While the effectiveness of drug therapy for COPD patients at advanced stages of disease has been proven, little evidence exists regarding starting treatment at earlier stages. The findings of the UPLIFT study, published in an Article Online First to coincide with this week's COPD special issue of the Lancet, show that treatment with inhaled tiotropium at an earlier stage of COPD reduces decline of lung function--and thus treatment should begin at this earlier stage. The Article is written by Professor Marc Decramer, University Hospital, University of Leuven, Belgium, and colleagues.
Although the UPLIFT study investigated patients at all stages of the disease, the authors in this paper did a pre-specified subgroup analysis of patients specifically at GOLD stage II* (moderate disease). From a total of 5993 patients, 2739 had GOLD stage II COPD at randomisation, with a mean age of 64 years. Pre-bronchodilator spirometry was done prior to administration of study drug in the morning of a clinic visit (i.e. 24 hours after the last dose of study medication). Post-bronchodilator spirometry was performed after study drug and short-acting bronchodilators (ipratropium and salbutamol). The patients had a mean post-bronchodilator FEV1** volume of 1.63L, 59% of the predicted value. A total of 2376 patients qualified for the final analysis--of these, 1218 patients had received tiotropium and 1158 placebo over a period of four years.
The researchers found that the rate of decline of mean post-bronchodilator FEV1 per year was 12% lower in the tiotropium group than the placebo group (43 mL vs 49 mL). The rate of decline of mean pre-bronchodilator FEV1 did not differ significantly between groups (35 mL v 37 mL per year). Patients given tiotropium were also found to have better health status (measured by questionnaire) at all timepoints. The risk of an exacerbation (serious worsening of symptoms) was reduced by 18% for patients who received tiotropium, and patients receiving tiotropium also saw the risk of a hospital admission due to an exacerbation fall by 26%.
The authors conclude: "In patients with GOLD stage II COPD, long-term treatment with tiotropium seemed to reduce the rate of decline of post-bronchodilator FEV1 and the risk of exacerbations. Since we also found that lung function and health-related quality of life were better in the tiotropium group than in the control group throughout the trial, treatment of COPD should begin in symptomatic patients with moderate disease."
In an accompanying Comment, Dr Lisa Davies, Aintree Chest Centre, University Hospital Aintree, Liverpool, UK and Professor Peter M A Calverley, University of Liverpool, Liverpool, UK, say: "As the UPLIFT investigators comment, there are still substantial numbers of symptomatic patients in GOLD stage II without a clinical diagnosis. Their data should encourage those developing plans for the early identification of COPD, which includes the UK Department of Health, that identifying such patients is indeed worthwhile and can provide the patient with better symptomatic control of their condition and improvements in their overall wellbeing."
Professor Marc Decramer, University Hospital, University of Leuven, Belgium T) +32-16-346807 E) Marc.Decramer@uzleuven.be
Professor Peter M A Calverley, University of Liverpool, Liverpool, UK. Currently travelling, contact by e-mail only. E) email@example.com
For full Article and Comment, see: http://press.
Notes to editors: *GOLD=Global Initiative for Chronic Obstructive Lung Disease (GOLD) a collaboration that includes WHO and the U.S. National Heart, Lung, and Blood Institute and which has set out guidelines for the various stages of COPD.
** FEV1 = the forced expiratory volume in one second, which is the greatest volume of air that can be breathed out in the first second of a large breath.