S Ramakrishnan MD, DM, FACC

•Secretary CSI – DB & PCSI

•Executive Editor, Indian Heart Journal

•Published 100 papers in indexed journals

•Awarded DP Basu award, Sujoy B Roy, Col Chopra awards, Best

paper awards at ACC, AEPC, APPCS, PCSI, CSI

Additional Professor of Cardiology

AIIMS, New Delhi

Evidence Based Selection of Statin: Case Based Approach

S RAMAKRISHNAN

ADDITIONAL PROF OF CARDIOLOGY

AIIMS, NEW DELHI

What has changed in ‘NEW’ guidelines?

Focus on ASCVD Risk Reduction

No Support For Use Of Specific LDL-C or Non-HDL

C Targets

Global Risk Assessment For Primary Prevention

Safety Recommendations Role of Biomarkers Fupture Updates

Siblings can have similar look but not the talent!

Drugs can have same structure and Mechanism of Action, but

not effects/ADRs!

ADR: Adverse Drug Reactions

So wait and think before prescribing statin to your patient

Four major statin benefit groups 6

Individuals with clinical ASCVD Primary elevations of LDL-C > 190

mg/dl

Diabetic patients aged 40-75 with LDL-C 70-189 mg/dl and without

clinical ASCVD

Individuals without ASCVD or diabetes aged 40-75 yr with LDL-C 70-189 mg/dl and with estimated

10-yr ASCVD risk > 7.5%

Case 1: 52-year-old with H/O ACS 1 year back. Smoker, no known risk factors. TC 210, TG 220, LDL 150, HDL 40

a. 1 mg Pitavastatin

b. 40 mg Atorvastatin

c. 10 mg Rosuvastatin

d. 20 mg Simvastatin

Has anything changed with ATP IV ?

Aim to Reduce RISK … not at Target levels

HIGH INTENSITY THERAPY MODERATE INTENSITY THERAPY

LOW INTENSITY THERAPY

Daily dose lowers LDL-C on average,by approximately ≥50%

Daily dose lowers LDL –C on average, by approximately 30-50%

Daily dose lowers LDL –C <30%

Atorvastatin (40) 80 mg Atorvastatin 10 (20) mg Simvastatin 10 mg

Rosuvastatin 20 (40) mg Rosuvastatin (5) 10 mg Pravastatin 10-20 mg

Simvastatin 20-40 mg Lovastatin 20 mg

Pravastatin 40 (80) mg Fluvastatin 20-40 mg

Lovastatin 40 mg Pitavastatin 1 mg

Fluvastatin XL 80 mg

Fluvastatin 40 mg bid

Pitavastatin 2-4 mg

ATP IV: Intensity of Statin Therapy

Major Secondary Prevention Studies On Statin

TNT: High Vs Low Dose Atorvastatin Primary Endpoint

22% risk reduction by 80 mg Vs 10 mg atorvastatin p<0.001

Waters DD et al. N Engl J Med 2005;352:1425-35

Primary Endpoint: Major cardiovascular event defined as coronary heart death (CHD),

nonfatal MI, resuscitated cardiac arrest, and fatal or nonfatal stroke

High dose atorvastatin is more effective for CV protection in stable IHD patients

Events Rates

RR Atorva 80 Prava 40

17% 1.9% 2.2%

18% 6.3% 7.7%

14% 12.2% 14.1%

16% 22.4%* 26.3%*

30 Days

90 Days

180 Days

End of Follow-up

PROVE IT TIMI 22: High Vs Moderate Intensity Statin : Primary Endpoint

Atorvastatin 80mg Better

0.5 0.75 1.0 1.25 1.5

Pravastatin 40mg Better *2-year event rates

High dose atorvastatin is more beneficial than moderate intensity statin for secondary prevention

Cannon CP et al. N Engl J Med 2004;350:1495-504

Time since randomization (years)

SPARCL Study : Primary End Point

*Adjusted

Fatal/ nonfatal stroke

(%)

0

0 1 2 3 4 5 6

16

12

8

4

16% RRR* HR 0.84 (0.71–0.99)

p=0.03

Placebo

Atorvastatin

NNT = 46 patients for 5 years

Primary outcome

SPARCL Investigators. N Engl J Med. 2006;355:549-59.

