What changes in therapy would you recommend if the patient is tolerating the current drug therapy but had not achieved the desire BP control (average BP162/88)?

Hypertension Case Study #1

D. G. is a 54-year-old African American male who comes into the clinic for a “blood pressure check”. He states that his previous physician told him that his blood pressure was high and too loose weight. He was supposed to follow up in four weeks but did not return to the clinic. His current blood pressure is 172/92. D.G. states that he feels fine and does not have time to exercise.

PMH

-hyperlipidemia

-hypertension

-surgical repair for broken ankle (7 years ago)

FH

Father died of heart disease at age 80, but his first MI was at 44; mother died at age 68 and had HTN and diabetes; brother (age 50) has HTN and high cholesterol; younger sister (age 42) has diabetes and HTN.

SH

He has been married for 30 years and has 1 daughter and 1 son who are healthy. He is a current smoker 1 ppd for 20 years. He occasionally drinks alcohol (1-2 drinks per week). His diet consists mainly of fast food and starchy carbohydrates. D. G. likes to drink regular soda pop

Meds

-Simvastatin 20 mg every evening

-Acetaminophen 500 mg as needed for pain

ALL

-NKDA

VS

BP 172/92, HR 80, wt 250 lbs., 6” ft. 5”

Questions: Please read all of the questions before answering. Your references should be from the textbook, clinical or evidenced based guidelines, or peer reviewed journals. Points will be deducted for references that are not from the above sources.

1. Define the patient’s problem. Refer to chapter 3 Rationale for prescribing

5pts

2. What is the therapeutic objective for treating this patient? 5pts

3. The patient has already been diagnosed with hypertension. What are his risk factors (modifiable and non-modifiable for cardiovascular disease)? 5pts

4. List the goals of treatment for this patient. This is different from question 2

5pts

5. What nonpharmacologic therapies are necessary for this patient to achieve and maintain adequate blood pressure reduction? 5pts

6. What reasonable pharmacotherapeutic options are available for controlling this patient’s blood pressure? 5pts

7. Outline a specific and appropriate pharmacotherapeutic regimen for this patient, including:

a. Drug name, dose & dosage, form, route, regimen, duration and purpose.

b. Identify the medication classification

c. Mechanism of action

d. Major adverse effects and side effects

e. Contraindications

f. Safety alerts and precautions

g. Determination of clinical efficacy 15pts

8. What clinical guideline/standard of practice guidelines support your medication selection?

State the specific clinical guideline used.

How do these guidelines relate to your patient?

Include dosage, patient variables, follow up, diagnostic tests, and maintenance regimens.

10pts

9. Outline specific lifestyle modifications for this patient. 5pts

10. Based on your recommendations, provide appropriate education to this patient. Include how you would assess the patient’s level of understanding.

10pts

Clinical Course

DG two month follow up appointment, he states that he has been walking 2 miles a day, and has been adherent to his medications as prescribed He states that he is having difficulty with healthy eating. His average blood pressure is 140/82.

11. What instructions should you give the patient at this point in his therapy. 5pts

12. What changes in therapy would you recommend if the patient now complains of intolerable adverse effects due to the current antihypertensive drug therapy. Outline an appropriate change to his current therapy. Include rationale and clinical guideline used to support the change.

10pts

13. What changes in therapy would you recommend if the patient is tolerating the current drug therapy but had not achieved the desire BP control (average BP162/88)? Outline an appropriate change to her current therapy. Include rationale and clinical guideline used to support the change.

10pts

Use of APA format to cite sources and references 5pts

Define the patient’s problem.

5pts

The prevalence of hypertension is high in the United States and worldwide, and treatment of hypertension is the most common reason for office visits of nonpregnant adults to clinicians in the United States and for use of prescription drugs. In addition, roughly half of hypertensive individuals do not have adequate blood pressure control

Hypertension — The following definitions and staging system, which are based upon appropriately measured blood pressure , were suggested in 2017 by the American College of Cardiology/American Heart Association (ACC/AHA); proper measurement technique, which is detailed below, is of paramount importance when identifying patients as having hypertension:

Normal blood pressure – Systolic <120 mmHg and diastolic <80 mmHg

Elevated blood pressure – Systolic 120 to 129 mmHg and diastolic <80 mmHg

Hypertension:

Stage 1 – Systolic 130 to 139 mmHg or diastolic 80 to 89 mmHg

Stage 2 – Systolic at least 140 mmHg or diastolic at least 90 mmHg

If there is a disparity in category between the systolic and diastolic pressures, the higher value determines the stage. Isolated systolic hypertension is defined as a blood pressure ≥130/<80 mmHg, and isolated diastolic hypertension is defined as a blood pressure <130/≥80 mmHg. Patients with a blood pressure ≥130/≥80 mmHg are considered to have mixed systolic/diastolic hypertension.

