普伐他汀钠/非诺贝特(Pravastatin sodium/Fenofibrate) - 药物靶点：HMGCR x PPARα_在研适应症：合并高脂血症，血脂障碍，复杂性血脂异常_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Duochol、Fenofibrate/Pravastatin、PravaFen

+ [3]

靶点

HMGCR x PPARα

作用方式

抑制剂、激动剂

作用机制

HMG-CoA reductase抑制剂(羟甲基戊二酰辅酶A合酶抑制剂)、PPARα激动剂(过氧化物酶体增长因子活化受体α激动剂)

治疗领域

内分泌与代谢疾病

在研适应症

合并高脂血症血脂障碍复杂性血脂异常

非在研适应症-

原研机构

Laboratoires S.M.B. SA

在研机构

Laboratoires S.M.B. SA

Yooyoung Pharm Co. Ltd.

非在研机构

Shionogi, Inc.

权益机构-

最高研发阶段批准上市

首次获批日期

欧盟 (2011-04-14),

复杂性血脂异常

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C43H57ClO11

InChIKeyYJRSIHJMINZRLT-IYNICTALSA-N

CAS号934374-67-1

关联

16

项与普伐他汀钠/非诺贝特相关的临床试验

JPRN-jRCTs031230067

/ Recruiting临床3期IIT

Study of Pravastatin for Prevention of Recurrent Hypertensive disordrs of Pregnancy

开始日期2023-07-13

申办/合作机构-

ACTRN12613000268741

/ Completed临床1期IIT

In patients with early onset preeclampsia does the addition of pravastatin compared to current practice (historical cohort from 2006) lead to a reduction in symptoms and signs and prolongation of pregnancy?

开始日期2014-06-02

申办/合作机构

Mercy Hospital for Women

NCT02166593

/ Completed临床3期

A Study to Evaluate the Efficacy and Safety of Pravastatin/Fenofibrate Complex in Patients With Combined Dyslipidemia With Adequately Controlled LDL-C But Inadequately Controlled Triglyceride Level by Atorvastatin Monotherapy

Target disease : Patients with combined dyslipidemia with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy
Study objective : The objective of this study is to demonstrate that Pravafenix Cap. is clinically superior to atorvastatin by evaluating a percent change in Non-HDL-C in each group after 8 weeks treatment with atorvastatin or Pravafenix Cap. (pravastatin sodium/fenofibrate) in patients with adequately controlled LDL-C but inadequately controlled triglyceride level by atorvastatin monotherapy in a multicenter, randomized, double blind setting.
Phase and design : A multicenter, double blind, randomized, active controlled, parallel-design, Phase 3 study
Duration of study : 12 months from the IRB approval date
Duration of administration : 4-week single blind run-in period plus 8-week double blind treatment period

开始日期2014-05-01

申办/合作机构

Yooyoung Pharm Co. Ltd.

100 项与普伐他汀钠/非诺贝特相关的临床结果

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100 项与普伐他汀钠/非诺贝特相关的转化医学

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100 项与普伐他汀钠/非诺贝特相关的专利（医药）

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4

项与普伐他汀钠/非诺贝特相关的文献（医药）

2014-07-01·Clínica e Investigación en Arteriosclerosis

Estudios de eficacia

Article

作者: Flores-Le Roux, Juana A ; Pedro-Botet, Juan

Pravafenix(®) is a fixed-dose combination of 40mg of pravastatin and 160 mg of fenofibrate. The rationale behind the use of Pravafenix(®) is based on the increased residual cardiovascular risk observed in high risk patients with hypertriglyceridemia and/or low HDL cholesterol levels despite treatment with statins in monotherapy. In this article, we review the available evidence on the clinical efficacy of Pravafenix(®), which shows complementary benefits in the overall lipid profile of high risk patients with mixed dyslipidemia not controlled with 40-mg pravastatin or 20-mg simvastatin.

2014-07-01·Clínica e Investigación en Arteriosclerosis

Asociación de pravastatina y fenofibrato (Pravafenix®). Estudios de seguridad

Review

作者: Hernández Mijares, Antonio

Although LDL cholesterol is the primary treatment objective for reducing cardiovascular risk, the increase in triglyceride levels and the reduction of HDL cholesterol levels constitute the so-called residual cardiovascular risk. Treatment with statins combined with fibrates is an actual possibility for the treatment of overall cardiovascular risk. However, this combination is often associated with adverse eff ects, especially muscular and hepatic. Due to its pharmacological characteristics, the combination of pravastatin and fenofibrate can be effective and safe, with few adverse eff ects. In this review, we analyze the available safety studies and conclude that Pravafenix(®) (the combination of 40-mg pravastatin and 160-mg fenofibrate) achieves complementary benefits on the overall atherogenic lipid profile, is well tolerated and has few adverse eff ects, which is similar to the monotherapy of each of its components. It remains to be seen whether this combination confers additional long-term benefits for patients treated with statins.

