【Eliquis】百时美施贵宝与辉瑞公布阿哌沙班的新数据

BMSandPfizerannouncenewdataforEliquisBristol-My...



BMS and Pfizer announce new data for Eliquis

Bristol-Myers Squibb and Pfizer have announced results from a post-hoc early time course subanalysis of the Phase 3 AMPLIFY trial of Eliquis (apixaban).



The subanalysis demonstrated Eliquis was comparable to conventional therapy in recurrent venous thromboembolism (VTE) and VTE-related death with significantly less major bleeding during the first 7, 21 and 90 days after starting treatment.

Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and blood clot formation.

“For the millions of patients worldwide who experience VTE, the risks of recurrence and major bleeding are highest during the first few weeks of anticoagulant therapy,” said Giancarlo Agnelli, M.D., Professor of Internal Medicine at the University of Perugia, Italy, Director of the Department of Internal and Cardiovascular Medicine and Stroke-Unit at the University Hospital in Perugia. “These findings indicate that the favorable benefit-to-risk profile of Eliquis was demonstrated early during treatment for VTE, including the use of a higher Eliquis dose of 10 mg twice daily for the initial seven days.”

Eliquis non-inferior to conventional therapy at each time point analysed

The results of the subanalyses at each pre-specified time interval were consistent with the overall results of the AMPLIFY trial at 6 months, which demonstrated non-inferiority of Eliquis versus conventional therapy in the primary efficacy endpoint of recurrent VTE and VTE-related death, and superiority in the primary safety endpoint by showing significantly fewer major bleeding events, with a 69% relative risk reduction (RRR) compared to conventional therapy.

In this post-hoc early time course subanalysis, recurrent VTE and VTE-related death at 7, 21, and 90 days after starting treatment occurred in 18 (0.7%), 29 (1.1%), and 46 (1.8%), patients who were given Eliquis, respectively, and in 23 (0.9%), 35 (1.3%), and 58 (2.2%) patients given conventional therapy, respectively. Outcomes at each time point were similar in patients by index event (deep vein thrombosis (DVT) alone or pulmonary embolism (PE) with or without DVT) and were consistent with the results for the entire study period. Major bleeding at the corresponding time points occurred in 3 (0.1%), 5 (0.2%), and 11 (0.4%) patients, who received Eliquis, respectively, and in 16 (0.6%), 26 (1.0%), and 38 (1.4%) patients given conventional therapy, respectively. Eliquis was non-inferior to conventional therapy in recurrent VTE and VTE-related death at each time point analysed, with no excess of early recurrences; and patients treated with Eliquis were less likely to have major bleeding early in the course of treatment than those treated with conventional therapy.

百时美施贵宝与辉瑞公布了阿哌沙班 3 期 AMPLIFY 试验一项事后早期间进程的亚组分析结果。这项分析证明，阿哌沙班在复发性静脉血栓栓塞及静脉血栓栓塞相关死亡指标上与常规疗法相仿，在初始治疗后 7、21 及 90 天大出血明显减少。

阿哌沙班是一款口服选择性因子 Xa 抑制剂。阿哌沙班通过抑制因子 Xa（一种关键的血液凝结蛋白），可降低凝血酶生成及血栓形成。

「对于世界各地成千上万经历静脉血栓栓塞的患者来说，在抗凝血治疗的头几周内复发及大出血风险是最高的，」意大利佩鲁贾大学内科教授兼佩鲁贾大学医院心血管医学和卒中科室主任、医学博士 Agnelli 称。「这些结果表明，阿哌沙班在静脉血栓栓塞治疗早期有有利的受益 - 风险性能，包括初始治疗 7 天内每天两次较高的 10 mg 剂量。」

在分析的每个时间点上，阿哌沙班非劣效于常规疗法

每个预先设定时间间隔的亚组分析结果与 AMPLIFY 试验 6 个月时的总体结果一致，这证明了阿哌沙班与常规疗法相比在主要疗效终点 - 复发性静脉血栓栓塞与静脉血栓栓塞相关死亡 上具有非劣效性，在主要安全性终点上具有优效性，该药物显示有明显更少的大出血事件，与常规疗法相比，相对风险降低 69%。

在这项事后早期时间的亚组分析中，起始治疗后 7、21 及 90 天，以阿哌沙班治疗患者的复发静脉血栓栓塞及静脉血栓栓塞相关死亡例数分别 18（0.7%）、29（1.1%）和 46（1.8%），而以常规疗法治疗患者的复发静脉血栓栓塞及静脉血栓栓塞相关死亡例数分别为 23（0.9%）、35（1.3%）和 58（2.2%）。

每个时间点的指标事件患者人数在结果上相似，与整体研究的结果一致。阿哌沙班治疗患者中，在以上时间点发生的大出血病例数分别为 3（0.1%）、5（0.2%）和 11（0.4%），常规疗法治疗患者在相应时间点发生的大出血病例数分别为 16（0.6%）、26（1.0%）和 38（1.4%）。

在分析的每个时间点上，阿哌沙班在复发性静脉血栓栓塞及静脉血栓栓塞相关死亡指标上与常规疗法相比具有非劣效性，早期复发病例数并未过多发生。与使用常规疗法治疗的患者相比，阿哌沙班治疗患者在治疗早期不太可能发生大出血。

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