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Initial Classification Based on Total Cholesterol and HDL-Cholesterol (NCEP Guidelines). Total Cholesterol <200 mg/dL Desirable Blood Cholesterol 200-239 mg/dL Borderline-High Blood Cholesterol > 240 mg/dL High Blood Cholesterol HDL-Cholesterol <35 mg/dL Low HDL-Cholesterol

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Initial classification based on total cholesterol and hdl cholesterol ncep guidelines l.jpg
Initial Classification Based on TotalCholesterol and HDL-Cholesterol (NCEP Guidelines)

Total Cholesterol

<200 mg/dL Desirable Blood Cholesterol

200-239 mg/dL Borderline-High Blood Cholesterol

> 240 mg/dL High Blood Cholesterol

HDL-Cholesterol

<35 mg/dL Low HDL-Cholesterol

Ref.: NIH Publication No. 93-3096, September 1993


Treatment decisions based on ldl cholesterol ncep guidelines l.jpg
Treatment Decisions Based on LDL-Cholesterol (NCEP Guidelines)

Dietary Therapy

Initiation level LDL Goal

Without CHD & with fewer than 2 risk factors >160 mg/dL <160 mg/dL

Without CHD & with 2 or more risk factors >130 mg/dL <130 mg/dL

With CHD >100 mg/dL <100 mg/dL

Drug Treatment

Consideration LDL Goal Level

Without CHD & with fewer than 2 risk factors >190 mg/dL* <160 mg/dL

Without CHD & with 2 or more risk factors >160 mg/dL <130 mg/dL

With CHD >130 mg/dL** <100 mg/dL

*In men under 35 years of age and premenopausal women with LDL-cholesterol levels 190-219 mg/dL, drug therapy should be delayed except in high-risk patients such as those with diabetes.

**In CHD patients with LDL-cholesterol levels 100-219 mg/dL, the physician should exercise clinical judgement in deciding whether to initiate drug treatment.

Ref.: NIH Publication No. 93-3096, September 1993


Chd risk factors l.jpg
CHD Risk Factors Guidelines)

  • Positive

    • Age s Smoking

    • Male > 45 years s Hypertension

    • Female > 55 years or s HDL-cholesterolpremature menopause without < 35 mg/dLestrogen replacement therapy s Diabetes

    • Family history of premature CHD

  • Negative

    • HDL-cholesterol > 60 mg/dL


Effect of statins on cardiovascular event reduction and ldl cholesterol levels l.jpg
Effect of Statins on Cardiovascular Guidelines)Event Reduction and LDL-Cholesterol Levels

Clinical Active Dosage, Study Baseline % On-treatment CHD

Trial Treatment mg/d Sample LDL-C Reduction LDL-C, Red-

size Levels, of LDL-C mmol/L uction

mmol/L %

WOSCOPS Pravastatin 40 6595 4.97 26 3.87 31

PLAC II Pravastatin 20-40 151 4.29 27 3.10 60

REGRESS Pravastatin 40 885 4.32 28 3.03 42

CARE Pravastatin 40 4159 3.59 28 2.59 24

CCAIT Lovastatin 40-80 331 4.47 29 3.26 25

MAAS Simvastatin 20 381 4.40 31 3.00 24

4S Simvastatin 20-40 4444 4.87 34 3.15 34

MARS Lovastatin 80 270 3.90 38 2.40 24

JAMA 1998; 279: 1643-1650.


Slide5 l.jpg

Vascular mechanisms by which cholesterol lowering may reduce coronary events

Potential Beneficial Effects

Of Lipid Lowering

Cells Present in Atheroma

­

Endothelial Dependent Vasodilation

-

¯

Superoxide (O

) Production

2

¯

Leukocyte Adhesion Molecule Expression

Endothelial Cell

¯

Secretion of Matrix-Degrading Proteases

¯

Release of Inflammatory Cytokines

Macrophage

¯

Procoagulant Tissue Factor Expression

Foam-Cell

¯

Growth Factor Production

Smooth

¯

Macrophage Stimulator

Muscle

Production (M-CSF & MCP-1)

