week 5 CS

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1 Advanced Pharmacology Jaya Aju Kattakayam South University NSG6005 Dr. Olson December 30, 2023

2 Advanced Pharmacology Q1: Research and updated guidelines recommended changes in first-line medications for hypertension (HTN), particularly for patients with comorbid conditions. Heart failure (HF), ST- elevation myocardial infarction (STEMI), diabetes mellitus (DM), and renal disease are a few comorbid conditions that worsen mortality and morbidity with HTN. First-Line Medications for Hypertension: Hypertension is a multifactorial global health problem. It is becoming a common diagnosis among teenagers to older adults. A n ormal Blood Pressure (BP) is stated as Systolic BP(SBP) < 130 and Diastolic BP(DBP) < 85. High normal BP is SBP 130-139 and /or DBP 85- 89. Grade 1 HTN is SBP 140-159 and /or DBP 90-99 and Grade 2 HTN is SBP> 160 and/or DBP >100 (Chakraborty et al., 2021). Ideal management and control of blood pressure requires proper guidelines as it varies depending on nationality, race, food habits, lifestyle, etc. (Chakraborty et al., 2021). Lifestyle modifications including daily exercise, obesity management, a healthy diet with salt limitation, alcohol limitation, and cessation of smoking, should be initiated with a diagnosis of HTN. After 3–6 months of lifestyle intervention, pharmacotherapy should be started in high-risk patients with cardiovascular disease, chronic kidney disease, diabetes, or organ damage. World Health Organization (WHO) recommends initiation of pharmacological antihypertensive treatment of individuals with a confirmed diagnosis of hypertension and systolic blood pressure of ≥140 mmHg or diastolic blood pressure of ≥90 mmHg (World Health Organization, 2021). Individuals with or without cardiovascular disease but with high cardiovascular risk, diabetes mellitus, chronic kidney disease, and systolic blood pressure of

3 130–139 mmHg should be initiated on antihypertensive therapy per WHO guidelines (World Health Organization, 2021). New guidelines include stepwise management like Step 1: use a dual low-dose drug combination (Angiotensin-converting enzyme inhibitor (ACEI) or Angiotensin II receptor blockers (ARB) + Dihydropyridines- Calcium channel blockers (DHP-CCB). Step 2: increase the therapy to the dual full-dose combination. Step 3 (triple combination): add a thiazide or thiazide-like diuretic and Step 4 (resistant hypertension): triple combination plus spironolactone or amiloride, doxazosin, eplerenone, clonidine, or a β-blocker (Chakraborty et al., 2021). Current Recommendation: The first-line medications recommended for patients with early hypertension are angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers (ARBs), and calcium channel blockers (CCBs) (Chakraborty et al., 2021). Lifestyle modifications are essential for managing hypertension, and optimal treatment starts with diet and activity. Dietary changes include salt reduction, moderation of alcohol consumption, and a diet high in vegetables and fruit that is low in added sugars and saturated fats (e.g., DASH diet). Activity recommendations include aerobic and resistance exercises for at least 30 minutes or more at least five days per week. Other important modifications include smoking cessation and stress reduction. Adequate treatment of comorbid conditions like obesity, obstructive sleep apnea (OSA), and chronic kidney disease plays a pivotal role in the management of HTN (Maraboto & Ferdinand, 2020). Indications to consider specific agents include diuretics or CCBs in patients over 65 years or those of African American descent, beta- blockers in ischemic heart disease, ACE /ARBs in patients with severe proteinuria, diabetes mellitus, heart failure, and kidney disease (Rosenthal & Burchum, 2020).

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4 Change from Past Practice: While thiazide diuretics and beta-blockers were commonly used as initial choices in the past, the shift is due to the stronger evidence supporting the cardiovascular benefits of ACE inhibitors, ARBs, and CCBs. These medications not only effectively lower blood pressure but also offer additional cardiovascular protection, prolong the onset, or slow down the progress of renal disease, retinopathy, neuropathy, etc associated with HTN. 2. Thiazide Diuretics or Beta-Blockers: Role Today: Thiazide diuretics and beta-blockers still have a role in hypertension management, but they are often considered second-line or adjunctive options. Thiazide diuretics are prescribed in specific patient populations like African Americans or as part of combination therapy. Beta-blockers are still used but are not the first choice, especially in uncomplicated hypertension. Beta-blockers are compelled to be added if the patient has a history of post- myocardial infarction. Also, beta-blockers are safe to use in pregnancy ( Burchum & R osenthal, 2020). Considerations: The choice of medication depends on individual patient characteristics, comorbidities, and any compelling indications ( Burchum & R osenthal, 2020). Beta-blockers are prescribed in patients with compelling indications like post-myocardial infarction, heart failure, or certain arrhythmias. Q2. Primary Choice for African American Patients: Hypertension is a major global disease burden. It is a leading preventable cause of worldwide premature death. In the United States, the burden of hypertension and its associated complications including coronary heart disease, heart failure, stroke, end-stage renal disease, and cardiovascular disease mortality affect African Americans more than other races. This excess

