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首页> 外文期刊>Current medical research and opinion >Real-world evidence of the safety and efficacy profile of suvorexant in elderly patients with insomnia: a sub-analysis of the post-marketing drug-use results survey in Japan
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Real-world evidence of the safety and efficacy profile of suvorexant in elderly patients with insomnia: a sub-analysis of the post-marketing drug-use results survey in Japan

机译:真实世界的证据表明,患者在失眠症患者中的安全性和有效性概况:日本营销后贩卖药物使用结果的分析

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Objective: Global Phase III trials of suvorexant showed no obvious differences in the safety and efficacy profile of suvorexant between elderly and non-elderly patients. However, the clinical profile of suvorexant in elderly patients with comorbidities in a real-world setting was not evaluated. To further understand the safety and efficacy profile of suvorexant in elderly patients with insomnia in a daily clinical practice setting, we conducted a sub-group analysis of the post-marketing drug-use results survey. Methods: Patients with insomnia who were treated with suvorexant for the first time were divided into three groups: group-1 ( = 65 years and = 75 years, N = 1028). Results: The incidence of overall adverse drug reactions (ADRs) were 11.28% (N = 168), 8.63% (N = 63), and 8.17% (N = 84) in group-1, -2, and -3, respectively. The ADRs most commonly observed in this survey were somnolence, insomnia, and dizziness, with no new safety concerns or differences in safety issues found. The numbers of patients in group-1, -2, and -3 who visited internal medicine departments were: 690 patients (46.3%), 521 patients (71.4%), and 793 patients (77.1%), respectively. The percentage of patients who were deemed to have "improved", based on the patient's self-assessment and their physician's assessment, was 70-75% of patients in all groups. Conclusion: These results reveal the safety and efficacy profile of suvorexant in elderly patients who often have various and multiple comorbidities and were treated in a daily clinical practice setting.
机译:目的:Suvorexant的全球III期试验表明,老年人和非老年患者的Suvorexant安全性和功效概况没有明显差异。然而,未评估在真实世界环境中的患者在老年人患者中的临床剖面。为了进一步了解日期临床实践环境中老年人失眠患者的Suvorexant的安全性和功效谱,我们对营销后的药物使用结果调查进行了分析。方法:第一次用Suvorex治疗的失眠患者分为三组:1(= 65岁,= 75岁,N = 1028)。结果:总不利药物反应(ADR)的发生率分别为11.28%(n = 168),8.63%(n = 63),分别为-1,-2和-3的8.17%(n = 84) 。在本调查中最常见的ADR是嗜睡,失眠和头晕,没有发现的安全问题或发现的差异。访问内科部门的1,-2和-3患者的数量分别为:690名患者(46.3%),521名患者(71.4%)和793名患者(77.1%)。基于患者的自我评估及其医生的评估,被视为“改进”的患者的百分比为70-75%的患者。结论:这些结果揭示了往往具有各种和多种合并症的老年患者的Suvorexant的安全性和有效性曲线,并在日常临床实践环境中进行治疗。

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