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Corticosteroid Response Trials Diagnostically Useless for COPD
Patients


By Will Boggs, MD

NEW YORK (Reuters Health) Aug 06 - A corticosteroid trial for patients
with chronic obstructive pulmonary disease (COPD) do not identify
potential responders to inhaled steroid therapy, according to a report
in the August issue of Thorax.

"Doing steroid trials is a waste of time and leads to withholding
beneficial treatment," Dr. P. Sherwood Burge from Birmingham
Heartlands Hospital in the UK, told Reuters Health by e-mail.

Dr. Burge and colleagues in the Inhaled Steroids in Obstructive Lung
Disease (ISOLDE) Study Group examined the distribution of spirography
results in 524 patients with non-asthmatic COPD. Oral prednisolone was
given for 14 days before patients were randomized to 3 years of
treatment with fluticasone or placebo.

The post-bronchodilator FEV1 response to prednisolone was normally
distributed about a single mean, the authors report, suggesting that
the definition of "responders" and "non-responders" is arbitrary.

This lack of distinction between responders and non-responders was
evidenced by the absence of a significant relationship between the
response to prednisolone and the subsequent decline in FEV1, the
report indicates, as well as the lack of a relationship between the
prednisolone response and the exacerbation rate.

The prednisolone response was greater in ex-smokers than in smokers,
the results indicate, but otherwise the FEV1 response to prednisolone
could not be correlated with age, atopy, ***, baseline FEV1, or
response to fluticasone.

"There is no evidence for separate responder and non-responder groups
in COPD," Dr. Burge concluded. "[There is] no reason ever for a trial
of steroids in patients with COPD. It does not predict prognosis or
the future response to inhaled steroids."

"All patients with symptomatic airflow obstruction should receive
inhaled steroids," Dr. Burge advised. "Those with a large response
(say FEV1 improving by >500 mL after 1 month) are probably best
labeled as asthmatic and managed along asthma guidelines, with the
dose of inhaled steroid being reduced to the minimum effective dose.
The rest should be labeled as COPD/irreversible asthma and the inhaled
steroid continued at a higher dose."

"I believe the right course is to keep an open mind about the
possibility that there may be responder and non-responder subgroups
and to continue to seek ways to identify and characterize them, if
they do exist," writes Dr. Nicholas J. Gross from Hines VA Hospital
and Stritch-Loyola School of Medicine in Chicago, Illinois in a
related editorial. "Meanwhile, I regretfully agree with the conclusion
that corticosteroid trials are not diagnostically helpful in primary
care."

Thorax 2003;58:654-658.

http://www.medscape.com/viewarticle/459692?mpid=17081