Prof Qaisar Khan Trials

8/10/2019 Prof Qaisar Khan Trials

1/56

COURAGECOURAGE

Clinical Outcomes Utilizing

Revascularization and

Aggressive Guideline-Driven

Drug Evaluation


2/56

BackgroundBackgroundMore than 1 million PCI procedures are performed in the

U.S. annually, the great majority of which are undertaken

electively in patients with stable CAD

Although successful PCI of flow-limiting stenoses might

be expected to reduce the rate of death, MI or

hospitalization for ACS, prior studies have shown only that

PCI decreases the frequency of angina and improves

short-term exercise performance


3/56

ConclusionsConclusions

As an initial management strategy in patients withAs an initial management strategy in patients with

stable coronary artery disease, PCI did not reducestable coronary artery disease, PCI did not reducethe risk of death, MI, or other majorthe risk of death, MI, or other majorcardiovascular events when added to optimalcardiovascular events when added to optimal

medical therapymedical therapy

As expected, PCI resulted in better angina reliefAs expected, PCI resulted in better angina relief

during most of the followduring most of the follow--up period, but medicalup period, but medicaltherapy was also remarkably effective, with notherapy was also remarkably effective, with nobetweenbetweengroup difference in anginagroup difference in angina--free status at 5free status at 5

yearsyears


4/56

ImplicationsImplications

Our findings reinforce existing ACC/AHA clinicalOur findings reinforce existing ACC/AHA clinical

practice guidelines, which state that PCI can be safelypractice guidelines, which state that PCI can be safelydeferred in patients with stable CAD, even in thosedeferred in patients with stable CAD, even in thosewith extensive,with extensive, multivesselmultivessel involvement and inducibleinvolvement and inducible

ischemia, provided that intensive, multifaceted medicalischemia, provided that intensive, multifaceted medicaltherapy is instituted and maintainedtherapy is instituted and maintained

Optimal medical therapy and aggressive managementOptimal medical therapy and aggressive managementof multiple treatment targets without initial PCI can beof multiple treatment targets without initial PCI can beimplemented safely in the majority of patients withimplemented safely in the majority of patients with

stable CADstable CADtwotwo--thirds of whom may not requirethirds of whom may not requireeven a first revascularization during longeven a first revascularization during long--term followterm follow--


5/56

ImplicationsImplications

Our findings reinforce existing ACC/AHA clinicalOur findings reinforce existing ACC/AHA clinical

practice guidelines, which state that PCI can be safelypractice guidelines, which state that PCI can be safelydeferred in patients with stable CAD, even in thosedeferred in patients with stable CAD, even in thosewith extensive,with extensive, multivesselmultivessel involvement and inducibleinvolvement and inducible

ischemia, provided that intensive, multifaceted medicalischemia, provided that intensive, multifaceted medicaltherapy is instituted and maintainedtherapy is instituted and maintained

Optimal medical therapy and aggressive managementOptimal medical therapy and aggressive managementof multiple treatment targets without initial PCI can beof multiple treatment targets without initial PCI can beimplemented safely in the majority of patients withimplemented safely in the majority of patients with

stable CADstable CADtwotwo--thirds of whom may not requirethirds of whom may not requireeven a first revascularization during longeven a first revascularization during long--term followterm follow--


6/56

TriCardinTriCardinwas successfully launched inwas successfully launched inPakistan by Trigen Pharma in March 2006Pakistan by Trigen Pharma in March 2006

HIGHEST SELLINGHIGHEST SELLING Cardiac MedicineCardiac Medicinein China and is available worldwide in 34in China and is available worldwide in 34

countriescountries Single Largest Selling Drug in anySingle Largest Selling Drug in any

therapeutic categorytherapeutic category


7/56

Over 100,000 international clinical trials haveOver 100,000 international clinical trials haveprovedprovedTriCardinTriCardin as the most effective drug toas the most effective drug to

treat cardiovascular diseases andtreat cardiovascular diseases andmicroangiopathiesmicroangiopathies

TriCardinTriCardin is widely used in all Chinese Armyis widely used in all Chinese Army

Hospitals and other hospitals asHospitals and other hospitals asFIRST LINE OF TREATMENTFIRST LINE OF TREATMENT


