1998 AGA News Releases
NEW YORK, NY, March 19, 1998 - New Roper Starch Worldwide survey results released today reveal that nearly 75 percent of the estimated 33 million Americans who regularly use non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen and naproxen, may be unaware or unconcerned that these common pain relievers may cause serious stomach problems such as bleeding ulcers. Commissioned by the American Gastroenterological Association (AGA) and Searle, the survey found almost 60 percent of respondents are estimated to be at moderate to high risk for developing gastrointestinal (GI) complications from NSAIDs. However, only 25 percent perceive themselves to be at moderate to high risk. Even more troublesome, a full 70 percent of respondents believe they are at low or no risk.
This national survey is the first to examine consumer knowledge about NSAID side effects and to scientifically measure the risk levels of NSAID users. A total of 4,799 adults were interviewed (by telephone) to determine NSAID usage; 807 were identified as having used prescription or over-the-counter NSAIDs to relieve pain and/or swelling on at least two occasions in the previous twelve months for at least five consecutive days at a time.
Magnitude of the Problem
Although Americans of all demographics tend to miscalculate their personal risk; adults over the age of 60 are more than twice as likely to understate their risk than to provide an accurate estimation of their risk.
"As people age, they can become more vulnerable to developing digestive tract complications. The fact that people over age 60 have the most dramatic gap in knowledge about pain relievers is a red flag pointing to a need for intervention among this potentially high-risk group, as well as other individuals with specific risk factors making them more susceptible to NSAID-induced ulcers," said AGA President Phillip P. Toskes, MD, professor and chairman of the Department of Medicine at the University of Florida College of Medicine.
In addition to age, factors examined in the survey and known to increase a person's risk of suffering from NSAID-induced GI complications include: duration of NSAID use; history of GI bleeding or peptic ulcer disease; overall health status (ability to perform normal activities); and the use of medications such as oral corticosteroids.1
GI complications caused by NSAIDs remain one of the most prevalent drug toxicities in the nation - leading to approximately 76,000 hospitalizations and 7,600 deaths annually -- a mortality rate comparable to that of asthma, cervical cancer or melanoma (skin cancer) (Centers for Disease Control and Prevention/National Center for Health Statistics). 2,3< "The benefits of NSAIDs are critically needed by millions of people, particularly those living with chronic pain from diseases like arthritis," noted Lee Simon, MD, associate professor of medicine, Harvard Medical School. "However, even though NSAIDs may be among the most commonly used drugs in America, that doesn't mean they're harmless - especially to patients with predisposing risk factors."
Further complicating the issue, only one in five people who suffer NSAID-induced GI complications experiences any prior warning signs.4< The survey found that less than one-third (31 percent) of prescription (Rx) and less than one-quarter (23 percent) of over-the-counter (OTC) NSAID users know this fact - possibly explaining why there appears to be a high level of complacency regarding NSAID risk. In fact, regardless of whether respondents took an Rx or OTC medication, almost 90 percent of those who consider themselves to be at "above ordinary risk" do not seek professional advice.
OTC Users Not Immune To Risks
The survey also uncovered the belief that OTC NSAIDs are safer with regard to inducing ulcers than Rx NSAIDs. This is especially true for exclusive OTC NSAID users as well as dual NSAID users (those who take both Rx and OTC NSAIDs). Forty-six percent of exclusive OTC users and 36 percent of dual users believe OTC NSAIDs are safer than Rx products. This is alarming because over three times as many OTC users take more than the recommended dosage as compared to Rx users (29 percent versus 8 percent), which increases their risk.
In addition, self-medication may present other dangers. Dual NSAID users, the largest sub-population (almost four out of every ten respondents), are the most likely NSAID group to have been hospitalized with ulcers (12 percent). They also are more disabled by pain and swelling than those exclusively taking Rx NSAIDs (70 percent versus 60 percent).
"It's imperative that people realize effective treatment of their pain is neither risk- nor responsibility-free," said James B. Lefkowith, MD, Director of Medical Affairs, U.S. Arthritis, Searle. "Whether taking a prescription or over-the-counter NSAID, one must be cognizant of potential side effects, and prepared to take necessary precautions with the guidance of a pharmacist or medical professional."
Communication Pivotal to Improved Health Outcomes
When it comes to managing pain and understanding side effects, it appears that Rx users have the advantage. Almost three-fourths (71 percent) of individuals using Rx NSAIDs who experienced side effects or were attempting to prevent them, had been informed about potential problems by their pharmacist, compared to less than one-third (32 percent) of those using OTC NSAIDs.
According to the survey, the majority of doctors (approximately 65 percent) warn both their Rx and OTC patients of possible NSAID side effects. However, while most patients are unlikely to return to their physicians with side effect issues once therapy has been initiated, Rx users are more willing than OTC users to do so - 27 percent versus 14 percent.
"As physicians, we need to underscore that medical care doesn't stop once drug therapy begins," said Dr. Toskes. "The road to improved health outcomes is as simple as communication between patients and their doctors. Anyone taking NSAIDs needs to have their personal risk monitored on an ongoing basis."
Bridging the Knowledge Gap
The Roper survey findings were announced today at a joint press briefing held by the AGA and Searle in New York City to launch the first comprehensive NSAID education campaign - REDUCE (Risk Education to Decrease Ulcer Complications and their Effects from NSAIDs). This multi-faceted national initiative will reach consumers and medical professionals through educational and public awareness outreach including a risk screening tool, toll-free hotline, Internet site and free brochure. Nationally, the campaign will roll out to local pharmacies, physician offices, senior centers and retirement communities.
At the heart of the REDUCE campaign is a first-of-its-kind Ulcer Quotient (U.Q.) Risk Screener, a user-friendly tool that estimates an individual's personal risk of NSAID complications. This simple screening device asks consumers a series of basic questions about risk factors and calculates a U.Q. rank indicating low to higher risk levels. NSAID users are encouraged to discuss their results with a medical professional. Consumers can access the U.Q. Risk Screener via a toll-free number (1-888-ARTH-LINE), jointly sponsored by the AGA and Searle, or assess their U.Q. on-line at Searle's Better Living Spa website, www.arthritisconnection.com, established to provide tips to arthritis patients on better managing their condition. Further information about the safer use of NSAIDs also is available in a new consumer brochure developed by the AGA and Searle, "Time to REDUCE," offered through ARTH-LINE and www.arthritisconnection.com.
Note to journalists:
Full Roper survey results and details about the AGA/Searle REDUCE campaign available upon request by calling Tara DiMilia at 212-508-0300.
1 Arthrotec(r) U.S. Labeling. G.D. Searle & Co.
2 Fries JF. NSAID Gastropathy: The Second Most Deadly Rheumatic Disease? Epidemiology and Risk Appraisal. Journal of Rheumatology. 1991; 18 (suppl 28): 7.
3 Anderson RN et al. Centers for Disease Control and Prevention/National Center for Health Statistics Report of Final Mortality Statistics, 1995. Monthly Vital Statistics Report. 1997; 145 (11) (suppl 2).
4 Singh G et al. Gastrointestinal Tract Complications of Nonsteroidal Anti-Inflammatory Drug Treatment in Rheumatoid Arthritis. Archives of Internal Medicine. 1996; 156: 1530-1536.