Four Studies Published in The Lancet Show roflumilast (Daxas(R)), a New Oral Approach to COPD, Improves Lung Function and Reduces Exa...(patients discontinued the trial in the r...),Health

Date:8/27/2009

patients discontinued the trial in the roflumilast group than those taking placebo (14 percent vs 11 percent). Diarrhoea, nausea and headache were the commonest reasons for discontinuation. A reduction in weight, around 2kg, was seen consistently across all the studies published in The Lancet. When patients stopped taking roflumilast the majority regained weight. In addition, in the 12- month studies, only four patients out of 1,547 dropped out because of weight loss.

Six-month trials

In the six-month trial patients used roflumilast or a placebo in conjunction with commonly used long acting bronchodilators (inhalers).

In one trial, patients used salmeterol with roflumilast or placebo. In the second trial, patients used tiotropium, a long-acting bronchodilator which also reduces the production of mucus, with roflumilast or placebo. Patients used "rescue medication" short-acting bronchodilators, as needed.

There were 933 patients in the salmeterol trial and 743 patients in the tiotropium trial. Overall patients had moderate to severe COPD; were over 40, current or former smokers with a history of smoking at least a pack a day for 10 years. In contrast to the 12-month trials, patients in the six-month trials did not require a history of exacerbations. Patients recruited to the tiotropium study were more symptomatic than those in the salmeterol study as they were required to have daily chronic cough and sputum production and a documented use of rescue medication.

Patients were seen and measured once a month for the first three months and every six weeks for the last three months of the trial.

Compared with placebo, patients taking roflumilast in addition to salmeterol, had an average increased pre-bronchodilator FEV(1) (forced expiratory volume in one second) of 49mL (p<0.001).

Compared with placebo, patients taking roflumilast in
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