CREDIT:

2.0

Continuing Education
AN ONGOING CPE PROGRAM OF THE UNIVERSITY OF CONNECTICUT SCHOOL OF PHARMACY AND DRUG TOPICS

EARN CPE CREDIT FOR THIS ACTIVITY AT WWW.DRUGTOPICS.COM

EDUCATIONAL OBJECTIVES
Goal: To assist pharmacists and pharmacy technicians in monitoring and counseling adult patients with cardiometabolic disease and its component risk factors. After participating in this activity, pharmacists will be able to: Dene metabolic syndrome and describe its incidence, epidemiology, and patient risk factor assessment. Summarize the treatment guidelines for hypercholesterolemia and hypertension. Describe the role of the pharmacist in collaborative practice agreements for patients with metabolic syndrome. Describe the self-care issues of patients with chronic cardiometabolic diseases, evaluate patient cases, and provide appropriate self-care recommendations. Given a case, provide a patient-specic treatment plan based on current clinical practice guidelines, including techniques for maximizing patient adhereence.

After participating in this activity, pharmacy technicians will be able to: Dene metabolic syndrome and describe its incidence, epidemiology, and patient risk factor assessment. Summarize the treatment guidelines for hypercholesterolemia and hypertension. Recognize the role of the pharmacist in collaborative practice agreements for patients with metabolic syndrome. Identify the self-care issues and appropriate recommendations for patients with chronic cardiometabolic diseases.
The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Pharmacists are eligible to participate in both the knowledge-based and application-based activities, and will receive up to 0.2 CEUs (2 contact hours) for completing the activity/activities, passing the quiz/ quizzes with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the online system. Pharmacy technicians are eligible to participate in the knowledge-based activity and will receive 0.1 CEU (1 contact hour) for completing the activity, passing the quiz with a grade of 70% or better, and completing the online evaluation. Statements of credit are available via the online system. ACPE # 0009-9999-12-001-H01-P (Part 1) ACPE # 0009-9999-12-001-H01-T (Part 1)
Grant Funding: Funding for this activity was provided by: Cephalon; Endo Pharmaceuticals, Inc.; Purdue Pharma L.P. Activity Fee: There is no fee for these activities.
Initial release date: 01/10/2012 Expiration date: 01/10/2014

Cardiometabolic disease: (part1)

The pharmacists tools for managing dyslipidemia and hypertension
Marissa C. Salvo, PharmD
ASSISTANT CLINICAL PROFESSOR, UNIVERSITY OF CONNECTICUT SCHOOL OF PHARMACY STORRS, CT ,

Stefanie C. Nigro, PharmD, BCACP, C-TTS, CNWC

ASSISTANT CLINICAL PROFESSOR, UNIVERSITY OF CONNECTICUT SCHOOL OF PHARMACY STORRS, CT ,

ardiometabolic disease, also known as syndrome X or metabolic syndrome, is a chronic medical condition that includes risk factors that together can progress to cardiovascular disease (CVD). Metabolic syndrome affects 47 million persons in the United States.1 As accessible and trusted healthcare professionals, pharmacists are ideally positioned to provide care for patients with cardiometabolic disease. A review of

metabolic syndrome and its management assists pharmacists in delivering care, monitoring outcomes, and providing individualized patient education. The components of metabolic syndrome are made up of a combination of underlying, major, and emerging risk factors.2-4 Underlying risk factors include obesity (particularly abdominal obesity), physical inactivity, and an atherogenic diet. The major risk factors are cigarette smoking,

To obtain immediate CPE credit, take the test online at www.drugtopics.com/cpe. Just click on the link you find under Free CPE Activities, which will take you to the CPE site. For first-time users, please complete the registration page. For those already registered, log in, find, and click on this lesson. Test results will be displayed immediately. Complete the evaluation form and you will receive a printable statement of credit by e-mail, showing your earned CPE credit. For questions concerning the online CPE activities, e-mail: cpehelp@advanstar.com.
IMAGE: GETTY IMAGES / FUSE

Dr. Salvo is assistant clinical professor, University of Connecticut, School of Pharmacy, Storrs, CT, and clinical pharmacist, Community Health Center, Inc., Meriden, CT. Dr. Nigro is assistant clinical professor, University of Connecticut School of Pharmacy, Storrs, CT, and clinical pharmacist, Community Health Center of New Britain, New Britain, CT. Editorial assistance was provided by Deborah Kaplan. Ms. Kaplans revisions were reviewed and approved by Drs. Salvo and Nigro. Faculty Disclosure: Drs. Salvo and Nigro have no actual or potential con ict of interest associated with this article. Disclosure of Discussions of Off-Label and Investigational Uses of Drugs: This activity may contain discussion of unlabeled/unapproved use of drugs. The content and views presented in this educational program are those of the faculty and do not necessarily represent those of Drug Topics or University of Connecticut School of Pharmacy. Please refer to the of cial prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Faculty: Marissa C. Salvo, PharmD, and Stefanie C. Nigro, PharmD, BCACP, C-TTS, CNWC

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hypertension, elevated low-density lipoprotein (LDL) cholesterol, low high-density lipoprotein (HDL) cholesterol, family history of premature coronary heart disease (CHD), and increasing age. Emerging risk factors include elevated triglycerides, small LDL particles, insulin resistance, glucose intolerance, and proin ammatory and prothrombotic states.3 Approximately 22% of adults in the United States have metabolic syndrome.2 With age, the prevalence increases.5 The prevalence also rises with increasing body mass index (BMI) in both sexes.5 It is speculated that metabolic syndrome will soon overtake cigarette smoking as the primary risk factor for CVD.6 The association between metabolic syndrome and race and ethnicity varies by sex. Non-Hispanic black and Mexican-American women are about 1.5 times more likely to meet the criteria for metabolic syndrome than non-Hispanic white women.5 Metabolic syndrome poses a signi cant burden on healthcare costs. A 2009 U.S. study evaluated healthcare use among 170,000 men and women, of whom 58% had risk factors such as obesity, high blood pressure, and elevated lipid levels. The study revealed that metabolic syndrome can increase a persons healthcare costs nearly 1.6-fold, or about $2,000 per year compared with individuals who do not have metabolic syndrome. For each additional risk factor those costs increase an average of 24%.7 The National Cholesterol Education

