This study demonstrated statistically significant and clinically relevant superiority of all three tested dosages of EPs 7630 over placebo. All dosages of EPs 7630 were well-tolerated. Taking into account both efficacy and safety, the results of this study indicate that the 20 mg tablets of EPs 7630 taken three times daily constitute the optimal dose with respect to the benefit-risk ratio.
Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups.
The aim of this work is to study the effect of cilostazol on regional hemodynamics, serotonin levels and functional activity of the brain, heart, lower extremities in patients with generalized atherosclerosis. A 12-week open-label, randomized, placebo-controlled study included 52 males with generalized atherosclerosis and 26 males with chronic coronary syndrome (comparison group). Patients in the generalized atherosclerosis group were randomized into two subgroups: 26 males in addition to basic therapy received cilostazol at a dose of 100 mg twice daily, and 26 patients who received additional placebo. Patients with generalized atherosclerosis had injury of four vascular territories: cerebral, coronary, mesenteric and lower extremities. It was found that in patients with generalized atherosclerosis, the level of serotonin in plasma exceeded this comparison group by 7.8 times, and a number of indicators were lower - in particular, indicators of volumetric blood flow (p<0,001), cognitive function, painless walking distance. Under the influence of treatment with the addition of cilostazol for 12 weeks before baseline therapy, the condition improved: plasma serotonin levels decreased 2,9 times (p<0,001), significantly (p<0,001) increased volumetric bold flow in all studied vascular territories, which contributed to a decrease in the number of both painful and painless episodes of myocardial ischemia (according to daily electrocardiographic monitoring), increased painless and maximum walking distance, and improved cognitive function of the brain. In the generalized atherosclerosis group, who was taking placebo, under the influence of treatment, the changes were not significant. Our data indicate a positive effect of cilostazol as an addition to basic therapy in patients with generalized atherosclerosis and the need for further research in this area.
Background. The role of statins in treatment of coronary artery disease cannot be overestimated [1]. This group of medicines is included into the complex therapeutic treatment of patients with unstable angina (UA) [2]. Besides its direct mechanism of action [3], this group is characterized by numerous pleiotropic effects [4], including influence on fibrinolytic potential of blood plasma [5]. However, the data regarding effect of different statins on tissue plasminogen activator (tPA) and its inhibitor (PAI-1) are rather controversial [6,7]. The aim of our study was to compare changes of fibrinolytic potential of blood plasma after short-term treatment with statin (atorvastatin or rosuvastatin) in patients with UA. Material and methods. 39 patients with UA were included in our prospective observational study. Written consent was obtained from each participating subject after the approval of the local ethics committee. The inclusion criteria were age of 50-70 years, hospitalization in Kyiv city hospital #12 with UA (progressive), no statin intake within at least 3 months prior to the current study, standardized treatment according to the European Society of Cardiology guidelines, namely enoxaparin 1 mg / kg twice daily 3 days, 0,5 mg/kg twice daily 2 days subcutaneously, acetylsalicylic acid (ASA) once daily, clopidogrel once daily, bisoprolol once daily, angiotensin-converting enzyme inhibitor (ACEi)
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