Cell

¯

Modified Lipoprotein Antigen Stimulation

¯

Production of Gamma Interferon

(a macrophage stimulator and matrix

T-Lymphocyte

synthesis inhibitor)


Simvastatin pharmacodynamics l.jpg
Simvastatin - Pharmacodynamics coronary events

  • Orally administered prodrug, hydrolysed to b-hydroxyacid simvastatin, the active metabolite

  • Potent inhibitor of cholesterol biosynthesis

  • Upregulates LDL receptors

  • Reduces total cholesterol, LDL cholesterol, triglycerides & increases HDL cholesterol

  • Decreases apolipoprotein B and increases apolipoproteins AI and AII

  • Inhibits platelet activation, decreases factor VIIc activity, produces modest reduction or no change in fibrinogen levels

  • Unlikely to alter adrenal function

  • Does not increase cataract formation

SIMCARD


4s trial summary l.jpg
4S Trial: Summary coronary events

Parameter % Reduction

Total cholesterol 25%

LDL cholesterol 35%

Triglycerides 10%

Total mortality 30%

Coronary mortality 42%

Non-fatal acute MI 37%

Cerebrovascular events 30%

Revascularisation procedures 37%

No. of hospital admissions 26%

Average length of stay 10%

Total days spent in hospital 34%

SIMCARD

Ref.: Lancet 1994; 344:1383-1389.


Life saving benefits of simvastatin maintained for up to eight years l.jpg
LIFE SAVING BENEFITS OF SIMVASTATIN MAINTAINED FOR UP TO EIGHT YEARS

  • 30% reduction in mortality observed during 5-year study maintained during the extended two-year follow-up of 4S trial

% Mortality

- 71st Scientific Sessions of American Heart Association, Nov 1998


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Simvastatin approved by US FDA in EIGHT YEARSpatients with elevated triglyceride levels

Results of analysis of 5 studies (n=359)

Baseline triglyceride Percentage reduction levels with simvastatin

TG > 200 mg/dL 31%

TG 150-200 mg/dL 21%

TG < 150 mg/dL 11%

SCRIP 1997; No. 2284:19

SIMCARD


Slide10 l.jpg

Simvastatin approved for use in patients with isolated hypertriglyceridemia (Frederickson type IV) and in patients with type III hyperlipoproteinemiaInpharma 1999; 1218: 22


Slide11 l.jpg
Main angiographic findings of the Multicentre Anti-Atheroma Study (MAAS)after 4 years of treatment with simvastatin 20 mg/day

Angiographic parameter Angiographic classification (per patient) (per patient) [mean change [no. (%) of patients] from baseline]

simvastatin placebo simvastatin placebo

Diffuse disease

Mean lumen –0.02 –0.08* diameter (mm)

Focal disease

Minimum lumen –0.04 –0.13** diameter (mm)

Diameter stenosis (%) 1.0 3.6**

Progressor 41 (23.0) 54 (32.3)*a

Regressor 33 (18.6) 20 (12.0)*a

a Statistically significant difference between treatment groups only for combined treatment effect.Statistically significant difference between treatment groups: *p < 0.05, **p < 0.01

Ref.: Lancet 1994; 344: 633-638.

SIMCARD


Simvastatin enalapril coronary atherosclerosis trial scat l.jpg
SIMVASTATIN/ENALAPRIL CORONARY ATHEROSCLEROSIS TRIAL (SCAT) Study (MAAS)

  • 460 patients with normal cholesterol levels (160 mg/dl - 240 mg/dl) and established CAD

  • Simvastatin significantly reduced LDL cholesterol, total cholesterol and triglycerides and increased HDL cholesterol

  • Simvastatin reduced need for revascularisation procedures by 53.6%; need for angioplasty was reduced by 61.9%

  • Addition of enalapril to the regimen had a neutral impact on the progression of CAD

Simvastatin slows CAD progression in patients of normal cholesterol

- 48th Annual Scientific Sessions of American College of Cardiology, March 1999


Effect of simvastatin on heart failure subset analysis of 4s trial l.jpg
EFFECT OF SIMVASTATIN ON HEART FAILURE (SUBSET ANALYSIS OF 4S TRIAL)

