A main problem with this study is the fact that only a small proportion of people were Using regular imports Ren inhaled treatment. For example, less than 20% were treated with long-acting b2-adrenergic receptor agonist, such as 20% . In a previous study of six weeks for three doses cilomilast compared GSK461364 with placebo in patients with COPD were studied. Cilomilast 15 mg twice t Resembled significantly improved FEV1 compared to placebo. Similar improvements were also in view of the accelerated Vitalkapazit t And peak flow observed although the Lebensqualit t did not differ significantly between the groups. In the same study, the postbronchodilator FEV1 improved in the treatment groups, suggesting that a zus Tzlicher benefit cilomilast compared to the weight obtained by the b2-adrenergic receptor agonist Can be performed.
It should also be noted that in this study, in patients with m Moderately severe bronchial obstruction, most people did not receive inhaled treatment to maximum. In a double-blind, controlled, controlled by placebo, parallel-group, multicenter, randomized COPDwere people in a 2: 1 ratio t ratio KSP Inhibitors to twice resembled cilomilast 15 mg or placebo for 24 medium Changes in the composition obtained from baseline week. FEV1 over 24 weeks in the cilomilast group was an increase of 10 ml compared to a decline of 30 ml in the placebo group. Taken for 24 weeks, a clinically significant reduction in the average Lebensqualit t score in subjects cilomilast versus placebo was significant. In addition, experienced a gr Erer share received cilomilast no exacerbations at 24 weeks compared to placebo.
Other studies have specifically examined the effects of PDE4 inhibitors in relation profile of inflammatory cells. For example, in a parallel group randomized placebo-controlled trial that lasted 12 weeks, CD8 and CD68 monocytes / macrophages significantly decreased in patients with bronchial cilomilast. There are no significant differences between the treatment and the placebo group in percentages Protect of sputum neutrophils, IL-8 levels and neutrophil elastase were observed. In contrast to the negative effects of theophylline, not PDE4 inhibitors no longer monitored plasma and less problematic in terms of interaction with other drugs, especially due to the fact that theophylline in the liver by the P450 system metabolizes.
However, the studies in this document show that PDE4 inhibitors with an h Heren incidence of gastrointestinal side effects associated introduced, dizziness usually, vomiting, diarrhea and abdominal pain compared to placebo. Table 3 summarizes the frequency of adverse events in the literature currently identified. In the gr Th study, the evaluation of roflumilast 250 mg and 500 mg, the number of patients who leave against randomized placebo and low and high doses of 32,100 or roflumilastwere 124th The h Common side effects, which were not considered treatment-related fortune assets were COPD exacerbations and nasopharyngitis. Diarrhea was the h Most frequent side effect as a result of roflumilast see and entered in any of the patients with a placebo and 13 and 34 people with low and high doses of roflumilast treated respectively.