1xbet 카지노 Pharmaceutical Co., Ltd.
Pharmaceuticals
May 2, 2017
Otsuka and Lundbeck Announce Results 1xbet 카지노 Brexpiprazole on Symptoms 1xbet 카지노 Agitation Related to Alzheimer's-type Dementia
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce top-line results from two phase III clinical trials evaluating the efficacy, safety and tolerability 1xbet 카지노 brexpiprazole in the treatment 1xbet 카지노 agitation in patients with dementia 1xbet 카지노 the Alzheimer's type.
The primary endpoint 1xbet 카지노 both trials was change from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score, a 29-item scale to systematically assess the symptoms 1xbet 카지노 agitation. The key secondary endpoint was the change from baseline in the Clinical Global Impression-Severity 1xbet 카지노 Illness (CGI S) score, a 7-point scale assessing overall severity 1xbet 카지노 the patient's agitation. These studies were conducted in multiple countries in North America and Europe, and in the Russian Federation.
In both studies, patients treated with brexpiprazole showed improvements in symptoms 1xbet 카지노 agitation relative to placebo. In the first study, the improvement in the primary endpoint 1xbet 카지노 CMAI for 2 mg brexpiprazole was statistically better than placebo (p<0.05) and appeared more robust than the improvements on the key secondary endpoint 1xbet 카지노 CGI-S (p0.05). In the second study, the improvements in the primary endpoint 1xbet 카지노 CMAI (p0.05) appeared less robust than improvements observed on the key secondary endpoint 1xbet 카지노 CGI-S (p<0.05). In both studies, there was variability in the data from different countries, perhaps associated with differing standards 1xbet 카지노 care; the data from Russian sites showed especially poor separation between placebo and drug.
Regarding safety and tolerability, both studies confirmed the pr1xbet 카지노ile 1xbet 카지노 brexpiprazole as observed in the clinical trials for schizophrenia and for adjunctive treatment 1xbet 카지노 major depressive disorder (MDD). The most common adverse events in patients receiving brexpiprazole versus placebo (incidence 3% and greater than placebo) were insomnia (4.7% vs. 3.3%), agitation (3.5% vs. 2.9%), and somnolence (3.3% vs. 2.2%). Overall mortality during the studies was 0.86% and none 1xbet 카지노 the deaths were considered to be related to treatment.
About 1xbet 카지노 studies
Both trials were randomized, double-blind, placebo-controlled phase III studies that enrolled a combined total 1xbet 카지노 approximately 700 participants. Trial participants were between 51 and 90 years 1xbet 카지노 age with a diagnosis 1xbet 카지노 probable Alzheimer's disease and symptoms 1xbet 카지노 agitation. Both outpatients and patients living in institutionalcare settings were included in the trials. One 1xbet 카지노 the trials studied fixed doses 1xbet 카지노 either 1 or 2 mg per day 1xbet 카지노 brexpiprazole or placebo, while the other trial studied a flexible-dose range 1xbet 카지노 0.5 mg, 1 mg or 2 mg per day 1xbet 카지노 brexpiprazole, or placebo. Both trials were 12-weeks in duration.
The companies plan to meet with the FDA to discuss the results 1xbet 카지노 the studies. The results will be presented in scientific congresses over the next year.
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