Problems with 2002 update of ACR guidelines on RA

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Dec 2, 2002

Problems with 2002 update of ACR guidelines on RA

Madrid, Spain - A Spanish rheumatologist has taken issue with some of the

recommendations made in the 2002 update of the ACR guidelines for the

management of rheumatoid arthritis (RA). In a letter in last month's issue

of Arthritis & Rheumatism [1], Dr José L Pablos (Hospital 12 de Octubre,

Madrid, Spain) says that the assumption in the guidelines that nonsteroidal

anti-inflammatory drugs (NSAIDs) have an antiplatelet effect is flawed.

In the 2002 update, prepared by the ACR subcommittee on RA guidelines, the

authors stress the need for antiplatelet therapy with low-dose aspirin for

patients at risk of cardiovascular disease taking selective COX-2

inhibitors, Pablos says. This infers that, unlike nonselective NSAIDs, COX-2

inhibitors have no effect on platelet adhesion or aggregation and that

antiplatelet therapy with aspirin is required only when selective COX-2

inhibitors are used, he points out.

But, " I believe nonselective NSAIDs neither ensure appropriate antiplatelet

prophylaxis nor do they appear to be better than selective COX-2 inhibitors

for patients at cardiovascular risk who are receiving concomitant aspirin

antiplatelet therapy, " Pablos says.

" I believe nonselective NSAIDs neither ensure appropriate antiplatelet

prophylaxis, nor do they appear to be better than selective COX-2 inhibitors

for patients at cardiovascular risk who are receiving concomitant aspirin

antiplatelet therapy. "

Pablos argues that NSAIDs vary greatly in their antiplatelet effects,

depending on 2 factors: their potency for inhibiting COX-1 at pharmacologic

doses and their half-life. " Thus neither NSAIDs with a short half-life, such

as ibuprofen, nor those with a relatively low COX-1 inhibitory effect, such

as diclofenac, provide efficient and sustained antiplatelet therapy, " he

states. " Only drugs with a long half-life and a potent COX-1 inhibitory

effect, such as indobufen, flurbiprofen, and naproxen, have been suggested

to be potentially useful as antiplatelet agents, " he adds.

But due to the reversibility of the antiplatelet effects of NSAIDs, the

cardioprotective effect of these drugs as shown in clinical trialswhere

compliance with the dose and treatment schedule is usually better " does not

necessarily apply to clinical practice, where intermittent use by patients

is common, " Pablos states, adding that " accordingly, epidemiologic studies

have failed to demonstrate cardioprotective effects of NSAIDs in contrast

with aspirin. "

The Spanish rheumatologist concludes that neither relying on the

antiplatelet effect of NSAIDs in patients at cardiovascular risk nor using

NSAIDs instead of selective COX-2 inhibitors when low-dose aspirin is needed

can be recommended based on available evidence.

Points well-taken; many questions remain

In reply [2], the ACR subcommittee on rheumatoid arthritis guidelines says,

" The points made by Dr Pablos are well-taken and raise important issues

surrounding the risks and benefits of treatment with selective and

nonselective NSAIDs in RA patients and other patient populations. "

" We would suggest that additional evidencepreferably from randomized

controlled trials, is needed to address the following questions:

* Does low-dose aspirin negate the gastrointestinal [GI] protective

effect of the coxibs over the nonselective NSAIDs, as suggested by data from

the CLASS study? Is this a class effect of the coxibs?

* Do coxibs and/or nonselective NSAIDs negate the cardioprotective

benefits of low-dose aspirin? If so, which ones have this effect?

* For older patients who need an NSAID for osteoarthritis or RA and need

low-dose aspirin for cardioprotection but are at higher risk for

NSAID-induced adverse GI events, is the safest regimen a combination of

low-dose aspirin and/or a proton pump inhibitor with either a coxib or a

nonselective NSAID? "

The subcommittee members add that data from longitudinal cohort studies will

also be needed to determine 2 other things. First, in clinical practice,

what is the effectiveness (vs efficacy in clinical trials) of various

nonselective NSAIDs in terms of cardioprotective benefits as compared with

low-dose aspirin in patients receiving long-term NSAID treatment for OA or

RA? Second, in clinical practice, what is the effectiveness of the coxibs vs

nonselective NSAIDs in terms of greater GI safety? And is this a class

effect for all coxibs?

Increasing burden of documentation

In another letter in the same issue of the journal [3], Dr Sidney J Block

(Bangor, ME) writes about the problems faced by the practicing physician in

a small office. The use of language such as " should document " and " must

assess " in the 2002 update on the guidelines for the management of RA is of

concern, he complains, because ultimately " these may become requirements " by

third-party payers and malpractice attorneys. Block also takes issue with

the potential impact of the documentation recommendations made by the

subcommittee on the actual clinical practice of rheumatology.

If the committee had considered this impact then it may also have formulated

practical suggestions to enable physicians to fulfill these goals, such as a

template acceptable to Medicare that would sufficiently document the

measurements needed, " all within the constraints of the usual 1-hour

consultation and 15- to 20-minute return visit times we have to devote to

our patients, " he comments.

" By the time such recommended documentation, as currently outlined in the

guidelines, is completed to the satisfaction of the subcommitteenot to

mention the other interested partiesthere will be no time left to actually

talk to our patients about what is going on in their lives, the changing

evolution and course of their disease, and the therapeutic changes we might

suggest and their ramifications. "

" By the time such recommended documentation . . . is completed to the

satisfaction of the subcommittee . . . there will be no time left to

actually talk to our patients about what is going on in their lives, the

changing evolution and course of their disease, and the therapeutic changes

we might suggest and their ramifications. "

In its reply, the subcommittee agrees that " increasing documentation

requirements for each clinical encounter have placed new and onerous burdens

on the rheumatology practitioner. " But these have been generated by the

likes of Medicare and other private payers rather than the practice

guidelines themselves, the members argue, adding also that guidelines " are

indeed just guidelines and should never be " requirements. " In an attempt to

assist physicians, the ACR has created written documentation templates,

provided multiple training sessions in evaluation and management coding,

" and is in the process of evaluating new practice management technologies

such as electronic medical records and hand-held devices, " about which

information is accessible through the ACR website, they conclude.

Nainggolan

Sources

1. Pablos JL. Aspirin antiplatelet therapy and nonsteroidal antiinflammatory

drugs: Comment on the 2002 update of the American College of Rheumatology

Guidelines for the Management of Rheumatoid Arthritis. Arthritis Rheum 2002

Nov; 46(11):3102.

2. Kwoh CK, LG, Greene JM, et al. Reply. Arthritis Rheum 2002 Nov;

46(11):3103-3104.

3. Block SR. Hidden hazards and practical problems: Comment on the 2002

update of the American College of Rheumatology Guidelines for the Management

of Rheumatoid Arthritis. Arthritis Rheum 2002 Nov; 46(11):3102-3103.