BACKGROUND Most of the randomized clinical trials that led to the wide use of non-vitamin K antagonist oral anticoagulants for stroke prevention in patients with atrial fibrillation(AF)originated from western countrie...BACKGROUND Most of the randomized clinical trials that led to the wide use of non-vitamin K antagonist oral anticoagulants for stroke prevention in patients with atrial fibrillation(AF)originated from western countries.AIM To systematically review and quantitatively synthesize the real-world data regarding the efficacy and safety of dabigatran,rivaroxaban,and apixaban compared to warfarin for stroke prevention in Asian patients with non-valvular AF.METHODS Medline,Cochrane,and ClinicalTrial.gov databases were reviewed.A randomeffect model meta-analysis was used and I-square was utilized to assess the heterogeneity.The primary outcome was ischemic stroke.The secondary outcomes were all-cause mortality,major bleeding,intracranial hemorrhage,and gastrointestinal bleeding.RESULTS Twelve studies from East Asia or Southeast Asia and 441450 patients were included.Dabigatran,rivaroxaban,and apixaban were associated with a significant reduction in the incidence of ischemic stroke[hazard ratio(HR)=0.78,95%confidence interval(CI):0.65-0.94;HR=0.79,95%CI:0.74-0.85,HR=0.70,95%CI:0.62-0.78;respectively],all-cause mortality(HR=0.68,95%CI:0.56-0.83;HR=0.66,95%CI:0.52-0.84;HR=0.66,95%CI:0.49-0.90;respectively),and major bleeding(HR=0.61,95%CI:0.54-0.69;HR=0.70,95%CI:0.54-0.90;HR=0.58,95%CI:0.43-0.78;respectively)compared to warfarin.CONCLUSION Dabigatran,rivaroxaban,and apixaban appear to be superior to warfarin in both efficacy and safety in Asians with non-valvular AF.展开更多
A rapid, specific, sensitive, and precise reverse-phase HPLC method for the quantitative determination of process related and degradation impurities of Apixaban, an anticoagulant drug is described. The developed RP-HP...A rapid, specific, sensitive, and precise reverse-phase HPLC method for the quantitative determination of process related and degradation impurities of Apixaban, an anticoagulant drug is described. The developed RP-HPLC method was successfully applied to the analysis of both Apixaban drug substance and drug product. The chromatographic separation was achieved on a Sigma-Aldrich’s Ascentis Express®C18 (4.6 mm × 100 mm, 2.7 μ) HPLC column with a runtime of 40 min. Mobile phase-A and mobile phase-B were phosphate buffer and acetonitrile respectively. The column oven temperature was set at 35°C and photodiode array detector was set at 225 nm. Nine process related impurities (Imp-1 to Imp-9) have been detected in test sample of Apixaban by using newly developed RP-HPLC method. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability-indicating nature of the developed RP-HPLC method. The developed method was validated as per ICH guideline and found to be specific, precise, sensitive and robust.展开更多
临床正在应用的抗血栓药物面临挑战,Apixaban作为新兴的抗血栓药物,正引起业界及临床研究的广泛关注。刚刚结束的欧洲心脏病学年会(European Society of Cardiology,ESC)上报告了关于急性冠脉综合征(Acute Coro-nary Syndrome,ACS)临床...临床正在应用的抗血栓药物面临挑战,Apixaban作为新兴的抗血栓药物,正引起业界及临床研究的广泛关注。刚刚结束的欧洲心脏病学年会(European Society of Cardiology,ESC)上报告了关于急性冠脉综合征(Acute Coro-nary Syndrome,ACS)临床Ⅱ期研究(APPRAISE-1)数据,包括对apixaban在冠心病患者中应用的调查性研究。AP-PRAISE-1试验显示,在合用阿司匹林和氯吡格雷的基础上,apixaban有减少ACS患者再发心血管事件、脑卒中、死亡的趋势;但与对照组比较,无统计学意义。因此Apixaban表现出来的较高的安全性和疗效引起业界广泛的关注。展开更多