Mr G a 54 years old African American male with a history significant for Hyperlipidemia, hypertension presented to the clinic with a blood pressure of 172/92 and asymptomatic. According to ACC/HA, he has a stage 2 Hypertension. And seemed to be non compliant with his management regimen including diet and exercise . He obviously needs to be on anti hypertensive medication. But one this however is to focus on what medication will be most effective According to (Woo , 2016), WHO recommends a proper diagnosis prior to prescribing any medication is the first step , a determination of the therapeutic goal and objectives . Having these factors in mind, it is important that Mr has a clear knowledge of the treatment plan and encouraged to participate in the selection options available to optimize compliance.

What is the therapeutic objective for treating this patient? 5pts

The therapeutic objectives for treating Mr G are to prevent the occurrence of cardiovascular disease due to damage to the heart and blood vessels caused by sustained high blood pressure, and consequent functional impairment and death. In patients who have already developed cardiovascular disease, treatment is aimed at preventing progression or recurrence, reducing mortality and, thus, helping patients with hypertension to lead their lives as do healthy people.

The higher the risk of cardiovascular disease, the greater the effect of hypertension treatment.The results of randomized case–control comparative studies provide the best scientific basis for evaluating the effects of antihypertensive treatment (lifestyle modifications and drug therapy). However, the effects of antihypertensive drug therapy are often underestimated in randomized case–control comparative studies, and the duration of such studies is only a few years, whereas hypertension is treated over a lifetime. Therefore, the significance of the results of randomized case–control comparative studies is limited. ( )

The patient has already been diagnosed with hypertension. What are his risk factors (modifiable and non-modifiable for cardiovascular disease)? 5pts

Hypertension is associated with a significant increase in risk of adverse cardiovascular and renal outcomes. Each of the following complications is closely associated with the presence of hypertension

Left ventricular hypertrophy (LVH)

Heart failure, both reduced ejection fraction (systolic) and preserved ejection fraction (diastolic)

Ischemic stroke ,Intracerebral hemorrhage , ischemic heart disease, including myocardial infarction and coronary interventions)

Quantitatively, hypertension is the most important modifiable risk factor for premature cardiovascular disease, being more common than cigarette smoking, dyslipidemia, or diabetes, which are the other major risk factors. Hypertension often coexists with these other risk factors as well as with overweight/obesity, an unhealthy diet, and physical inactivity. The presence of more than one risk factor increases the risk of adverse cardiovascular events.

The likelihood of having a cardiovascular event increases as blood pressure increases. In a meta-analysis of over one million adults, risk began to rise in all age groups with blood pressures greater than 115/75 mmHg . For every 20 mmHg higher systolic and 10 mmHg higher diastolic blood pressure, the risk of death from heart disease or strokes doubles.

The 2017 American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the management of hypertension summarized the available meta-analyses of observational data by comparing the cardiovascular risk of different blood pressure strata with a reference group that had a blood pressure <120/80 mmHg. A blood pressure of 120 to 129/80 to 84 mmHg was associated with a hazard ratio of 1.1 to 1.5 for cardiovascular events, and blood pressure of 130 to 139/85 to 89 mmHg was associated with a hazard ratio of 1.5 to 2.0. This relationship was consistent across sex and race/ethnic subgroups but was somewhat attenuated among older adults.

The prognostic significance of systolic and diastolic blood pressure as a cardiovascular risk factor appears to be age-dependent. The systolic pressure and the pulse pressure are greater predictors of risk in patients over the age of 50 to 60 years . Under age 50 years, diastolic blood pressure is a better predictor of mortality than systolic readings . Systolic hypertension and pulse pressure in older individuals are discussed in detail separately.