High dose atorvastatin reduces CV events in patients with stroke or TIA

Why No targets in Prevention?

ATP IV

Gi i g up the Goals…

▪ Many clinicians use targets such as LDL–C <70 mg/dL

▪ However, the RCT evidence clearly shows that ASCVD events are reduced by using the maximum tolerated statin intensity in those groups shown to benefit.

▪ After a comprehensive review, no RCTs were identified that titrated drug therapy to specific LDL–C or non-HDL–C goals to improve ASCVD outcomes.

No to Target based approach???

▪ There Is No Scientific Basis to Support Treating to LDL Targets

▪ The Safety of Treating to LDL Targets Has Never Been Proven

▪ Tailored Treatment Is a Simpler, Safer, More Effective, More Evidence-Based Approach

No to Target based approach???

Case 2; 55 year old diabetic female with no other risk factors – LDL C 125

Has anything changed with ATP IV ?

a. Should I start a Statin

b. Which one & what dose

ATP III- Risk Categories & Goals

▪ The foremost feature was the concept of risk assessment, both life time & short term – 10 years

▪ As per ATP-III guideline, the intensity of risk reduction intervention/s ust e at hed to a i di idual’s a solute risk as a fu da e tal

principle to prevention.

CARDS: Statin For Primary Prevention In T2DM

*Acute CHD event, coronary revascularization, stroke. RRR: Relative risk reduction

Colhoun HM et al. Lancet. 2004;364:685-696.

0

5

10

15

0 1 2 3 4 5 6

RRR=37% p=0.001

Cu

mu

lati

ve

in

cid

en

ce

of

ev

en

ts (

% o

f p

ati

en

ts)

127 events

83 events

Time (years)

Atorvastatin 10 mg (n=1428)

Placebo (n=1410)

median follow-up 3.9 years

22

25

21 21

0

5

10

15

20

25

30

Major CV event Coronary

revascularization

Stroke Major Vascular event

RR

R f

or

1 m

mo

l/L

red

uct

ion

of

LDL

Risk reduction per 40 mg/dl LDL reduction

Meta-analysis of statin studies in DM for primary prevention of CVD

Data from 18 686 DM patients Vs 71 370 without DM in 14 randomised trials of statins

Lancet 2008; 371: 117–25 CVD: Cardiovascular disease

Statin therapy can reduce CV events T2DM patients without CVD

ATP IV Primary prevention in patients with diabetes

Statins

Age

Diabetes LDLcholesterol

70-189 mg/dl

40-75 yrs

Moderate intensity statins

I A

High intensity statins

with risk >7.5%

IIa B

<40 yrs,

>75yrs

Balance between ASCVD benefits and

adverse effects

IIa C

Case 3: 60 year old male with LDL 195 No other risk factors

▪ Least controversial

Management

Evaluate for cause

Age>21 years LDL-C

>190mg/dl

primary

High dose statin

I B

Maximum tolerated

dose

I B

LDL-C reduction of atleast 50%

IIaB

secondary

Evaluate and treat

accordingly

STELLAR: Rosuvastatin reduce LDL-C better than all

other statins

-45.87

-52.34-54.96

-36.73

-42.57

-47.79-51.05

-20.13-24.29

-29.67-28.3

-34.98-38.81

-45.78

-70

-60

-50

-40

-30

-20

-10

010 20 40 80

Dose, mg

% c

ha

ng

e f

rom

ba

se

lin

e

Rosuvastatin (n = 156 - 160)Atorvastatin (n = 158 - 165)

Pravastatin (n = 158 - 165)Simvastatin (n = 161 - 164)

P < .001 vs comparators on a mg-to-mg basis.

