Advances in Lipid Management. The National Cholesterol Education Program (NCEP) Launched by National Heart, Lung, and Blood Institute (NHLBI), a part

Advances inLipid Management

The National Cholesterol Education Program (NCEP)

Launched by National Heart, Lung, and Blood Institute (NHLBI), a part of the NIH, in November, 1985

Impetus: Definitive evidence linking coronary heart disease (CHD) to elevated total cholesterol levels

Goal: Educating, monitoring, and developing guidelines for lowering blood cholesterol levels

NCEP web site.

50% Coronary Heart Disease1% Congenital

Heart Defects

1% Rheumatic Fever/Rheumatic Heart Disease

4% CongestiveHeart Failure

2% Atherosclerosis

4% High Blood Pressure

22% Other

Coronary Heart Disease: Despite Advances, Still the #1 KillerPercentage Breakdown of Deaths From Cardiovascular DiseasesUnited States: 1995 Mortality, Final Data

16% Stroke

American Heart Association. 1998 Heart and Stroke Facts: Statistical Update.

Major Risk Factors for CHDThe NCEP Adult Treatment Panel Identifies Positive Risk Factors (RF) for CHD

Risk Factors

Family history of early CHD — parent or sibling <55 years of age if male, <65 years of age if female

Age— male 45 years— female 55 years, or premature menopause without estrogen replacement therapy (ERT)

Hypertensive (BP 140/90 mm/Hg or taking antihypertensive medication)

Current smoker

Diabetes mellitus

Low HDL-cholesterol (<35 mg/dL)

Negative Risk Factor

If HDL-C is 60 mg/dL, subtract one risk factor

Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, NHLBI; September 1993.

Risk Stratification for Adults Without CHDClassification Based on LDL-C

<130 mg/dL

130-159 mg/dL

160 mg/dL

LDL-C Level

Desirable

Borderline-high risk

High risk

Classification


NCEP Primary CHD Risk Categories and Goals for Lowering LDL-C

LDL-C Goal

No CHD <2 RF <160 mg/dL

No CHD 2 RF <130 mg/dL

CHD 100 mg/dL

The NCEP recommends lowering LDL-C even further than these goals, if possible.


Risk Category

83% of CHD patients did not reach NCEP goal

55% of patients with 2 risk factors and no CHD

did not reach NCEP goal

83%55%

High-Risk Adults Not Reaching LDL-C Goals in NHANES-III(National Health and Nutrition Examination Survey)

Unpublished data from the Third National Health and Nutrition Examination Survey (NHANES-III), CDC 1994; data from 1988–1991.

Lipid Treatment Assessment Project (L-TAP)

Hypothesis— majority of dyslipidemic patients do not achieve NCEP

target LDL-C levels

Primary Objective— to determine percentage of primary care patients on diet

and/or drug therapy who are achieving NCEP LDL-C goals

Pearson TA, Laurora IM. Scientific Sessions of the American Heart Association; 1997; Abstract 361.

L-TAP: % of Patients at LDL-C Goal

Diet therapy2RF (n=282)2RF (n=361)CHD (n=108)Total (n=751)

Drug therapy2RF (n= 861)2RF (n=1924)CHD (n=1352)Total (n=4137)

Risk group—Lipid-lowering therapy % Success

5922

734

70401839

41789366

30608261

% Failure P-Value

0.001

0.001

Does not include patients who were nonevaluable.Person’s chi-square=682.91; d=2; P=0.001.

LDL-C goal

Data on file. Parke-Davis; Morris Plains, NJ.Pearson TA, Laurora IM. Scientific Sessions of the American Heart Association; 1997; Abstract 361.

L-TAP: Identifying the Patient at Risk

Patient Profile With 2 Risk Factors

92% Male 45 yearsFemale 55 years

70% Hypertensive (140/90 mm Hg)

41% Family history of early CHD

22% Low HDL-C level

21% Diabetes mellitus

19% Current smokers47%30%CHD Patients

23%

No CHD <2 RF

No CHD2 RF

Data on file. Parke-Davis; Morris Plains, NJ.

