佐芬普利钙(Zofenopril Calcium) - 药物靶点：ACE_在研适应症：高血压，心肌梗塞，原发性高血压_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Bifril、Zantipress、Zofenil

+ [12]

靶点

ACE

作用机制

ACE抑制剂(血管紧张素转化酶抑制剂)

治疗领域

心血管疾病

在研适应症

高血压心肌梗塞原发性高血压

非在研适应症

心脏衰竭

原研机构

Menarini International Operations Luxembourg SA

在研机构

上海医药工业研究院有限公司Menarini International Operations Luxembourg SA

江苏康缘药业股份有限公司

非在研机构

A. Menarini Industrie Farmaceutiche Riunite SRL

Bristol Myers Squibb Co.

BioSyent, Inc.

最高研发阶段批准上市

首次获批日期

荷兰 (2008-07-05),

高血压心肌梗塞

最高研发阶段(中国)临床2期

特殊审评-

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结构/序列

分子式C22H23NO4S2

InChIKeyIAIDUHCBNLFXEF-MNEFBYGVSA-N

CAS号81872-10-8

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关联

7

项与佐芬普利钙相关的临床试验

NCT05279807

/ Completed临床4期

Interventional Clinical Trial to Assess Efficacy and Safety of the Extemporaneous Combination of Zofenopril Calcium and Amlodipine in Grade 1-2 Hypertensive Patients Versus Each Monotherapy - (MASOLINO Study)

Study to assess the anti-hypertensive efficacy and safety of the extemporaneous combination of Zofenopril 30 mg in combination with Amlodipine 5 mg or AML 10 mg in lowering the sitting diastolic BP after 8 weeks of treatment in patients with uncontrolled BP previously treated with Zofenopril or Amlodipine (5 mg) monotherapies for at least 4 weeks.

开始日期2021-10-15

申办/合作机构

Menarini International Operations Luxembourg SA

NCT05257148

/ Completed临床4期

Open-label, Multicenter, Multinational, Interventional Clinical Trial to Assess Effectiveness and SAfety of the Extemporaneous Combination of Nebivolol and Zofenopril Calcium in Grade 1 to 2 Hypertensive patIents Versus Each mOnotherapy

Open-label, interventional clinical trial to assess effectiveness and safety of the extemporaneous combination of nebivolol and zofenopril calcium in grade 1 to 2 hypertensive patients versus each monotherapy

开始日期2021-05-26

申办/合作机构

Menarini International Operations Luxembourg SA

DRKS00020911

/ Completed临床1期

Bioequivalence of Zofenopril and Nebivolol following their oral co-administration as fixed or extemporaneous combination in healthy volunteers. An open label, randomized, two periods, two sequences, cross-over study - ZOF-NEB-01

开始日期2020-06-18

申办/合作机构

Menarini Ricerche SpA

100 项与佐芬普利钙相关的临床结果

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100 项与佐芬普利钙相关的转化医学

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100 项与佐芬普利钙相关的专利（医药）

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202

项与佐芬普利钙相关的文献（医药）

2023-12-02·Current Medical Research and Opinion

Extemporaneous combination therapy with amlodipine/zofenopril in hypertensive patients: a real-world data analysis in Italy

Article

作者: Pegoraro, Valeria ; Heiman, Franca ; Volpe, Massimo ; Cipelli, Riccardo

OBJECTIVESTo provide clinical characteristics and to quantify the number of patients receiving the extemporaneous combination of the calcium channel blocker amlodipine and the angiotensin converting enzyme inhibitor zofenopril in a real-world setting. This evidence can provide a snapshot of the potential users of the two molecules in a single pill combination (SPC).METHODSRetrospective observational study using data from the IQVIA Italian Longitudinal Patient Database. Adult patients firstly prescribed with amlodipine and zofenopril between 1 July 2011 and 30 June 2020 were identified and demographic and clinical characteristics were extracted. Treatment adherence was evaluated as proportion of days covered (PDC). The potential number of patients eligible for a SPC was calculated.RESULTSA population of 2394 hypertensive patients, mean age of 68.6 years ±12.7, 52.6% male were treated with amlodipine and zofenopril. The majority of patients (54.5%) were low adherent (PDC <40%), 25.9% were intermediate adherent and only 19.6% were high adherent (>80%) to therapy. Around 42,500 adult hypertensive patients were estimated to be prescribed the extemporaneous combination in 2019 in Italy, being potentially eligible for treatment with amlodipine and zofenopril SPC.CONCLUSIONSThe administration of the extemporaneous combination of zofenopril and amlodipine in hypertensive patients is a common practice in Italy. The development of a SPC can be a viable treatment option to simplify therapy and to increase adherence in hypertensive patients who are already on the two monotherapies in combination.

