Nearly half of patients on coxibs also take aspirin, possibly negating GI benefits

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Nearly half of patients on coxibs also take aspirin, possibly negating

GI benefits

June 17, 2004 Janis

Rheumawire

land Heights, MO - An unexpectedly high proportion of patients

taking a prescribed coxib drug are also self-medicating with

over-the-counter aspirin, acetaminophen (paracetamol), and nonsteroidal

anti-inflammatory drugs (NSAIDs). The use of these additional

medications may be placing these patients at an increased risk for

gastrointestinal (GI) adverse events and may negate any GI safety

advantage offered by the selective coxib drugs, warn the researchers

reporting the finding.

The data come from a telephone survey of 325 long-term users of coxibs

carried out by Dr and colleagues from the US pharmacy benefit

manager Express Scripts Inc and reported in the June 14, 2004 issue of

the Archives of Internal Medicine [1]. About half of the respondents

were taking aspirin for cardiovascular protection in addition to the

prescribed coxib, and 76% reported having used an additional OTC pain

reliever in addition to the coxib.

The rate of aspirin use (50%) found in this survey is higher than that

found (21%) in the Celecoxib Long-term Arthritis Safety Study (CLASS),

the researchers note. They also point out that it was aspirin use by

study subjects (which was higher than had been expected) that has been

cited as the reason that CLASS failed to demonstrate a significant

gastroprotective advantage for celecoxib compared with nonselective

NSAIDs [2].

" The findings from the CLASS study suggest that concomitant aspirin use

negates the GI benefit of the COX-2s, calling into question 1 of the

fundamental rationales for prescribing this expensive therapythe

minimization of serious bleeding in the GI tract, " said.

" There is mounting evidence [that calls into question] the

cost-effectiveness of COX-2s compared with traditional NSAIDs in a

general population, " tells rheumawire [3].

" I don't think we have the definite answer on the most cost-effective

anti-inflammatory treatment for patients at risk for cardiovascular (CV)

disease and gastrointestinal problems, " she continues. " There has not

been a study that I'm aware of that compares COX-2s with traditional

NSAIDs plus a proton pump inhibitor (PPI), measuring GI and CV outcomes,

which is really the only logical comparison. "

and colleagues conducted the telephone survey among patients who

obtained at least a 90-day supply of either celecoxib or rofecoxib from

the mail-order pharmacy service during a 3-month period. The survey

asked subjects about their use of COX-2 inhibitors and OTC agents over

the previous 30 days. The final sample size was 325, with a mean age of

71 years.

tells rheumawire that long-term COX-2 users had unexpectedly high

rates of comedication with aspirin, acetaminophen, or OTC NSAIDs and

that approximately half of those on aspirin were taking doses of 325 mg

or higher. " This dosage is higher than necessary for primary

cardiovascular protection, " points out.

The analysis showed that more than 76% of subjects had used at least 1

OTC NSAID or acetaminophen on 1 or more days during the previous month.

Of these, 48% used aspirin, 43% used acetaminophen, 7% used ibuprofen,

and 3% used naproxen. Nearly one quarter of the patients had used 2 or

more OTC agents during the previous 30 days, in addition to the

prescribed coxib.

" Fifty-three percent of the respondents used at least 1 OTC product on

15 days or more over the past 30 days, " the investigators reported.

The data analysis revealed 2 patterns among long-term COX-2 users: a

high rate of aspirin use for cardioprotection and a significant rate of

comedication with OTC pain relievers, primarily acetaminophen.

points out that physicians may not be aware of the extent of this

type of self-medication in their arthritis patients. Her advice to

clinicians is to assess GI risk (age alone is not a factor), to ask

about OTC aspirin and NSAID use (and dosage of each), to encourage the

lowest dose of aspirin if it is used, and to consider switching patients

who need cardioprotection to less costly NSAIDs plus generic omeprazole.

" There is a sizable group of chronic COX-2 users who are taking aspirin

for cardioprotection and also at risk for GI problems. Whether COX-2s

are the most cost-effective NSAID in this scenario is questionable, " she

says.

More than 90% of patients taking aspirin said they were taking it for

cardioprotection rather than pain relief. " We didn't ask patients why

they were taking the higher doses, but there could be a couple of

reasons. Often the store-brand regular-strength aspirin is much less

expensive than a bottle of 100-count Bayer 81-mg aspirin. Also, there

may be a perception that 'more is better,' along with the thought that

they may be receiving some added pain relief in taking a higher dose.

Finally, patients may not have been told to take the lowest dose

possible to protect their stomachs, " says.

" This study highlights the complexity of the issue and the need for

further research to guide the development of treatment guidelines for

those patients needing pain relief and cardioprotection. Also, given

that many of the patients fitting this category are without drug-expense

coverage, the economic waste is a concern, " et al say.

Sources

ER, Frisse M, Behm A, et al. Over-the-counter pain

reliever and aspirin use within a sample of long-term cyclooxygenase 2

users. Arch Intern Med 2004; 164:1243-1246.

Silverstein FE, Faich G, Goldstein JL, et al.

Gastrointestinal toxicity with celecoxib vs nonsteroidal

anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the

CLASS study: a randomized controlled trial. JAMA 2000; 284:1247-1255.

ER, Motheral BR, and Mager D. Verification of a

decision analytic model assumption using real-world practice data:

implications for the cost effectiveness of cyclo-oxygenase 2 inhibitors

(COX-2s). Am J Manag Care 2003; 9(12):785-794.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org