8/56

TriCardin is a very highTriCardin is a very high--profile, safe, multiprofile, safe, multi--functionalfunctional

research medicine, manufactured onresearch medicine, manufactured on 44thth Generation HiGeneration Hi--Tech Dripping Pills Technology PlantTech Dripping Pills Technology Plantthe only of itsthe only of its

kind in the worldkind in the world

Dripping Pills Technology ensures very quick onset ofDripping Pills Technology ensures very quick onset ofaction, rapid absorption and immediate improvement inaction, rapid absorption and immediate improvement in

symptomssymptoms


9/56

Highest Quality StandardsHighest Quality Standards Tasly Pharma Group isTasly Pharma Group is

highly certifiedhighly certified TriCardinTriCardin isis FDAFDAINDIND

approved medicine, withapproved medicine, with

99.99% purity and99.99% purity andaccurate composition ofaccurate composition of

ingredients, ensured byingredients, ensured by

patentedpatented multimulti--fingerprint technologyfingerprint technology


10/56

International RegistrationsInternational Registrations

USA


11/56

2121stst Century ConceptCentury Conceptofof

Treating Cardiovascular System &Treating Cardiovascular System &

MicroangiopathiesMicroangiopathies


12/56

COMPOSITION OFCOMPOSITION OF

TriCardinTriCardin

The ingredients ofThe ingredients ofTricardin are registeredTricardin are registered

in Chinesein Chinese PharmacopiaPharmacopia

DanshenformCompound

Salvia Miltiorrhiza

207mg

Notogenseng

40.5mg

Borneol

2.5mg


13/56

SALVIA MILTIORRHIZA (SM)SALVIA MILTIORRHIZA (SM)

WaterWater soluablesoluable

compounds of SM:compounds of SM: ProtocatechuicProtocatechuic aldehydealdehyde

ProtocatechuicProtocatechuic acidacid

CaffeicCaffeic acidacid 3,43,4 dihydroxyphenoldihydroxyphenol

lactic acidlactic acid

LithospermicLithospermic acidacid SalvianolicSalvianolic acid A & Bacid A & B

RosmarinicRosmarinic acidacid

LipophilicLipophilic compounds ofcompounds of

SM:SM: TanshinoneTanshinone II

TanshinoneTanshinone IIA & IIBIIA & IIB

CryptotanshinoneCryptotanshinone TanshinodiolTanshinodiol CC

15,1615,16 dihydrotanshinonedihydrotanshinone

II IsotanshinoneIsotanshinone II

IsotanshinoneIsotanshinone IIII


14/56

ROLE OFROLE OF TriCardinTriCardin

Improves MicrocirculationImproves Microcirculation

Large Arteries & Veins onlyLarge Arteries & Veins onlyact as a passage.act as a passage.

Microcirculation transportsMicrocirculation transports

blood cells and substancesblood cells and substances(O2, CO2, Nutrients,(O2, CO2, Nutrients,Hormones, Water) to andHormones, Water) to andfrom the tissues. It alsofrom the tissues. It also

contribute to tissuecontribute to tissue colourcolourand stiffnessand stiffness


15/56

MICROCIRCULATIONMICROCIRCULATION

Microcirculation comprises the greatest portionMicrocirculation comprises the greatest portion

of the peripheral vasculature in terms of lengthof the peripheral vasculature in terms of lengthand surface area of blood vessels, so it is theand surface area of blood vessels, so it is the

bulk of peripheral circulationbulk of peripheral circulation

(Microcirculation in Hypertension: Circulation. 2001;104:735(Microcirculation in Hypertension: Circulation. 2001;104:735--740)740)


16/56

REPERFUSION INJURYREPERFUSION INJURY

Microcirculation is the prime site involved in theMicrocirculation is the prime site involved in the

pathophysiologypathophysiologyof reperfusion injury. It is an important site ofof reperfusion injury. It is an important site ofnitric oxide production & superoxide (free radical) formation.nitric oxide production & superoxide (free radical) formation.

It is the primary location for leukocyteIt is the primary location for leukocyte-- endothelial cellendothelial cell

interaction which is the hall mark of reperfusion injuryinteraction which is the hall mark of reperfusion injury

Reperfusion injury is initiated within minutes of reperfusion byReperfusion injury is initiated within minutes of reperfusion by

the generation of superoxide radicals that inactivate NO. Thethe generation of superoxide radicals that inactivate NO. The

reduced bioavailability of NO triggers an endothelial dysfunctioreduced bioavailability of NO triggers an endothelial dysfunctionn

that promotesthat promotes neutrophilneutrophil adherence and injuryadherence and injury( ( 3 .3 1998)3 .3 1998)


17/56

ENDOTHELIAL CELLSENDOTHELIAL CELLS These cells are the majorThese cells are the major

functional element of blood vesselfunctional element of blood vessel

wall that allow arterioles,wall that allow arterioles,capillaries andcapillaries and venulesvenules to carryto carry

out their functions.out their functions.

Endothelial cells produce varietyEndothelial cells produce variety

of substances that can affectof substances that can affect

underlying smooth muscle cellsunderlying smooth muscle cells

and circulating blood cells.and circulating blood cells.