L-TAP: Many High-Risk Adults Are Not Reaching LDL-C Goals

63% of patients with 2 risk factors and no CHD

did not reach NCEP goal

63% 82%

82% of CHD patients did not reach NCEP goal


L-TAP: Distance From LDL-C Goal in Patients With 2 Risk Factors

0

100

200

300

400

500

600

700

800

900

1000


n=849

63%

LDL-C (mg/dL)

No.of patients

Not at goalAt goal

n=816

n=494

n=126

<130 130-160 >200161-200

L-TAP: Distance From LDL-C Goal in Patients With CHD

0

100

200

300

400

500

600


n=256

82%

LDL-C (mg/dL)

No.of patients

Not at goal

At goal

n=545

n=416

n=243

100 101-130 >160131-160

0

25

50

75

100

125

150

Gotto AM Jr, et al. Circulation. 1990;81:1721-1733.Castelli WP. Am J Med. 1984;76:4-12.

Relationship Between Cholesterol and CHD Risk: Epidemiologic Trials

10-y

ear

CH

D d

eath

rat

e (D

eath

s/10

00)

Serum cholesterol (mg/dL)

1% reduction in total cholesterol resulted in a 2% decrease in CHD risk

CH

D in

dic

atio

ns

per

100

0Each 1% increase in total cholesterol level is associated with a 2% increase in CHD risk

Serum cholesterol (mg/100 mL)

Framingham Study (n=5209)Multiple Risk Factor Intervention Trial

(MRFIT) (n=361,662)

204

205-234 235-264 265-294 295

150 200 250 3000

50

40

30

20

10

Relationship Between Cholesterol and CHD Risk: Epidemiologic Trials (cont’d)

Cumulative incidence of AMI in each quartile of basal serum cholesterol, expressed per 100,000 screened subjects in 3 years.Serum cholesterol was measured between April 1, 1983 and March 31, 1984.

† 25-year CHD mortality rates per baseline cholesterol quartile adjusted for age, cigarette smoking, and systolic blood pressure.Wakugami K, Iscki R, Kimura Y, et al. Japanese Circulation Journal. 1998;62:7-14. Verschuren WMM, Jacobs DR, Bloemberg BPM, et al. JAMA. 1995;274:131-136.

Cu

mu

lati

ve in

cid

ence

of

AM

Ipe

r 100

,000

scr

eene

d su

bjec

ts in

2 y

ears

0

100

200

300

400

500

Men

Women

Cumulative incidence of acute myocardial infarction (AMI) increased with the level of serum cholesterol


Range 167 168-191 192-217 218Mean 149.3 179.8 203.7 245.3

Okinawa, Japan

CH

D m

ort

alit

y ra

tes

(%)

Using linear approximation, a 20-mg/dL increase in total cholesterol corresponded to a 17% increase in mortality risk


Seven Countries Study†

125 175 225 275 325

0

10

20

30

40Northern EuropeSouthern Europe, MediterraneanUnited StatesSerbiaSouthern Europe, InlandJapan

Atorvastatin Calcium (LIPITOR®): Mechanism of Action

Reduced cholesterol synthesis

HMG-CoA reductase inhibition

Increased removal and catabolism of LDL Conversion of VLDL to LDL

Upregulation of LDL receptors Decreased VLDL production

Decreased TC, LDL-C, and TG

Atorvastatin Calcium (LIPITOR®) Indications

An adjunct to diet to reduce elevated total-C, LDL-C, apoB, and TG levels in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb)

As adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV)

For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet

To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable

The effect of LIPITOR on cardiovascular morbidity and mortality has not been determined

Atorvastatin Calcium (LIPITOR®) Dose-Response Relationship

-41% -44%-50%

-61%

-70%

-60%

-50%

-40%

-30%

-20%

-10%

0%

Mea

n %

LD

L-C

redu

ctio

n fr

om b

asel

ine

P<0.05 vs placebo.

Nawrocki JW, et al. Arterioscler Thromb Vasc Biol. 1995;15:678-682.

10 mg 20 mg 80 mg40 mg

In Head-to-Head Trials, Atorvastatin Calcium Showed Superior LDL-C Reductions at Starting Doses

-30%

-37%

-40%

-35%

-30%

-25%

-20%

-15%

-10%

-5%

0%

Mea

n %

LD

L-C

cha

nge

from

bas

elin

e

P 0.05

atorvastatin(n=132)

simvastatin(n=45)

-23%

-35%

P 0.05

atorvastatin(n=222)

pravastatin(n=77)

-27%

-36%

P 0.05

atorvastatin(n=707)

lovastatin(n=191)

Dart et al. Bertolini et al. Davidson et al.

