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LESCOL ® XL (fluvastatin sodium)

LESCOL ® XL (fluvastatin sodium). Cholesterol Management and Adherence to Therapy. LES-900551. Please see accompanying Full Prescribing Information. Millions of Adults May Need LDL-C Lowering Treatment. U.S. Population, aged 20 and older, millions. LDL-C ≥ 130 mg/dL.

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LESCOL ® XL (fluvastatin sodium)

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  1. LESCOL® XL (fluvastatin sodium) Cholesterol Management and Adherence to Therapy LES-900551 Please see accompanying Full Prescribing Information

  2. Millions of Adults May NeedLDL-C Lowering Treatment U.S. Population, aged 20and older, millions LDL-C ≥130 mg/dL ~79 million (~32% of the U.S. population aged 20+) have LDL-C levels ≥130 mg/dL Rosamond W et al. Heart Disease and Stroke Statistics — 2007 Update. Circulation. 2007;115:1-102. Please see accompanying Full Prescribing Information

  3. NCEP ATP III Guidelines (Revised 2004) *CHD includes history of myocardial infarction, unstable angina, stable angina, coronary artery procedures (angioplasty or bypass surgery), or evidence of clinically significant myocardial ischemia. †CHD risk equivalents include clinical manifestations of non-coronary forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and carotid artery disease [transient ischemic attacks or stroke of carotid origin or >50% obstruction of a carotid artery]), diabetes, and 2+ risk factors with 10-year risk for hard CHD >20%. ‡Risk factors include cigarette smoking, hypertension (BP ≥140/90 mm Hg or on antihypertensive medication), low HDL cholesterol (<40 mg/dL), family history of premature CHD (CHD in male first-degree relative <55 years of age; CHD in female first-degree relative <65 years of age), and age (men ≥45 years; women ≥55 years). Grundy SM et al. Circulation. 2004;110:227-239. Please see accompanying Full Prescribing Information

  4. Millions of Adults AreNot at LDL-C Goal Adults With LDL-C Levels Above ATP III Goal Number (Millions) ATP III Risk Categories Persell SD et al. J Gen Intern Med. 2006;21:171-176. Please see accompanying Full Prescribing Information

  5. Millions of Adults NeedLDL-C Lowering Treatment Adults With LDL-C Levels Above ATP III Threshold for Medication* Number (Millions) ATP III Risk Categories * Includes those with LDL-C above optional thresholds: lower-risk with LDL-C 160-189 mg/dL and moderately high-risk with LDL-C 100-129 mg/dL. Persell SD et al. J Gen Intern Med. 2006;21:171-176. Please see accompanying Full Prescribing Information Please see accompanying Full Prescribing Information

  6. Dramatic LDL-C Reductions Are Typically Not Required1,2* • * Individual patient responses can vary considerably and cannot be predicted. • Grundy SM et al. Circulation. 2004;110:227-239. • Adapted from Grundy SM et al. National Institutes of Health. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication No. 02-5215. Bethesda, MD: National Institutes of Health; 2002. Please see accompanying Full Prescribing Information

  7. Strategies for Reducing LDL-C and CHD Risk Therapeutic lifestyle changes (TLC)1 Reduced intakes of saturated fats and cholesterol Therapeutic dietary options to enhance LDL lowering (plant stanols/sterols and increased viscous fiber) Weight control Exercise Drug therapy1,2 HMG-CoA reductase inhibitors (statins) Bile acid sequestrants Nicotinic acid Fibric acids Selective cholesterol-absorption inhibitors (azetidinones) • Adapted from Grundy SM et al. National Institutes of Health. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication No. 02-5215. Bethesda, MD: National Institutes of Health; 2002. • Clader JW. Curr Top Med Chem. 2005;5(3):243-256. Please see accompanying Full Prescribing Information