Am J Cardiol 2003;92:152–160)

As Rosuvastatin causes maximum reduction in LDL-C among all the statins, it is preferable in those without

CVD, LDL-C > 190 mg/dl

▪ Mr C, A 58 years old man working in corporate office,

▪ K/C/o Hypertension 5 years. Smoker since 40 yrs (10 cigarettes/day)

▪ No H/o DM,IHD or CKD

▪ BP: 136/82 mm Hg, FPG: 98 mg/dl,

▪ eGFR: 101 mg/dl, S. Creatinine : 1.1 mg/dl Urine Protein: Nil, hsCRP: 3.9 mg/L

▪ TC:194 mg/dl, LDL:127mg/dl, HDL-C:31mg/dl, TG: 133 mg/dl

▪ He is on

▪ Olmesartan 40 mg 1 OD

Case 4: Non DM with risk factors

AHA Guidelines For Statin In Non-DM And Non-IHD Patients

Case 4: 10 years ASCVD risk: 21.7%

Moderate to high dose statin is required

Rosuvastatin 20 mg (N=8901)

MI Stroke

Unstable Angina

CVD Death CABG/PTCA

Randomized Double Blind Placebo Controlled Trial of Rosuvastatin in

the Prevention of CV Events In Individuals With Low LDL and high

hsCRP

4-week run-in

Ridker PM et al, Circulation 2003;108:2292-2297

No Prior CVD or DM Men >50, Women >60

LDL <130 mg/dL hsCRP >2 mg/L

Placebo (N=8901)

Follow up: 1.9 yrs

JUPITER study

Placebo 251 / 8901

Rosuvastatin 142 / 8901

Risk Reduction: 44 %

0 1 2 3 4

0.0

0

0.0

2

0.0

4

0.0

6

0.0

8

Cu

mu

lati

ve

In

cid

en

ce

Follow-up (years)

Ridker PM et al, N Engl J Med 2008;359:2195-207

JUPITER :primary trial endpoint

In patients without DM and CVD, with high hs-CRP (>2

mg/dl), rosuvastatin significantly reduces CV events by 44%

▪ A sub analysis to evaluate CV benefits in patients who achieved LDL-C< 50mg/dl with rosuvastatin (n= 4154) Vs those on placebo

▪ Following benefits were seen those with LDL-C< 50 mg/dl vs those on placebo

JUPITER : LDL < 50 mg/Dl Provides Maximum CV Protection

65% Risk reduction in

Primary End Point

46% Risk reduction in

All Cause Mortality

J Am Coll Cardiol 2011;57:1666–75

▪ Olmesartan 40 mg OD

▪ Rosuvastatin 20 mg OD or Atorvastatin 40 mg OD

Final Therapy for Case 4

Case 5: 68-year-old lady Non DM & HTN, No ASCVD, Non Smoker TC 145, TG 200, LDL 88, HDL 42. 130/85 on treatment.

a. No Statins.

b. 40 mg Atorvastatin.

c. 80 mg Atorvastatin.

d. 40 mg Rosuvastatin.

e. 2 mg Pitavastatin.

Case 6: 42-year-old IT professional. Male Smoker, no known risk factors. TC 210, TG 220, LDL 150, HDL 40

a. Only life style management

b. 10 mg Atorvastatin

c. 20 mg Rosuvastatin

d. 10 mg Rosuvastatin + Fenofibrate

How do you decide ? ATP IV Guidelines

▪ Individuals without clinical ASCVD or diabetes

▪ 40 to 75 years of age

▪ LDL-C 70-189 mg/dL

▪ Estimated 10-year ASCVD risk of 7.5% or higher

Moderate- or high-intensity statin

The New CV Risk Assessment Calculator

▪ Previously used Framingham risk score - inadequate

▪ “deri atio in an exclusively White sample population and the limited scope of the outcome

▪ Based on data collected from several large, racially & geographically diverse, modern NHLBI sponsored studies, including ARC, CARDIA, Framingham study.