Data on file. Parke-Davis; Morris Plains, NJ. Dart A, et al. Am J Cardiol. 1997;80:39-44. Bertolini S, et al. Atherosclerosis. 1997;130:191-197. Davidson M, et al. Am J Cardiol. 1997;79:1475-1481.

20 mg10 mg 10 mg 10 mg 20 mg10 mg

The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in this slide is not known. This chart does not contain data comparing the effects of atorvastatin with higher doses of simvastatin, pravastatin, and lovastatin.

In Head-to-Head Trials, Atorvastatin Calcium Showed Superior TG Reductions at Starting Doses

-23%

-15%

-25%

-20%

-15%

-10%

-5%

0%

Mea

n %

trig

lyce

ride

chan

ge fr

om b

asel

ine

atorvastatin(n=132)

simvastatin(n=45)

-9%

-17%

atorvastatin(n=222)

pravastatin(n=77)

-6%

-17%

atorvastatin(n=707)

lovastatin(n=191)

Dart et al. Bertolini et al. Davidson et al.P 0.05 P 0.05 P 0.05

20 mg10 mg 10 mg 10 mg 20 mg10 mg

Data on file. Parke-Davis; Morris Plains, NJ. Dart A, et al. Am J Cardiol. 1997;80:39-44. Bertolini S, et al. Atherosclerosis. 1997;130:191-197. Davidson M, et al. Am J Cardiol. 1997;79:1475-1481.

The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in this slide is not known. This chart does not contain data comparing the effects of atorvastatin with higher doses of simvastatin, pravastatin, and lovastatin.

CURVES Trial Design and Objective

CURVES is a multicenter, open-label, randomized, parallel- group, 8-week, comparative-dose efficacy and safety study of once-daily atorvastatin compared with simvastatin, pravastatin, lovastatin, and fluvastatin in patients with elevated LDL-C

Designed to assess comparative efficacy and safety of atorvastatin relative to simvastatin, pravastatin, lovastatin, and fluvastatin on lipids in patients with baseline LDL-C 160 mg/dL and TG 400 mg/dL

Jones P, Kafonek S, Laurora I, Hunninghake D, for the CURVES Investigators. Am J Cardiol. 1998;81:582-587.

Treatment arm Mean baseline No. of (mg) LDL-C (mg/dL) patients

atorvastatin 10 213 n=7320 213 n=5140 206 n=6180 213 n=10

simvastatin 10 207 n=7020 230 n=4940 219 n=61

pravastatin 10 225 n=1420 237 n=4140 215 n=25

lovastatin 20 244 n=1640 218 n=1680 219 n=11

fluvastatin 20 236 n=1240 192 n=12

CURVES Trial: Mean Baseline LDL-C Levels


Treatment arm sizes were powered to show statistical significance vs mg-equivalent dose of the other agents.

CURVES Trial: Patient Inclusion Criteria and Demographics

Patient inclusion criteria

At two consecutive visits— LDL-C 160 mg/dL— TG 400 mg/dL

Men and women 18 and 80 years of age

Body Mass Index (BMI) 32 kg/m2

Patient demographics

Mean age: 55.2 years

Modified intent-to-treat patients— 59% male— 41% female

Family history of CHD: 37%

Smokers: 13%

Average BMI: 26.7 kg/m2

Evenly distributed across treatment groups.


CURVES Trial:LDL-C Reductions vs Other Statins

Significantly less than atorvastatin 10 mg (P<0.02).†Significantly less than atorvastatin 20 mg (P<0.01).‡Significantly greater than mg-equivalent doses of comparative agents (P 0.01).

The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in this chart is not known.

Mean % changein LDL-C

-50

-40

-30

-20

-10

Dose range (mg)

-6020 40 8010

fluvastatin

lovastatin(40 mg bid)

atorvastatin(80 mg qd)

†

†

†

‡

‡

‡

simvastatin

pravastatin


CURVES Trial:Superior LDL-C Reductions at Usual Starting Doses

pravastatin fluvastatinsimvastatin lovastatinatorvastatin

-38%

-28%†

-24%†

-29%†

-17%†

atorvastatin 10 mg efficacy(38%)

0

-10

-20

-30

-40

20 mg20 mg20 mg10 mg10 mg

Mean% LDL-C

reduction


Most commonly prescribed doses for each product. Source: IMS National Prescription Audit; February 1998.†Significantly less than atorvastatin 10 mg (P <0.01).