  8. How Big an Issue Is Compliance? Only about 33% of treated persons are achieving their LDL goal;<20% of CHD patients are at their LDL goal About 50% who are prescribed a lipid-lowering drug are still taking it6 months later; after 1 year this falls to 30%–40% <50% who qualify for any kind of lipid-modifying treatment for CHD risk reduction are receiving it <50% of even the highest-risk persons, those who have symptomatic CHD, are receiving lipid-lowering treatment Adapted from Grundy SM et al. National Institutes of Health. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication No. 02-5215. Bethesda, MD: National Institutes of Health; 2002. Please see accompanying Full Prescribing Information

  9. Among Patients: Most people do not successfully self-administer medical treatments as prescribed without some intervention designed to enhance adherence1 Some people forget to take their doses Others do not believe that they are sick enough to require drug treatment Still others fear side effects from their treatment, e.g., muscle aches orjoint pains Among Health Providers: Few mechanisms exist to support health professionals in addressing adherence among patients1 Clinical inertia—failure to initiate or intensify therapy when indicated, due to:2 overestimation of care provided; use of “soft” reasons to avoid intensification of therapy; and lack of education, training, and practice organization aimed at achieving therapeutic goals Some Reasons for Noncompliance • Adapted from Grundy SM et al. National Institutes of Health. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication No. 02-5215. Bethesda, MD: National Institutes of Health; 2002. • Phillips LS et al. Ann Intern Med. 2001;135(9):825-834. Please see accompanying Full Prescribing Information

  10. Some Suggested Ways ProvidersCan Make a Difference Provide simple medication regimens1 Provide explicit patient instruction and use good counseling techniques to teach the patient how to follow the prescribed treatment1 Encourage the use of prompts to help patients remember treatment regimens1 Encourage the support of family and friends1 Increase patient visits for persons unable to achieve treatment goal1 Revise education programs to emphasize:2 the benefits of treating to therapeutic targets the practical complexity of treating to target for different disorders the need to structure routine practice to facilitate effective management of disorders for which resolution of patient symptoms is not sufficient to guide care Create and employ a system of reminders and performance feedback measures to ensure necessary care2 • Grundy SM et al. National Institutes of Health. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication No. 02-5215. Bethesda, MD: National Institutes of Health; 2002. • Phillips LS et al. Ann Intern Med. 2001;135(9):825-834. Please see accompanying Full Prescribing Information

  11. Why is LESCOL® XL a Good Option? Please see accompanying Full Prescribing Information

  12. LESCOL® XL Tough on Cholesterol, Proven Tolerability and a Patient Support Program You Can Count On Please see accompanying Full Prescribing Information

  13. LESCOL® XL (fluvastatin sodium) Indications – Adults • Therapy with lipid-lowering agents should be used in addition to a diet restricted in saturated fats and cholesterol. The effect of LESCOL® XL on cardiovascular mortality has not been determined • Hypercholesterolemia (heterozygous familial and nonfamilial) • and mixed dyslipidemia • LESCOL® and LESCOL® XL are indicated to reduce elevated Total-C, LDL-C, TGs and Apo B levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia • Fredrickson Type IIa (elevated LDL only) • Fredrickson Type IIb (elevated LDL, VLDL, and TGs) • Whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate • In patients with coronary heart disease, LESCOL® and LESCOL® XL are indicated to reduce the risk of undergoing coronary revascularization procedures and to slow the progression of coronary atherosclerosis as part of a treatment strategy to lower total and LDL cholesterol to target levels Please see accompanying Full Prescribing Information 13

  14. LESCOL®(fluvastatin sodium) andLESCOL® XL (fluvastatin sodium) LESCOL® 40 mg (n=492) LESCOL ® XL 80 mg(n=835) 0 -5 -10 -15 % Change from Baseline -20 -25 -26% -30 -27% -35 -36% -40 -38% Substantial LDL-C Reductions* Mean Median *Pooled data presented differ from approved product labeling due to different statistical analysis. The effect of LESCOL ® or LESCOL®XL induced changes in lipoprotein levels, including reduction of serum cholesterol, on cardiovascular mortality has not been determined Most common side effects associated with LESCOL ® XL include influenza-like symptoms, headache, and muscle pain. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise of fever. Ballantyne CM et al. Clin Ther. 2001;23:177-192. Please see accompanying Full Prescribing Information