2023-09-13·Molecular biotechnology

Effects of Zofenopril on Arterial Stiffness in Hypertension Patients.

Article

作者: Sher, Farooq ; Abdelghani, Heba Taha Mohmmed ; Brizić, Ivica ; Džidić-Krivić, Amina ; Palić, Benjamin ; Sher, Emina Karahmet ; Cvetković, Ivona

Angiotensin-converting enzyme inhibitors (ACEIs) reduce arterial stiffness beyond their antihypertensive effect. Studies showed that sulfhydryl ACEIs have the antioxidative potential to improve endothelial function, which might have a clinical effect on arterial distensibility. However, there are no studies that directly compare the effects of sulfhydryl (zofenopril) and non-sulfhydryl ACEIs (enalapril) on arterial stiffness. Therefore, this prospective study aims to compare the effects of enalapril and zofenopril on arterial stiffness and oxidative stress in both short- and long-term treatment of arterial hypertension (AH). Baseline and post-treatment peripheral and central arterial pressure indices, augmentation index (Aix), aortic pulse wave velocity (ao-PWV), serum levels of oxidized low-density cholesterol lipoprotein, LDL and uric acid (UA) were measured. The results showed that acute treatment with zofenopril, in contrast to enalapril, significantly decreased peripheral and central Aix (p < 0.001). Chronic treatment with zofenopril showed a superior effect over enalapril on the reduction of the peripheral systolic arterial pressure with reduction of ao-PWV (p = 0.004), as well as a reduction in peripheral Aix (p = 0.021) and central Aix (p = 0.021). Therefore, this study indicates that zofenopril has beneficial effects on the reduction of arterial stiffness compared to enalapril. It has potent clinical efficacy in AH treatment and further studies should compare its safety and long-term efficacy to other AH drugs that would aid clinicians in treating AH and other various cardiovascular diseases that have arterial stiffness as a common denominator.

2022-10-03·Current Medical Research and Opinion

Extemporaneous combination therapy with nebivolol/zofenopril in hypertensive patients: usage in Italy

Article

作者: Heiman, Franca ; Pegoraro, Valeria ; Meto, Suada ; Peduto, Ilaria ; Volpe, Massimo

OBJECTIVEClinically describing hypertensive patients initiating nebivolol/zofenopril extemporaneous combination (NZ-EXC) and estimating the number of patients currently receiving NZ-EXC and of those potentially eligible for the fixed-dose combination of the two molecules (NZ-FDC) in Italy.METHODSThis retrospective observational study used data from IQVIA Italian Longitudinal Patient Database (LPD). Adult hypertensive patients firstly prescribed NZ-EXC between 1 July 2011 and 30 June 2020 were identified and their demographic and clinical characteristics were extracted. Treatment adherence was evaluated as proportion of days covered (PDC) and classified as low (PDC <40%), intermediate (PDC ≥40% and <80%) or high (PDC ≥80%). Two additional cohorts were identified in 2019 to provide the national-level yearly estimates of patients prescribed NZ-EXC and of patients eligible for NZ-FDC.RESULTSIn total 1745 patients were prescribed NZ-EXC: 60% were women; mean age was 65 years. The most frequent comorbidities were dyslipidemia (19.0%), diabetes (15.5%) and thyroid diseases (13.1%); the most common co-prescribed treatments were antithrombotics (29.1%), lipid-lowering agents (28.8%), nonsteroidal anti-inflammatory drugs (26.1%) and antihyperglycemic agents (13.5%). Mean PDC was 39%, and 57% of the patients had a PDC < 40%. The yearly estimate of patients prescribed NZ-EXC in 2019 was 59,000, while potential users of NZ-FDC were estimated to be 29,000.CONCLUSIONSNZ-EXC in hypertensive patients is a common practice in Italy and the development of a NZ-FDC can be a viable treatment option for hypertensive patients who are already receiving nebivolol and zofenopril through the concomitant assumption of two distinct pills. As supported by scientific literature, FDCs of antihypertensive drugs could simplify treatment, improve adherence and potentially reduce health-care costs as related to a better control of blood pressure.

