Delving into the Latest Updates on Amlodipine besilate/Valsartan with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Amlodipine (as besylate)/Valsartan, Amlodipine /Valsartan, Amlodipine/Valsartan

+ [16]

Target

AT1R x VDCCs

Action

antagonists, blockers

Mechanism

AT1R antagonists(Angiotensin II Receptor Type 1 antagonists), VDCCs blockers(Voltage-gated calcium channel blockers)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

HypertensionEssential Hypertension

Inactive Indication-

Originator Organization

Novartis Pharma AG

Active Organization

Novartis Europharm Ltd.

Novartis Pharmaceuticals Corp.Novartis Pharmaceuticals Australia Pty Ltd.

+ [2]

Inactive Organization

Novartis Pharmaceuticals Canada, Inc.

Mylan NV

Novartis AG

License Organization-

Drug Highest PhaseApproved

First Approval Date

European Union (15 Jan 2007),

Essential Hypertension

Regulation-

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Structure/Sequence

Molecular FormulaC24H29N5O3

InChIKeyACWBQPMHZXGDFX-QFIPXVFZSA-N

CAS Registry137862-53-4

View All Structures (2)

The American College of Cardiology/American Heart Association hypertension guidelines recommend treatment initiation with dual antihypertensive therapy in adults with stage 2 hypertension (corresponding to grade 1 and 2 in the ESH classification) and an average BP >20/10 mm Hg above target. Amlodipine and valsartan are two of the most commonly prescribed medications for the treatment of hypertension (high blood pressure). In Pakistan multiple studies were conducted on Hypertension and use of Single Pill Combination in uncontrolled Hypertension. However, no study was conducted to assess the role of Single Pill Combination (SPC) like Amlodipine and Valsartan in newly diagnosed hypertension and to assess their quality of life by patients' satisfaction with their medication after managing the hypertension with the SPC.

Start Date28 Sep 2024

Sponsor / Collaborator

The Searle Co. Ltd.

100 Clinical Results associated with Amlodipine besilate/Valsartan

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100 Translational Medicine associated with Amlodipine besilate/Valsartan

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100 Patents (Medical) associated with Amlodipine besilate/Valsartan

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17

Literatures (Medical) associated with Amlodipine besilate/Valsartan

04 Oct 2022·Journal of the American Heart Association

Global Longitudinal Strain and Biomarkers of Cardiac Damage and Stress as Predictors of Outcomes After Transcatheter Aortic Valve Implantation

Article

Author: Patel, Jay N. ; Vatterott, Anna ; Gupta, Deepak K. ; Kumbhani, Dharam J. ; Baker, Michael ; Mallugari, Ravinder R. ; Clark, Daniel E. ; Jackson, Natalie ; Gillam, Linda ; Gonzales, Holly ; Fearon, William F. ; Lindman, Brian R. ; Kapadia, Samir ; Piana, Robert N. ; Kim, Juyong B. ; Zajarias, Alan ; Perry, Andrew S. ; Biersmith, Michael ; Quader, Nishath ; Stein, Elliot J. ; Bavry, Anthony A. ; Elmariah, Sammy ; Whisenant, Brian ; Coylewright, Megan ; Huang, Shi ; Welt, Frederick G.

Background:

Global longitudinal strain (GLS) is a sensitive measure of left ventricular function and a risk marker in severe aortic stenosis. We sought to determine whether biomarkers of cardiac damage (cardiac troponin) and stress (NT‐proBNP [N‐terminal pro‐B‐type natriuretic peptide]) could complement GLS to identify patients with severe aortic stenosis at highest risk.

Methods and Results:

From a multicenter prospective cohort of patients with symptomatic severe aortic stenosis who underwent transcatheter aortic valve implantation, we measured absolute GLS (aGLS), cardiac troponin, and NT‐proBNP at baseline in 499 patients. Left ventricular ejection fraction <50% was observed in 19% and impaired GLS (aGLS <15%) in 38%. Elevations in cardiac troponin and NT‐proBNP were present in 79% and 89% of those with impaired GLS, respectively, as compared with 63% and 60% of those with normal GLS, respectively ( P <0.001 for each). aGLS <15% was associated with increased mortality in univariable analysis ( P =0.009), but, in a model with both biomarkers, aGLS, and clinical covariates included, aGLS was not associated with mortality; elevation in each biomarker was associated with an increased hazard of mortality (adjusted hazard ratio, >2; P ≤0.002 for each) when the other biomarker was elevated, but not when the other biomarker was normal (interaction P =0.015).

Conclusions:

Among patients with symptomatic severe aortic stenosis undergoing transcatheter aortic valve implantation, elevations in circulating cardiac troponin and NT‐proBNP are more common as GLS worsens. Biomarkers of cardiac damage and stress are independently associated with mortality after transcatheter aortic valve implantation, whereas GLS is not. These findings may have implications for risk stratification of asymptomatic patients to determine optimal timing of valve replacement.