▪ Includes

▪ Smoking status

▪ Diabetes

▪ Systolic BP & treatment status

▪ Total & HDL cholesterol

▪ Age

▪ Gender

▪ Race

10 year ASCVD Risk

Age of the patient

10 yr ASCVD risk estimate

Individuals without diabetes- primary

prevention

LDLcholesterol

70-189 mg/dl

>7.5%

40-75 yrs

Moderate to high intensity therapy

I A

>75

yrs

Assess risk,

benefits

5-7.5%

40-75 yrs

Moderate intensity therapy

IIa B

>75 yrs

Assess risks

benefits

Case 5: 68-year-old lady Non DM & HTN, No ASCVD, Non Smoker TC 145, TG 200, LDL 88, HDL 42. 130/85 on treatment.

a. No Statins.

b. 40 mg Atorvastatin.

c. 80 mg Atorvastatin.

d. 40 mg Rosuvastatin.

e. 2 mg Pitavastatin.

ASCVD Risk 10%

Case 6: 42-year-old IT professional. Male Smoker, no known risk factors. TC 210, TG 220, LDL 150, HDL 40

a. Only life style management

b. 10 mg Atorvastatin

c. 20 mg Rosuvastatin

d. 10 mg Rosuvastatin + Fenofibrate

ASCVD Risk 5.7%

Additional Risk Markers?

▪ Primary LDL–C ≥ g/dL

▪ Other evidence of genetic hyperlipidemias,

▪ Family history of premature ASCVD with onset <55 years of age in a first degree male relative or <65 years of age in a first degree female relative,

▪ High-sensitivity C-reactive protein >2 mg/L,

▪ CAC s ore ≥ Agatston u its or ≥ per e tile for age, sex, a d ethnicity,

▪ Ankle-brachial index <0.9, or

▪ Elevated lifetime risk of ASCVD

Why 7.5?

ATP IV

Paris computer games store. In fact, the floor is

absolutely flat

The results of HPS led to the widespread concept that there are benefits of statin

therapy in high-risk individuals regardless of baseline cholesterol levels.

Lower LDL-C Level is associated with better outcomes

2012 Redefining the risk threshold for primary prevention

2012

▪ Reduction of LDL with a statin reduced the risk of major vascular events (RR 0・79, per 1 mmol/L reduction), largely irrespective of age, sex, baseline LDL cholesterol or previous vascular disease, and of vascular and all-cause mortality.

▪ In individuals with 5-year risk of major vascular events lower than 10%, each 1 mmol/L reduction in LDL cholesterol produced an absolute reduction in major vascular events of about 11 per 1000 over 5 years.

▪ This benefit greatly exceeds any known hazards of statin therapy.

Lancet 2012; 380: 581–90

Effects on major coronary events, strokes, coronary revascularisation procedures, and major vascular events per 1·0 mmol/L reduction in LDL cholesterol at different levels of risk

▪ Lancet 2012; 380: 581–90

Statin can it be Satin?

Number needed to harm – New onset diabetes – 120 - 450

Muscle problems – 5-10%

Why Statin for estimated risk of > 7.5?

Case 7a. 52-year-old lady. Euthyroid TC 212, TG 300, LDL123, HDL 68

a. Statin + Fenofibric acid.

b. No treatment (only LSM).

c. Niacin.

d. Fish oil.

ASCVD Risk 1.1%

Case 7b: 44-year-old male TC 220, TG 580, LDL 111, No other risk factors

a. Fenofibrate

b. Rosuvastatin

c. Statin + Fenofibrate.

d. Niacin.

ATP III- Non-HDL Cholesterol

▪ Established the concept of non-HDL-C as a secondary target for therapy in patients with TG greater than 200 mg/dL

▪ The non-HDL-C encompasses all atherogenic lipoproteins, including not just LDL but also VLDL and IDL.

▪ Thus, after focusing initially on lowering the LDL-C or if the LDL-C cannot be determined, one should use the non-HDL-C as a secondary target for therapy.