Program-Adult Treatment Panel III (NCEPATP III) defines metabolic syndrome as the presence of 3 out of 6 components, including abdominal obesity, atherogenic dyslipidemia (elevated triglycerides and low HDL cholesterol), elevated blood pressure, and insulin resistance (with or without glucose intolerance). Updated guidelines, Adult Treatment Panel IV, are expected for release this year. Table 1 lists the NCEP-ATP III diagnostic criteria for metabolic syndrome.2 In addition, other organizations, such as the American Heart Association and the World Health Organization, similarly de ne metabolic syndrome. The most frequently occurring risk factors for metabolic syndrome include abdominal obesity (53%), hypertension (40%), and hyperglycemia (39%).2,4 In addition, individuals may have characteristics of prothrombotic and proin ammatory states. A proin ammatory state is characterized by the elevation of an acutephase reactant, C-reactive protein (CRP). One of the causes of a proin ammatory state is obesity, as adipose tissue releases inflammatory cytokines and causes an elevation in CRP levels, whereas a prothrombotic state is characterized by increased plasma plasminogen activator inhibitor-1 and brogen.3 Individuals with metabolic syndrome are at increased risk for CVD. Most will have insulin resistance, which increases the risk for type 2 diabetes mellitus. In addition, individuals with metabolic syndrome ap-

TABLE 1

CLINICAL IDENTIFICATION OF THE METABOLIC SYNDROME Abdominal obesity, given as waist circumference
Men >40 in (>102 cm) Women >35 in (>88 cm) 150 mg/dL

Triglycerides HDL cholesterol Blood pressure

130/85 mm Hg >110 mg/dL

Men <40 mg/dL Women <50 mg/dL

Fasting glucose
Abbreviations: HDL, high-density lipoprotein Source: Ref 2

pear to be susceptible to other conditions, including polycystic ovary syndrome, non-alcoholic fatty liver disease, high cholesterol, gallstones, asthma, sleep apnea, and some forms of cancer.3

Treatment strategies for metabolic syndrome

NO RANDOMIZED controlled clinical trials have established evidence-based guidelines for the treatment of metabolic syndrome alone.6 However, prospective epidemiologic studies have established that readily measured and often modi able risk factors are associated with the development of clinical CHD in asymptomatic individuals.8,9 Several validated risk tools, including the Framingham Heart Study (which added general CVD and vascular age as risk factors in 2009), SCORE (Systematic Coronary Risk Evaluation), Menster Heart Study (PROCAM), and Reynolds risk score, indicate that risk factors can be used in predictive models to estimate cardiovascular risk.10-14 The primary goal for managing metabolic syndrome is to mitigate or modify the underlying and major risk factors to prevent or delay the onset of CVD through nonpharmacologic and pharmacologic interventions.2,4,6 Nonpharmacologic strategies focus on modifying risk factors through lifestyle changes such as weight loss, physical activity, and diet.6 Pharmacologic strategies focus on modifying and controlling risk factors with drug therapy, for example, lipidlowering and antihypertensive medications as recommended by national guidelines.
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Abstract

Pharmacists are in an ideal setting to provide a high level of clinical care for patients with cardiometabolic disease. Cardiometabolic disease, also known as syndrome X or metabolic syndrome, is a chronic medical condition that includes risk factors that together can progress to cardiovascular disease (CVD). The metabolic syndrome poses a signicant burden on healthcare costs. The primary goal for managing metabolic syndrome is to mitigate or modify the underlying risk factors of abdominal obesity, physical inactivity, and atherogenic diet. Aggressive management of the metabolic syndrome by nonpharmacologic and pharmacologic strategies should prevent or delay the onset of diabetes mellitus, hypertension, and CVD. First-line therapies for all lipid and nonlipid risk factors associated with the metabolic syndrome are weight reduction and increased physical activity. To achieve full effectiveness of therapeutic programs, national guidelines recommend multidisciplinary methods targeting the patient, providers, and health-delivery systems and the collaborative care of pharmacists, nurses, nutritionists, and patient advocates for thorough patient education adherence.