CURVES Trial:Superior LDL-C Reductions at Usual First Titrations

atorvastatin 10 mg efficacy(38%)

pravastatin fluvastatinsimvastatin lovastatinatorvastatin

-46%

-35%† -34%†

-31%†

-23%†

0

-10

-20

-30

-40

-50

20 mg 20 mg 40 mg 40 mg 40 mg

Mean% LDL-Creduction


Most commonly prescribed doses for each product. Source: IMS National Prescription Audit; February 1998.†Significantly less than atorvastatin 20 mg (P<0.01).


CURVES Trial:LDL-C Reductions at Every Dose

Mean LDL-C reductions at 80-mg doses: LIPITOR® 80 mg (qd)=54% vs lovastatin 80 mg (40 mg bid)=48%, P >0.05.


Mean % LDL-C reduction from baseline

0

pravastatin

fluvastatin

simvastatin

lovastatin

atorvastatin

-15 -20 -25 -30 -35 -40 -45 -50 -55

80 mg (40 mg bid)

(qd)10 mg 20 mg 40 mg80 mg

10 mg 20 mg 40 mg

10 mg 20 mg 40 mg

20 mg40

20 mg 40 mg

mg


CURVES Trial: Conclusions

At usual starting doses and usual first titrations, atorvastatin demonstrated significantly greater LDL-C reductions vs other statins

All statins were well tolerated and no serious adverse events were considered related to any of the study medications


Treat-to-Target Trial: Design and Objectives

A 54-week, open-label, randomized study comparing the efficacy and safety of

atorvastatin

fluvastatin

lovastatin

simvastatin

in the reduction of LDL-C levels to NCEP goals


Treat-to-Target Trial: Patient Entry Criteriaand Demographics

Lipid entry criteria— LDL-C: patients with <2 risk factors (190 mg/dL),

patients with 2 risk factors (160 mg/dL)— TG: all patients (400 mg/dL)

LDL-C range: 129-448 mg/dL; LDL-C mean: 205 mg/dL

Demographics— mean age: 56 years (53% women, 47% men)— 24% had <2 CHD risk factors, 76% had 2 risk factors— baseline LDL-C values were similar for all treatment groups


Treat-to-Target Trial: Dosing Schedule

Statin Dosing schedule With colestipol

atorvastatin 10 mg 20 mg 40 mg 80 mg 5 g bid

fluvastatin 20 mg 40 mg 5 g bid 10 g bid

lovastatin 20 mg 40 mg 80 mg 5 g bid 10 g bid

simvastatin 10 mg 20 mg 40 mg 5 g bid 10 g bid


Treat-to-Target Trial: Study Design

4-week lead-in

344 patients randomized (1:1:1:1)atorvastatin vs fluvastatin vs lovastatin vs simvastatin for

54 weeks to reach <160 mg/dL for patients with <2 risk factors (24%) or <130 mg/dL for patients with 2 risk factors (76%)

12 weeksatorvastatin 10 mg

(n=85)

12 weeksfluvastatin 20 mg

(n=82)

12 weekslovastatin 20 mg

(n=83)

12 weekssimvastatin 10 mg

(n=87)

If not at NCEP LDL-C goal, titrate at 12-week intervals for 54 weeks to maximum

dose and add colestipol if needed

8-week dietary assessment (optional)


Treat-to-Target Trial: 12-Week Results

0

10

20

30

40

50

60

70

80

fluvastatin(n=82)

simvastatin(n=87)

lovastatin(n=83)

atorvastatin(n=85)

20 mg 20 mg 10 mg10 mg

% Patientsreaching NCEP

LDL-C goalby week 12

Significantly less than atorvastatin 10 mg (P<0.001).


71%

16%

34%41%


Treat-to-Target Trial: 24-Week Results

atorvastatin 10 mg efficacy at week 12% Patients

reaching NCEP LDL-C goalby week 24

fluvastatin20-40 mg

(n=82)

simvastatin10-20 mg

(n=87)

lovastatin20-40 mg

(n=83)

atorvastatin10-20 mg

(n=85)

84%

28%

46%53%


Significantly less than atorvastatin (P<0.001).


