The GOLD guidelines and COPD treatment
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend specific pharmacologic therapy based on symptoms and risk of exacerbations. After evaluation that includes spirometric testing, history of exacerbations, and a patient-reported dyspnea survey, patients are categorized into four stages from A to D. Recommended therapies begin with short-acting beta agonists or muscarinic antagonsists (stage A) and progress to long-acting agents or combination therapy (stage B), then to the addition of inhaled corticosteroids or phosphodiesterase-4 inhibitor (stage C), and finally to multiple combinations of all agents (stage D).
The investigators of the retrospective study “Effects of GOLD-adherent prescribing on COPD symptom burden, exacerbations, and health care utilization in a real-world setting” [Mannino D, Yu T-C, Zhou H, et al. J COPD F. 2015; 2(3):223-235] used an electronic health record (EHR) database to assess the effect of adherence and nonadherence to GOLD prescribing recommendations on a variety of COPD-related outcomes and healthcare resource utilization (HCRU).
The Humedics EHR database contains data that include medications, physician notes, laboratory results, diagnoses, and information pertaining to both inpatient hospital stays and ambulatory settings. Study participants were patients who ranged in age from 40 to 90 years old and had a diagnosis of COPD with a valid GOLD stage.
COPD treatment was determined by the prescribing of a short- or long-acting beta agonist or muscarinic antagonist, an ICS or ICS-combination agent, or a PDE-4 inhibitor within 180 days of the GOLD staging date. Assessed outcomes included COPD-related symptoms (shortness of breath, coughing, wheezing, fever), exacerbations (defined as using oral or intravenous steroids with an antibiotic), COPD-related emergency department (ED) visits or hospitalizations, and HCRU (all-cause ED visits, office visits, or hospitalizations).
The EHR database contained over 700,000 thousand patients with a diagnosis of COPD. A total of 5,775 patients met all inclusion criteria and received evaluation. The evaluated group included 1,521 patients who received no COPD treatment and 1,531 patients who received treatment that was adherent to GOLD guidelines (26.5% of the study population). The group characterized as non-adherent to GOLD guidelines included 1,158 undertreated patients and 1,545 overtreated patients.
The results demonstrated that patients in the GOLD-adherent group had lower odds of all COPD-related symptoms than those in the non-adherent group (absolute reduction 4%-6%). A specific comparison of the undertreated patients to the adherent group showed a decreased risk for all symptoms in the adherent group.
The group of patients defined as overtreated had numerically less occurrence of symptoms, but only shortness of breath was a statistically significant difference from those in the adherent group.
A significant reduction in the number of ED visits for respiratory reasons was seen in the GOLD adherent group compared to the overall non-adherent group (2.3% vs 3.5%).
A numeric reduction in the frequency of respiratory-specific hospitalizations and office visits occurred in the adherent group vs. the non-adherent group, but this did not reach statistical significance.
A comparison of the all-cause hospitalizations and ED visits in the adherent group vs. those in the non-adherent group demonstrated a decreased risk (odds risk, 0.69 and 0.63) for patients treated according to GOLD recommendations in the adherent group. Both the undertreated and overtreated groups had more all-cause ED visits than the GOLD-adherent patient group.
Taken as a whole, the results of the study indicated that only 36% of COPD patients were prescribed treatment according to the GOLD guidelines. The patients that were on GOLD-recommended pharmacological therapies had only a moderate improvement in symptoms and HCRU.
Limitations of the study may explain why a more robust difference between the groups was not seen. The EHR data set did not include information such as prescription refills or other indicators of patient compliance; therefore it is unknown how many patients actually received the prescribed therapies.
The study also followed patients to assess the key outcomes for only 180 days. Perhaps if the trial had collected data over a longer period, a greater difference between the groups would have been seen.
Finally, as with any study of this nature, the true intentions of the prescribing providers and the complete clinical picture of the patient cannot be known. There might be many valid reasons for a particular patient to receive therapies that are not consistent with the GOLD guidelines; more commonly in this patient population, there was a high incidence of co-morbid asthma symptoms, especially in the overtreated subset.