Treatment with the inhaled anticholinergic tiotropium (Spiriva; Boehringer Ingelheim) significantly improves lung function and quality of life and reduces exacerbations and mortality in patients with chronic obstructive pulmonary disease (COPD), according to results from the landmark UPLIFT study reported at the European Respiratory Society annual congress ( 4-8 October 2008; Berlin, Germany). Further results showed no increase in cardiovascular events, confirming the drug’s safety.

The study randomised 5993 patients with COPD and reduced lung function (mean FEV1 of 48% of predicted value) to tiotropium (18mcg once daily) or placebo, in addition to other therapies, including long acting bronchodilators and inhaled corticosteroids (but not anticholinergics) at the discretion of the treating physician.

Results showed that patients treated with tiotropium had significantly greater FEV1 than control patients throughout the four years of the trial (87-103ml before bronchodilation; p

The researchers suggested the low rate of FEV11 decline seen in the study, which was lower than in previous COPD trials, may have been associated with the widespread use of corticosteroids and long-acting beta-agonists. Nearly two-thirds of patients were on a long-acting beta-agonist and/or an inhaled corticosteroid at baseline, increasing to three-quarters by the end of the study. This may explain the lack of impact on FEV1 decline compared to the control group in the tiotropium group as a whole, they said. A sub-group analysis showed the rate of FEV1 decline was significantly lower (p=0.046) in the 1554 tiotropium-treated patients who were not on inhaled corticosteroids or long-acting beta-agonists at baseline, compared with controls.

Patients treated with tiotropium showed a significant delay in time to first exacerbation, by an average of 4.1 months (p

“This study reaffirms the safety profile for tiotropium, showing a reduction in cardiac morbidity and mortality and in respiratory failure,” Professor Decramer concluded.

NEJM 2008; 359: 153-54.

Written by
Susan Mayor PhD
medical journalist, London, UK
susanmayor (at) mac.com