COPD Guidelines Shake Up Staging and Antibiotic Use Recommendations

LEIDEN, Netherlands, Sept. 14 - The first complete overhaul of chronic obstructive pulmonary disease (COPD) guidelines eliminated a staging category and made recommendations for antibiotic use during exacerbations.

The updated Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines also now call COPD "preventable and treatable," which Klaus F. Rabe, M.D., Ph.D., of the Leiden University Medical Center here, called one of the most important aspects of the revision.

Dr. Rabe and colleagues published the update in the second September issue of the American Journal of Respiratory and Critical Care Medicine.

The definition of COPD was changed to include the phrase "a preventable and treatable disease with some significant extrapulmonary effects."

This change was, in part, "to present a positive outlook for patients," Dr. Rabe and colleagues wrote. And, Dr. Rabe added, to eliminate the feeling of "therapeutic nihilism" that had been common among healthcare professionals who treat the disease.

The update also eliminated stage 0, the "at-risk" category, from spirometric classification of COPD severity. This category first appeared in the 2001 guideline update, expanding the then four stages-stage I, mild; stage II, moderate; stage III, severe; and stage IV, very severe-to five.

However, "there is incomplete evidence that the individuals who meet the definition of 'at risk' (chronic cough and sputum production, normal spirometry) necessarily progress on to stage I," Dr. Rabe and colleagues wrote.

"Nevertheless," they added, "the importance of the public health message that chronic cough and sputum are not normal is unchanged."

The re-worked GOLD guidelines also added a definition of COPD exacerbation: "an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD."

The revised guidelines also addressed antibiotic use during exacerbations among other aspects of disease management. Antibiotics were recommended for patients with the following exacerbations:

• Increased dyspnea, sputum volume, and sputum purulence (Evidence B)
• Increased purulence of sputum and either increased dyspnea or increased sputum volume (Evidence C)
• A severe exacerbation requiring mechanical ventilation whether invasive or noninvasive (Evidence B)

Recommendations for spirometric classification of disease severity remained dependent on the post-bronchodilator forced expiratory volume in one second-to-forced vital capacity ratio greater than 0.7.

But, the guidelines noted that this somewhat arbitrary cutpoint is "particularly problematic" in elderly patients with milder disease because normal aging affects lung volumes.

Spirometry-based diagnosis and assessment of COPD severity has a host of other problems as well, commented Leonardo M. Fabbri, M.D., of the University of Modena and Reggio Emilia in Modena, Italy, and colleagues in an accompanying editorial.

It lumps together emphysema and bronchiolitis along with other different pulmonary phenotypes, they noted, and, "there is evidence that pathological abnormalities of COPD may be present even in the absence of airflow limitation."

Furthermore, they wrote, "clinical diagnosis of COPD is not confirmed in a significant proportion of patients at spirometry, suggesting that a more comprehensive approach is required."

Future updates should probe these issues, as well as include important new findings that have been reported but not yet published, particularly the TORCH trial of the inhaled combination of salmeterol (Serevent) and fluticasone (Flovent) on survival in moderate to severe COPD, they said.

Other updates to the GOLD guidelines included:

• Revised prevalence estimates that indicate about 15 to 25% of adults age 40 and older may have stage I mild COPD or higher and that prevalence is higher in smokers and ex-smokers, those over age 40. New estimates are that COPD is likely to become the third leading cause of death worldwide by 2020.
• Emphasis on eliminating not only cigarette smoke as a risk factor but also occupational exposures and indoor air pollution.
• Recommendations for identifying and building comprehensive healthcare teams for coordinated treatment of patients with COPD to ensure accurate diagnosis and effective treatment, particularly because comorbidities are common among these patients.

Dr. Fabbri reported conflicts of interest for Altana Pharma, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline, Merck, Sharp & Dohme, Novartis, Roche, Pfizer, Menarini, Miat, Schering Plough, and UCB. The other editorialists reported no conflicts of interest.