A new analysis of the landmark UPLIFT trial, published today in the Lancet, shows that tiotropium (SPIRIVA Handihaler 18 µg) administered to Chronic Obstructive Pulmonary Disease (COPD) patients with moderate disease severity (GOLD – Global Initiative for Chronic Obstructive Lung Disease – Stage II) produced significant and sustained improvements in lung function for up to 4 years.
This pre-specified subgroup analysis involved 2,739 patients – the largest group of early stage COPD patients treated with a long-acting anticholinergic in a randomised, placebo-controlled study.
The new UPLIFT analysis shows that in patients with GOLD Stage II COPD, tiotropium may slow the progression of COPD as measured by the rate of decline in lung function. Tiotropium reduced the rate of decline in postbronchodilator FEV1 over 4 years compared with control (43 mL per year vs. 49 mL per year; p=0.024). The rate of decline in prebronchodilator FEV1 was similar between the groups.
Improvements in pre- and postbronchodilator FEV1 were maintained vs. control throughout the trial (101-119 mL and 52-82 mL respectively;). GOLD Stage II patients taking tiotropium had an 18% lower risk for exacerbations and 20% fewer exacerbations compared with control. Health-related quality of life, as measured by the St. George’s Respiratory Questionnaire (SGRQ), was better in patients treated with tiotropium than in control patients throughout the study. There was also a trend for reduced mortality with tiotropium compared with control.
“These results are very important for clinical practice because this is the first large, long-term study to show that treatment with a long-acting anticholinergic has substantial benefits in patient in the early stages of COPD. UPLIFT has shown that a significant decline in lung function occurs early in the disease, and it is known that exacerbations accelerate disease progression. Therefore this new analysis confirms that we should treat COPD in the early stages with a medication such as tiotropium that can improve lung function and quality of life, and reduce exacerbations,” said Professor Marc Decramer, UPLIFT lead investigator, Professor of Medicine and Chief of the Respiratory Division at the Katholieke Universiteit Leuven, Belgium.
The social and economic burden of COPD increases steadily, with patients becoming less independent as the disease gets worse. GOLD Stage II is typically when patients may start to realise their lung function is abnormal and experience breathlessness on exertion. As COPD progresses, lung function continues to decline and physical activity becomes severely limited, disrupting the patients’ and their caregivers’ ability to lead a full life, interfering with everyday tasks and participation in family routines.
This can lead to people feeling afraid, anxious, frustrated, isolated and depressed., It is therefore important to ensure that patients are diagnosed and treated as early as possible, including smoking cessation.
“The results from the UPLIFT analysis in GOLD Stage II patients are extremely heartening. They clearly demonstrate that if patients seek treatment from their primary care physicians earlier they may be able to impact the clinical course of their disease and improve their quality of life,” said Dr Anders Østrem, Specialist in Family Medicine, Norway and Director, International Primary Care Respiratory Group.