Delving into the Latest Updates on Pravastatin sodium/Fenofibrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Duochol, Fenofibrate/Pravastatin, PravaFen

+ [3]

Target

HMGCR x PPARα

Action

inhibitors, agonists

Mechanism

HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors), PPARα agonists(Peroxisome proliferator-activated receptor α agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Combined hyperlipidemiaDyslipidemiasComplex dyslipidemia

Inactive Indication-

Originator Organization

Laboratoires S.M.B. SA

Active Organization

Laboratoires S.M.B. SA

Yooyoung Pharm Co. Ltd.

Inactive Organization

Shionogi, Inc.

Drug Highest PhaseApproved

First Approval Date

European Union (14 Apr 2011),

Complex dyslipidemia

Regulation-

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Structure/Sequence

Molecular FormulaC43H57ClO11

InChIKeyYJRSIHJMINZRLT-IYNICTALSA-N

CAS Registry934374-67-1

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

Start Date01 May 2014

Sponsor / Collaborator

Yooyoung Pharm Co. Ltd.

100 Clinical Results associated with Pravastatin sodium/Fenofibrate

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100 Translational Medicine associated with Pravastatin sodium/Fenofibrate

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100 Patents (Medical) associated with Pravastatin sodium/Fenofibrate

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4

Literatures (Medical) associated with Pravastatin sodium/Fenofibrate

01 Jul 2014·Clínica e Investigación en Arteriosclerosis

Estudios de eficacia

Article

Author: 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.

01 Jul 2014·Clínica e Investigación en Arteriosclerosis

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

Review

Author: 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.

01 May 2012·Expert Review of Cardiovascular Therapy

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

Review

Author: 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 Deals associated with Pravastatin sodium/Fenofibrate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C10BA03	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Combined hyperlipidemia	Liechtenstein	Laboratoires S.M.B. SA	17 Jan 2025
Combined hyperlipidemia	Norway	Laboratoires S.M.B. SA	17 Jan 2025
Combined hyperlipidemia	European Union	Laboratoires S.M.B. SA	17 Jan 2025
Combined hyperlipidemia	Iceland	Laboratoires S.M.B. SA	17 Jan 2025
Dyslipidemias	South Korea	Yooyoung Pharm Co. Ltd.	27 Jul 2012
Complex dyslipidemia	Liechtenstein	Laboratoires S.M.B. SA	14 Apr 2011
Complex dyslipidemia	Iceland	Laboratoires S.M.B. SA	14 Apr 2011
Complex dyslipidemia	Norway	Laboratoires S.M.B. SA	14 Apr 2011
Complex dyslipidemia	European Union	Laboratoires S.M.B. SA	14 Apr 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Combined hyperlipidemia	Phase 2	United States	Shionogi, Inc.	01 Apr 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


J-STARS Echo Study (ISC2017)	Not Applicable	Carotid Intimal Medial Thickness 1 hyperlipidemia	793	Pravastatin	rcjdabaqsz(tkcclscknm) = vepdovyhlo owstfgnnxj (ehhbbtllhf )	-	01 Feb 2017
				Pravastatin (Control)	rcjdabaqsz(tkcclscknm) = tdrjzhxygl owstfgnnxj (ehhbbtllhf )
ISC2016	Not Applicable	-	-	Pravastatin	aejtjytcbg(folmlpvrmt): HR = 0.3 (95% CI, 0.1 - 1.0), P-Value = 0.051	-	01 Feb 2016
				Simvastatin
IAS2009	Not Applicable	Lipodystrophy	45	Uridine	zuzwnpehfb(uaiyxtlppi) = ofjrwzyvxd blarheiqxv (mqpeeljjsc ) View more	-	01 Jan 2009
				Pravastatin	zuzwnpehfb(uaiyxtlppi) = orhhytgphw blarheiqxv (mqpeeljjsc )