ABSTRACT
Background: Insomnia often responds to the orexin receptor antagonist suvorexant. This study aimed to evaluate the efficacy and adverse events of suvorexant for Chinese patients with primary insomnia over 6 months. Methods: A total of 120 patients with primary insomnia were assigned randomly to two groups that received placebo or suvorexant (40 mg) for 6 months. The primary outcomes were the total sleep time (sTST), time to sleep onset (sTSO), and sleep quality (sQUAL). The secondary outcomes were the Insomnia Severity Index (ISI) score and adverse events. Results: A total of 111 patients completed the study and all of them were included in the final analysis. Suvorexant showed greater efficacy than the placebo in enhancing sTST, sTSO, sQUAL and ISI score at months 1 and 6. Serious adverse events were documented in 2 patients (3.3%) in the suvorexant group and 1 patients (1.7%) in the placebo group. The most common adverse event was somnolence, which occurred in 7 patients (11.7%) in the suvorexant group and 2 patients (3.3%) in the placebo group. No death related to suvorexant treatment was recorded. Conclusions: Suvorexant was efficacious and well-tolerated in a group of Chinese patients with primary insomnia over 6 months.
Subject(s)
Sleep Initiation and Maintenance DisordersABSTRACT
Objective To investigate the prognostic value of CDKN2A mRNA in glioblastoma (GBM).Methods CDKN2A gene mRNA data were obtained from three different GBM database online (TCGA,REMBARNDT and GSE16011).The correlations between overall survival (OS) and CDKN2A expression were analyzed by Kaplan-Meier method and multivariate Cox regression analysis.Results In the TCGA database (n =358),patients with high CDKN2A mRNA level got longer OS than those with low expression level [median OS:18.0 months (95 ％ CI 15.0-21.0 months) vs 13.9 months (95 ％ CI 12.4-15.4 months),P =0.001].In another two validation datasets,patients with high CDKN2A mRNA level had longer OS than those with low expression level [median OS in REMBRANT:16.6 months (95 ％ CI 13.3-19.8 months) vs 11.8 months (95 ％ CI 7.3-16.4 months),P =0.019; in GSE16011:11.9 months (95 ％ CI 8.3-15.6 months) vs 8.4 months (95 ％ CI 6.2-10.5 months),P =0.005].CDKN2A mRNA level was an independent prognostic factor for GBM.The combination of CDKN2A mRNA expression with MGMT promoter methylation status or G-CIMP status/IDH1 mutations provided an optimized prognostic factor in GBM patients.Conclusion The CDKN2A mRNA has prognostic value in GBM patients,which provided an optimized stratification strategy based on multiple biomarkers.