▪ The recommended targets for non-HDL-C are 30 mg/dL higher than the LDL-C targets

JAMA 2001;285:2486– 9 .

What ATP IV says?

With few exceptions, use of lipid-modifying drugs other than statins is discouraged.

Non-statin lipid lowering drugs (Ezitimibe, Fibrates, Niacin, Efastenol, Sterols) have no evidence of CV protection

The New CV Risk Assessment Cal ulator…. Good, Bad or Ugly?

▪ It was derived from five population-based cohorts of African Americans and non-Hispanic whites and relies heavily on age and sex to determine ASCVD risk while ignoring other important factors such as family history.

▪ Several leading researchers have suggested that it overestimated the CV risk

▪ They applied the new risk algorithm in three large scale primary prevention studies- Women health study, Physician health study, women health initiative observational study and found that the new scoring system overestimated risk by 75-150%

▪ The new risk algorithm can not be applied to Asian population as the Asian population were not adequately represented in the studies used to develop the new algorithm

Case 8: 35 year old, Hypertensive patient TC 180, LDL 108, HDL 45

No recommendations

Individuals 21-39 years and >75 years age???

▪ No primary prevention RCT data were available for individuals 21 to 39 years of age and few data were available for individuals >75 years of age.

▪ Therefore, in adults with LDL–C <190 mg/dL who are not otherwise identified in a statin benefit group, clinician knowledge, experience and skill, and patient preferences, all contribute to the decision to initiate statin therapy in these individuals

▪ Future RCTs will be needed to determine the optimal age at which to initiate statin therapy to reduce ASCVD risk, as well as to determine the optimum duration of statin therapy.

Statins in Heart Failure, Hemodialysis patients

Common practical questions

▪When should I repeat a lipid profile

▪ Should I get a CPK done prior to high dose statin

▪ Should I get a LFT done

▪What if LDL < 40 on FU

ATP IV: Safety recommendations of statins

NHLBI ACC/AHA

COR

LOE

1.Creatine Kinase, routinely not needed A III no benefiit A

2.Baseline CK in pts at risk of events E IIa C

3.Baseline ALT before initiating statins B I B

4.Decreasing the statin dose,if 2 consecutive

values of LDL-C <40 mg/dl.

C IIb C

5.Simvastatin at 80 mg daily harmful B III harm A

6.New onset diabetes on statin therapy,

continue statins

B I B

7.If muscle symtpoms

develop,discontinue,use again

E II a C

8.Confusional state,see secondary causes E II b C

Safety considerations

Patient groups that may influence statin safety

• Impaired renal or hepatic function

• History of previous statin intolerance of muscle disorders

• Concomitant use of drugs affecting statin metabolism

• History of hemorrhagic stroke

• Age > 75 yr

• Asian race

▪ Mrs F, a 62 years old woman presented in OPD

▪ She is K/c/o HT since 15 years, DM since 6 years and CKD since 2 years

▪ BP: 128/78 mm Hg. FPG: 149 mg/dl, PPBG: 201 mg/dl

▪ TC: 204 mg/dl, LDL: 126 mg/dl, TG: 160 mg/dl, HDL: 47 mg/dl

▪ S. creatinine 1.8 mg/dl, eGFR: 67 mg/dl

▪ She is on

▪ Antidaibetic

▪ Tab Voglibose 0.2 mg 1 TDS

▪ Tab Telmisartan 80 mg + Amlodipine 5 mg 1 OD

▪ Tab Aspirin 75 mg 1 OD

Case 9: Chronic Kidney Disease

2013 KDIGO Guidelines For Lipid Management In CKD

KDIGO Kidney Disease: Improving Global Outcomes

▪ Atorvastatin: No dose adjustment required

▪ Rosuvastatin: In patients severe CKD with creatinine clearance < 30

ml/min (not on hemodialysis), Maximum dose: 10 mg/day

▪ Pitavastatin: in patients with moderate/severe CKD (GFR: 15-59

ml/min) Maximum dose: 2 mg/day,

Dose of statins in patients with CKD

GFR: Glomerular Filtration Rate

▪ A meta-analysis of 11 studies including 21,295 CKD patients (14,202 not on dialysis)

