The investigators do not yet understand why the inhaled corticosteroid budesonide (Pulmicort), would be associated with cardiac protection in patients with COPD, according to principal investigator Claes-Göran Löfdahl, MD, professor of respiratory medicine, Lund University, Lund, Sweden.

"This is, to my knowledge, the first controlled trial looking at the occurrence of cardiac events in patients with COPD with regard to treatment by inhaled corticosteroids," Dr. Löfdahl said, noting that he and his coinvestigators plan to study the inflammatory markers in patients treated with the drug.

His research team had shown in earlier studies an increased risk for comorbid cardiovascular disease in COPD patients, and that patients who are treated with corticosteroids experience less COPD-related mortality.

In their new study, they decided to see whether treatment with budesonide would affect the rate of cardiovascular events in such patients, and they initiated the European Respiratory Society study On Chronic Obstructive Pulmonary Disease (EUROSCOP). The study was 3 years in duration and involved 1175 patients with confirmed COPD, who were randomized 582 to receive placebo and 593 to treatment with 800-mcg daily of budesonide.

The investigators found that 60 first-time ischemic cardiac events occurred during the study: 32 events of angina pectoris, 23 myocardial infarctions, 4 cases of coronary artery disorder, and 1 case of myocardial ischemia.

When the investigators examined the rate of events by usage of budesonide they found that the 60 events had occurred in 49 patients (4.2%). Within the 2 treatment groups, 18 events (3.0%) occurred in the patients taking budesonide, and 31 (5.3%) occurred in the placebo group (P < .05).

The data also show that patients who had had ischemic cardiac events had similar pulmonary function and pack-years of cigarette smoking to those who had not.

Dr. Löfdahl noted the unique opportunity to benefit another system in the body with a therapy that focuses on the inflammation in the airways. He added that he and his co-authors plan to study the same patients further for inflammatory markers and for other biomarkers of cardiovascular disease.

The study was funded by AstraZeneca, maker of Pulmicort.


[Presentation title: Does Inhaled Budesonide Protect Against Cardio-Ischemic Events in Mild-Moderate COPD a Post-Hoc Evaluation of the EUROSCOP Study. Abstract 2333]

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