1. Advances in Lipid Management

2. 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.

3. 50% Coronary Heart Disease 1%Congenital Heart Defects 1%Rheumatic Fever/ Rheumatic Heart Disease 4%Congestive Heart Failure 2% Atherosclerosis 4% High Blood Pressure 22% Other Coronary Heart Disease: Despite Advances, Still the #1 Killer Percentage Breakdown of Deaths From Cardiovascular Diseases United States: 1995 Mortality, Final Data 16% Stroke American Heart Association. 1998 Heart and Stroke Facts: Statistical Update.

4. Major Risk Factors for CHD The 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.

5. Risk Stratification for Adults Without CHD Classification Based on LDL-C <130 mg/dL 130-159 mg/dL  160 mg/dL LDL-C Level Desirable Borderline-high risk High risk Classification Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, NHLBI; September 1993.

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

7. 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goal 83%55% High-Risk Adults Not Reaching LDL-C Goals in NHANES-III (National Health and Nutrition Examination Survey) Unpublished data from the Third National Health and Nutrition Examination Survey (NHANES-III), CDC 1994; data from 1988–1991.

8. 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.

9. L-TAP: % of Patients at LDL-C Goal Diet therapy  2RF(n=282)  2RF(n=361) CHD(n=108) Total(n=751) Drug therapy  2RF(n= 861)  2RF(n=1924) CHD(n=1352) Total(n=4137) Risk group— Lipid-lowering therapy % Success 59 22 7 34 70 40 18 39 41 78 93 66 30 60 82 61 % FailureP-Value  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.

10. L-TAP: Identifying the Patient at Risk Patient Profile With  2 Risk Factors  92%Male  45 years Female  55 years  70%Hypertensive (  140/90 mm Hg)  41%Family history of early CHD  22%Low HDL-C level  21%Diabetes mellitus  19%Current smokers 47% 30% CHD Patients 23% No CHD <2 RF No CHD  2 RF Data on file. Parke-Davis; Morris Plains, NJ.

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

12. L-TAP: Distance From LDL-C Goal in Patients With  2 Risk Factors Data on file. Parke-Davis; Morris Plains, NJ. n=849 63% LDL-C (mg/dL) No. of patients Not at goal At goal n=816 n=494 n=126 <130130-160>200161-200

13. L-TAP: Distance From LDL-C Goal in Patients With CHD Data on file. Parke-Davis; Morris Plains, NJ. 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

14. 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-year CHD death rate (Deaths/1000) Serum cholesterol (mg/dL) 1% reduction in total cholesterol resulted in a 2% decrease in CHD risk CHD indications per 1000 Each 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)  204 205-234235-264265-294  295 150 200 250 300 0 50 40 30 20 10

15. 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. Cumulative incidence of AMI per 100,000 screened subjects in 2 years Cumulative incidence of acute myocardial infarction (AMI) increased with the level of serum cholesterol Serum cholesterol (mg/dL) Range  167168-191192-217  218 Mean149.3179.8203.7245.3 Okinawa, Japan  CHD mortality rates (%) Using linear approximation, a 20-mg/dL increase in total cholesterol corresponded to a 17% increase in mortality risk Serum cholesterol (mg/dL) Seven Countries Study † 125175225275325 Northern Europe Southern Europe, Mediterranean United States Serbia Southern Europe, Inland Japan

16. Atorvastatin Calcium (LIPITOR ® ): Mechanism of Action Reduced cholesterol synthesis HMG-CoA reductase inhibition Increased removal and catabolism of LDLConversion of VLDL to LDL Upregulation of LDL receptorsDecreased VLDL production Decreased TC, LDL-C, and TG

17. 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

18. Atorvastatin Calcium (LIPITOR ® ) Dose-Response Relationship Mean % LDL-C reduction from baseline      P <0.05 vs placebo. Nawrocki JW, et al. Arterioscler Thromb Vasc Biol. 1995;15:678-682. 10 mg20 mg80 mg40 mg

19. In Head-to-Head Trials, Atorvastatin Calcium Showed Superior LDL-C Reductions at Starting Doses Mean % LDL-C change from baseline P  0.05 atorvastatin (n=132) simvastatin (n=45) P  0.05 atorvastatin (n=222) pravastatin (n=77) 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 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.

20. In Head-to-Head Trials, Atorvastatin Calcium Showed Superior TG Reductions at Starting Doses Mean % triglyceride change from baseline atorvastatin (n=132) simvastatin (n=45) atorvastatin (n=222) pravastatin (n=77) atorvastatin (n=707) lovastatin (n=191) Dart et al.Bertolini et al.Davidson et al. P  0.05 20 mg10 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.

21. 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.

22. Treatment armMean baselineNo. of (mg) LDL-C (mg/dL)patients atorvastatin 10213n=73 20213n=51 40206n=61 80213n=10 simvastatin 10207n=70 20230n=49 40219n=61 pravastatin 10225n=14 20237n=41 40215n=25 lovastatin 20244n=16 40218n=16 80219n=11 fluvastatin 20236n=12 40192n=12 CURVES Trial: Mean Baseline LDL-C Levels Jones P, Kafonek S, Laurora I, Hunninghake D, for the CURVES Investigators. Am J Cardiol. 1998;81:582-587. Treatment arm sizes were powered to show statistical significance vs mg-equivalent dose of the other agents.

23. 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/m 2 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/m 2  Evenly distributed across treatment groups. Jones P, Kafonek S, Laurora I, Hunninghake D, for the CURVES Investigators. Am J Cardiol. 1998;81:582-587.