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Pause&Ponder
Are there community- and neighborhood- sponsored events that would provide opportunities for your patients to engage in physical activities within an organized, supportive structure?
tions for the highest and moderately high-risk individuals. The highest risk individuals include those with CHD, CHD risk equivalents, or a 10-year risk greater than 20% for experiencing a CHD event. For these patients, the LDL cholesterol goal remains lower than 100 mg/dL, with an optional goal of lower than 70 mg/dL. For moderately high-risk patients (2+ risk factors and 10%-20% 10year risk), the LDL cholesterol goal remains lower than 130 mg/dL, with an optional goal of lower than 100 mg/dL. The update also states that any person at highest risk or moderately high risk with lifestyle-related risk factors (e.g., obesity, physical inactivity, elevated triglycerides, low HDL cholesterol, or metabolic syndrome) should modify the present risk factors regardless of current LDL cholesterol level.17 designed to reduce CHD risk. Its essential features include: Reduced intake of saturated fats (<7% of total calories) and cholesterol (<200 mg/d) Increased use of plant stanols/sterols and increased viscous ber (10-25 g/d) Weight reduction and maintenance Increased regular physical activity Weight reduction enhances LDL lowering and improves the risk factors associated with metabolic syndrome and CHD. Regular physical activity improves cardiovascular tness, raises HDL cholesterol level, and in some persons, lowers LDL cholesterol level. Physical activity also can lower blood pressure, reduce insulin resistance, and favorably in uence cardiovascular function.2 Patients can increase their physical activity by making small changes in their everyday routine (Table 3).2 An appropriate trial of TLC for about 3 months is suggested before starting drug therapy. The ATP III TLC approach for the most part recommends the Dietary Guidelines for Americans. Persons following the TLC diet, however, need to increase total fat intake in the form of unsaturated fat to help reduce triglycerides and raise HDL cholesterol. Dietary Guidelines for Americans was updated in 2010 and will be discussed along with weight management in part 2 of this CPE activity in the Drug Topics February 2012 issue. In addition, the 1998 Clinical Guidelines on the Identication, Evaluation, and Treatment of Overweight and Obesity in Adults from the National Heart Lung and Blood Institute Obesity Education Initiative is an excellent source for assisting in weight management. It can be found online at http://www.ncbi.nlm.nih.gov/books/ NBK2003/pdf/TOC.pdf. Some patients may lower their cholesterol levels with TLC; however, a number of individuals will require drug therapy to achieve the desired LDL cholesterol goal (Table 4).2,18-20 One option for lipid-lowering therapy focuses on the use of an HMG-CoA reductase inhibitor (statin) because of its
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Hypercholesterolemia
IN THE UNITED STATES, an estimated 35.7 million adults (16.2%) aged 20 years and older have total serum cholesterol level at or above 240 mg/dL.15 A desirable total cholesterol level is at or below 200 mg/dL. Individuals with an elevated total cholesterol level have approximately twice the risk of heart disease as those with optimal levels. More women (16.9%) than men (15.6%) have high total cholesterol in the United States.16 The primary goal for treating dyslipidemia is to lower LDL cholesterol. The target goals for cholesterol levels are based on the presence of CHD, CHD risk equivalents, or CHD risk factors. The presence of CHD includes a history signi cant for myocardial infarction (MI), unstable or stable angina, coronary artery procedures, or evidence of clinically signi cant myocardial ischemia. CHD risk equivalents include peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease, diabetes, and a 10-year risk greater than 20% for experiencing a CHD event. CHD risk factors include cigarette smoking, hypertension (blood pressure >140/90 mm Hg or on antihypertensive medication), low HDL cholesterol (<40 mg/ dL), age (men >45 years; women >55 years), and family history of premature CHD (male rst-degree relative <55 years of age or female rst-degree relative <65 years of age). The ATP III LDL cholesterol goal for each risk category is included in Table 2.2 The 2004 update to the NCEPs clinical practice guidelines on cholesterol management advises more intensive treatment opTABLE 2

Treatment recommendations for dyslipidemia

THE PRIMARY TARGET of therapy for individuals with metabolic syndrome is achievement of a patient-speci c LDL goal. Following this goal, management focuses on other lipid factors, including non-HDL cholesterol. The rstline approach to achieving LDL cholesterol goals employs therapeutic lifestyle changes (TLC). TLC is a multifaceted lifestyle approach

ATP III LDL CHOLESTEROL GOALS

Risk category
CHD, CHD risk equivalents,* or 10-year risk >20% (high risk) Multiple (2+) risk factors or 10-year risk 10%-20% (moderate high risk) Multiple (2+) risk factors or 10-year risk <10% (moderate risk) 01 risk factor

LDL goal
<100 mg/dL (optional: <70 mg/dL) <130 mg/dL (optional: <100 mg/dL) <130 mg/dL <160 mg/dL

Initiate drug therapy

100 mg/dL (optional therapy with LDL <100 mg/dL to achieve at least 30%-40% reduction in LDL) 130 mg/dL (optional therapy with LDL 100-129 mg/dL at baseline targeting LDL goal <100 mg/dL) 160 mg/dL 190 mg/dL

*CHD risk equivalents (abdominal aortic aneurysm, carotid artery disease, diabetes mellitus, peripheral arterial disease) Note: Any person at highest risk or moderately high risk with lifestyle-related risk factors (e.g., obesity, physical inactivity, elevated triglycerides, low HDL cholesterol, or metabolic syndrome) should modify the present risk factors regardless of current LDL cholesterol level. Abbreviations: ATP III, Adult Treatment Panel III; CHD, coronary heart disease; HDL, high-density lipoprotein; LDL, low-density lipoprotein. Source: Ref 2, 17, 27

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TABLE 3

TYPES OF MODERATE PHYSICAL ACTIVITY Walk or bicycle as a means of transportation Park car further away in parking lots Get off bus at earlier stop and walk Use the stairs instead of an elevator or escalator Engage in active play with children Walk 10 minutes in the morning, mid-day, and evening

