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Lung function, as measured by FEV1 (how much volume can be exhaled in one second), was the primary or co-primary endpoint in all four studies.
The pooled data for lung function using the pre-bronchodilator FEV1 measurement (forced expiratory volume in one second) showed an average increase of 48mL (p<0.
Roflumilast is expected to act on the underlying mechanism of COPD and related inflammatory diseases.
May diminish public expectation that drugs will be evaluated for safety and efficacy before use.
The phase III placebo-controlled trials of roflumilast evaluated the treatment in two 12-month (Lancet 2009; 374: 685
The researchers found that patients who took warfarin increased their risk of stroke; however, the increase in risk was related to the degree of blood thinning in response to the drug.