  15. Percent Reduction to Achieve Target LDL-C Goals1,2 Where LESCOL® XL may be effective*… “…in high-risk or moderately high-risk persons, it is advised that intensity of therapy be sufficient to achieve at least a 30-40% reduction in LDL-C levels.”1 • *Individual patient responses can vary considerably and cannot be predicted. • Grundy SM et al. Circulation. 2004;110:227-239. • Adapted from Grundy SM et al. National Institutes of Health. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication No. 02-5215. Bethesda, MD: National Institutes of Health; 2002. Please see accompanying Full Prescribing Information

  16. ATP III Classification of HDL-C While some clinical trials provide suggestive evidence that raising HDL-cholesterol levels may reduce risk for CHD, the independent effect of raising HDL on the risk of coronary and cardiovascular morbidity and mortality has not been determined Adapted from Grundy SM et al. National Institutes of Health. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication No. 02-5215. Bethesda, MD: National Institutes of Health; 2002. Please see accompanying Full Prescribing Information

  17. LESCOL® XL (fluvastatin sodium)Significant HDL-C Increases, Especially in Patients With High Triglycerides* P<.05 25 LESCOL® 40 mg 21% LESCOL ® XL 80 mg 20 P<.05 15 12% % Change from Baseline p = ns 10% 10 7% 7% 6% 5 n=331 n=511 n=98 n=203 n=21 n=36 0 <200 200-299 ≥300 Baseline Triglycerides (mg/dL) The independent effect of raising HDL or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined. *Pooled data presented differ from approved product labeling due to different statistical analysis. Ballantyne CM et al. Clin Ther. 2001;23:177-192. Please see accompanying Full Prescribing Information

  18. LESCOL® XL (fluvastatin sodium) Substantial TG Reductions Especially in Patients with High TGs Baseline Triglycerides (mg/dL) <200 200-299 ≥300 0 -5 n=331 n=511 n=98 n=203 n=21 n=36 -10 -10% -15 % Change in TG at 24 weeksFrom Baseline -17% -17% -20 -25 -24% -24% -30 LESCOL® 40 mg -31% -35 LESCOL ® XL 80 mg The independent effect of lowering triglycerides on the risk of coronary and CV morbidity and mortality has not been determined *Pooled data presented differ from approved product labeling due to different statistical analysis. Ballantyne CM et al. Clin Ther. 2001;23:177-192. Please see accompanying Full Prescribing Information 18

  19. LESCOL® XL (fluvastatin sodium)Indications – Adults • Secondary Prevention of Coronary Events • To reduce the risk of undergoing coronary revascularization procedures in patients with CHD • Atherosclerosis • To slow the progression of coronary atherosclerosis in patients with CHD as part of a treatment strategy to lower total and LDL cholesterol to target levels Please see accompanying Full Prescribing Information 19

  20. LESCOL® XL–Indicated to Slow the Progression of Coronary Atherosclerosis in Coronary Heart Disease Atherosclerosis Progression -74%* (P=0.016) vs placebo -41%†New Lesion Formation From baseline LESCOL®in minimum lumen diameter (MLD) vs placebo was -.0.094 mm and -0.024 mm respectively and reduction was calculated as follows: 0.094-0.024/0.094 is equal to 74% reduction P=0.005 Results from the Lipoprotein and Coronary Atherosclerosis Study (LCAS) In this double-blind trial, 429 patients with coronary artery disease were randomized to fluvastatin 20 mg BID or placebo for 2.5 years. Atherosclerotic lesion progression was assessed by measuring change in minimum lumen diameter (MDL). *LESCOL® (fluvastatin sodium) 40 mg vs placebo measured as change in MLD mm. †Among all patients, new lesions defined as lesions with reference diameter minus MLD showed a statistically significant reduction of 41% (P=0.003). LESCOL® and LESCOL® XL are indicated to reduce elevated total cholesterol (Total-C), LDL-C, TGs, and Apo B levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate. In patients with coronary artery disease, LESCOL® and LESCOL® XL are indicated to reduce risk of undergoing coronary revascularization procedures and to slow the progression of coronary atherosclerosis as part of a treatment strategy to lower Total-C and LDL-C to target levels. Therapy with lipid-altering agents should be used in addition to a diet restricted in saturated fats and cholesterol. Most common side effect associated with LESCOL ® and LESCOL ® XL include influenza-like symptoms, headache, and muscle pain and dyspepsia. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever. The effect of LESCOL ® and LESCOL ® XL on cardiovascular mortality has not been determined. 1. LESCOL ® XL full Prescribing Information. 2. Herd JA et al. Am J Cardiol. 1997;80:278-286 Please see accompanying Full Prescribing Information