Source: Ref 2

beneficial cardiovascular outcomes.21-26 The statin dose should be based on the needed LDL reduction. If after 6 weeks of therapy the LDL cholesterol goal is not achieved, a higher dose of the statin may
TABLE 4

be considered.2 In addition to statins, other currently available drugs that affect lipoprotein metabolism are bile acid sequestrants, niacin (nicotinic acid), bric acid derivatives, omega-3 fatty acids (also available OTC), and the cholesterol absorption inhibitor ezetimibe. Their effects on lipids and lipoproteins vary.17 Statins are recommended for the primary prevention of CVD for high-risk patients and for secondary prevention in all patients with CVD or CVD risk equivalents.27 Omega-3 fatty acids are a good option after MI for patients who cannot tolerate statins. Fibric acid derivatives and nicotinic acid have not been proven to reduce mortality in secondary prevention.28,29 Nicotinic acid has been shown to raise HDL cholesterol level, but does not reduce mortality in pri-

mary prevention.29,30-32 Although bile acid sequestrants reduce cholesterol levels, they do not affect mortality.29 It is also unclear if dietary or supplemental omega-3 fatty acids reduce total mortality or cardiovascular events in persons at high risk or in the general population.33 Even so, there is no evidence to advise patients against consuming omega-3 fatty acids. Ezetimibe in combination with a statin may increase the likelihood of attaining LDL cholesterol goal more often than with a high-dose statin alone; however, ezetimibe has not been shown to affect all-cause mortality.34 Following initiation of drug therapy, TLC should continue to maximize lipid lowering. Table 5 offers guidance on ways the pharmacist can promote patient adherence to improve lipid and cardiovascular outcomes.2

DRUGS AFFECTING LIPOPROTEIN METABOLISM

Drug class
HMG-CoA reductase inhibitors (statins)

Agents and daily doses

Lovastatin (20-80 mg) Pravastatin (20-80 mg) Simavastatin (20-40 mg) Fluvastatin (20-80 mg) Pitavastatin (1-4 mg) Atorvastatin (10-80 mg) Rosuvastatin (5-40 mg) Cholestyramine (4-24 g) Colestipol (5-30 g) Colesevelam (2.6-4.4 g) Immediate-release (crystalline) nicotinic acid (1.5-4.5 g), extended-release nicotinic acid (1-2 g), sustainedrelease nicotinic acid (1-2 g) Gem brozil (600-1200 mg) Feno brate (200 mg)

Lipid/lipoprotein effects
LDL- C HDL-C TG 18%-60% 5%-15% 7%-30%

Adverse drug reactions

Myopathy Increased liver enzymes

Contraindications
ABSOLUTE: Active or chronic liver disease Pregnancy RELATIVE: Concomitant use of certain drugs*

Bile acid sequestrants

LDL- C 15%-30% HDL-C 3%-5% TG no change or increase LDL- C HDL-C TG 5%-25% 15%-35% 20%-50%

GI distress Constipation Decreased absorption of other drugs Flushing Hyperglycemia Hyperuricemia (or gout) Upper GI distress Hepatotoxicity Dyspepsia Upper GI complaints Gallstones Myopathy Diarrhea Arthralgia Myalgia Fishy aftertaste GI disturbances

ABSOLUTE: Familial dysbeta-lipoproteinemia TG >400 mg/dL RELATIVE: TG >200 mg/dL ABSOLUTE: Chronic liver disease, Severe gout RELATIVE: Poorly controlled diabetes Hyperuricemia, Peptic ulcer disease ABSOLUTE: Severe renal disease Severe hepatic disease

Niacin (nicotinic acid)

Fibric acids

LDL- C 5%-20% (may be increased in patients with high TG) HDL-C 10%-35% TG 20%-50% LDL-C HDL-C TG LDL-C HDL-C TG 18% 1% 8% 45% 9% up to 45%

Cholesterol absorption inhibitors Omega 3acid ethyl esters

Ezetimibe (10 mg)

Active liver disease Persistent elevation in hepatic transaminases Hypersensitivity

*Cyclosporine, macrolide antibiotics, various anti-fungal agents, and cytochrome P-450 inhibitors; fibrates and niacin should be used with appropriate caution. Abbreviations: GI, gastrointestinal; HDL-C, high-density-lipoprotein cholesterol; LDL-C, low-density-lipoprotein cholesterol; TG, triglycerides Source: Ref 2,18-20

(4 g)

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First-line therapy for the metabolic syndrome is change in lifestyle, particularly weight reduction and increased physical activity.2

TABLE 5

Hypertension
IN THE UNITED STATES, an estimated 33.6% of community-dwelling adults age 20 years and older have hypertension, with nearly equal prevalence between men and women.35 African-American adults have among the highest rates of hypertension in the world at greater than 43%.13 Among adults with hypertension (systolic blood pressure 140 mm Hg or diastolic blood pressure 90 mm Hg or on antihypertensive medication), approximately 78% are aware of their condition and 68% are prescribed antihypertensive medication(s); however, only 44% of those treated have controlled hypertension.13 The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) identi es risk factors for major CVD. These include hypertension, age (>55 years for men and 65 years for women), diabetes, dyslipidemia, microalbuminuria or estimated glomerular ltration rate less than 60 mL/min/1.73 m2, family history of premature CVD (men <55 years of age, women <65 years of age), obesity (BMI >30 kg/m2), physical inactivity, and cigarette smoking.36 The updated guidelines, JNC 8, are expected for release this year. The diagnosis and classi cation of hypertension in adults aged 18 years and older is based on the average of 2 or more properly measured, seated blood-pressure readings on each of 2 or more in-of ce visits (Table 6).36 It is important to evaluate patients with elevated blood pressure for lifestyle and other cardiovascular risk factors, identi able causes of hypertension, and the presence of
TABLE 6

METHODS FOR ENHANCING PATIENT ADHERENCE Keep the medication regimen as simple as possible; use combination products when appropriate. Provide the patient with clear instructions on use of his/her medication(s). Discuss medication adherence at each patient encounter. Identify and intervene with patients who do not reach treatment goals. Encourage the use of prompts to help patients. Call patients who miss visit appointments. Use 2 or more strategies for those who miss treatment goals. Involve patients in their care through self-monitoring Encourage the support of family and friends.