Endothelial dysfunctionEndothelial dysfunction

contributes to the pathogenesis ofcontributes to the pathogenesis of

number of cardiovascularnumber of cardiovascular

diseases, includingdiseases, including

atherosclerosis, hypertension,atherosclerosis, hypertension,insulin resistance (diabetesinsulin resistance (diabetes

mellitus) & hypercholesterolemiamellitus) & hypercholesterolemia


18/56

LEUKOCYTELEUKOCYTE--ENDOTHELIAL CELLENDOTHELIAL CELL

ADHESIONADHESION

Circulating leukocytes areCirculating leukocytes are

recruited to sites ofrecruited to sites of

inflammation and tissueinflammation and tissueinjury by a highly coinjury by a highly co--

ordinatedordinated processprocess

Adhesion molecules areAdhesion molecules are

expressed on the surfaceexpressed on the surfaceof the endothelial cells andof the endothelial cells and

their respective circulatingtheir respective circulating

leukocytesleukocytes

SelectinsSelectins (P and E)(P and E)mediate leukocyte rollingmediate leukocyte rolling


19/56

LEUKOCYTELEUKOCYTE--ENDOTHELIAL CELLENDOTHELIAL CELL

ADHESIONADHESION Endothelial cell adhesion molecules that ensure firm adhesion ofEndothelial cell adhesion molecules that ensure firm adhesion of

leukocytes includes intercellular adhesion moleculeleukocytes includes intercellular adhesion molecule--11 (ICAM(ICAM--1)1) &&

vascular cell adhesion moleculevascular cell adhesion molecule--11 (VCAM(VCAM--1)1) Nitric oxide &Nitric oxide & ProstacyclinProstacyclin produced by endothelial cells tendproduced by endothelial cells tend

to prevent adhesion, while the oxygen radicals (superoxide,to prevent adhesion, while the oxygen radicals (superoxide,

hydrogen peroxide) generated by activated leukocytes andhydrogen peroxide) generated by activated leukocytes and

endothelial cells promote leukocyte adhesionendothelial cells promote leukocyte adhesion

Vascular endothelial cells serves as a barrier to the movement oVascular endothelial cells serves as a barrier to the movement off

fluid and proteins from blood tofluid and proteins from blood to interstitiuminterstitium. The barrier is lost. The barrier is lost

due to damage of endothelial cells which results in increasedue to damage of endothelial cells which results in increase

vascular permeability.vascular permeability.

LeukocyteLeukocyte--endothelial cell adhesion and increased vascularendothelial cell adhesion and increased vascularpermeability is present in cardiovascular system and regionalpermeability is present in cardiovascular system and regional

circulatory disorder (Hypertension, Stroke, Diabetes Mellitus)circulatory disorder (Hypertension, Stroke, Diabetes Mellitus)


20/56

MICROCIRCULATORYMICROCIRCULATORY

DYSFUNCTIONDYSFUNCTION

HypercoagulabilityPlatelet

activation

Endothelial

Injury

Cell

adhesion

peroxide

Vascular

Permeability

Microcirculatorydysfunction


21/56

EFFECTS OF IMPAIREDMICROCIRCULATION

ON BRAIN:

CERBRALISCHEMIA

INFARCTION

PARALYSIS

ON EYES:DAMAGE TO

RETINALVESSELS

RETINOPATHY

BLINDNESS

ON HEART:

ANGINA

M.I

DEATH

ON LUNGS:PLUMONARYINFARCTION

ACUTE RT. HEARTFAILURE

DEATH

ON KIDNEY:PARENCHYMAL

DAMAGE

RENAL FAILURE

DEATH

ON LEGS:

GANGRENE

DEATH


22/56

Action of Tricardin onAction of Tricardin on HeartHeart

Tricardin stimulates nitric oxide production of endothelial cellTricardin stimulates nitric oxide production of endothelial cells bys byincreasing endothelial nitric oxideincreasing endothelial nitric oxide synthasesynthase ((eNOSeNOS) expression level.) expression level.( & :10.1016/..2007.09.00( & :10.1016/..2007.09.008)8)

TriCardin scavenge oxygen free radicals and inhibits myocardialTriCardin scavenge oxygen free radicals and inhibits myocardial cellcellapoptosis.apoptosis.( 2005;45:1345( 2005;45:13451359)1359)

TriCardin inhibits CaTriCardin inhibits Ca++++ aggregation in cardiac cells and preventsaggregation in cardiac cells and preventsCaCa++++ overloadoverload( , 2005;45:1345( , 2005;45:13451359)1359)

Tricardin inhibits homocysteine and protects the myocardial cellTricardin inhibits homocysteine and protects the myocardial cellssagainst homocystenemiaagainst homocystenemia( , 2005;45:1345( , 2005;45:13451359)1359)

Tricardin inhibits DNA synthesis ofTricardin inhibits DNA synthesis of noncardiomyocytesnoncardiomyocytes and inhibitsand inhibitsStressStress--activated protein (SAP) kinase activity.activated protein (SAP) kinase activity.( , 2005;45:1345( , 2005;45:13451359)1359)( , 45, 5, ( , 45, 5, 2005) 2005)