▪ Following were benefits of statin therapy (P < 0.05 for all)

▪ 36% relative risk reduction in all cause death

▪ 31% relative risk reduction in CV death

▪ 45% relative risk reduction in CV events

▪ 34% relative risk reduction in stroke

Benefit Of Statin In CKD Patients (Not On Dialysis): A Meta-analysis

Pharmacological Research 2013 ;72:35– 44

de Zeeuw D. 2010European Renal Association-European Dialysis and Transplant Association Congress; June 27, 2010; Munich, Germany.

Atorvastatin vs Rosuvastatin for renal

function PLANET I:

Adverse event

Rosuvastatin

10 mg/day

(n = 116)

Rosuvastatin 40

mg/day

(n = 123)

Atorvastatin 80

mg/day

(n = 110) p

Any renal

adverse event

7.8 9.8 4.5 NS

Acute renal failure 0.0 4.1 0.9 <0.05

Serum creatinine

doubling

0.0 4.9 0.0 <0.01

Serum creatinine

doubling or acute

renal failure

0.0 7.3 0.9 <0.01

Atorvastatin is safer than rosuvastatin in DM patients

with proteinuria

▪ A meta-analysis of 5 clinical trials head to head comparing atorvastatin vs rosuvastatin

Atorvastatin Vs Rosuvastatin For Proteinuria: A Meta-analysis

Atorvastatin is better than rosuvastatin for reduction in

proteinuria

Circ J 2012;76:1259-66

Effect of pitavastatin on eGFR in CKD patients with

baseline eGFR<60 ml/min

J Atheroscler Thromb 2010;17:601-609 CKD: Chronic Kidney disease,

eGFR: estimated Glomerular Filtration Rate

Pitavastatin improves renal function in CKD patients with

eGFR< 60 ml/min

Effect of 12 Weeks of Pitavastatin Therapy On Proteinuria

**p< 0.01

Am J Cardiol 2011;107:1644 –1649

Pitavastatin significantly reduced proteinuria in dyslipidemic patients

within 12 weeks

▪ Tab Metformin 500 mg 1 BD

▪ Tab Glimepiride 1 mg 1 OD

▪ Tab Voglibose 0.2 mg 1 TDS

▪ Tab Telmisartan 80 mg + Amlodipine 5 mg 1 OD

▪ Tab Aspirin 75 mg 1 OD

▪ Patient can be treated with 10 mg atorvastatin or 2 mg pitavastatin

Final therapy of Case 9

▪ Mr G, 53 old man working as engineer, presented for follow up for hypertension

▪ K/c/o Hypertension since 6 years, No H/o DM, IHD

▪ Smoker since 30 years, 10 bidis/day,

▪ Obese, Weight: 85 kg BMI: 28 kg/m2

▪ BP: 138/82 mm Hg, FPG: 116 mg/dl, HbA1c: 6.3%

▪ TC: 210 mg/dl, LDL-C: 138 mg/dl, TG: 167 mg/dl and HDL: 38 mg/dl

▪ He is on Ramipril 10 mg 1 OD and Amlodipine 5 mg 1 OD

Case 10: Impaired Glucose Tolerance Patient

Statin increases risk of new DM by 13%

▪ A meta-analysis has shown that with statin therapy, risk of new onset of diabetes is increased by 13%

FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs

Increases in HbA1c and fasting serum glucose levels have been reported with statin use

LIVES : Pitavastatin does not increase HbA1c in DM patients even at 2 yrs

Expert Opin Pharmacother. 2010;11(5):817–828.