Source: Ref 2

target-organ damage or CVD. The JNC 7 guideline recommends target blood-pressure goals of lower than 130/80 mm Hg for individuals with chronic kidney disease or diabetes and a goal of lower than 140/90 mm Hg for all other individuals. In 2007, the American Heart Association issued hypertension guidelines recommending a target of lower than 130/80 mm Hg for patients with coronary artery disease (CAD) or CAD risk equivalents (carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm), as well as for those at high risk of CAD (diabetes, chronic renal disease, or a 10-year Framingham risk score >10%). With ventricular dysfunction, the recommended blood-pressure goal is lower than 120/80 mm Hg.37

CLASSIFICATION OF HYPERTENSION

Blood-pressure classication
Normal Prehypertension Stage 1 Stage 2

SBP (mm Hg)

<120 120-139 140-159 160

DBP (mm Hg)

And <80 Or 80-89 Or 90-99 Or 100

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure. Source: Ref 36

TREATMENT RECOMMENDATIONS FOR HYPERTENSION The JNC 7 guidelines recommend lifestyle modi cation strategies for the prevention and treatment of hypertension. The essential features of the recommendations include: Dietary Approaches to Stop Hypertension (DASH) eating plan Sodium restriction (no more than 2.4 g/d) Weight reduction (to maintain BMI of 18.5-24.9 kg/m2) Physical activity (regular aerobic activity for 30 minutes per day most days of the week) Moderate alcohol consumption (no more than 2 drinks per day for men and 1 drink per day for women) Smoking cessation Compared to the typical American diet, the DASH plan emphasizes inclusion of fruits, vegetables, fat-free or low-fat milk/ milk products, and whole grains in the diet. Favorable foods include those that are rich in potassium, magnesium, and calcium. In addition, DASH recommends protein and ber from whole grain products, sh, poultry, and nuts.38 By following the DASH diet, patients can reduce systolic blood pressure by 8 to 14 mm Hg. Physical activity provides a 4 to 9 mm Hg reduction, while a 10-kg weight loss provides a 5 to 20 mm Hg reduction. Sodium restriction can result in a 2 to 8 mm Hg decrease, and limiting alcohol consumption can reduce blood pressure by 2 to 4 mm Hg.36 For individuals who use tobaccocontaining products, interest in cessation should be continually assessed and encouraged. Those who are interested in tobacco cessation should receive appropriate guidance on selection of pharmacologic therapy if desired and tobacco cessation counseling. Clinical trial evidence shows that antihypertensive therapy reduces the risk of stroke, MI, and heart failure.39-41 The JNC 7 guideline provides recommendations for initial therapy based on several compelling indications for drug therapy. For patients with a history of post MI, JNC 7 recommends beta blockers, angiotensinconverting enzyme (ACE) inhibitors, or aldosterone antagonists; ACE inhibitors or angiotensin receptor blockers (ARBs) for patients with chronic kidney disease; and
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thiazide diuretics or ACE inhibitors for recurrent stroke prevention. For patients with diabetes, JNC 7 recommends treatment with thiazide diuretics, beta blockers, ACE inhibitors, ARBs, or calcium channel blockers. For patients with an increased risk of CVD, the recommended treatment includes a thiazide diuretic, beta blockers, ACE inhibitors, or calcium channel blockers. The guidelines recommend diuretics, beta blockers, ACE inhibitors, ARBs, or aldosterone antagonists for the treatment of patients with heart failure.36 The guideline also notes that because more than two-thirds of patients with hypertension cannot be controlled with monotherapy and many will need 2 or more antihypertensive agents to achieve bloodpressure control, combination therapy with separate agents or a xed-dose combination drug may take less time to achieve target blood-pressure goals and may offer better tolerability than high doses of a single agent.36,42 It is suggested that choosing a rst-line agent may be less important than choosing a bene cial combination. Patients with compelling indications such as heart failure, post MI, chronic kidney disease, recurrent stroke prevention, diabetes, or high risk of CVD may bene t from agents with different mechanisms of action. Selection of an antihypertensive agent is patient speci c based on bene cial clinical outcomes. Consideration should be given to guideline recommendations for management of the compelling indication along with hypertension, side effects, and cost of therapy. Initial management with combination therapy should be considered in any patient whose blood pressure is greater than 20 mm Hg above systolic goal or 10 mm Hg above diastolic goal.36,43