5 burden of hypertension among African Americans has been identified since the 1900s and explains health disparities. Hypertension in African ancestry has geographical variances related to high sodium intake, low potassium intake, obesity, and inactivity (Maraboto & Ferdinand, 2020). African Americans are affected with hypertension higher than other populations of African origin (Maraboto & Ferdinand, 2020). Compared with white Americans, hypertension is not only more prevalent in this population, but it is also observed at a younger age, has greater severity, and is accompanied by a target organ damage (1.8-fold higher rate of stroke, 4.2-fold higher rate of end-stage renal disease, 1.7-fold higher rate of heart failure, 1.5-fold higher rate of coronary heart disease mortality) (Maraboto & Ferdinand, 2020). Researchers proved that African Americans have unique pathophysiology increasing their prevalence and severity of hypertension, including the epithelial sodium channels, renin-angiotensin-aldosterone system (RAAS), adrenergic receptors, nitric oxide pathways, and transforming growth factor hyperexpression (Maraboto & Ferdinand, 2020). A complete evaluation is to be done on patients with risk factors, clinical manifestations, or laboratory markers suggestive of secondary causes of HTN, to allow early diagnosis and establishment of optimal therapy (Maraboto & Ferdinand, 2020). Increased sodium absorption and salt sensitivity appear more common and prominent in African Americans and more commonly appear to have an increased favorable response to thiazide diuretics (Maraboto & Ferdinand, 2020). Additionally, the transforming growth factor is elevated in African Americans with hypertension and is also associated with salt-sensitive hypertension. This inflammatory cytokine increases fibrosis and leads to target organ damage. Additionally, African Americans are noted to lack the absence of dipping in BP and have a blunted nocturnal decline in blood pressure. This absence of nocturnal decline may be a

6 marker of more severe hypertension and target organ damage. In the African American population, target organ damage including stroke, hypertensive nephropathy, end-stage renal disease, left ventricular hypertrophy (LVH), coronary heart disease, and heart failure is more common and severe ( Burchum & R osenthal, 2020). African Americans have approximately four times greater stroke rate than white Americans in their younger 30s. The increased prevalence of renal insufficiency and end-stage renal disease represents an independent adverse cardiovascular risk. Moreover, LVH is severe in African Americans related to an increase in sudden cardiac death ( Burchum & R osenthal, 2020). The initial approach to HTN management in African Americans is lifestyle modifications like other people, including the implementation of a healthy eating pattern, such as the DASH (Dietary Approaches to Stop Hypertension), with low-sodium and high-potassium intake, increased physical activity and weight loss. Physical activity has overall health-beneficial effects ( Burchum & R osenthal, 2020). In conjunction with lifestyle interventions, individualized drug therapy is the key. In African Americans with HTN, but without renal impairment or HF, thiazide-type diuretics, and calcium channel blockers (CCBs) are preferred as initial therapy. The effectiveness of drug regimens based on diuretic chlorthalidone, ARB amlodipine, and ACEI lisinopril in African subgroups showed significant differences in strokes and lowering SBP (Maraboto & Ferdinand, 2020). Studies showed reduced effectiveness in BP lowering with monotherapy using Angiotensin-converting enzyme inhibitors (ACEI) and (ARBs) among African American patients, which stated they have suppressed RAAS activity (Maraboto & Ferdinand, 2020). African Americans presented a higher risk of angioedema with ACEI, so this class of medications has been treated as a second step or add-on drug unless a compelling indication is

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7 present. In African American patients with Chronic Kidney Disease, RAAS inhibition slowed the decline of renal function: hence, this group of drugs is recommended (Maraboto & Ferdinand, 2020). Recent studies found that amlodipine plus either hydrochlorothiazide or perindopril was more effective at reducing BP at six months, compared with perindopril plus hydrochlorothiazide (Maraboto & Ferdinand, 2020). CCB stands as a cornerstone in the pharmacologic management of African American patients with HTN (Maraboto & Ferdinand, 2020). The CCB-ACEI combination was found effective as CCB-thiazide when two medications are required (Maraboto & Ferdinand, 2020). The 2017 ACC/AHA HTN guideline recommends a thiazide-type diuretic or CCB when given as monotherapy or as an initial agent in a multidrug therapy of African Americans with HTN but without HF or CKD (Maraboto & Ferdinand, 2020). Thiazides are more effective than RAAS inhibitors in this population and are recommended for African Americans with CKD and those with HF (Maraboto & Ferdinand, 2020). Current Recommendation: For African American patients, without compelling indications, calcium channel blockers (CCBs) or thiazide diuretics are given as initial therapy. They do not respond well to ACE inhibitors. Even if ACE inhibitors and ARBs are protective against diabetic nephropathy, in high-risk African Americans with hypertension, diuretics or CCBs are needed to control BP. After a myocardial infarction, beta-blockers (BB) should be used in all patients (Helmer et al., 2018). A novel BB, nebivolol, restores nitric oxide bioavailability in African Americans and is effective in high-risk African American hypertensive patients. The removal of ACE inhibitors and ARBs as first-line agents in the treatment of hypertension in African American patients is based on evidence that other antihypertensive drugs are more effective in this population (Helmer et al., 2018).