Patients withheart failure (%)

- Journal of Failure 1997; 3: 249-254


Simvastatin approved by us fda for raising hdl levels l.jpg
SIMVASTATIN APPROVED BY US FDA FOR RAISING HDL LEVELS 4S TRIAL)

  • New approval based on four studies

  • In one study (n=130), simvastatin lowered LDL cholesterol by 29-36%, triglycerides by 28-33% and raised HDL levels by 13-16%

  • HDL is anti-atherogenic; high levels of HDL reduce CHD risk

  • HDL-C > 60mg/dl is a negative risk factor for CHD and HDL-C < 35 mg/dl is a positive risk factor for CHD (NCEP guidelines)

- SCRIP 1999; 2463: 19


Safety of simvastatin l.jpg
Safety of simvastatin 4S TRIAL)

Common adverse effects include

  • increase in liver enzymes

  • myopathy (increase in creatine kinase)

  • GI problems

  • CNS disturbances

    Discontinuation rates : 0.3 to 0.7%

SIMCARD

Ref.: Annals of Pharmacotherapy 1995; 29:743-759.


Simvastatin vs lovastatin twice as potent l.jpg
Simvastatin Vs. Lovastatin (Twice as potent) 4S TRIAL)

Reference No. of Dosage Mean percentage change in serum lipid/

evaluable regimen lipoprotein levels versus baselinea

patients (mg/day) Total-C LDL-C HDL-C TG LDL-C/ HDL-C

Farmer 134 S10 -19.6 -27.5 +4.6 -3.9 -29.5et al 135 S20 -25.4*b -34.7*b +4.6 -10.3 -37.1*b(24-week 137 L20 -18.6 -25.4 +4.2 -10.5 -27.4study) 134 L40 -22.6 -31.2 +7.4 -10.3 -34.9

Frohlich 149 S10-40 -26 to -34 to +8 -16 toet al -30 -37 -17(18-week 149 L20-80 -26 to -34 to +4 to -11 tostudy) -31 -38 +10 -22

S=Simvastatin; L=Lovastatin; a All changes in total-C & LDL-C were statistically significant compared with baseline, b Statistically significant difference between treatment groups refers to S 20 versus L20. *indicates p < 0.01.

SIMCARD

- Drugs 1995; 50(2): 334-363. - Can. J. Cardiol. 1993; 9:405-412.


Simvastatin vs lovastatin greater percentage of responders l.jpg
Simvastatin Vs. Lovastatin (Greater percentage of responders)

% of patients with LDL Cholesterol< 130 mg/dL at 18 weeks

SIMCARD

Ref.: Annals of Pharmacotherapy 1995; 29: 743-759.


Simvastatin vs lovastatin contd l.jpg
Simvastatin vs. Lovastatin responders)(Contd.)

Adverse Event % incidence of adverse events Simvastatin Lovastatin 20 mg twice daily 20 mg twice daily (n=84) (n=42)

Headaches 3.6% 7.1%

Abdominal discomfort 2.4% 4.8%

Sleep disorders 3.6% 7.1%

Muscle pain 2.4% 4.8%

­in creatine kinase 4.8% 11.9%

­in liver enzymes 4.8% 11.9%

Discontinuation rates with simvastatin have been reported to range between 0.3 and 0.7% as compared to 2.8 to 4% with lovastatin.

SIMCARD


Simvastatin dosage and administration l.jpg
Simvastatin: Dosage and Administration responders)

  • The recommended starting dose is 5-10 mg once daily in the evening. Doses should be individualised according to baseline LDL cholesterol levels and the LDL goal recommended by the NCEP. Patients requiring reductions in LDL-C of 20% or more to achieve their goal should be started on 10 mg/day. A starting dose of 5 mg should be considered for patients requiring smaller reduction in LDL-C, for the elderly and in patients with severe renal insufficiency

  • The recommended dosing range is 5-80 mg/day; the maximum recommended dose is 80 mg/day

  • Adjustments of dosage should be made at intervals of 4 weeks or more


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