Pause&Ponder
Consider your practice environment. Is it possible to establish specic hours or days during which one-onone patient counseling and education can be offered?
style behavior adherence and glucose and blood-pressure self-monitoring (Table 7) and provide patient education and information (Table 8). The pharmacists role and impact on patient care in cardiometabolic disease has been examined in numerous studies in the literature.44-46 A longitudinal pre-post cohort study (for periods as long as 5 years) assessed the clinical and economic outcomes of the Asheville Project, a community pharmacybased care project for patients with diabetes. This program, implemented at 12 community pharmacies in Asheville, NC, included patients with diabetes from 2 employer groups. The pharmacist intervention 55 mg/dL for women. Patients were followed over a 5-year period at 7 follow-up pharmacist visits. The results indicated that the number of patients with the goal of an improved (lowered) A1C value increased by 24.3% (33 patients) at rst follow-up, 27.2% (22 patients) at the second follow-up, and 18.2% (10 patients) at the third follow-up. Subsequent follow-ups of smaller groups of patients showed that optimal A1C values were achieved. In addition, mean LDL cholesterol decreased and HDL cholesterol increased at each follow-up point.44 Investigators assessed the economic outcomes of the Asheville Project by determining direct medical costs during the study period. Outcomes indicated that mean insurance costs decreased per patient per year by $2,704 in the rst followup year to $6,502 in the fth follow-up year. Although mean total prescription costs increased from $656 to $2,188 during the same time, total direct medical costs decreased every year compared to the baseline cost. The investigators concluded that patients with diabetes who received ongoing community-based pharmacist care services maintained improvements in A1C over time while employers bene ted from a decline in medical costs.44 In a medical group in suburban Chicago, clinical pharmacists collaborated with other healthcare professionals (physicians, registered nurses, and registered dieticians) to provide an interdisciplinary diabetes health management program with the goal of improving diabetes care. Between April 2002 and April 2004, 707 patients were enrolled in the program, of whom 84% had diagnosed type 2 diabetes while 69% met the ATP III criteria for classi cation of metabolic syndrome. Patients met with pharmacists on an ongoing basis for comprehensive medication management and education. Through a collaborative practice agreement, pharmacists initiated or modi ed pharmacotherapy regimens, ordered pertinent laboratory tests, and made podiatry referrals within the scope of the protocol.45
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...Patients with diabetes who received ongoing communitybased pharmacist care services maintained improvements in A1C over time...
included a one-on-one consultation with the patient to set and monitor treatment goals, provide diabetes education and home glucose meter training, and inform the patient about adherence to the treatment regimen. Patient participation was promoted through receipt of incentives, such as free testing equipment and waiver of co-payments.44 The primary clinical outcomes included changes in glycosylated hemoglobin (A1C), with a goal of less than 7%; LDL cholesterol, with a goal of less than 100 mg/dL; and HDL cholesterol, with a goal of greater than 45 mg/dL for men and greater than

The pharmacists role in the management of cardiometabolic disease

PHARMACISTS ARE in an ideal setting as accessible healthcare professionals to provide care for patients with cardiometabolic disease. They can assess patient risk, communicate metabolic syndrome risk factors to the public, identify and recommend patientspeci c interventions, and identify barriers to lifestyle modi cations. Pharmacists can assist patients with medication and lifeDrugTopics .c om

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A retrospective review demonstrated a signi cant increase (P<.001) in the percent of patients with an A1C of less than 7% from baseline (18%) to 6 months (48%). In addition, an increase was noted in the percent of patients with total cholesterol less than 200 mg/dL (35% at baseline and 52% at 6 months, P<.001) and LDL cholesterol
TABLE 7

PATIENT SELF-MANAGEMENT OF CARDIOMETABOLIC DISEASE Develop a comprehensive wellness plan that includes dietary modi cations, physical activity, weight management, smoking cessation, and moderate alcohol consumption. Utilize available resources (pharmacist, doctor, nurse) to assist in the plans development.

Set speci c, measurable, and achievable healthcare goal(s). Share with family, a friend, or doctor, so held accountable for goal(s). Determine a timeline for achieving goal(s). Share progress toward goal(s) with others. Identify challenges for appropriate self-care and seek assistance to modify. Engage in group activities, such as an aerobics class, diet program, or support groups. Adhere to medication regimens as prescribed. Encourage patient to keep up-to-date personal medication record, including names, strength, dose, frequency, and indication for all prescription and nonprescription medications, vitamins, and herbal supplements. Monitor blood pressure, blood sugar, and/or weight. Seek assistance for education on correct use of the device(s). Know your goal(s) for blood pressure and/or blood glucose readings. Attend all appointments with your primary care provider, specialists, and other healthcare professionals. Ask healthcare providers questions.

less than 100 mg/dL (25% at baseline and 44% at 6 months, P<.001).45 In a cross-sectional study, a metabolic syndrome screening and education program was implemented in a single Pennsylvania community pharmacy.46 The objective was to determine the prevalence of metabolic syndrome in the community, the 10-year risk of CHD in those with metabolic syndrome, and the effectiveness of pharmacist-provided lifestyle modi cation education. Patients scheduled and completed a pharmacist-led 20-minute interview. The pharmacist assessed cardiovascular risk factors and patients use of cholesterol, glucose, and blood-pressure lowering prescription medications. In addition, blood pressure, hip and waist measurements, glucose concentration, and cholesterol levels were obtained and assessed. Patients were classi ed as having metabolic syndrome if they met 3 of the 5 American Heart Association criteria: Elevated waist circumference >40 inches in men or >35 inches in women Elevated triglycerides 150 mg/dL or on drug treatment for elevated triglycerides Reduced HDL <40 mg/dL in men or <50 mg/dL in women Systolic blood pressure 130 mm Hg, diastolic blood pressure 85 mm Hg, or on antihypertensive medication with history of hypertension Elevated fasting glucose >100 mg/dL or on drug treatment for elevated glucose.4,46 Of the 239 screened patients, 86 met the criteria for metabolic syndrome. The Framingham 10-year risk scores for CHD in those with metabolic syndrome revealed
TABLE 8

65.3% were low risk (10-year risk 0%-10%), 26.4% were moderate risk (10-year risk 10%20%), and 8.3% were high risk (10-year risk >20%). A follow-up questionnaire completed by 176 participants measured patient adherence with pharmacist recommendations for lifestyle modi cations. Of patients with metabolic syndrome 87% reported lifestyle modi cations in diet, exercise, or weight loss in the 3- to 6-month follow-up compared to 67% without metabolic syndrome. Of those patients with metabolic syndrome, 91% indicated they would be interested in returning for follow-up screening.46

Conclusion
PHARMACISTS are in an ideal setting as accessible healthcare professionals to provide care for patients with cardiometabolic disease. They can assess patient risk, communicate metabolic syndrome risk factors to the public, identify and recommend patient-speci c interventions, and identify barriers to lifestyle modi cations. Pharmacists can assist patients with medication and lifestyle behavior adherence and glucose and blood-pressure self-monitoring and provide patient education and information.