24. 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 % change in LDL-C -50 -40 -30 -20 -10 Dose range (mg) -60 20408010 fluvastatin lovastatin (40 mg bid) atorvastatin (80 mg qd)   † † †     ‡ ‡ ‡ simvastatin pravastatin Jones P, Kafonek S, Laurora I, Hunninghake D, for the CURVES Investigators. Am J Cardiol. 1998;81:582-587. 

25. CURVES Trial: Superior LDL-C Reductions at Usual Starting Doses  pravastatinfluvastatinsimvastatinlovastatinatorvastatin -38% -28% † -24% † -29% † -17% † atorvastatin 10 mg efficacy (38%) 0 -10 -20 -30 -40 20 mg 10 mg Mean % LDL-C reduction Jones P, Kafonek S, Laurora I, Hunninghake D, for the CURVES Investigators. Am J Cardiol. 1998;81:582-587.  Most commonly prescribed doses for each product. Source: IMS National Prescription Audit; February 1998. † Significantly less than atorvastatin 10 mg (P <0.01). The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in this chart is not known.

26. CURVES Trial: Superior LDL-C Reductions at Usual First Titrations  atorvastatin 10 mg efficacy (38%) pravastatinfluvastatinsimvastatinlovastatinatorvastatin -46% -35% † -34% † -31% † -23% † 0 -10 -20 -30 -40 -50 20 mg 40 mg Mean % LDL-C reduction Jones P, Kafonek S, Laurora I, Hunninghake D, for the CURVES Investigators. Am J Cardiol. 1998;81:582-587.  Most commonly prescribed doses for each product. Source: IMS National Prescription Audit; February 1998. † Significantly less than atorvastatin 20 mg (P<0.01). The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in this chart is not known.

27. 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. The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in this chart is not known. 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 mg 80 mg 10 mg 20 mg 40 mg 10 mg 20 mg 40 mg 20 mg 40 20 mg 40 mg mg Jones P, Kafonek S, Laurora I, Hunninghake D, for the CURVES Investigators. Am J Cardiol. 1998;81:582-587.

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

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

30. Treat-to-Target Trial: Patient Entry Criteria and 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 Data on file. Parke-Davis; Morris Plains, NJ.

31. Treat-to-Target Trial: Dosing Schedule StatinDosing scheduleWith colestipol atorvastatin10 mg20 mg40 mg80 mg5 g bid fluvastatin20 mg40 mg5 g bid10 g bid lovastatin20 mg40 mg80 mg5 g bid10 g bid simvastatin10 mg20 mg40 mg5 g bid10 g bid Data on file. Parke-Davis; Morris Plains, NJ.

32. 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 weeks atorvastatin 10 mg (n=85) 12 weeks fluvastatin 20 mg (n=82) 12 weeks lovastatin 20 mg (n=83) 12 weeks simvastatin 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) Data on file. Parke-Davis; Morris Plains, NJ.

33. Treat-to-Target Trial: 12-Week Results fluvastatin (n=82) simvastatin (n=87) lovastatin (n=83) atorvastatin (n=85) 20 mg 10 mg % Patients reaching NCEP LDL-C goal by week 12  Significantly less than atorvastatin 10 mg (P<0.001). The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in this chart is not known. 71% 16%  34%  41%  Data on file. Parke-Davis; Morris Plains, NJ.

34. Treat-to-Target Trial: 24-Week Results atorvastatin 10 mg efficacy at week 12 % Patients reaching NCEP LDL-C goal by week 24 fluvastatin 20-40 mg (n=82) simvastatin 10-20 mg (n=87) lovastatin 20-40 mg (n=83) atorvastatin 10-20 mg (n=85) 84% 28%  46%  53%  Data on file. Parke-Davis; Morris Plains, NJ.  Significantly less than atorvastatin (P<0.001). The impact on clinical outcomes of the differences in lipid-altering effects between treatments shown in this chart is not known.

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

36. Effective for a Broad Range of Patient Populations Elderly (>70 years) (n=183) Mean % change from baseline Women (n=689) Hypertensives (n=510) CHD (n=196) NIDDM (n=156) Mixed dyslipidemics (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. Data on file. Parke-Davis; Morris Plains, NJ. LDL-CTGLDL-CTGLDL-CTGLDL-CTGLDL-CTGLDL-CTG

37. Atorvastatin Calcium in Hard-to-Treat Patient Populations Atorvastatin 80 mg in severe hypercholesterolemia (baseline total cholesterol 368 mg/dL; LDL-C 289 mg/dL) Mean % change from baseline Total-CLDL-CTGApoB HDL-C Data on file. Parke-Davis; Morris Plains, NJ.

38. Hypercholesterolemia CHD events Medications Dietary counseling Adverse events Titration Monitoring Hospitalization Surgeries Physician visits Economic Considerations in the Management of Hypercholesterolemia

39. Cost Considerations in LDL-C Reduction CURVES 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% -60-55-50-45-40-35-30-25-20-15-10-50 atorvastatin 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 $60.33 $64.95 $106.77 $69.85 $125.74 $37.70 Percent LDL-C reductionMonthly cost 

40. 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 mg 20 mg 40 mg 10 mg 20 mg 40 mg 80 mg 10 mg 20 mg 40 mg 20 mg 40 mg 20 mg 40 mg 0.2 mg 0.3 mg $1.82 $2.82 $3.40 $2.10 $3.66 $2.01 $2.17 $3.56 $2.33 $4.19 $1.26 $1.32 $54.72 $84.60 $101.88 $62.99 $109.88 $60.33 $64.95 $106.77 $69.85 $125.74 $37.70 $39.60 Dose AWP cost/day AWP cost/month atorvastatin simvastatin pravastatin lovastatin fluvastatin cerivastatin

41. 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

42. 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 contribution of active metabolites)

43. Well Tolerated in Clinical Trials In 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.

44. 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

45. 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

46. 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.