Chiglitazar(Carfloglitazar)is a novel non-thiazolidinedione(TZD)structured peroxisome proliferatoractivated receptor(PPAR)pan-agonist that has shown promising effects on glycemic control and lipid regulation in patien...Chiglitazar(Carfloglitazar)is a novel non-thiazolidinedione(TZD)structured peroxisome proliferatoractivated receptor(PPAR)pan-agonist that has shown promising effects on glycemic control and lipid regulation in patients with type 2 diabetes in previous clinical studies.This randomized phase 3 trial aimed to compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes with insufficient glycemic control by strict diet and exercise alone.Eligible patients were randomly assigned to receive chiglitazar 32 mg(n=167),chiglitazar 48 mg(n=166),or placebo(n=202)once daily.The primary endpoint was the change in glycosylated hemoglobin A_(1c)(HbA_(1c))at week 24 with superiority of chiglitazar over placebo.The results showed that both chiglitazar 32 and 48 mg resulted in significant and clinically meaningful reductions in HbA_(1c),and placebo-adjusted estimated treatment differences at week 24 for chiglitazar 32 and 48 mg were-0.87%(95%confidential interval(CI):-1.10 to-0.65;P<0.0001)and-1.05%(95%CI:-1.29 to-0.81;P<0.0001),respectively.Secondary efficacy parameters including glycemic control,insulin sensitivity and triglyceride reduction were also significantly improved in the chiglitazar groups.The overall frequency of adverse events and study discontinuation attributable to adverse events were similar among the groups.Low incidences of mild edema and body weight gain were reported in the chiglitazar dose groups.The results from this phase 3 trial demonstrated that the PPAR pan-agonist chiglitazar possesses an overall good efficacy and safety profile in patients with type 2 diabetes inadequately controlled with lifestyle interventions,thereby providing adequate supporting evidence for using this PPAR pan-agonist as a treatment option for type 2 diabetes.展开更多
Objective:This study conducted inverse probability of treatment weighting(IPTW)survival analysis to examine survival in pancreatic adenocarcinoma patients.Methods:In this population-based study,data from the Surveilla...Objective:This study conducted inverse probability of treatment weighting(IPTW)survival analysis to examine survival in pancreatic adenocarcinoma patients.Methods:In this population-based study,data from the Surveillance,Epidemiology,and End Results program of the United States were analyzed to identify patients diagnosed with adenocarcinoma of the pancreas 2004 to 2014.Differences in survival rates were examined among patients who underwent pancreatectomy alone,radiotherapy alone,and those who had pancreatectomy plus adjuvant radiotherapy.Kaplan-Meier estimates and Cox proportional hazards models with the IPTW were performed to determine the effect of different treatments on overall and cancer-specific survival.This study was approved by the Ethics Review Board of Weifang Medical University.Results:A total of 8191 patients were included,with 3409 taking pancreatectomy only,2865 taking radiotherapy only,and 1917 taking pancreatectomy plus adjuvant radiotherapy.Patients who received surgery plus adjuvant radiotherapy had statistically a higher survival rate than those who received the other 2 treatments.Survival analysis with the IPTW for the 3 different groups showed that the difference in median overall survival time among these patient groups was significant.Conclusion:Using IPTW survival analysis,the present study shows that surgery with adjuvant radiotherapy is significantly associated with improved overall and cancer-specific survival among patients with pancreatic adenocarcinoma.展开更多
基金grants from Chinese National and Provincial Major Project for New Drug Innovation(National:2008ZX09101-002 and 2013ZX09401301Provincial:2011A080501010)Shenzhen Municipal Major Project(2010-1746)。
文摘Chiglitazar(Carfloglitazar)is a novel non-thiazolidinedione(TZD)structured peroxisome proliferatoractivated receptor(PPAR)pan-agonist that has shown promising effects on glycemic control and lipid regulation in patients with type 2 diabetes in previous clinical studies.This randomized phase 3 trial aimed to compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes with insufficient glycemic control by strict diet and exercise alone.Eligible patients were randomly assigned to receive chiglitazar 32 mg(n=167),chiglitazar 48 mg(n=166),or placebo(n=202)once daily.The primary endpoint was the change in glycosylated hemoglobin A_(1c)(HbA_(1c))at week 24 with superiority of chiglitazar over placebo.The results showed that both chiglitazar 32 and 48 mg resulted in significant and clinically meaningful reductions in HbA_(1c),and placebo-adjusted estimated treatment differences at week 24 for chiglitazar 32 and 48 mg were-0.87%(95%confidential interval(CI):-1.10 to-0.65;P<0.0001)and-1.05%(95%CI:-1.29 to-0.81;P<0.0001),respectively.Secondary efficacy parameters including glycemic control,insulin sensitivity and triglyceride reduction were also significantly improved in the chiglitazar groups.The overall frequency of adverse events and study discontinuation attributable to adverse events were similar among the groups.Low incidences of mild edema and body weight gain were reported in the chiglitazar dose groups.The results from this phase 3 trial demonstrated that the PPAR pan-agonist chiglitazar possesses an overall good efficacy and safety profile in patients with type 2 diabetes inadequately controlled with lifestyle interventions,thereby providing adequate supporting evidence for using this PPAR pan-agonist as a treatment option for type 2 diabetes.
基金partially supported by the National Natural Science Foundation of China(No.81872719)the National Bureau of Statistics Foundation Project(No.2018LY79)+6 种基金the Natural Science Foundation of Shandong Province(No.2019MH034)the Poverty Alleviation Fund project of Weifang Medical University(No.FP1801001)partially supported by the National Natural Science Foundation of China(No.81803337)the Shandong Provincial Youth Innovation Team Development Plan of Colleges and Universities(No.2019-6-156,Lu-Jiao)the Shandong Provincial Government Fund for Overseas Study(No.27,2019,Lu-Jiao)the Shandong Science and Technology Development Plan Project(No.2015 WS0067)the Weifang Medical University Doctoral Foundation Project(No.2017BSQD51).
文摘Objective:This study conducted inverse probability of treatment weighting(IPTW)survival analysis to examine survival in pancreatic adenocarcinoma patients.Methods:In this population-based study,data from the Surveillance,Epidemiology,and End Results program of the United States were analyzed to identify patients diagnosed with adenocarcinoma of the pancreas 2004 to 2014.Differences in survival rates were examined among patients who underwent pancreatectomy alone,radiotherapy alone,and those who had pancreatectomy plus adjuvant radiotherapy.Kaplan-Meier estimates and Cox proportional hazards models with the IPTW were performed to determine the effect of different treatments on overall and cancer-specific survival.This study was approved by the Ethics Review Board of Weifang Medical University.Results:A total of 8191 patients were included,with 3409 taking pancreatectomy only,2865 taking radiotherapy only,and 1917 taking pancreatectomy plus adjuvant radiotherapy.Patients who received surgery plus adjuvant radiotherapy had statistically a higher survival rate than those who received the other 2 treatments.Survival analysis with the IPTW for the 3 different groups showed that the difference in median overall survival time among these patient groups was significant.Conclusion:Using IPTW survival analysis,the present study shows that surgery with adjuvant radiotherapy is significantly associated with improved overall and cancer-specific survival among patients with pancreatic adenocarcinoma.