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USEFUL WEBSITES CONTAINING PATIENT INFORMATION National Heart Blood and Lung Institute http://www.nhlbi.nih.gov/index.htm Centers for Disease Control and Prevention http://cdc.gov/ National Institutes of Health http://health.nih.gov/ MedlinePlus http://www.nlm.nih.gov/medlineplus/ FamilyDoctor.org http://familydoctor.org United States Department of Agriculture http://www.choosemyplate.gov/ American Heart Association http://www.heart.org/HEARTORG/ American Diabetes Association http://www.diabetes.org/ Smokefree.gov http://www.smokefree.gov/

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References

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Improving Centers for Disease Control and blood pressure control rates: is there Prevention. National Center for more we can do? J Clin Hypertens Health Statistics. NCHS Data Brief. (Greenwich). 2007;9(2):134142. Hypertension awareness, treatment, and controlcontinued disparities in 44. Cranor CW, Bunting BA, Christensen DB. adults: United States, 2005-2006. CDC/ The Asheville Project: Long-term clinical NCHS, National Health and Nutrition and economic outcomes of a community Examination Survey. January 2008. pharmacy diabetes care program. J Am Available at: http://www.cdc.gov/nchs/ Pharm Assoc. 2003;4392):173184. data/databriefs/db03.pdf. Accessed 45. Brooks AD, Rihani RS, Derus CL. December 24, 2011. Pharmacist membership in a medical Chobanian AV, Bakris GL, Black HR, et al; groups diabetes health management Joint National Committee on Prevention, program. Am J Health Syst Pharm. Detection, Evaluation, and Treatment of 2007;64(6):617621. 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CARDIOMETABOLIC DISEASE
d. Sodium restriction, 2-8 mm Hg e. Weight loss, 5-20 mm Hg 10. In the Asheville Project, a pharmacy-based care project for patients with diabetes, community-based pharmacists demonstrated all of the following EXCEPT: a. Pharmacists consulted with patients to set and monitor treatment goals, provide diabetes education, home glucose meter training, and address program adherence. b. Incentives such as free self-monitoring equipment and copay waivers encouraged patients to participate. c. Improved hemoglobin A1C results for patients. d. Participation of physicians, nurses, and pharmacists in a collaborative agreement. e. Mean insurance costs increased per patient per year by $2,704 to $6,502.

1. Which of the following is NOT a component in the diagnosis of metabolic syndrome? a. Blood pressure (130/85 mm Hg) b. High-density lipoprotein (HDL) cholesterol (men <40 mg/dL; women <50 mg/dL) c. Abdominal obesity (waist circumference: men >102 cm [>40 in]; women >88 cm [>35 in]) d. Fasting glucose (>110 mg/dL) e. A proin ammatory state (elevated C-reactive protein) 2. True or false. Major risk factors for metabolic syndrome include all of the following: cigarette smoking, hypertension, elevated low-density lipoprotein (LDL) cholesterol, low HDL cholesterol, family history of premature coronary heart disease, and aging. a. True b. False 3. What is the prevalence of metabolic syndrome in the U.S. adult population? a. 16% b. 22% c. 37% d. 41% e. 52% 4. True or false. The primary goal for managing metabolic syndrome is to modify the underlying risk factors of abdominal obesity, physical inactivity, and atherogenic diet as well as the major risk factors of hypertension, high LDL cholesterol, low HDL cholesterol, and cigarette smoking. a. True b. False 5. What is the estimated number of adults aged 20 years and older in the United States with total serum cholesterol levels >240 mg/dL? a. 10 million b. 20.5 million c. 35.7 million d. 47.5 million e. more than 50 million 6. Many patients will lower their cholesterol levels with which of the following? a. Reduction in saturated fats and cholesterol b. Inclusion of plant sterols and viscous ber c. Weight control d. Exercise e. All of the above 7. True or false. A 2004 update to the National Cholesterol Education Programs clinical practice guidelines on cholesterol management advised that for high-risk patients, the overall goal remains an LDL level lower than 100 mg/dL; however, for people at high risk, the update offers the option of treating to an LDL level lower than 70 mg/dL. a. True b. False 8. The following statements concerning hypertension are true EXCEPT: a. It is estimated that 33.6% of noninstitutionalized adults in the United States aged 20 years and older have hypertension. b. The prevalence of hypertension in the United States is higher in men than women. c. African-American adults have the highest rates of hypertension in the world at >43%. d. Among adults with hypertension, approximately 78% are aware of their condition. e. Only 44% of treated adults have controlled hypertension. 9. According to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, the following lifestyle changes produced documented systolic blood-pressure reductions EXCEPT: a. DASH plan, systolic blood pressure, 8-14 mm Hg b. Physical activity, 4-9 mm Hg c. Smoking cessation, 3-5 mm Hg

Case Studies
Case A
E.H. is a 58-year-old woman presenting for her initial appointment with you in the pharmacist-managed cardiovascular risk reduction clinic. She has a past medical history signi cant for hypertension (prescribed lisinopril, 5 mg 1 tablet orally daily; hydrochlorothiazide [HCTZ], 25 mg 1 tablet orally daily), obesity, and major depressive disorder (prescribed sertraline, 20 mg 1 tablet orally daily). She currently smokes 3 cigarettes a day and exercises about 15 minutes a week. Her bloodpressure reading and pulse today are 152/86 mm Hg and 76 bpm, respectively. Calculated BMI is 20.6 kg/m2. 1. Which of the following lifestyle recommendations is most appropriate? a. Increase alcohol consumption to 2 drinks per day b. Smoking cessation c. Reduce weight to achieve BMI <18.5 kg/m2 d. Decrease exercise to 100 minutes per week e. Increase protein and ber in diet 2. What is the desired blood-pressure goal for E.H.? a. <140/90 mm Hg b. <140/80 mm Hg c. <135/85 mm Hg d. <130/80 mm Hg e. <120/80 mm Hg 3. Which of the following will allow the patient to take an active role in her blood-pressure management? a. Record daily home blood-pressure measurement. b. Keep a personal medication record. c. Set speci c lifestyle goals. d. Adhere to medications and medical appointments. e. All of the above.

