Budesonide for COPD May Also Protect Against Heart Disease

Paula Moyer, MA

September 21, 2005

Sept. 21, 2005 (Copenhagen) — When patients with chronic obstructive pulmonary disease (COPD) are treated with an inhaled corticosteroid, they are less likely to experience ischemic cardiac events, according to a team of investigators who presented their findings here at the 15th annual congress of the European Respiratory Society.

The findings are promising because of the potential for cardioprotection in a group of frail, typically elderly people. However, the investigators do not yet know why an inhaled corticosteroid like budesonide (Pulmicort), the study drug, would confer such protection, according to principal investigator Claes-Göran Löfdahl, MD. Dr. Löfdahl is a professor of respiratory medicine at Lund University in Sweden.

One possibility is that the treatment may ameliorate the systemic inflammatory factors that patients with COPD have in anatomic sites beyond lung tissue, such as C-reactive protein (CRP) levels. "One can speculate that the increase in systemic inflammation, as seen by an elevated CRP in patients with COPD, is a reason" for the cardiovascular disease and will be explored in further research, Dr. Löfdahl said.

"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. The findings showed that patients treated with budesonide had significantly less cardiovascular morbidity than did patients receiving placebo.

Dr. Löfdahl and coinvestigators had seen that earlier studies had shown an increased risk for comorbid cardiovascular disease in COPD patients and that those patients treated with corticosteroids experienced a lower COPD-related mortality rate. Therefore, they decided to see whether treatment with budesonide would affect the rate of cardiovascular events in such patients.

They therefore initiated the EUropean RespiratOry Society study On Chronic Obstructive Pulmonary disease (EUROSCOP). The three-year study involved 1,175 patients with confirmed COPD who were randomized to receive either a placebo (n = 582) or treatment with 800 µg daily of budesonide (n = 593).

At the study's end, 60 first-time ischemic cardiac events had occurred in 49 patients (4.2%). These consisted of 32 events of angina pectoris, 23 myocardial infarctions, four cases of coronary artery disease, and one case of myocardial ischemia.

Within the two treatment groups, 18 events (3.0%) occurred in the patients taking budesonide, and 31 events (5.3%) occurred in the placebo group ( P < .05). When the investigators compared patients' pulmonary function and pack-years, they found those who had had ischemic cardiac events had similar results to those who had not.

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

The study was funded by AstraZeneca, the maker of Pulmicort.

ERS 15th Annual Meeting: Abstract 2333. Presented Sept. 19, 2005.

Reviewed by Gary D. Vogin, MD

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