100 项与佐芬普利钙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03767	佐芬普利钙	C09AA15	DB13166

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
高血压	荷兰	Menarini International Operations Luxembourg SA	2008-07-05
心肌梗塞	荷兰	Menarini International Operations Luxembourg SA	2008-07-05

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
原发性高血压	临床2期	中国	上海医药工业研究院有限公司	2013-08-30
原发性高血压	临床2期	中国	江苏康缘药业股份有限公司	2013-08-30
心脏衰竭	临床前	欧盟	A. Menarini Industrie Farmaceutiche Riunite SRL	-
高血压	临床前	美国	Bristol Myers Squibb Co.	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SMILE (EULAR2017)	N/A	心肌梗塞 hyperuricemic	525	Zofenopril + XOI	(遞獵構蓋範窪餘餘鹽顧) = 艱醖鏇網糧膚範襯廠繭鹽鏇鏇廠鹽築蓋廠遞鹽 (窪衊鬱壓壓簾夢築獵艱 )	积极	2017-06-14
				Zofenopril (Placebo or other ACEIs + XOI)	(遞獵構蓋範窪餘餘鹽顧) = 膚製積鏇齋積蓋繭窪憲鹽鏇鏇廠鹽築蓋廠遞鹽 (窪衊鬱壓壓簾夢築獵艱 )
EUCTR2004-001150-88-IE (SMILE-4, ESH2015)	临床3期	急性心肌梗塞	265	Zofenopril + ASA	選廠顧願齋齋夢艱膚鹽(艱廠醖範壓餘鬱膚齋蓋): OR = 0.61 (95% CI, 0.37 ~ 0.99), P-Value = 0.047 更多	积极	2015-06-01
				Ramipril + ASA
[PP.35.26] (ESH2015)	N/A	高血压	30	Zofenopril 36.0 mg	願窪憲鹹鏇憲壓餘鏇齋(壓繭鏇製襯遞醖鏇積襯) = 壓獵鑰鑰壓築繭廠淵廠蓋繭網遞襯鏇築餘艱範 (網構糧觸糧鏇顧選衊廠 ) 更多	积极	2015-06-01
EUCTR2004-001150-88-IE (SMILE-4, EASD2012)	临床3期	左心室收缩功能障碍 diabetes mellitus	716	Zofenopril + ASA	壓窪鑰積糧廠淵窪餘憲(鑰夢鏇範餘簾繭積遞壓) = 築積遞壓廠廠鑰觸遞憲構觸築範廠夢鏇簾鬱鹹 (選餘鑰糧窪憲壓艱艱構, 0.31 ~ 1.30)	积极	2012-10-04
				Ramipril + ASA	壓窪鑰積糧廠淵窪餘憲(鑰夢鏇範餘簾繭積遞壓) = 網糧艱夢壓願鏇蓋範築構觸築範廠夢鏇簾鬱鹹 (選餘鑰糧窪憲壓艱艱構 )
SMILE-4 Study (ESH2012)	N/A	-	716	Zofenopril 60 mg plus ASA	繭鹽壓醖蓋選膚艱遞艱(積範簾鏇積鬱膚構製鏇) = 願鏇廠壓膚築鏇積淵築鹹遞鑰淵襯醖壓鹽鹹壓 (齋壓網淵積鬱簾衊簾遞 )	积极	2012-09-01
				Ramipril 10 mg plus ASA 100 mg	繭鹽壓醖蓋選膚艱遞艱(積範簾鏇積鬱膚構製鏇) = 壓襯憲襯鑰遞鏇築願衊鹹遞鑰淵襯醖壓鹽鹹壓 (齋壓網淵積鬱簾衊簾遞 )