  21. LESCOL® XL in Coronary Heart Disease1,2 Late Revascularizations* MACE† -22%vs placebo (P=0.013) -32%vs placebo (P=0.002) Risk Reduction Results from the Lescol Intervention Prevention Study (LIPS) In this double-blind trial, 1677 patients who had undergone their first percutaneous intervention (eg, coronary angioplasty with or without stent insertion) were randomized to with coronary artery disease were randomized to fluvastatin 40 mg BID or placebo for 3.9 years. *Coronary Artery Bypass Graft (CABG) or Percutaneous Coronary Interventions (PCI) occurring at the original site >6 months after the initial procedure, or at another site.1 †MACE (major adverse cardiac events) = cardiac death, nonfatal MI, revascularization (CABG, repeat PCI, or PCI for a new lesion).1 LESCOL® and LESCOL® XL are indicated to reduce elevated total cholesterol (Total-C), LDL-C, TGs, and Apo B levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate. In patients with coronary artery disease, LESCOL® and LESCOL® XL are indicated to reduce risk of undergoing coronary revascularization procedures and to slow the progression of coronary atherosclerosis as part of a treatment strategy to lower Total-C and LDL-C to target levels. Therapy with lipid-altering agents should be used in addition to a diet restricted in saturated fats and cholesterol. Most common side effect associated with LESCOL ® and LESCOL ® XL include influenza-like symptoms, headache, and muscle pain and dyspepsia. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever. The effect of LESCOL ® and LESCOL ® XL on cardiovascular mortality has not been determined. 1. LESCOL® XL full Prescribing Information. 2. Serruys PWJC et al. JAMA. 2002;287:3215-3222. Please see accompanying Full Prescribing Information

  22. LESCOL® in CHDLIPS: Important Subpopulations1 MACE Risk ReductionLESCOL® vs Placebo: 0.25 0.50 0.75 1.00 1.25 Favors fluvastatin Favors placebo The effect of LESCOL® or LESCOL® XL induced changes in lipoprotein levels, including reduction of serum cholesterol, on cardiovascular mortality has not been determined.2 *Based on Cox proportional hazards model. 1. Serruys PWJC et al. JAMA. 2002;287:3215-3222. 2. LESCOL® XL full Prescribing Information. Please see accompanying Full Prescribing Information 22

  23. LESCOL® XL (fluvastatin sodium) Indications and Usage • Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol • Therapy with lipid-altering agents should be considered only after secondary causes for hyperlipidemia such as poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other medication, or alcoholism, have been excluded • Prior to therapy initiation of fluvastatin sodium, a lipid profile should be performed to measure • Total-C • HDL-C • Triglycerides • LDL-C (either calculated or directly measured) • Lipid determinations should be performed at intervals of no less than 4 weeks and dosage adjusted according to the patient’s response to therapy • The NCEP Treatment Guidelines should be used to guide therapy Please see accompanying Full Prescribing Information 23

  24. LESCOL® XL Tough on Cholesterol, Proven Tolerability and a Patient Support Program You Can Count On Please see accompanying Full Prescribing Information