0102030405060708090

100

Treat-to-Target Trial: Summary of Results Compared with patients on fluvastatin, lovastatin, and simvastatin, significantly more

patients on atorvastatin reached NCEP LDL-C goal at usual starting doses by every study interval with fewer titrations in fewer office visits

95% of those on atorvastatin reached LDL-C goal by end of study—all on monotherapy


Effective for a Broad Range of Patient Populations

-21%

-39%

-40%

-35%

-30%

-25%

-20%

-15%

-10%

-5%

0%

Elderly(>70 years)

(n=183)

-18%

-38% -37%

-18%-21%

-37%

-21%

-36%

-24%

-35%Mea

n %

cha

nge

from

bas

elin

e

Women(n=689)

Hypertensives(n=510)

CHD(n=196)

NIDDM(n=156)

Mixeddyslipidemics

(n=550)

LDL-C and TG reductions with atorvastatin at the 10-mg starting dose

Pooled results from separate trials of atorvastatin 10 mg in more than 2000 patients for up to 52 weeks.


LDL-C TG LDL-C TG LDL-C TG LDL-C TG LDL-C TG LDL-C TG

Atorvastatin Calcium in Hard-to-TreatPatient PopulationsAtorvastatin 80 mg in severe hypercholesterolemia(baseline total cholesterol 368 mg/dL; LDL-C 289 mg/dL)

+7%

-46%

-33%

-53%

-44%

-60%

-50%

-40%

-30%

-20%

-10%

0%

10%

Mea

n %

cha

nge

from

bas

elin

e Total-C LDL-C TG ApoB

HDL-C


Hypercholesterolemia CHD events

Medications

Dietarycounseling

Adverse events

Titration

Monitoring

Hospitalization

Surgeries

Physician visits

Economic Considerations in the Management of Hypercholesterolemia

Cost Considerations in LDL-C ReductionCURVES Trial Results:

LIPITOR® 10 mg (n=73), 20 mg (n=51), 40 mg (n=61), 80 mg (n=10); simvastatin 10 mg (n=70), 20 mg (n=49), 40 mg (n=61); pravastatin 10 mg (n=14), 20 mg (n=41), 40 mg (n=25); lovastatin 20 mg (n=16), 40 mg (n=16), 80 mg (n=11); fluvastatin 20 mg (n=12), 40 mg (n=12). Baseline LDL-C values were similar for all groups. LDL-C reductions at 80-mg doses: LIPITOR 80 mg (qd)=54% vs lovastatin 80 mg (40 mg bid)=48%, P >0.05.

Average wholesale price (AWP) per tablet provided by Red Book® Update, August 1998. Actual pharmacy or out-of-pocket costs may differ. Cost comparisons do not imply comparable efficacy or safety. Dosage price for LIPITOR and lovastatin 80 mg is equal to double their 40-mg tablet cost.

Jones P, Kafonek S, Laurora I, Hunninghake D, for the CURVES Investigators. Am J Cardiol. 1998;81:582-587. Red Book® Update. Montvale, NJ: Medical Economics Data Production Company. August 1998;46,47,51,59,71.

-38%

-28%

-19%

-46%

-35%

-24%

-29%

-17%

-51%

-41%

-34%

-31%

-23%

-60-55-50-45-40-35-30-25-20-15-10-50atorvastatin

simvastatin

pravastatin

lovastatin

fluvastatin

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

20 mg

40 mg

20 mg

40 mg

$54.72

$84.60

$101.88

$62.99

$109.88

$109.88

$60.33

$64.95

$106.77

$69.85

$125.74

$37.70

$37.70

Percent LDL-C reductionMonthly

cost

Atorvastatin Calcium: Great Value at Every Dose

Red Book ® Update. Montvale, NJ: Medical Economics Data Production Company. August 1998;23,46,47,51,59,71.