目的制定阿哌沙班临床应用合理性评价标准(以下简称“标准”),为规范其合理使用提供依据。方法汇总国内外阿哌沙班相关的临床指南及权威文献,并结合药品说明书形成“标准”。回顾性收集河南省人民医院2019年1月至2021年12月使用阿哌沙...目的制定阿哌沙班临床应用合理性评价标准(以下简称“标准”),为规范其合理使用提供依据。方法汇总国内外阿哌沙班相关的临床指南及权威文献,并结合药品说明书形成“标准”。回顾性收集河南省人民医院2019年1月至2021年12月使用阿哌沙班的住院患者病例,根据“标准”对其适应证、用法用量、给药时机、相互作用、桥接转换等进行分析。结果系统检索PubMed、Web of Science、中国知网、万方和维普等数据库后,对最终纳入的11篇文献进行汇总分析,形成“标准”。纳入完整病例815份,用药合理率69.69%(568/815),使用科室主要集中在骨科(688/815,84.42%)。不合理病例数共计247例,按频数进行统计,实际发生频数共计259次,包括不适宜的超说明书用药96次(37.07%),给药频次不合理87次(33.59%),给药剂量不合理28次(10.81%),存在禁忌的药物相互作用31次(11.97%),给药时机不合理7次(2.70%),抗凝转换不合理6次(2.32%),禁忌证用药4次(1.54%)。结论住院患者阿哌沙班的临床使用现状与“标准”存在一定差距,主要集中在不适宜的超说明书用药、给药频次和给药剂量不合理。临床药师应及时关注阿哌沙班循证医学证据和临床指南的更新,积极参与药物管理,进一步规范阿哌沙班的临床应用。展开更多
文摘BACKGROUND Most of the randomized clinical trials that led to the wide use of non-vitamin K antagonist oral anticoagulants for stroke prevention in patients with atrial fibrillation(AF)originated from western countries.AIM To systematically review and quantitatively synthesize the real-world data regarding the efficacy and safety of dabigatran,rivaroxaban,and apixaban compared to warfarin for stroke prevention in Asian patients with non-valvular AF.METHODS Medline,Cochrane,and ClinicalTrial.gov databases were reviewed.A randomeffect model meta-analysis was used and I-square was utilized to assess the heterogeneity.The primary outcome was ischemic stroke.The secondary outcomes were all-cause mortality,major bleeding,intracranial hemorrhage,and gastrointestinal bleeding.RESULTS Twelve studies from East Asia or Southeast Asia and 441450 patients were included.Dabigatran,rivaroxaban,and apixaban were associated with a significant reduction in the incidence of ischemic stroke[hazard ratio(HR)=0.78,95%confidence interval(CI):0.65-0.94;HR=0.79,95%CI:0.74-0.85,HR=0.70,95%CI:0.62-0.78;respectively],all-cause mortality(HR=0.68,95%CI:0.56-0.83;HR=0.66,95%CI:0.52-0.84;HR=0.66,95%CI:0.49-0.90;respectively),and major bleeding(HR=0.61,95%CI:0.54-0.69;HR=0.70,95%CI:0.54-0.90;HR=0.58,95%CI:0.43-0.78;respectively)compared to warfarin.CONCLUSION Dabigatran,rivaroxaban,and apixaban appear to be superior to warfarin in both efficacy and safety in Asians with non-valvular AF.
文摘A rapid, specific, sensitive, and precise reverse-phase HPLC method for the quantitative determination of process related and degradation impurities of Apixaban, an anticoagulant drug is described. The developed RP-HPLC method was successfully applied to the analysis of both Apixaban drug substance and drug product. The chromatographic separation was achieved on a Sigma-Aldrich’s Ascentis Express®C18 (4.6 mm × 100 mm, 2.7 μ) HPLC column with a runtime of 40 min. Mobile phase-A and mobile phase-B were phosphate buffer and acetonitrile respectively. The column oven temperature was set at 35°C and photodiode array detector was set at 225 nm. Nine process related impurities (Imp-1 to Imp-9) have been detected in test sample of Apixaban by using newly developed RP-HPLC method. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability-indicating nature of the developed RP-HPLC method. The developed method was validated as per ICH guideline and found to be specific, precise, sensitive and robust.
文摘临床正在应用的抗血栓药物面临挑战,Apixaban作为新兴的抗血栓药物,正引起业界及临床研究的广泛关注。刚刚结束的欧洲心脏病学年会(European Society of Cardiology,ESC)上报告了关于急性冠脉综合征(Acute Coro-nary Syndrome,ACS)临床Ⅱ期研究(APPRAISE-1)数据,包括对apixaban在冠心病患者中应用的调查性研究。AP-PRAISE-1试验显示,在合用阿司匹林和氯吡格雷的基础上,apixaban有减少ACS患者再发心血管事件、脑卒中、死亡的趋势;但与对照组比较,无统计学意义。因此Apixaban表现出来的较高的安全性和疗效引起业界广泛的关注。
文摘目的制定阿哌沙班临床应用合理性评价标准(以下简称“标准”),为规范其合理使用提供依据。方法汇总国内外阿哌沙班相关的临床指南及权威文献,并结合药品说明书形成“标准”。回顾性收集河南省人民医院2019年1月至2021年12月使用阿哌沙班的住院患者病例,根据“标准”对其适应证、用法用量、给药时机、相互作用、桥接转换等进行分析。结果系统检索PubMed、Web of Science、中国知网、万方和维普等数据库后,对最终纳入的11篇文献进行汇总分析,形成“标准”。纳入完整病例815份,用药合理率69.69%(568/815),使用科室主要集中在骨科(688/815,84.42%)。不合理病例数共计247例,按频数进行统计,实际发生频数共计259次,包括不适宜的超说明书用药96次(37.07%),给药频次不合理87次(33.59%),给药剂量不合理28次(10.81%),存在禁忌的药物相互作用31次(11.97%),给药时机不合理7次(2.70%),抗凝转换不合理6次(2.32%),禁忌证用药4次(1.54%)。结论住院患者阿哌沙班的临床使用现状与“标准”存在一定差距,主要集中在不适宜的超说明书用药、给药频次和给药剂量不合理。临床药师应及时关注阿哌沙班循证医学证据和临床指南的更新,积极参与药物管理,进一步规范阿哌沙班的临床应用。
