs, along with recommendations for prescribing them.
CME Weighing the Risks and Benefits of Coxibs, NSAIDs and Antiplatelet Therapy: Where the Data Lead
Discuss the cardiovascular and gastrointestinal risks of selective COX-2 inhibitors and some traditional NSAIDs, describe current research developments and expert recommendations regarding the clinical use of traditional NSAIDs and selective COX-2 inhibitors, and illustrate the management strategies for patients with cardiovascular and/or gastrointestinal risks for which NSAID therapy is warranted.
CME Changing the Patterns of Coxibs/NSAIDs Prescribing: Balancing CV and GI Risks
Assess the gastrointestinal and cardiovascular complications caused by traditional nonselective NSAIDs, COX-2-selective inhibitors, and aspirin combined with NSAIDs and analyze approaches to managing gastrointestinal symptoms and/or risk for complications associated with NSAIDs in patients with and without cardiovascular risk factors.
CME/CE Management of Mild-to-Moderate Osteoarthritic Pain
Are NSAIDs still the best option?
Study: Vioxx, Celebrex Were Widely Overprescribed
Almost two thirds of the growth in COX-2 inhibitor use from 1999 to 2002 occurred in patients at minimal risk for GI bleeding from NSAIDs.
Mechanisms Underlying the Growth Inhibitory Effects of the Cyclo-Oxygenase-2 Inhibitor Celecoxib in Human Breast Cancer Cells
Data suggest a role for COX-2 not only in growth of cancer cells but also in activating the angiogenic pathway.
Current Use of Nonsteroidal Antiinflammatory Drugs and the Risk of Acute Myocardial Infarction
This retrospective case-control analysis found that the risk of first-time acute MI during current use of NSAIDs is not materially altered.
Commentary: NSAID Hysteria -- Chicken Little Revisited
Two practicing rheumatologists are disturbed by the data "sensationalizing" the adverse gastrointestinal, renal, and cardiovascular outcomes associated with NSAIDs and COX-2 NSAIDs.
Parecoxib and Valdecoxib for Postoperative Pain Following CABG or Major General Surgery
Experts at the American College of Cardiology meeting report that risk for adverse events was seen only with the IV coxib prodrug in CAGB patients.
The Current State of Pain Management: An Expert Interview With Scott M. Fishman, MD
Scott M. Fishman, MD, the recently installed president of the American Academy of Pain Medicine, addresses questions about the safety of nonsteroidal anti-inflammatory drugs.
What Are the Options Available for Anti-inflammatory Drugs in the Aftermath of Rofecoxib's Withdrawal?
The withdrawal of rofecoxib (a selective COX-2 inhibitor) has led to an intense debate (and significant confusion) about the benefits and risks of other NSAIDs.
Feeling the Pulse: Figuring the Benefits and Risks of Drug Therapy: Lessons From the Vioxx Withdrawal
How can we know whether the benefits of a drug clearly outweigh its risks?
Life After Rofecoxib
For short-term treatment of joint pain, analgesics such as acetaminophen, tramadol, or even opiates are as effective as NSAIDs.
CME The Pulse of Current Cardiovascular Concern: Anti-inflammatory Medications
The updated editorial note includes information on where to find the latest news on these medications.
NSAIDs Still Under Surveillance – Celecoxib, Valdecoxib, and Naproxen Have Been Added to the List of Suspects
In the wake of Vioxx's notorious publicity, researchers, regulators, and clinicians are now putting Celebrex, Bextra, naproxen, and all NSAIDs under the microscope.
Information From the FDA
FDA Warning Letter
Jan. 10, 2005 - The FDA warns Pfizer Inc. that advertisements for Celebrex and Bextra misled consumers.
FDA Talk Paper
Dec. 23, 2004 - FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Check here periodically for safety information on drugs and other medical products.
Public Statements From Industry, the Medical Profession, and Government
American College of Rheumatology Offers Guidance for Assessing Arthritis Pain Medication Usage (December 22, 2004)
FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex (December 17, 2004)
NIH Halts Use of COX-2 Inhibitor in Large Cancer Prevention Trial (December 17, 2004)
Pfizer Statement on New Information Regarding Cardiovascular Safety of Celebrex (December 17, 2004)
Discussions
Participate in a discussion on NSAIDs and heart risks
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