10 mg20 mg40 mg

10 mg20 mg40 mg80 mg

10 mg20 mg40 mg

20 mg40 mg

20 mg40 mg

0.2 mg0.3 mg

$1.82$2.82$3.40

$2.10$3.66$3.66$3.66

$2.01$2.17$3.56

$2.33$4.19

$1.26$1.26

$1.32$1.32

$54.72$84.60

$101.88

$62.99$109.88$109.88$109.88

$60.33$64.95

$106.77

$69.85$125.74

$37.70$37.70

$39.60$39.60

DoseAWP

cost/dayAWP

cost/month

atorvastatin

simvastatin

pravastatin

lovastatin

fluvastatin

cerivastatin

Atorvastatin Calcium Pharmacokinetics

Absorption— rapidly absorbed— maximum plasma concentrations in 1 to 2 h— absorption increases in proportion to dose

Bioavailability— absolute: ~14%— systemic: ~30%

Distribution— mean Vd ~381 L 98% bound to plasma proteins

Atorvastatin Calcium Pharmacokinetics (cont’d) Metabolism

— metabolized by hepatic cytochrome P450 3A4— ~ 70% of inhibitory activity attributed to active metabolites

Excretion— eliminated primarily in bile — mean plasma elimination half-life ~14 h

Half-life for inhibitory effects is 20 to 30 h (due to contributionof active metabolites)

Well Tolerated in Clinical TrialsIn head-to-head clinical trials, atorvastatin provided discontinuation rates comparable with other statins

Discontinuation due to associated adverse events

2.7% 3.4%

atorvastatin (n=1148) Combined statins (n=383)

Pooled data from three comparative trials of patients taking either atorvastatin (10-20 mg), simvastatin (10-20 mg, n=45), pravastatin (20-40 mg, n=78), or lovastatin (20-40 mg, n=260) for 52 weeks.

Atorvastatin Calcium Safety Profile In clinical trials, the most common adverse events were constipation, flatulence, dyspepsia, and abdominal pain

It is recommended that liver function tests be performed prior to and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically thereafter

LIPITOR is contraindicated in patients with hypersensitivity to any component of this medication; in patients with active liver disease or unexplained persistent elevations of serum transaminases; in women during pregnancy and in nursing mothers

With any statin, tell patients to promptly report muscle pain, tenderness, or weakness. Discontinue drug if myopathy is suspected, if creatine phosphokinase (CPK) levels rise markedly, or if the patient has risk factors for rhabdomyolysis

Atorvastatin Calcium Safety Profile (cont’d) Contraindications

— hypersensitivity to atorvastatin components— active liver disease— unexplained persistent elevations of serum transaminases— pregnancy and lactation

Potential drug interactions— cyclosporine— fibric acid derivatives— niacin— erythromycin— azole antifungals— digoxin— oral contraceptives

Atorvastatin for a Broad Range of Hypercholesterolemic Patients

72% of patients reach NCEP LDL-C goal at the 10-mg starting dose

Greater LDL-C reductions vs other statins at milligram-equivalent doses across the 10- to 40-mg dose range

Reduces LDL-C 39% to 60% across the 10- to 80-mg dose range

Reduces TG 19% to 37% across the 10- to 80-mg dose range

Increases HDL-C 5% to 9%

10-mg starting dose lowers lipid measures (TC, TG, apoB) significantly more than simvastatin, lovastatin, or pravastatin in comparative trials

Indicated to reduce elevated LDL-C and TG in patients with hypercholesterolemia

Data on file. Parke-Davis; Morris Plains, NJ. Nawrocki JW, et al. Arterioscler Thromb Vasc Biol. 1995;15:678-682. Dart A, et al. Am J Cardiol. 1997;80:39-44. Bertolini S, et al. Atherosclerosis. 1997;130:191-197. Davidson M, et al. Am J Cardiol. 1997;79:1475-1481.

A multicenter, double-blind study of all hypercholesterolemic patients taking LIPITOR (10 mg, n=707) for 16 weeks. Baseline lipid level:192 mg/dL. Target NCEP LDL-C goal based on CHD risk status, percentage of patients reaching goal, and total number of patients: <2 CHD risk factors, <160 mg/dL, 95%, n=329; 2 CHD risk factors, <130 mg/dL, 67%, n=268; with CHD, 100 mg/dL, 18%, n=110.

Documents

Advances in Lipid Management. The National Cholesterol Education Program (NCEP) Launched by National Heart, Lung, and Blood Institute (NHLBI), a part