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        Esmirtazapine for the Treatment of Chronic Primary Insomnia: A Randomized Long-Term Safety Study in Elderly Outpatients

        Neely Ivgy-May,Qing Chang,Annpey Pong,Andrew Winokur 대한수면연구학회 2020 Journal of sleep medicine Vol.17 No.1

        Objectives: This 52-week, double-blind, randomized, Phase 3 study evaluated the long-term safety of esmirtazapine 1.5 mg and 3.0 mg in elderly outpatients (aged ≥65 years) with insomnia. Methods: Participants were randomized to receive esmirtazapine 1.5 mg or 3.0 mg administered once nightly. Safety and tolerability (primary objectives) were assessed via adverse event (AE) reporting, routine clinical measurements [vital signs; electrocardiogram (ECG); laboratory parameters], and residual-effects assessments. Total sleep time (TST), wake time after sleep onset (WASO), and sleep latency (SL) were assessed (secondary objectives). Results: Of 259 randomized participants, 153 completed treatment. AEs and serious AEs were reported by 89.8% and 7.0%, respectively, of 1.5 mg recipients, and 88.5% and 3.8%, respectively, of 3.0 mg recipients. Discontinuations due to AEs were reported in 16.4% and 18.3% of participants receiving esmirtazapine 1.5 mg and 3.0 mg, respectively. The most frequent AEs (>10%) were nasopharyngitis, somnolence, dizziness, headache, dry mouth, weight increase, and fatigue. One participant died; the death was judged unrelated to treatment. Elevated eosinophil counts were noted, but not considered clinically significant. No remarkable or clinically relevant changes in laboratory parameters, vital signs, or ECG were observed. There was no evidence of residual effects; alertness at awakening increased by a median of 17 (1.5 mg) and 15 (3.0 mg) points from baseline, respectively, and ability to work/function by 12 points (both groups; all p<0.0001). Improvements from baseline in TST, WASO, and SL were observed. Conclusions: Esmirtazapine was reasonably tolerated in elderly outpatients with insomnia. No significant safety signals were observed.

      • 열처리로 제조된 물결모양 와이어 철망 층 구조의 압축강도

        최정호(J. H. Choi),이정환(J. H. Lee),Krishna Shankar,Murat Tahtali,Andrew Neely 한국소성가공학회 2012 한국소성가공학회 학술대회 논문집 Vol.2012 No.5

        The objective in this paper presents an attempt to understand and characterize the behavior of corrugated wire mesh laminates (CWML) under transverse compression loading. Specimens of the CWML are made of stainless steel type 316 woven metal and crossed points in the mesh are bonded with eutectic at low temperature. Experimental testing is conducted on several samples of single layer, two layer, and four layer wire mesh laminates under transverse compression The load deflection behaviors of the single and multi layer laminates observed in the tests are analyzed. Therefore, it does provide significant insight into aspects that influence the deformation behavior of CWML.

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