23/56

Action of TriCardin onAction of TriCardin on Blood VesselsBlood Vessels

TriCardin increases endothelium derivesTriCardin increases endothelium derivesprostacyclinprostacyclin or PGI2or PGI2(potent vasodilator & platelet aggregation inhibitor) and inhibi(potent vasodilator & platelet aggregation inhibitor) and inhibitstsThromboxaneThromboxaneA2 (potent vasoconstrictor) and B2A2 (potent vasoconstrictor) and B2( , 2005;45:1345( , 2005;45:13451359) ( , 2003;126:1359) ( , 2003;126:140414041410)1410)

TriCardin inhibits endotheliumTriCardin inhibits endothelium--derived vasoconstrictorderived vasoconstrictorendothelinendothelin--1 (ET1 (ET--1)1)( , 2003;126:1404( , 2003;126:14041410)1410)

Tricardin inhibits the activation of nuclear transcription factoTricardin inhibits the activation of nuclear transcription factor NFr NF--kB by blocking its translocation from cytoplasm to nucleikB by blocking its translocation from cytoplasm to nuclei( , 45, 5, ( , 45, 5, 2005) 2005)

TriCardin stimulates glutathione synthesis (an intracellularTriCardin stimulates glutathione synthesis (an intracellular

antioxidant) which inhibits NFantioxidant) which inhibits NF--kB activation and resultantkB activation and resultantadhesion molecule expression.adhesion molecule expression.( ( 45, 5 2005)45, 5 2005)


24/56

Action of TriCardin onAction of TriCardin on BloodBlood

TriCardin dissolves preformed microthrombi, interferes withTriCardin dissolves preformed microthrombi, interferes with

extrinsic blood coagulation and exhibit antithrombin III likeextrinsic blood coagulation and exhibit antithrombin III likeactivity.activity.(( 2001 , 35) 2001 , 35)

Tricardin significantly decreases PTricardin significantly decreases P--selectin, G IIb/IIIaselectin, G IIb/IIIaexpression and intracellular calcium in both unactivated andexpression and intracellular calcium in both unactivated and

ADP activated platelet.ADP activated platelet.(( & &17:25917:259264,2006.264,2006. & ) & )

Inhibits mast cellInhibits mast cell degranulationdegranulation( & :10.1016/..2007.09.00( & :10.1016/..2007.09.008)8)

Inhibits cytokines releaseInhibits cytokines release( & :10.1016/..2007.09.00( & :10.1016/..2007.09.008)8)

Effectively reduces the expression of VCAMEffectively reduces the expression of VCAM--1 and ICAM1 and ICAM--1 on1 onvascular endothelium.vascular endothelium.(( , 45, 5, , 45, 5, 2005)2005)


25/56

Action of TriCardin onAction of TriCardin on Lipid ProfileLipid Profile

Total cholesterol, TG and LDL cholesterol levels wereTotal cholesterol, TG and LDL cholesterol levels weresignificantly reduced by 28.3%, 34.3% and 29.9% respectivelysignificantly reduced by 28.3%, 34.3% and 29.9% respectivelyand HDL cholesterol was significantly high by 33.2%and HDL cholesterol was significantly high by 33.2%( . 1998;18;481( . 1998;18;481486)486)

Tricardin inhibits LDL oxidation by inhibiting 1Tricardin inhibits LDL oxidation by inhibiting 1--diphenyldiphenyl--22--

picrylhydrazyl radicals.picrylhydrazyl radicals.( . 1998;18;481( . 1998;18;481486)486)

Tricardin prevents of uptake of LDL by cultured macrophages.Tricardin prevents of uptake of LDL by cultured macrophages.( . 1998;18;481( . 1998;18;481486)486)


26/56

VASCULAR COMPLICATIONS OFVASCULAR COMPLICATIONS OF

DIABETES MELLITUSDIABETES MELLITUS MicrovascularMicrovascular ComplicationsComplications

( )( )

Diabetic foot is often due to aDiabetic foot is often due to a

combination of neuropathycombination of neuropathy

and arterial disease, may causeand arterial disease, may cause

skinskin ulcerulcer andand infectioninfection and, inand, inserious cases,serious cases, necrosisnecrosis andand

gangrene.gangrene.