  25. LESCOL® XL Has a Patented Extended-Release Formulation1,2 Lower Systemic Exposure vs LESCOL® and May Be Dosed at Any Time of Day 80 mg fluvastatin immediate release 1,000 800 80 mg dose of LESCOL® XL does not mean high levels of statin in the blood Mean PlasmaFluvastatin Concentration (ng/mL) 600 400 200 80 mg fluvastatin XL 0 0 12 24 Hours Only LESCOL®XLis indicated to be dosed 80 mg once daily • Sabia H et al. J Cardiovasc Pharmacol. 2001;37(5):502-511. • Data on File. XUO320B Study W 251.Novartis Pharmaceuticals Corporation Please see accompanying Full Prescribing Information

  26. LESCOL® XL is predominantly metabolized by the cytochrome P450 2C9 pathway1 ~75% by 2C9 ~20% by 3A4 ~5% by 2C8 Approximately 60% of prescription drugs are metabolized by the cytochrome P450 3A4 pathway2 Changes in pharmacokinetic measures have been demonstrated when fluvastatin has been administered with cytochrome P450 3A4 inhibitors/substrates, however, clinical significance of these effects has not been shown*1 Low Potential for Clinically Significant CYP450 3A4 Drug-Drug Interactions • *Data from studies using immediate-release fluvastatin. Similar studies have not been conducted with LESCOL ®XL. • LESCOL® XL full Prescribing information. • Zhou S et al. Clin Pharmacokinet. 2005;44:279-304. Please see accompanying Full Prescribing Information

  27. 7.0% 6.0% 5.0% 4.5% 5.0% 3.8% 4.0% 3.0% 2.0% 1.0% 0.0 Placebo1 (N=960) LESCOL® 40mg1 (N=2326) LESCOL® XL 80mg2 (N=912) Proven Low Rates of Myalgia Percentage of Patients Reporting Myalgia With LESCOL® (fluvastatin sodium) and LESCOL®XL In LESCOL® clinical trials, uncomplicated myalgia has been observed infrequently in patients treated with LESCOL® at rates comparable to placebo • Controlled trials with LESCOL® capsules (20 and 40 mg daily and 40 mg twice daily). • Controlled trials with LESCOL® XL 80 mg tablets. Please see accompanying Full Prescribing Information

  28. LESCOL® XL (fluvastatin sodium)Important Information • LESCOL® XL is indicated to reduce elevated total cholesterol (Total-C), LDL-C, TGs, and Apo B levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate. In patients with coronary artery disease, LESCOL® XL is indicated to reduce risk of undergoing coronary revascularization procedures and to slow the progression of coronary atherosclerosis as part of a treatment strategy to lower Total-C and LDL-C to target levels. Therapy with lipid-altering agents should be used in addition to a diet restricted in saturated fats and cholesterol. • LESCOL® XL is indicated as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia whose response to dietary restriction has not been adequate and in whom the following findings are present: LDL-C remains ≥190 mg/dL or LDL-C remains ≥160 mg/dL, and there is either a positive family history of premature cardiovascular disease or two or more other cardiovascular disease risk factors are present. • In pediatric population, most adverse events (AEs) were mild or moderate. The most frequently reported AEs (≥5%) were: influenza (40%), headache (31%), nasopharyngitis (29%), rhinitis (19%), nausea (14%), abdominal pain (13%), upper respiratory tract infection (11%), and vomiting (11%). • The long term efficacy of LESCOL® XL therapy in childhood to reduce morbidity and mortality in adulthood has not been established Please see accompanying Full Prescribing Information 28

  29. LESCOL® XL (fluvastatin sodium) Important Information (cont.) • LESCOL® XL is contraindicated in patients with active liver disease or persistent transaminase elevations, in pregnant or nursing patients, and in patients with hypersensitivity to this drug. LESCOL®XL is also contraindicated in pregnant or nursing women. Fluvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. Please see accompanying Full Prescribing Information 29

