A Cohort Study of NSAID Use: DISCUSSION
NSAIDs represent one of the most widely prescribed classes of drugs in the U.S. Although data on NSAIDs abound in randomized, controlled trials, they are limited in terms of patients’ experiences in actual practice. Ours is one of the first studies to examine patient-reported, NSAID-related experiences and behaviors in a primary care setting. We limited our study population to patients 50 years of age and older because of their increased risk of NSAID-related gastropathy.
Regardless of their previous experience with NSAIDs, most patients continued taking these agents two and six weeks after receiving their index prescriptions. All patient groups experienced a reduction in pain at the two-week visit, even those who received a renewal prescription for a presumably chronic condition.
GI symptoms, two-thirds of which were dyspeptic in quality, were common in these NSAID users. Among patients receiving chronic NSAID therapy (the renewal NSAID group), 20% reported dyspeptic symptoms at the baseline visit, a number consistent with the 10% to 20% rate reported in earlier studies. Interestingly, the proportion of patients reporting dyspeptic symptoms decreased at the two-week and six-week visits; this finding could not be explained by the small number of patients who discontinued NSAIDs because of side effects.
The incidence of dyspepsia in patients who had changed their prescription NSAID at the index visit was higher than that in patients who either were given a renewal prescription or who had not recently been taking NSAIDs. These “changed” NSAID patients were also more likely to have been prescribed a COX-2 inhibitor (39%) than were “new” NSAID users (19%) or “renewal” NSAID users (13%). It is possible that patients prone to NSAID-related dyspepsia would be overrepresented in the changed NSAID group because their prescription adjustments might have been prompted by dyspeptic symptoms associated with previous NSAID use.
Only limited data have previously addressed NSAID-asso-ciated GI symptoms in primary care patients. In an observational study from England, Jones and Tait found no difference in the prevalence of dyspepsia over 12 months between NSAID users and controls (46% vs. 43%). In contrast, Talley et al. used the Elderly Bowel Symptom Questionnaire to determine how much upper abdominal pain and heartburn in older patients could be explained by NSAID use; they found an odds ratio of 1.9 for dyspepsia among NSAID users compared with non-NSAID users. Apcalis Oral Jelly
Perhaps our most surprising finding is that patients reported managing their dyspeptic symptoms without involving or even informing their doctors. For the most part, patients reported adjusting their own doses or schedules, taking their medication with food, or starting nonprescription or already available prescription gastroprotective medicines in order to continue their NSAID use. This might be attributed to the perceived beneficial effects of the NSAIDs on pain and quality of life.
Previous research in patients with rheumatoid arthritis has demonstrated a clear hierarchy in desired treatment out-comes.12 Patients with this chronic illness consistently value relief of disability and discomfort above freedom from iatro-genic effects. In short, from the study by Gabriel et al.,
. . . patients desire, first, to function normally; second, to be free from pain and other physical, psychological, or social symptoms; third, to be free of iatrogenic problems from the treatment regimen; fourth, to remain in financial health after medical expenses; and fifth, to be alive as long as possible.
According to this model, then, patients would accept symptoms of dyspepsia (without consulting a doctor) as a trade-off for relief of pain and disability.
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In other studies, patients also tolerated upper GI symptoms during NSAID treatment. Gabriel et al. interviewed patients with rheumatoid arthritis and asked them to rank 18 mutually exclusive health states.13 Respondents ranked the following states as least desirable (in order of increasing desirability): surgery, hospitalization, prophylaxis-induced diarrhea, and outpatient ulcer treatment. Scenarios that included ulcer symptoms (dyspepsia) and the inconvenience of an additional medication taken four times daily (misoprostol) did not significantly affect the patients’ preferences. The patients placed a much higher value on avoiding lower-bowel symptoms, such as diarrhea, than on any upper GI symptoms.
Figure 2 Percentage of all patients taking nonsteroidal anti-inflammatory agents who reported gastrointestinal symptoms. Rx = prescription.
Jones and Tait also found that NSAID users were more likely to stop taking these agents because of constipation than because of dyspepsia. In our six-week observational study, the low incidence of constipation and diarrhea might also help explain our low reported dropout rate. A longer period of follow-up might have increased the number of patients who discontinued NSAIDs.
Our study did not address physician management of NSAID-associated dyspepsia. Algorithms in the literature for physician management of dyspepsia with no “alarm symptoms” (i.e., bleeding, anemia, or weight loss) include:
• discontinuing the NSAID, if possible.
• decreasing the dose.
• switching to another class of NSAIDs.
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they prescribed the NSAID. In any event, the patients indicated that they did not consult their physicians when symptoms of dyspepsia developed. Instead, they used their own remedies to manage their dyspeptic symptoms by stopping the medicine, lowering the dose, taking NSAIDs with food, or adding non-prescription histamine H2-blockers or antacids.
Our study was observational in design, with no control group, and we did not account for baseline GI diagnoses such as gastroesophageal reflux disease (GERD) or peptic ulcer disease, which would influence symptoms and medication usage. For these reasons, we cannot definitively attribute the GI symptoms of our patients to the use of NSAIDs.
Regardless of the cause of the symptoms, we found that most patients tolerated and managed their upper GI symptoms without calling their physicians and continued taking NSAIDs as long as they provided pain relief. We did not assess patients’ perceptions of how accessible their physician was for follow-up visits or for telephone consultations regarding the management of side effects. Many factors (e.g., type of insurance coverage, office scheduling, and telephone systems) might have affected patients’ perceptions of the physicians’ availability. In addition, the racial mix and the predominance of women in our sample, although not reflective of the U.S. population as a whole, were representative of the urban Philadelphia practices from which subjects were recruited. Our study results might not be generalizable to the wider population of older patients.
Although we made attempts not to influence the behavior of either physicians or patients, the enrollment of patients by research assistants at the index visit and the administration of three surveys may have affected patients’ medication-taking routines and their reporting of symptoms. Consistent with this, we found that nearly all patients reported less pain and general improvement at their follow-up visits, perhaps because of the involvement of the research assistants.
Physicians who treat patients with chronic NSAID therapy are likely to be most concerned about the 1% to 4% rate of serious adverse GI events (perforations, symptomatic ulcers, and bleeding). These events can occur without warning; in fact, 81% of patients with serious adverse GI complications reported no prior dyspepsia. Patients, however, do have other concerns. The American Gastroenterological Association, in a survey of 807 patients who had taken NSAIDs, found that 75% of regular NSAID users did not know about—or were unconcerned about—NSAID-related GI complications. buy cialis soft tabs
Our study suggests that physicians should be proactive when informing patients about possible side effects associated with NSAID use. Older patients are more likely to have chronic medical problems for which NSAIDs are commonly prescribed. Because older patients usually continue to take
NSAIDs despite symptoms as long as the medications are providing relief, physicians should help patients to recognize warning signals and should review strategies for avoiding or managing side effects at follow-up visits.