Long term pitavastatin therapy does not affect glycemic

control in DM patients

▪ A prospective randomized, controlled trial

▪ 1,269 individuals with impaired glucose tolerance (IGT)

randomized to either pitavastatin (lifestyle modification and

pitavastatin [1-2 mg/day]) or control group (lifestyle modification

only)

▪ Pitavastatin significantly reduced new onset of DM [the hazard ratio

0.82 (p=0.041)]

J PREDICT : Pitavastatin In IGT Patients

ADA 2013, Late breaking abstract No. 61-LB

J-PREDICT-Japan Prevention Trial of Diabetes by Pitavastatin in Patients with Impaired Glucose Tolerance study

J PREDICT : Pitavastatin In IGT Patients

Atherosclerosis Supplements 2015;161:1–27

J PREDICT - Japan PREvention Trial of Diabetes

by Pitavastatin in Patients with Impaired GluCose Tolerance

J PREDICT study - Lifestyle modification plus 1–2 mg/day of

pitavastatin significantly reduced the cumulative incidence of

T2DM (by 18%) in 1,269 high-risk patients with impaired glucose tolerance,

compared to lifestyle modifications alone

18%

NOD – New onset Diabetes

J-PREDICT Sub-analysis from EASD September 2014

Pitavastatin does not increase risk of new onset of DM in any subgroup of patients

▪ Mr I, a 41 years old person presented in OPD for follow up

▪ He is K/c/o Dyslipidemia since 6 months

▪ No H/o HT, DM IHD or other diseases

▪ FPG: 85mg/dl, PPPG: 138 mg/dl BP:

▪ He is not on any medication. He was prescribed Rosuvastatin 10 mg before 6 months, stopped after 1 month due to severe myalgia

▪ TC: 250 mg/dl, LDL-C: 161 mg/dl, TG: 130 mg/dl, HDL: 38 mg/dl

Case 11: Statin intolerant patient

▪ In Florida, USA, 152 patients intolerant to > 2 previous statins due to myopathy (average 2.7 statins) were placed on pitavastatin therapy.

▪ Percentage (%) of patients tolerating pitavastatin and achieving NCEP ATP-III LDL-C goal non-HDL-C goal were measured

▪ 104 patients (76%) patients tolerated pitavastatin therapy and continued it for > 6 months

▪ 87% of patients with intermediate CV risk achieved their NCEP-ATP III LDL-C goals with pitavastatin therapy

Pitavastatin For Statin Intolerant Patients

Journal of Clinical Lipidology 2012: 6(3) : 274

LDL

cholesterol

>190 mg/dl

Pt had CAD, HTN,smoker,not

on statins

Age 45 yrs

Start Statins to the maximum tolerated dose

Age 75 yrs

Assess risk,benefits

Pt diabetic,no CAD,

ASCVDrisk >7.5%

High intensity statins

Pt not diabetic,

noCAD

Evaluate secondary causes

High dose statin

therapy

70-189 mg/dl

Pt CAD

Statins

Pt diabetic

Moderat dose

statins

Pt no h/o CAD,

DM2,

risk <7.5%

Assess risk,

benefits

Pt having CKD

No EBT for statins

Summarizing ATP IV

Worth the ait….???

No Target

Only Statins

Based on RCTs

2004.. BE MORE AGGRESSIVE!!

2013 Revolution (Stavolution) of ATP IV STATIN THERAPY IS BENEFICIAL IN HIGH-RISK PATIENTS VIRTUALLY REGARDLESS OF THE BASELINE LDL-C LEVEL

So, how to select a statin finally?

Patient’s Profile Preferred Statin

Secondary prevention of CVD Atorvastatin

Primary prevention of CVD for DM and high risk patients Atorvastatin/

Rosuvastatin

Primary prevention of CVD without DM and high hsCRP (> 2 mg/dl) Rosuvastatin

Difficult to achieve LDL-C goal Atorvastatin/

Rosuvastatin

Acute Coronary Syndrome/PCI Atorvastatin/Rosuvasta

tin

For patients with CKD Atorvastatin/

Pitavastatin*

Patients with IGT Pitavastatin

Statin intolerance Try Pitavastatin

*If eGFR > 15 ml/min

Thank You