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葛均波院士牵头奥美沙坦酯氨氯地平片真实世界研究在沪启动!

2019-07-31 Fiona MedSci原创

2019年7月31日,由复旦大学附属中山医院葛均波院士牵头的《奥美沙坦酯氨氯地平片对于中国原发性高血压人群的临床效果和安全性的多中心观察性研究》研讨会在上海正式拉开帷幕。复旦大学附属中山医院葛均波院士、复旦大学附属中山医院崔兆强教授、第一三共株式会社Head of ASCA MA东山浩先生、第一三共(中国)投资有限公司医学部总监张莹女士及中国心血管健康联盟医学部等共同出席了会议。葛均波院士表示,《

2019年7月31日,由复旦大学附属中山医院葛均波院士牵头的《奥美沙坦酯氨氯地平片对于中国原发性高血压人群的临床效果和安全性的多中心观察性研究》研讨会在上海正式拉开帷幕。

复旦大学附属中山医院葛均波院士、复旦大学附属中山医院崔兆强教授、第一三共株式会社Head of ASCA MA东山浩先生、第一三共(中国)投资有限公司医学部总监张莹女士及中国心血管健康联盟医学部等共同出席了会议。

葛均波院士表示,《健康中国2030》中明确指出,我国各级医疗机构的医生需开展高血压防治工作。而高血压作为最常见的慢性病之一,在我国的发病率逐年增加,已构成极大的社会及医疗负担。因此,规范高血压的治疗和管理,提高血压控制率是十分必要的。此次开展的多中心高血压真实世界研究致力于为中国的高血压防治提供更多的临床数据,为高血压治疗提供更有力的决策支持。


复旦大学中山医院葛均波院士发表致辞

第一三共株式会社Head of ASCA MA东山浩先生表示,第一三共作为全球排名前20的企业,一直致力于为患者提供更好的治疗药物。在高血压治疗领域,第一三共奥美沙坦家族多年来表现出色,去年新上市的思卫卡(奥美沙坦酯氨氯地平片)为血压控制不佳的患者提供了新的选择。此外,第一三共也致力于改善心血管系统疾病,新上市的艾多沙班(新型口服抗凝药)也为房颤患者的抗凝治疗保驾护航。第一三共将通过提供优质的药品,持续为提升中国人民的健康而努力。

 
第一三共株式会社Head of ASCA MA东山浩先生发表致辞

崔兆强教授在会中详细介绍了SVK项目方案。他表示,奥美沙坦酯氨氯地平片的强效降压效果已经在诸多RCT试验中有所体现,而这项真实世界研究不仅可以回答之前注册试验中没有回答的临床问题及药物安全性问题,还可以通过研究结果给医生更多的临床证据和指导。

 
复旦大学中山医院崔兆强教授发表致辞

高血压是一种由多种病因引起的处于不断进展状态的心血管综合征,在我国,高血压的患病率呈升高趋势。虽然我国高血压患者的知晓率(51.5%)、治疗率(46.1%)和控制率(16.9%)近年来有所提高,但总体仍处于较低水平。

对于高血压患者来说,控制血压达标十分重要。高血压治疗的根本目标是降低心、脑、肾及血管等并发症的发生率和降低死亡的总风险。在改善患者生活方式的基础上,应根据高血压患者的总体风险水平决定给予降压药物,纠正危险因素、靶器官损害和并存的临床疾病。

2018年7月,第一三共研发的降压药物奥美沙坦酯氨氯地平片在我国正式获批,成为继奥美沙坦酯片、奥美沙坦酯氢氯噻嗪片后又一枚治疗高血压的利器。而2018年ESH/ESC指南也明确指出,大多数高血压患者应起始采用联合治疗,且复方制剂有助于改善患者依从性,提高达标率。可见,ARB/CCB联合的单片复方制剂应是大多数高血压患者的优选起始联合治疗方案。

目前,诸多临床研究已表明,奥美沙坦酯氨氯地平片降压效果快速、显著且耐受性良好,其循证医学证据充足。而由葛均波院士牵头的这项前瞻性、非干预、多中心观察性研究,旨在探索奥美沙坦酯氨氯地平片治疗原发性高血压的临床效果,获得在不同病程、不同高血压程度、不同合并症等具有不同临床特点的人群中奥美沙坦酯氨氯地平片的循证医学证据。

该研究由第一三共(中国)投资有限公司提供资金支持,上海梅斯医药科技有限公司负责项目全程管理,由心血管健康(苏州工业园区)研究院协调监督。

在该研讨会中,上海梅斯医药科技有限公司的江敏总监针对SVK项目执行进行了详细介绍,包括项目执行、监查、药物警戒(PV)及不良反应(AE)等。梅斯医学创始人杨春先生表示,真实世界研究是临床实践和科学研究的桥梁,它的核心特征是以患者为中心,得出的结论可直接推之于临床实践,而慢性病更是开展真实世界研究的理想对象。相比于其他研究类型,RWS(Real-World study)是更综合和深入的研究,而梅斯医学能提供专业的学术服务,协助临床专家们更高效和低成本地进行研究。

在大量循证医学证据的推动下,奥美沙坦无论是单药应用还是联合应用,在全球的临床应用都效果喜人,表现出强效的降压优势及良好的靶器官保护作用。作为目前国内第三个上市的ARB+CCB单片复方制剂,奥美沙坦酯氨氯地平片将带领奥美沙坦酯片全体家族一起,助力中国高血压防治改善,促进中国心血管疾病慢病管理有效实现。希望在高血压治疗中造福更多患者,不止“助力达标”,还能“引领卫来”!

 
参与研究医院代表与主要研究者合影

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    2019-08-01 junJUN

    院士是学术至高点,也是大家必争之地呀

    0

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