MacrovascularMacrovascular ComplicationsComplications

It leads to cardiovascularIt leads to cardiovasculardisease, to which accelerateddisease, to which accelerated

atherosclerosisatherosclerosis is ais a

contributorcontributor


27/56

ROLE OFROLE OF TriCardinTriCardin

IN DMIN DM The effect of oralThe effect of oral hypoglycaemicshypoglycaemics is only aimed to lower level ofis only aimed to lower level of

blood glucose where asblood glucose where asTriCardinTriCardin acts multi dimensionally inacts multi dimensionally in

diabetes mellitus:diabetes mellitus:

TriCardinTriCardin minimizes insulin resistance by promoting bloodminimizes insulin resistance by promoting blood

microcirculationmicrocirculation

TriCardinTriCardin

reduces whole blood viscosity and decreases urinary albuminreduces whole blood viscosity and decreases urinary albumin& retards the process of diabetic nephropathy& retards the process of diabetic nephropathy

TriCardinTriCardin significantly increases the superoxidesignificantly increases the superoxide dismutasedismutase (SOD) levels;(SOD) levels;

it resists lipidit resists lipid peroxidationperoxidation injury and be helpful for diabeticinjury and be helpful for diabetic

complicationscomplications No side effects as compared to those of oralNo side effects as compared to those of oral hypoglycaemicshypoglycaemics

((hypoglycaemiahypoglycaemia, lactic acidosis, GI upset), lactic acidosis, GI upset)


28/56

ROLE OFROLE OF TriCardinTriCardin ININ

METABOLIC SYNDROMEMETABOLIC SYNDROME People with metabolic syndrome are at increasedPeople with metabolic syndrome are at increased

risk of CHD, Stroke, PVD & DMrisk of CHD, Stroke, PVD & DM AHA recommendation for managing metabolicAHA recommendation for managing metabolic

syndrome is to reduce the risk for CV diseases &syndrome is to reduce the risk for CV diseases &

DM Type2 by reducing LDL, controlling BPDM Type2 by reducing LDL, controlling BPand glucose levelsand glucose levels

TriCardin (2xBID or 1xTID)TriCardin (2xBID or 1xTID) is the only optionis the only option

available to achieve above targets by improvingavailable to achieve above targets by improvingmicrocirculationmicrocirculation


29/56

ROLE OFROLE OF TriCardinTriCardin ININ

HYPERTENSIONHYPERTENSION The reduction or improvement in endThe reduction or improvement in endorgan damage seenorgan damage seen

during antiduring anti--hypertensive therapy do not always correlate wellhypertensive therapy do not always correlate well

with the reduction in arterial blood pressure achieved.with the reduction in arterial blood pressure achieved. There seemsThere seems

to be a need for new therapeutic perspective in the treatment ofto be a need for new therapeutic perspective in the treatment ofhypertensionhypertension

One important new perspective is provided by an enhancedOne important new perspective is provided by an enhanced

appreciation of the importance of the microcirculation in theappreciation of the importance of the microcirculation in thepathophysiologypathophysiologyand treatment of hypertension.and treatment of hypertension. (Microcirculation in(Microcirculation inHypertension: Circulation. 2001;104:735Hypertension: Circulation. 2001;104:735--740)740)

By addingBy adding Tricardin (2xBID or 1xTID)Tricardin (2xBID or 1xTID) hypertensionhypertension

control can be achieved because it overcomes the vascularcontrol can be achieved because it overcomes the vascularresistance offered by the microcirculationresistance offered by the microcirculation


30/56

INDICATIONS OFINDICATIONS OF TriCardinTriCardin

Tricardin is indicated in the treatment &Tricardin is indicated in the treatment &

prevention of the following:prevention of the following: Ischemic Heart Diseases (Angina Pectoris/MI)Ischemic Heart Diseases (Angina Pectoris/MI)

HyperlipidemiaHyperlipidemia

Atherosclerosis/ArteriosclerosisAtherosclerosis/Arteriosclerosis Diabetic & Hypertensive Nephropathy, RetinopathyDiabetic & Hypertensive Nephropathy, Retinopathy

& Neuropathy& Neuropathy

Stroke & PVDStroke & PVD Metabolic SyndromeMetabolic Syndrome


31/56

DOSAGE OFDOSAGE OF TriCardinTriCardin


32/56

TriCardinTriCardinAS AN ANTIAS AN ANTI--ANGINALANGINALA Meta AnalysisA Meta Analysis

TriCardinTriCardin (SM) for the treatment of chronic stable angina(SM) for the treatment of chronic stable anginapectoris compared with Nitratespectoris compared with Nitrates , 2006;12(1):1, 2006;12(1):177

: 26369479: 26369479

....