While hypertension is associated with a relative increase in cardiovascular risk regardless of other cardiovascular risk factors, importantly, the absolute risk of cardiovascular risk is dependent on age and other cardiovascular risk factors in addition to the level of blood pressure

List the goals of treatment for this patient. This is different from question 2

5pts

The ultimate goal of antihypertensive therapy for Mr G is a reduction in cardiovascular events. The higher the absolute cardiovascular risk, the more likely it is that Mr G will benefit from a more aggressive blood pressure goal. However, although cardiovascular events generally decrease with more intensive lowering of blood pressure, the risk of adverse effects, cost, and patient inconvenience increase as more medication is added.

According to recommendations made by the 2017 ACC/AHA guidelines) , a goal blood pressure of <130 mmHg systolic and <80 mmHg diastolic using out-of-office measurements (or, if out-of-office blood pressure is not available, then an average of appropriately measured office readings) in most patients who qualify for antihypertensive pharmacologic therapy. Identifying patients for initiation of antihypertensive drug therapy is presented above.

Some believe that, among selected hypertensive patients who qualify for antihypertensive therapy but who are at low absolute cardiovascular risk, a less aggressive goal blood pressure of <135/<85 mmHg (using out-of-office measurement) or <140/<90 mmHg (using an average of appropriately measured office readings) is appropriate.

Once blood pressure goal is determined on Mr. G, it should be recorded in his medical record, explicitly explained to the him. After antihypertensive therapy is initiated, Mr G should be re-evaluated and therapy should be increased monthly until adequate blood pressure control is achieved. Once blood pressure control is achieved, patients should be reevaluated every three to six months to ensure maintenance of control.

What nonpharmacologic therapies are necessary for this patient to achieve and maintain adequate blood pressure reduction? 5pts

Nonpharmacologic therapy — Treatment of hypertension should involve nonpharmacologic therapy (also called lifestyle modification) alone or in concert with antihypertensive drug therapy . We suggest that at least one aspect of nonpharmacologic therapy should be addressed at every office visit.

Dietary salt restriction – In well-controlled randomized trials, the overall impact of moderate sodium reduction is a fall in blood pressure in hypertensive and normotensive individuals of 4.8/2.5 and 1.9/1.1 mmHg, respectively. The effects of sodium restriction on blood pressure, cardiovascular disease, and mortality as well as specific recommendations for sodium intake, are discussed in detail elsewhere.

Potassium supplementation, preferably by dietary modification, unless contraindicated by the presence of chronic kidney disease or use of drugs that reduce potassium excretion

Weight loss – Weight loss in overweight or obese individuals can lead to a significant fall in blood pressure independent of exercise. The decline in blood pressure induced by weight loss can also occur in the absence of dietary sodium restriction , but even modest sodium restriction may produce an additive antihypertensive effect. The weight loss-induced decline in blood pressure generally ranges from 0.5 to 2 mmHg for every 1 kg of weight lost, or about 1 mmHg for every 1 pound lost.

DASH diet – The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is high in vegetables, fruits, low-fat dairy products, whole grains, poultry, fish, and nuts and low in sweets, sugar-sweetened beverages, and red meats. The DASH dietary pattern is consequently rich in potassium, magnesium, calcium, protein, and fiber but low in saturated fat, total fat, and cholesterol. A trial in which all food was supplied to normotensive or mildly hypertensive adults found that the DASH dietary pattern reduced blood pressure by 6/4 mmHg compared with a typical American-style diet that contained the same amount of sodium and the same number of calories. Combining the DASH dietary pattern with modest sodium restriction produced an additive antihypertensive effect. These trials and a review of diet in the treatment of hypertension are discussed in detail elsewhere.

Exercise – Aerobic exercise, and possibly resistance training, can decrease systolic and diastolic pressure by, on average, 4 to 6 mmHg and 3 mmHg, respectively, independent of weight loss. Most studies demonstrating a reduction in blood pressure have employed three to four sessions per week of moderate-intensity aerobic exercise lasting approximately 40 minutes for a period of 12 weeks.

Limited alcohol intake – Women who consume two or more alcoholic beverages per day and men who have three or more drinks per day have a significantly increased incidence of hypertension compared with non drinkers . Adult men and women with hypertension should consume, respectively, no more than two and one alcoholic drinks daily

What reasonable pharmacotherapeutic options are available for controlling this patient’s blood pressure? 5pts

Pharmacologic therapy — In large-scale randomized trials, pharmacologic antihypertensive therapy, as compared with placebo, produces a nearly 50 percent relative risk reduction in the incidence of heart failure, a 30 to 40 percent relative risk reduction in stroke, and a 20 to 25 percent relative risk reduction in myocardial infarction These relative risk reductions correspond to the following absolute benefits: antihypertensive therapy for four to five years in patients whose blood pressure is 140 to 159 mmHg systolic or 90 to 99 mmHg diastolic prevents a coronary event in 0.7 percent of patients and a cerebrovascular event in 1.3 percent of patients for a total absolute benefit of approximately 2 percent

Equal if not greater relative risk reductions have been demonstrated with antihypertensive treatment of older hypertensive patients (over age 65 years), most of whom have isolated systolic hypertension. Because advanced age is associated with higher overall cardiovascular risk, even modest and relatively short-term reductions in blood pressure may provide absolute benefits that are greater than that observed in younger patients.

