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| |  Roflumilast Improves Lung Function, Reduces Exacerbations in Patients With COPD and Bronchitis: Presented at CHEST 2009 By Betty S. Riggs SAN DIEGO -- November 10, 2009 -- In patients with chronic obstructive pulmonary disease (COPD) and bronchitic symptoms, treatment with roflumilast improves lung function and reduces the frequency of disease exacerbations, according to a study presented here on November 4 at CHEST 2009, the annual meeting of the American College of Chest Physicians. Andrew McIvor, MD, St. Joseph’s Healthcare, Hamilton, Ontario, and colleagues conducted a 12-month, double-blind, randomised, placebo-controlled, parallel-group, multicentre trial in patients with COPD, cough and sputum production, severe airflow obstruction, and a history of exacerbations. Patients were aged 40 years and older and were current or past smokers with a smoking history of at least 20 pack-years, and had documented moderate or severe COPD exacerbation requiring systemic glucocorticosteroids and/or treatment in hospital within 1 year prior to study. Patients entered a 4-week placebo run-in period during which they could have no moderate or severe COPD exacerbation, and they had to have a total cough and sputum score >=14 during the last week preceding the randomisation visit. Qualifying patients were then randomised to either oral roflumilast 500 mcg daily (n = 772) or to placebo (n = 796) for 12 months. Short-acting beta2-agonists could be used as needed, and patients could continue using long-acting beta-agonists or short-acting anticholinergics at stable doses. Inhaled corticosteroids and long-acting anticholinergics were not allowed. Coprimary endpoints were mean change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) and the rate of moderate and/or severe COPD exacerbations. Secondary endpoints included change from baseline in post-BD FEV1 and time to death from any cause. Pre-BD FEV1 increased significantly from baseline with roflumilast compared with a decrease with placebo. The difference between groups for this endpoint was 58 mL (P < .0001). The mean rate of moderate and/or severe COPD exacerbations/patient/year was 18.5% lower in the roflumilast group; the mean rate was 1.21 in the roflumilast group and 1.49 in the placebo group (P = .0035). Roflumilast was also superior to placebo on the secondary endpoint of change in post-BD FEV1, which increased significantly from baseline with roflumilast compared with a decrease with placebo (P < .0001). Adverse events (AEs) were mostly mild, and at least 1 AE was reported in 66.2% of patients receiving roflumilast and 61.8% receiving placebo. Mortality rates per year were 3% in both the roflumilast and placebo groups, and the mean time to death from any cause was 201.0 and 214.6 days in the roflumilast and placebo groups, respectively (P = .5028). According to Dr. McIvor, roflumilast represents an important potential addition to the armamentarium of drugs available for treating patients with COPD. Since different subsets of patients exist within the broad spectrum of COPD, selective and specific therapies could improve disease management. Funding for this study was provided by Nycomed GmbH (formerly Altana Pharma AG). [Presentation title: Efficacy and Safety of the Phosphodiesterase 4 Inhibitor Roflumilast in Patients With Symptomatic Chronic Obstructive Pulmonary Disease in the M2-125 Study.]
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