01 Sep 2018·Georgian medical news

[THE COMBINED THERAPY IN HYPERTENSIVE PATIENTS WITH DYSLIPIDEMIA].

Article

Author: Gegeshidze, N ; Tabukashvili, R ; Tchaava, K ; Kapetivadze, V ; Maglapheridze, Z ; Lazashvili, T

Purpose - studying of clinical efficiensy of the combined therapy (Amlodipin with Valsartan and fibrates) in hypertensive patients with dyslipidemia. Were studied 58 patients (40-65 years old) with hypertension (the level of arterial pressure was ≥140/90 and ≤180/110mm.Hg.RR). The patients have been divided into 3 groups: Group 1( n=18, middle age 55,8±5,9) were given Amlodipin 10 mg., Fenofibrates 200mg. (Lipantil); Group 2 (n=20, middle age 58,0±4,9) were given Exforge (Amlodipin 5mg./Valsartan 160mg.) and Lipantil 200mg.; Group3 (n=20, middle age 57,0±6,9) were given Exforge. Research duration- 4 months. Was done collection of anamnesis, calculation of BMI, Heart rate, Blood pressure. Before and after observation were investigated: lipid range, Total Cholesterol, Triglycerides, High Density Lipoproteins, Low Density Lipoproteins by using W.Friedwald's formula. After 4 month in group 3 was found significantly reduce of Blood Pressure, systolic- 26,6%, (р<0,001), and diastolic - 18,0%; Significantly improve Lipid range. Were decreased the levels of Total Cholesterol -14,5%, Triglycerides-15,9%, Low Density Lipoproteins -20,2%. The combined therapy by Exforge and fibrates provides effective decrease in levels of blood pressure and improvement in lipid range in hypertensive patients with dyslipidemia.

01 Sep 2014·AMERICAN JOURNAL OF THERAPEUTICS

Azilsartan, Aliskiren, and Combination Antihypertensives Utilizing Renin–Angiotensin–Aldosterone System Antagonists

Review

Author: Lanier, Gregg ; Aronow, Wilbert S ; Sankholkar, Kedar

Health care providers managing hypertension (HTN) have a large selection of pharmacologic agents to choose from, including several different classes of drugs and many similar drugs within each class. Antagonism of the renin-angiotensin-aldosterone system has been shown to be very effective for HTN, especially in patients with cardiovascular disease, diabetes, and heart failure. Within this group, there have been 2 new agents recently introduced to the US market and approved by the Food and Drug Administration. It is important for the HTN specialist to be familiar with the merits of these 2 drugs: the angiotensin receptor blocker Edarbi (azilsartan) and the renin inhibitor Tekturna (aliskiren). Additionally, there have been several new, fixed-dose combination antihypertensives introduced to the market since 2006 that use a renin-angiotensin-aldosterone antagonist. Seven of these combine 2 drugs together in a single pill: Edarbyclor (azilsartan/chlorthalidone), Exforge (amlodipine/valsartan), Azor (olmesartan/amlodipine), Twynsta (amlodipine/telmisartan), Tekturna HCT [aliskiren/hydrochlorothiazide (HCTZ)], Valturna (aliskiren/valsartan), Tekamlo (aliskiren/amlodipine). Three triple-drug combination medications have also been introduced recently: Exforge HCT (amlodipine/valsartan/HCTZ), Tribenzor (olmesartan/amlodipine/HCTZ), and Amturnide (aliskiren/amlodipine/hydrocholorothiazide). This review will summarize the trial data and important pharmacologic merits of these 2 new renin-angiotensin-aldosterone antagonists and the advantages of initiating treatment with one of the new fixed-dose, combination drugs approved over the last 5 years.

1

News (Medical) associated with Amlodipine besilate/Valsartan

29 Dec 2022

·www.reuters.com

Novartis to pay $245 mln to end antitrust cases over Exforge drug generics

NEW YORK, Dec 28 (Reuters) - Novartis AG (NOVN.S) said on Wednesday it will pay $245 million to end antitrust litigation accusing the Swiss drugmaker of trying to delay the launch in the United States of generic versions of its Exforge hypertension drug. The settlements with so-called direct purchasers, indirect purchasers and retailers require approval by a federal judge in Manhattan, and will resolve all outstanding claims against the company over the matter, Novartis said. CVS Health Corp (CVS.N) , Kroger Co (KR.N) , Rite Aid Corp (RAD.N) and Walgreens Boots Alliance Inc (WBA.O) are among the plaintiffs in the civil litigation, which began in 2018. The class-action litigation stemmed from a 2011 licensing agreement between Novartis and Endo International Plc's (ENDPQ.PK) Par Pharmaceutical unit. Novartis and Par were accused of entering an illegal "reverse payment" agreement to delay launches of less expensive, generic versions of Exforge, which treats hypertension to lower blood pressure and reduce the risk of strokes. Plaintiffs said Par agreed not to launch an Exforge generic for two years after the expiration of one of Novartis's patents, and Novartis agreed not to compete with Par by launching its own Exforge generic during the 180-day exclusivity period following Par's entry into the market. Novartis's annual U.S. sales of brand-name Exforge exceeded $400 million before generic versions were sold, court papers show. The case is In re Novartis and Par Antitrust Litigation, U.S. District Court, Southern District of New York, No. 18-04361. Our Standards: The Thomson Reuters Trust Principles.