Compared with Nitrates,treatment withCompared with Nitrates,treatment with TriCardinTriCardin hadhadsignificant effect on improvement of angina symptoms,significant effect on improvement of angina symptoms,showed greater increased effect on the improvement ofshowed greater increased effect on the improvement of

ECG results and the percentage of patients with adverseECG results and the percentage of patients with adverseevents was significantly decreased in comparison withevents was significantly decreased in comparison withnitratesnitrates


33/56

TriCardinTriCardinAS ANTIAS ANTI--ATHEROSCLEROSIS, ANTIATHEROSCLEROSIS, ANTI--

THROMBOTIC & ANTITHROMBOTIC & ANTI--HYPERLIPIDEMICHYPERLIPIDEMIC

Increase of Vitamin E content in LDL and ReductionIncrease of Vitamin E content in LDL and Reduction

of Atherosclerosis in Cholesterolof Atherosclerosis in Cholesterol--Fed Rabbits byFed Rabbits byTriCardinTriCardin (Salvia Miltiorrhiza)(Salvia Miltiorrhiza)

....1998;18;481....1998;18;481486486 ://..////18/3/481://..////18/3/481

TriCardinTriCardin (SM) acts as a potent anti(SM) acts as a potent anti--oxidant thusoxidant thus

inhibiting LDL oxidation,inhibiting LDL oxidation, TriCardinTriCardin reducedreduced

endothelial damage and severity of atherosclerosisendothelial damage and severity of atherosclerosis


34/56

TriCardinTriCardin AS AN ANTIAS AN ANTI--PLATELETPLATELET

Inhibitory Effects ofInhibitory Effects of TriCardinTriCardin on Platelet Functionon Platelet Function

in Dogs Fed a Highin Dogs Fed a High

--Fat DietFat Diet

& &2006, 17:2592006, 17:259264264 & &

Compared with Aspirin,Compared with Aspirin, TriCardinTriCardin showed a moreshowed a more

exaggerated inhibitory effect on platelet function.exaggerated inhibitory effect on platelet function.The lipid lowering and antiThe lipid lowering and anti--oxidant effects ofoxidant effects of

TriCardinTriCardin are responsible for this result.are responsible for this result.

Research has suggested thatResearch has suggested that TriCardinTriCardinproduceproducemultiple beneficial effects on cardiovascularmultiple beneficial effects on cardiovascularprotection.protection.


35/56

VERY HIGH SAFETY PROFILE &VERY HIGH SAFETY PROFILE &

TOLERABLITY OFTOLERABLITY OF TriCardinTriCardin Rarely reported mild effects are headache,Rarely reported mild effects are headache,

dizziness and flushing (1.93%) and GI upsetdizziness and flushing (1.93%) and GI upset(1.14%). Will disappear with continuous usage(1.14%). Will disappear with continuous usage

No animal died even after administration of 700No animal died even after administration of 700times oral dose or 350 timestimes oral dose or 350 times intraperitonealintraperitoneal dosedoseof that used clinically for adultsof that used clinically for adults

Proven wide safety marginProven wide safety margin


36/56

CONTRAINDICATIONSCONTRAINDICATIONS TriCardinTriCardin


37/56

CONVENTIONAL MANAGEMENTCONVENTIONAL MANAGEMENT

OF ISCHEMICOF ISCHEMIC HEARTHEART DISEASEDISEASE

AspirinAspirin

ClopidogrelClopidogrel

AntiAnti--anginalanginal

BetaBeta--BlockersBlockers Calcium AntagonistsCalcium Antagonists

NitratesNitrates

StatinsStatins


38/56

ADDITION OFADDITION OF TriCardinTriCardin

AspirinAspirin

ClopidogrelClopidogrel

AntiAnti--anginalanginal BetaBeta--BlockersBlockers

Calcium AntagonistsCalcium Antagonists NitratesNitrates

StatinsStatins

Net Result:Net Result:

Reduction in number ofReduction in number ofmedications. Patient will feelmedications. Patient will feelgoodgood

Significant decrease inSignificant decrease in

anginalanginal episodesepisodes Marked improvement inMarked improvement in

ECG and ETTECG and ETT

Improvement in EjectionImprovement in Ejection

fractionfraction Remarkable improvement inRemarkable improvement in

General Condition of patientGeneral Condition of patientwithin weekswithin weeks

Better quality of lifeBetter quality of life

AddingAddingTriCardin 1TriCardin 1--2 Capsules2 Capsules

two to three times a daytwo to three times a day


39/56

Recently ConcludedRecently ConcludedLocal Clinical TrialsLocal Clinical Trials


40/56

Clinical Trial Conducted atClinical Trial Conducted atThe Department ofThe Department of

Cardiology, Lady ReadingCardiology, Lady Reading

Hospital, PeshawarHospital, Peshawar


41/56

Efficacy ofEfficacy ofTriCardinTriCardin forforimproving Ischemic Symptoms &improving Ischemic Symptoms &

reducing episodes of Angina inreducing episodes of Angina in

patients with known cases of CADpatients with known cases of CADProfessor Dr. Mohammad HafizullahProfessor Dr. Mohammad Hafizullah

Dr. Mahmood ul HassanDr. Mahmood ul Hassan

Dr.Dr.