2012-05-01·Expert Review of Cardiovascular Therapy

Pravastatin and fenofibrate in combination (Pravafenix^®) for the treatment of high-risk patients with mixed hyperlipidemia

Review

作者: Farnier, Michel

Pravafenix(®) is a fixed-dose combination of pravastatin 40 mg and fenofibrate 160 mg. The rationale for the use of Pravafenix is based on the increased residual cardiovascular risk observed for high-risk patients with either increased triglycerides or low HDL cholesterol levels despite statin monotherapy. This article reviews the current available information on the pharmacology, clinical efficacy and safety of Pravafenix. Pravafenix is recommended to be taken with food in the evening. In clinical trials, Pravafenix consistently produces complementary benefits on the overall atherogenic lipid profile of high-risk patients with mixed hyperlipidemia not controlled by either pravastatin 40 mg or simvastatin 20 mg. Within the limitations of the database, Pravafenix seems to be well tolerated up to 64 weeks, with an overall tolerability and safety profile consistent with findings generally observed with fenofibrate treatment. In particular, no myopathy or rhabdomyolysis has been reported. The actual European indication is restricted to high-risk patients with mixed hyperlipidemia whose LDL cholesterol levels are adequately controlled on pravastatin 40 mg monotherapy. Whether Pravafenix confers additional cardiovascular benefits in high-risk patients treated with a statin remains to be determined.

100 项与普伐他汀钠/非诺贝特相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	C10BA03	-

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
合并高脂血症	冰岛	Laboratoires S.M.B. SA	2025-01-17
合并高脂血症	挪威	Laboratoires S.M.B. SA	2025-01-17
合并高脂血症	欧盟	Laboratoires S.M.B. SA	2025-01-17
合并高脂血症	列支敦士登	Laboratoires S.M.B. SA	2025-01-17
血脂障碍	韩国	Yooyoung Pharm Co. Ltd.	2012-07-27
复杂性血脂异常	列支敦士登	Laboratoires S.M.B. SA	2011-04-14
复杂性血脂异常	欧盟	Laboratoires S.M.B. SA	2011-04-14
复杂性血脂异常	挪威	Laboratoires S.M.B. SA	2011-04-14
复杂性血脂异常	冰岛	Laboratoires S.M.B. SA	2011-04-14

未上市

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适应症	最高研发状态	国家/地区	公司	日期
合并高脂血症	临床前	美国	Shionogi, Inc.	2007-04-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


J-STARS Echo Study (ISC2017)	N/A	1型颈动脉内膜中层厚度 hyperlipidemia	793	Pravastatin	鑰繭衊鑰網鬱構糧繭餘(簾積範築鹹膚範獵醖構) = 餘構艱顧範壓憲繭淵製繭鏇鹹壓鑰獵遞選夢選 (憲築夢廠蓋夢繭淵網鬱 )	-	2017-02-01
				Pravastatin (Control)	鑰繭衊鑰網鬱構糧繭餘(簾積範築鹹膚範獵醖構) = 獵鏇淵衊積夢繭廠鹽醖繭鏇鹹壓鑰獵遞選夢選 (憲築夢廠蓋夢繭淵網鬱 )
ISC2016	N/A	-	-	Pravastatin	窪鑰鏇鹹窪鏇積鹹鹹鏇(艱鏇窪蓋糧糧膚範顧餘): HR = 0.3 (95% CI, 0.1 ~ 1.0), P-Value = 0.051	-	2016-02-01
				Simvastatin
IAS2009	N/A	脂肪营养不良	45	Uridine	鬱鏇遞襯膚窪糧蓋網積(簾鏇淵顧醖觸淵窪齋夢) = 膚鬱淵製鹹築鏇醖積範網膚築窪壓餘衊襯鏇膚 (觸衊糧襯齋鬱夢鬱鏇夢 ) 更多	-	2009-01-01
				Pravastatin	鬱鏇遞襯膚窪糧蓋網積(簾鏇淵顧醖觸淵窪齋夢) = 艱觸齋鬱衊觸蓋夢獵網網膚築窪壓餘衊襯鏇膚 (觸衊糧襯齋鬱夢鬱鏇夢 )