  30. LESCOL® XL (fluvastatin sodium)Important Information (cont.) • Rhabdomyolysis and renal dysfunction secondary to myoglobinuria have been reported with fluvastatin and with other drugs in this class. Discontinue drug if myopathy or rhabdomyolysis is diagnosed or suspected. The risk of these events during treatment with HMG-CoA reductase inhibitors has been reported to increase if therapy with cyclosporine, gemfibrozil, erythromycin, or niacin is administered concurrently. • Myopothy should be considered in any patients with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Fluvastatin sodium therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Fluvastatin sodium therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development or renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Please see accompanying Full Prescribing Information 30

  31. LESCOL® XL (fluvastatin sodium)Important Information (cont.) • It is recommended that liver function tests be performed before initiation of therapy and at 12 weeks following initiation of treatment or elevation in dose. • If serum transaminase levels rise, monitor more often; if they occur at >3 times the upper limit of normal on 2 consecutive occasions, discontinue LESCOL® XL. • Most common side effects associated with LESCOL® XL include influenza-like symptoms, headache, and muscle pain. Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. • The effect of LESCOL® XL on cardiovascular mortality has not been determined. Please see accompanying Full Prescribing Information 31

  32. LESCOL® XL (fluvastatin sodium)in the Elderly Plasma levels of fluvastatin are not affected by age For the general patient population plasma concentrations of fluvastatin sodium do not vary as a function of age Elderly patients (65 years of age) demonstrated a greater treatment response in respect to LDL-C, Total-C, and LDL/HDL ratio than patients <65 years of age Please see accompanying Full Prescribing Information

  33. LESCOL® XL (fluvastatin sodium)Indications – Pediatrics • Heterozygous Familial Hypercholesterolemia in Pediatric Patients • As an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least 1 year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia whose response to dietary restriction has not been adequate and the following findings are present: • LDL-C remains ≥190 mg/dL, or • LDL-C remains ≥160 mg/dL, and: • There is a positive family history of premature CVD, or • Two or more other CVD risk factors are present Please see accompanying Full Prescribing Information 33

  34. LESCOL® XL (fluvastatin sodium)in Children and Adolescents Safety and efficacy of LESCOL® and LESCOL® XL in children and adolescent patients 9-16 years of age with heterozygous familial hypercholesterolemia have been evaluated in open-label uncontrolled clinical trials of 2 years’ duration The most common adverse events observed were influenza and infections…[with]…no detectable effect on growth or sexual maturation in the adolescent boys or on menstrual cycle length in girls The long-term efficacy of LESCOL® or LESCOL ® XL therapy in childhood to reduce morbidity and mortality in adulthood has not been established Please see accompanying Full Prescribing Information

  35. LESCOL® XL Tough on Cholesterol, Proven Tolerability and a Patient Support Program You Can Count On Please see accompanying Full Prescribing Information

  36. LESCOL® XL (fluvastatin sodium) —Simple Support No titration necessary Easy for patients to remember Can be taken any time of day without regard to meals Motivate and educate patients through XL Everyday A new provider reinforcement program to educate patients on issues relevant to their care Please see accompanying Full Prescribing Information

  37. LESCOL® XL (fluvastatin sodium) – Helping Patients XL Everyday Online resources designed to help patients remember to take their LESCOL ® XL Therapy Simple solutions to achieve diet and exercise goals Reinforcement of your messages to your patients Please see accompanying Full Prescribing Information

  38. LESCOL® XL (fluvastatin sodium) SummaryTough on Cholesterol, Proven Tolerability • Positive impact across the lipid profile: • LDL-C: ↓38% • TGs: Up to ↓ 31% (in patients with TGs ≥300 mg/dL) • HDL-C: ↑ up to 21% (in patients with TGs ≥300 mg/dL) • Low potential for clinically significant CYP450 3A4 drug-drug interactions • Patented formulation limits systemic availability • Low rates of muscle and joint pain • Proven tolerability in children, adolescents, adults and elderly • LESCOL®XL provides a simple solution for many of your patients needing cholesterol control • LESCOL® XL provides a unique vehicle to help keep patients informed and motivated to XL Everyday and follow your treatment recommendations The independent effect of raising HDL or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined. Please see accompanying Full Prescribing Information

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