SaqibSaqib

QureshiQureshi

Dr. MohammadDr. Mohammad FahimFahim

Dr.Dr. CheraghCheragh HassanHassan

Cardiology Department,Postgraduate Medical Institute, Lady ReadiCardiology Department,Postgraduate Medical Institute, Lady Reading Hospital,ng Hospital,

Peshawar.Peshawar.

LRH


42/56

ObjectiveObjective: To assess the efficacy of: To assess the efficacy of TriCardinTriCardin in patient with anginain patient with anginapectorispectoris already on optimal dosealready on optimal dose for reducing the duration of episode of anginafor reducing the duration of episode of angina

attacks subjectively and to see it objectively on ETT in our popattacks subjectively and to see it objectively on ETT in our population.ulation.

Material and methodsMaterial and methods: Twenty patients who are known cases of CHD: Twenty patients who are known cases of CHDwith CCSwith CCS--II Angina included in the study who were already taking optimumII Angina included in the study who were already taking optimum

doses of antidoses of anti anginalanginal medications like aspirin,beta blocker, lipid loweringmedications like aspirin,beta blocker, lipid lowering

nitrates,ACE inhibitors andnitrates,ACE inhibitors and clopidegrolclopidegrol..Patients were exercised on treadmill according to Bruce pPatients were exercised on treadmill according to Bruce protocol at baseline androtocol at baseline and

one week later. At second week TriCardin 500mg was given for fouone week later. At second week TriCardin 500mg was given for four weeks. Atr weeks. At

the end of four weeks again exercise tolerance test was performethe end of four weeks again exercise tolerance test was performed. Duration andd. Duration and

number ofnumber of anginalanginal episodes before and at the end of fourth week recorded.episodes before and at the end of fourth week recorded.Total exercise time, onset of ST segment depression before and aTotal exercise time, onset of ST segment depression before and after treatmentfter treatment

with TriCardin recorded.with TriCardin recorded.

LRH


43/56

CLINICAL VARIABLES OF THECLINICAL VARIABLES OF THE

RESPONDENTSRESPONDENTS

LRH

Total duration of anti-anginal med 7.95 + 7.7 months

Total duration of Angina 8.5 + 7.7 months

Total no. 19Male 13 (68.4%)Female 6 (31.6%)Age (years) 46.74 + 8.73Heart rate 77.37 + 15.86

Prior MI 3 (15.8%)HTN 6(31.6%)DM 1( 5.3%)


44/56

Comparison of variablesComparison of variables

0.0010.0018.328.32 ++ 2.332.336.526.52 ++ 1.931.93Exercise durationExercise duration

7.717.71++ 1.681.68

1.471.47++ 1.641.64

After treatmentAfter treatment

5.855.85 ++ 1.741.74

4.264.26++ 2.422.42

Before TreatmentBefore Treatment

0.0010.001Onset of STOnset of ST

depressiondepression

0.0010.001Anginal episodesAnginal episodes

P valueP valuevariablesvariables

LRH


45/56

RESULTSRESULTS The number ofThe number of anginalanginal episodesepisodes after 4after 4

weeks treatment withweeks treatment with TriCardinTriCardinwaswasreduced significantly from 4.2 to 1.6 /reduced significantly from 4.2 to 1.6 /

week (p=0.001)week (p=0.001)

AnginalAnginal class improved significantlyclass improved significantly

after 4 weeks treatment withafter 4 weeks treatment withTriCardinTriCardin(p(p=0.001)=0.001)

LRH


46/56

CONCLUSIONCONCLUSION

TriCardinTriCardin is effective inis effective in reducingreducing anginalanginal episodesepisodes

increasing exercise durationincreasing exercise duration improving functionalimproving functional anginalanginal classclass

delaying the onset of ST depression ondelaying the onset of ST depression on

ETT in patients with ischemic heartETT in patients with ischemic heartdiseasedisease

LRH


47/56

Clinical trial at NICVD 2006Clinical trial at NICVD 2006--0707 Name of doctors participating in the trialName of doctors participating in the trial

Dr. Azhar Masood A. FarooquiDr. Azhar Masood A. FarooquiDr. Tariq AshrafDr. Tariq Ashraf

Dr. Syed Ishtiaq RasoolDr. Syed Ishtiaq Rasool

Dr. Hamid TirmiziDr. Hamid Tirmizi

NICVD


48/56

NICVD TRIALNICVD TRIAL ::To observe ST segment changes in patients undergoingTo observe ST segment changes in patients undergoing

ETT after giving TriCardinETT after giving TriCardin

: :Thirty patients were taken from ETTThirty patients were taken from ETTdepartment. After having history and physical examination, patiedepartment. After having history and physical examination, patients takingnts takingno cardiac medication and ETT positive for ischemia were taken.no cardiac medication and ETT positive for ischemia were taken.TheseThesepatients were given TriCardin caps 250mg, 2+2+2 for ten days andpatients were given TriCardin caps 250mg, 2+2+2 for ten days and 2+0+22+0+2

for eleven days as a monotherapy. Patients called on first day ofor eleven days as a monotherapy. Patients called on first day of fourth weekf fourth weekfor repeat ETT.for repeat ETT.

