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
Our case is a 72-year-old female with Fibromuscular Dysplasia (FMD) presented to the Emergency Department (ED) with acute coronary syndrome (ACS), more specifically NSTEMI. In ED, troponin levels were elevated and non...Our case is a 72-year-old female with Fibromuscular Dysplasia (FMD) presented to the Emergency Department (ED) with acute coronary syndrome (ACS), more specifically NSTEMI. In ED, troponin levels were elevated and non-ST segment elevation myocardial infarction (NSTEMI) was detected on electrocardiogram (ECG). Computed tomography (CT) scan showed Internal Carotid artery (ICA) pseudoaneurysm. Cardiac catheterization (CATH) was performed and revealed occlusion of the Left anterior descending (LAD) artery. Spontaneous coronary artery dissection (SCAD) was suspected due to the history of FMD without a history of hypertension, smoking or substance use.展开更多
Background Enoxaparin is routinely used for prevention of venous thromboembolism （VTE） after total hip or knee arthroplasty. The purpose of this study was to compare the efficacy and safety of apixaban, a newly oral...Background Enoxaparin is routinely used for prevention of venous thromboembolism （VTE） after total hip or knee arthroplasty. The purpose of this study was to compare the efficacy and safety of apixaban, a newly oral direct inhibitor of factor Xa versus enoxaparin. Methods We performed a meta-analysis of relevant randomized-controlled trials （RCTs） identified in PubMed, Cochrane Library, Embase China Biological Medical Literature database, Countries Journal full-text database, VIP database, and WanFang database. The primary efficacy outcome for our meta-analysis was all VTE and all-cause mortality. The secondary efficacy outcomes included major VTE, non-fatal pulmonary embolism, and mortality. The primary safety outcome was bleeding events, categorized as major, clinically relevant non-major, or minor events. Results Four RCTs, involving 14065 patients, were included in our meta-analysis. Compared to enoxaparin, thromboprophylaxis with apixaban was associated with significantly fewer VTE and all-cause mortality （8346 patients, risk ratio （RR）： 0.63, 95% CI 0.42-0.95） and similar incidence of bleeding events （major bleeding, 11 525 patients, RR 0.76, 95% CI 0.43-1.33; clinically relevant non-major bleeding, 11 525 patients, RR 0.83, 95% CI 0.69-1.01; and minor bleeding, 11 828 patients, RR 0.93, 95% CI 0.79-1.09）. However, our meta-analysis revealed similar effects of apixaban with enoxaparin for thromboprophylaxis with regard to the secondary efficacy outcomes. Conclusions Apixaban was more effective than recommended dose of enoxaparin and had a similar safety profile for thromboprophylaxis after hip and knee arthroplasty. But more evidence, especially well designed head-to-head RCTs, is needed to confirm the superior efficacy of apixaban.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Our case is a 72-year-old female with Fibromuscular Dysplasia (FMD) presented to the Emergency Department (ED) with acute coronary syndrome (ACS), more specifically NSTEMI. In ED, troponin levels were elevated and non-ST segment elevation myocardial infarction (NSTEMI) was detected on electrocardiogram (ECG). Computed tomography (CT) scan showed Internal Carotid artery (ICA) pseudoaneurysm. Cardiac catheterization (CATH) was performed and revealed occlusion of the Left anterior descending (LAD) artery. Spontaneous coronary artery dissection (SCAD) was suspected due to the history of FMD without a history of hypertension, smoking or substance use.
文摘Background Enoxaparin is routinely used for prevention of venous thromboembolism （VTE） after total hip or knee arthroplasty. The purpose of this study was to compare the efficacy and safety of apixaban, a newly oral direct inhibitor of factor Xa versus enoxaparin. Methods We performed a meta-analysis of relevant randomized-controlled trials （RCTs） identified in PubMed, Cochrane Library, Embase China Biological Medical Literature database, Countries Journal full-text database, VIP database, and WanFang database. The primary efficacy outcome for our meta-analysis was all VTE and all-cause mortality. The secondary efficacy outcomes included major VTE, non-fatal pulmonary embolism, and mortality. The primary safety outcome was bleeding events, categorized as major, clinically relevant non-major, or minor events. Results Four RCTs, involving 14065 patients, were included in our meta-analysis. Compared to enoxaparin, thromboprophylaxis with apixaban was associated with significantly fewer VTE and all-cause mortality （8346 patients, risk ratio （RR）： 0.63, 95% CI 0.42-0.95） and similar incidence of bleeding events （major bleeding, 11 525 patients, RR 0.76, 95% CI 0.43-1.33; clinically relevant non-major bleeding, 11 525 patients, RR 0.83, 95% CI 0.69-1.01; and minor bleeding, 11 828 patients, RR 0.93, 95% CI 0.79-1.09）. However, our meta-analysis revealed similar effects of apixaban with enoxaparin for thromboprophylaxis with regard to the secondary efficacy outcomes. Conclusions Apixaban was more effective than recommended dose of enoxaparin and had a similar safety profile for thromboprophylaxis after hip and knee arthroplasty. But more evidence, especially well designed head-to-head RCTs, is needed to confirm the superior efficacy of apixaban.
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。