8 Individual response to a medication cannot be predicted based on race (Helmer et al., 2018). Single-drug therapy for hypertension in African Americans is more effective with thiazide diuretics and CCBs versus BBs or ACE inhibitors. However, a single drug is not adequate to control BP in this population and requires treatment with two or three antihypertensive agents of different classes to achieve the goal of BP. Therefore, the decision to use a specific drug should be based on efficacy in individual patients, compelling indications, and cost (Helmer et al., 2018). African Americans respond well to thiazide diuretics as first-line therapy for BP reduction, stroke, and cardiovascular risk benefits (Helmer et al., 2018). However, when single- drug therapy is not sufficient, thiazide diuretics increase the efficacy of ACE inhibitors, ARBs, and BBs (Helmer et al., 2018). Long-acting CCBs, both dihydropyridine and non- dihydropyridine, have been shown to reduce BP effectively in blacks and to reduce stroke and cardiovascular events (Helmer et al., 2018). Monotherapy with ACE inhibitors, ARBs, and BBs demonstrates fewer BP-lowering effects in African Americans and aldosterone antagonists such as spironolactone and eplerenone have equal efficacy in African Americans versus whites. A complication of ACE therapy is the higher rate of angioedema with cough in African- Americans (Helmer et al., 2018). ARB (losartan regimen) versus the BB (atenolol regimen) showed a less effective decrease in cardiovascular morbidity, including stroke, with losartan-based therapy (Helmer et al., 2018). Although ACE inhibitors and ARBs are protective against diabetic nephropathy, in high-risk African American hypertensive patients’ diuretics or CCBs are usually needed to control BP effectively (Helmer et al., 2018). After a myocardial infarction, BBs should be used in all patients. (Helmer et al., 2018). As a result, current hypertension management guidelines,

9 including those from the American College of Cardiology (ACC) and American Heart Association (AHA), recommend initial therapy with CCBs or thiazide diuretics in these patients without compelling indications for other drug classes. Rationale: Studies, such as the Antihypertensive Lipid-Lowering Treatment to Prevent Heart Attack (ALLHAT) trial, have shown that CCBs and thiazide diuretics may be more effective in reducing blood pressure in African American populations (Helmer et al., 2018). While ACE inhibitors and ARBs are still effective, they may be less so in this specific population (Helmer et al., 2018). It's crucial to individualize treatment based on the patient's specific clinical characteristics, preferences, and any compelling indications. It's important to note that individual patient factors and comorbidities should be considered in treatment decisions, and healthcare providers should tailor the choice of antihypertensive medications based on the specific needs and characteristics of each patient. Additionally, lifestyle modifications, including dietary changes and increased physical activity, play a crucial role in hypertension management. Regular monitoring and follow-up are essential to assess the effectiveness of therapy and adjust the dose as needed.

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10 References Burchum, J., & Rosenthal, L. D. (2021). Lehne’s Pharmacotherapeutics for Advanced Practice Nurses and Physician Assistants (2nd ed.). Elsevier Health Sciences (US). https://digitalbookshelf.southuniversity.edu/books/9780323554954 Chakraborty, D. S., Lahiry, S., & Choudhury, S. (2021). Hypertension Clinical Practice Guidelines (ISH, 2020): What Is New? Medical principles and practice: international journal of the Kuwait University, Health Science Centre , 30 (6), 579–584. https://doi- org.su.idm.oclc.org/10.1159/000518812 Helmer, A. M., Slater, N., & Smithgall, S. (2018). A review of ACE inhibitors and ARBs in Black patients with hypertension. Annals of Pharmacotherapy , 52 (11), 1143– 1151. https://doi.org/10.1177/1060028018779082 Maraboto, C., & Ferdinand, K. C. (2020). Update on hypertension in African- Americans. Progress in Cardiovascular Diseases , 63 (1), 33– 39. https://doi.org/10.1016/j.pcad.2019.12.002 World Health Organization. (2021). Recommendations . Guideline for the Pharmacological Treatment of Hypertension in Adults - NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK573627/#ch3.s4

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