Another group of 30 patients with similar characteristics, diagnAnother group of 30 patients with similar characteristics, diagnosis andosis andECG changes or ETT were given isosorbide dinitrate(Elantan) 10 mECG changes or ETT were given isosorbide dinitrate(Elantan) 10 mg TDSg TDSfor three weeks and Aspirin 150mg OD.for three weeks and Aspirin 150mg OD.

The two groups with ECG changes were compared.The two groups with ECG changes were compared.

NICVD


49/56

ResultResult:: Before treatment(n=20)Before treatment(n=20)

2(10%)2(10%)5(25%)5(25%)3mm3mm

16(80%)16(80%)15(75%)15(75%)2mm2mm0.1900.190

2(10%)2(10%)

1mm1mm

ISDNISDNTriCardinTriCardin

PP--valuevalueTreatmentTreatmentSTST--SegmentSegmentdepression(mdepression(m

m)m)

NICVD

Aft T t t( 20)


50/56

0.5980.5982(10%)2(10%)2(10%)2(10%)3mm3mm

0.008*0.008*11(55%)11(55%)3(15%)3(15%)2mm2mm

0.001*0.001*2(10%)2(10%)14(70%)14(70%)1mm1mm

0.1840.1845(25%)5(25%)1(5%)1(5%)NoneNone


PP--valuevalueTreatmentTreatmentSTST--SegmentSegmentdepression (mm)depression (mm)

After Treatment(n=20)

NICVD

After TriCardinTriCardin treatment ST-segment depression 1 mm wereSignificantly high (70%) as compared to ELANTANpatients (10%) p


51/56


001(5%)1(5%)DizzinessDizziness

17(85%)17(85%)1(5%)1(5%)HeadacheHeadache

17(85%)17(85%)2(10%)2(10%)YESYES

0.001*0.001*3(15%)3(15%)18(90%)18(90%)NONO

PP--valuevalueTreatmentTreatmentSide effectsSide effects

Side effects were significantly less in TriCardinTriCardin (10%)as compared to Elantan (85%) (p


52/56

Ongoing trialsOngoing trials 300 patients of unstable angina registered.300 patients of unstable angina registered.

150 Post150 Post--PCI and postPCI and post--CABG patients.CABG patients. 50 patients of ischemic50 patients of ischemic cardiomyopathycardiomyopathy..

Also being evaluated in ischemic stroke.Also being evaluated in ischemic stroke. Evaluation for its role proposed in HAPE, HACE.Evaluation for its role proposed in HAPE, HACE.


53/56

HIGHLIGHTSHIGHLIGHTS

TriCardinTriCardin

100% Imported100% Imported

FDAFDA INDIND approvedapproved

Improves Microcirculation at all levelsImproves Microcirculation at all levels

Inhibits platelet adhesion & aggregation (more effective than asInhibits platelet adhesion & aggregation (more effective than aspirin)pirin)

Potent antioxidant; eliminates free radicalsPotent antioxidant; eliminates free radicals

Promotes the production of nitric oxide & inhibits endothelinPromotes the production of nitric oxide & inhibits endothelin--11

Lowers total blood cholesterol; inhibits oxidation of LDL; improLowers total blood cholesterol; inhibits oxidation of LDL; improves HDLves HDL

More effective than nitroglycerin for improving heart function aMore effective than nitroglycerin for improving heart function and circulationnd circulation

Significantly improves ECG, ETT and general condition of patientSignificantly improves ECG, ETT and general condition of patient

Improves survival rate after heart attackImproves survival rate after heart attack Effectively treat & prevent diabetic vascular complicationsEffectively treat & prevent diabetic vascular complications

Modern TCM with virtually no side effectsModern TCM with virtually no side effects


54/56

SUMMARYSUMMARYWhen u add Tricardin 2 x BID or 1 x TID toWhen u add Tricardin 2 x BID or 1 x TID to

your patient, you will get:your patient, you will get: Amazing improvement in the generalAmazing improvement in the general

condition within dayscondition within days

Significant improvement in ECG and ETTSignificant improvement in ECG and ETT

Significant reduction inSignificant reduction in anginalanginal episodesepisodes

Significant improvement in ejection fractionSignificant improvement in ejection fraction

Your patient will definitely share smile with youYour patient will definitely share smile with you


55/56


56/56

Prof Qaisar Khan Trials

Documents

Transcript of Prof Qaisar Khan Trials