Case B
S.K. is a 61-year-old man presenting for his initial appointment with you in the pharmacist-managed lipid clinic. His fasting lipid panel indicates the following: total cholesterol 224 mg/dL, triglycerides 194 mg/dL, low-density lipoprotein (LDL) cholesterol 157 mg/dL, and high-density lipoprotein (HDL) cholesterol 28 mg/dL.

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1. S.K. has a calculated 10-year risk of coronary heart disease (CHD) at 21%. Which of the following would be an appropriate initial therapy for lipid management? a. Therapeutic lifestyle changes for 2 months. b. Simvastatin, 20 mg 1 tablet daily at bedtime. c. Niacin extended release, 500 mg 1 tablet daily at bedtime. d. Ezetimibe/simvastatin, 10/10 mg 1 tablet daily at bedtime. e. Reassess fasting lipids in 4 weeks. 2. What is S.K.s desired LDL cholesterol goal with a 21% 10year risk of CHD? a. <160 mg/dL b. <145 mg/dL c. <130 mg/dL d. <100 mg/dL e. <75 mg/dL 3. Which of the following is S.K.s primary target of therapy for hyperlipidemia according to National Cholesterol Education Program Adult Treatment Panel (ATP) III? a. LDL cholesterol b. Non-HDL cholesterol c. HDL cholesterol d. Triglycerides e. Total cholesterol 4. During your discussion with S.K., you learn that he is interested in learning more about how to take an active role in his care. Which of the following self-care recommendations can you suggest that is in line with ATP IIIs TLC recommendations? a. Limit alcohol intake to no more than 1 drink per day b. Reduce saturated fat intake to < 10% of total calories c. Increase regular physical activity d. Smoking cessation b. Address the importance of medication adherence. c. Recommend she begin home BP monitoring. d. Develop a wellness plan that includes physical activity and weight management. e. All of the above. 3. Which of the following recommendations is most appropriate for managing metabolic syndrome in C.S.? a. Begin pravastatin, 10 mg 1 tablet orally at bedtime. b. Increase metformin to 850 mg 1 tablet orally 3 times daily. c. Begin 30 minutes of moderate-intensity exercise daily. d. Increase caloric intake. e. Increase omega-3 fatty acids. 4. During your appointment, you learn that she misses at least 1 day of her medications a week. She explains that she always forgets to take her medications with her when she goes out. Which of the following counseling points may assist C.S. in improving her medication adherence? a. Educate her on the risks associated with medication nonadherence. b. Educate her on the side effects of her medications. c. Recommend that she keep her medications in the kitchen. d. Suggest she set an alarm to remember to take her medications while out. e. Suggest keeping a days supply of medications in a pillbox in her purse.

Case D
Please review Sur DK, Scandale S. Treatment of Allergic Rhinitis. Am Fam Physician. 2010 Jun 15;81(12):1440-46. to assist in the completion of the following case. J.C. is a 74 year-old female who presents to your pharmacy to pick up her prescriptions for enalapril and hydrochlorothiazide. After she purchases the prescriptions, you notice J.C. in the cough and cold aisle; you decide to assist her with appropriate product selection. J.C. shares with you that she has been experiencing a runny nose, itchy, watery eyes, and sneezing for the past 3 days, ever since she started cat-sitting for her daughter. 1. Which of the following medications would be the best recommendation for J.C.s symptoms? a. Diphenhydramine 25mg q6 hours b. Loratadine 10mg daily c. Pseudoephedrine 30mg q6 hours d. Nasal saline intranasal spray use as needed e. Cromolyn intranasal spray use 1 spray in each nostril q6-8 hours 2. Which of the following medications is not associated with epistaxis? a. Mometasone ( Nasonex) b. Azelastine ( Astelin) c. Cromolyn ( NasalCrom) d. Ipratropium ( Atrovent) e. Sodium Chloride ( Simply Saline)

Case C
C.S. is a 47-year-old woman who is a frequent customer at your community pharmacy. She presents today for her medication therapy management appointment with you. During your assessment you collect the following information: blood pressure 142/84 mm Hg and waist circumference of 40 inches. Prior to this appointment she completed fasting lab work. The results include: glucose 98 mg/dL, HDL 38 mg/ dL, and triglycerides 148 mg/dL. Currently, she is prescribed metformin, 1 g 1 tablet orally twice daily, chlorthalidone, 25 mg 1 tablet orally daily, escitalopram, 10 mg 1 tablet orally daily, and zolpidem, 5 mg 1 tablet at bedtime. C.S. offers that she consumes a diet low in salt, eats plenty of veggies, and exercises 10 minutes every day. She denies smoking and limits her alcohol intake to less than 1 drink per day. 1. Which of the following characteristics in her indicate the presence of metabolic syndrome according to ATP III? a. Waist circumference, glucose, triglycerides b. Waist circumference, blood pressure, HDL c. Waist circumference, HDL, triglycerides d. Blood pressure, triglycerides, glucose e. Blood pressure, HDL, glucose 2. C.S. is concerned with the diagnosis of metabolic syndrome and wants to what she can do to reduce her future CHD risk. Which is the following are important points to discuss with C.S. today? a. Recommend she schedule an appointment with her primary care provider.
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