License out/inPatent Infringement

100 Deals associated with Amlodipine besilate/Valsartan

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Amlodipine besilate/Valsartan	C09DB01	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	United States	Novartis Pharmaceuticals Corp.	20 Jun 2007
Essential Hypertension	European Union	Novartis Europharm Ltd.	15 Jan 2007
Essential Hypertension	Iceland	Novartis Europharm Ltd.	15 Jan 2007
Essential Hypertension	Liechtenstein	Novartis Europharm Ltd.	15 Jan 2007
Essential Hypertension	Norway	Novartis Europharm Ltd.	15 Jan 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESH2023	Not Applicable	-	22,148	Compound reserpine and triamterene tablets (R/L)	mxhtdhzxkl(msicprmjea) = zulhyylirb tachkgeqha (yrwnaaiqfq )	Positive	01 Jun 2023
				Losartan/hydrochlorothiazide	mxhtdhzxkl(msicprmjea) = hpniaaxzuv tachkgeqha (yrwnaaiqfq )
CHINA STATUS III (ESC2018)	Not Applicable	Hypertension	985	Valsartan/amlodipine fixed-dose combination	bvubmfdmwd(rykztsztse) = AEs were reported in 23.3% of patients rmidtswgwy (usbzoquhju ) View more	-	26 Aug 2018
NCT02062645 (CTgov)	Phase 4	Essential Hypertension	115	amlodipine/valsartan	zkzrrcqvlr = zbmplrxdhj evbwymbjde (tklbrebdia, ogskvriyup - hyedkbavwi) View more	-	28 Mar 2017
PP.07.32 (ESH2015)	Not Applicable	Hypertension	-	Amlodipine 5 mg/valsartan 80 mg combination	wmlqadsxsw(cwicrgmvtc) = The adverse events(AEs) were reported in 13.9 % of participants. The majority of AEs were reported as mild or moderate in severity. ixwlfiscbn (sfkpzvtqiz )	Positive	01 Jun 2015
NCT01030458 (NOAAH, CTgov)	Phase 4	Hypertension	183	amlodipine 5/10 mg per day plus valsartan 160 mg/day (Amlodipine Plus Valsartan)	ioaxngxjey(wuttbbmyhn) = bnesmthcoa eproikraag (uhgfqplzyi, 10.7) View more	-	15 Nov 2013
				hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day (Hydrochlorothiazide Plus Bisoprolol)	ioaxngxjey(wuttbbmyhn) = djgkelcooa eproikraag (uhgfqplzyi, 13.1) View more
488 (ESH2012)	Not Applicable	-	366	Amlodipine/valsartan	snizubeivh(nrmaqmmiou) = 1.1% shfuvhscnp (ouvrbvmlbf )	Positive	01 Sep 2012
NCT01167153 (EXAM STUDY \| EXAM, CTgov)	Phase 4	Hypertension	564	Valsartan/Amlodipine (Valsartan/Amlodipine)	wdatyhqmdn(iqsuqhojkw) = mrbcyhgdkp rdkbkafvlf (tsosiabyba, 11.69) View more	-	01 Jun 2012
				Nifedipine (Nifedipine)	wdatyhqmdn(iqsuqhojkw) = ioaknsyqdm rdkbkafvlf (tsosiabyba, 12.02) View more
NCT01070043 (CTgov)	Phase 4	Hypertension	60	Valsartan	zsaztpvufi(yvmrklttpq) = xohsdpqoqo nsavfckvtr (uqhfvkakbl, 12.71) View more	-	19 Oct 2011
NCT01001572 (CTgov)	Phase 3	Essential Hypertension	932	Placebo+Valsartan/amlodipine 160/5 mg (Valsartan/Amlodipine 160/5 mg)	zreckhzyel(uawjfhsdsu) = hidicewsgz lwlidjgusy (zlltobytwy, 0.39) View more	-	24 May 2011
				Placebo+Valsartan 160 mg (Valsartan 160 mg)	zreckhzyel(uawjfhsdsu) = xoazhrmisj lwlidjgusy (zlltobytwy, 0.40) View more
NCT00666536 (Pubmed \| Blood Press Monit)	Phase 4	Hypertension	728	Intensive treatment with amlodipine/valsartan	qnszmftqvz(adfgbaraqa) = rxlaezrqgo onveidzwga (oalxgrkvxa ) View more	-	01 Apr 2011
				Moderate treatment with amlodipine/valsartan	qnszmftqvz(adfgbaraqa) = cagtiqelyp onveidzwga (oalxgrkvxa )