M2 recruited 128 patients who were more symptomatic, as they were required to have a history of chronic cough and sputum production and FREQUENt use of beta-2-agonists, short-acting. Patients were t to roflumilast 500 mg or placebo once Possible for 24 weeks, additionally Tzlich treatment with salmeterol twice t T possible 50 mg or 18 mg once Resembled tiotropium simultaneously. In the study of salmeterol, a bronchodilator FEV1 say 49 ml in the roflumilast 500 mg groups compared to placebo, w While in the study RAD001 Everolimus of tiotropium, was to improve improved 80 ml. In addition, Were similar improvements in postbronchodilator FEV1 in roflumilast 500 mg group compared to placebo, with improvements of 60 ml and 81 ml in the salmeterol and tiotropium studies each observed. Given the poor reversibility t reference these patients showed this improvement in FEV1 that roflumilast can additionally Tzlichen .
Although these studies have been con Ue to detect an improvement in lung function, M2 noted 127 a year on average 36.8% reduction in exacerbation rates. This reduction was not in M2 128 simultaneous significant reduction in the average j Hrlichen exacerbation rate of 23.2%. The low rate of exacerbations in 6 months versus 12 months of clinical studies are shown in Figure 4. However, k Can these studies 6 months on average COPD tosevere be of sufficient duration to ensure reliable detection of an effect on exacerbations erm Equalized. In addition, the patients were enrolled in these studies were not at risk of exacerbations or no history of exacerbations. In order to continue the effect of roflumilast in patients with concomitant medication, a pooled analysis of studies 124 and 125 M2 M2 was investigated.
This analysis focuses on the effect of roflumilast on exacerbations, not only when used in combination with long-term bronchodilators, but also in previously treated patients with SCI. The average rate of moderate and severe exacerbations per patient per year in patients receiving roflumilast was significantly lower than in the placebo group, independently Ngig of concomitant use of LABA and ICS SAMA or previous treatment. Both bronchodilator FEV1 postbronchodilator ago and were also significantly improved in patients with roflumilast versus placebo, independently Ngig of previous or concomitant LABA use or processing SAMA ICS. In addition, patients receiving concomitant ICS responded well roflumilast, a 18.
8% reduction in exacerbations compared to placebo in a meta-analysis of 12 studies of two months. These results together with the results of 127 and 128 m2 M2 support the addition of roflumilast in the treatment of patients whose symptoms My not adequately controlled Insulated with other therapies. Security Roflumilast was generally well tolerated in clinical studies. The side effects on the h Observed common are those w with the PDE4 inhibitors, n Expected namely gastrointestinal effects and weight loss Re. In a pooled analysis of over 6000 patients treated with roflumilast in clinical trials, the rate of side effects Similar to patients who received placebo. H Here diarrhea, weight loss, nausea, headache, back pain, insomnia, loss of appetite and dizziness with roflumilast 500 mg compared with placebo reported.