My preferred therapy for Mr G would a Long acting dipyridamole calcium channel blocker like amlodipine and then add an additional group of anti hypertensive if the treatment is not meeting the goal. This is contrary to the recommendations by JNC-8. The reason for my preferred treatment option is to monitorthe effect of one medication before adding an additional group. Also Mr G problem isnon compliant with very few comorbidity.

Amlodipine

Amlodipine (Novasc) Oral: Initial: 2.5 to 5 mg once daily; will titrate every 1 to 2 weeks as needed based on Mr G’s response; maximum: 10 mg/day (ACC/AHA [Whelton 2017])

Classification: Norvasc is an anti hypertensive , it belongs to Dihydropyridine

calcium channel blocker

Mechanism of action :Amlodipine is a calcium channel blocker that acts by inhibiting the influx of calcium ions into the myocytes and vascular smooth layer, thereby blocking contraction of the cardiac muscle cell and vascular smooth muscle layer . The effect is to normalize blood pressure.

The Major adverse effects and side effects of amlodipine includes: Peripheral

edema ,Pulmonary edema , palpitation, Fatigue, drowsiness`,abdominal pain muscle cramps and weakness

Amlodipine is contraindicated in people with known hypersensitivity to amlodipine or its formulation, some argue that it is also contra indicated during breast feeding

Safety alerts and precautions ; it is recommended that amlodipine be initiated at a low dose. Symptomatic hypotension can occur; acute hypotension upon initiation is unlikely due to the gradual onset of action. Blood pressure must be lowered at a rate appropriate for the patient’s clinical condition.

Determination of clinical efficacy 15pts

Efficacy is the capacity to produce an effect (eg, lower BP). Efficacy can be assessed accurately only in ideal conditions (ie, when patients are selected by proper criteria and strictly adhere to the dosing schedule). Thus, efficacy is measured under expert supervision in a group of patients most likely to have a response to a drug, such as in a controlled clinical trial.

Obviously, a drug (or any medical treatment) should be used only when it will benefit a patient. Benefit takes into account both the drug’s ability to produce the desired result (efficacy) and the type and likelihood of adverse effects (safety). Cost is commonly also balanced with benefit ( ESH/ESC 2013 )

Amlodipine is an excellent first-line choice among the myriad options of antihypertensive agents. According to (Packer M, Carson P, Elkayam U et al ), amlodipine was highly effective for the treatment of HTN and stable angina as evidenced by the fewer hospitalizations for unstable angina and revascularization in randomized controlled trials Amlodipine has also shown robust reductions on CV end points (especially stroke) but has not altered the prognosis in HF. Its abilities to prevent activation of counter-regulatory mechanisms, to slow the progression of atherosclerosis, to confer antioxidant properties and to enhance NO production are all unique actions. The management of HTN is shifting more towards dual or even triple combination therapy and requires a patient profiling approach as the number of comorbid states increases. Amlodipine is a superior option in the HTN armamentarium, not only for controlling BP but also for safely improving patient outcomes.

Clinical guideline for Hypertensive treatment .

Guideline recommendations: The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults recommends if monotherapy is warranted, in the absence of comorbidities (eg, cerebrovascular disease, chronic kidney disease, diabetes, heart failure, ischemic heart disease), that thiazide-like diuretics or dihydropyridine calcium channel blockers may be preferred options due to improved cardiovascular end points (eg, prevention of heart failure and stroke). ACE inhibitors and ARBs are also acceptable for monotherapy. Combination therapy may be required to achieve blood pressure goals and is initially preferred in patients at high risk (stage 2 hypertension or atherosclerotic cardiovascular disease [ASCVD] risk ≥10%) (ACC/AHA [Whelton 2017]).

Outline specific lifestyle modifications for this patient. 5pts

Life style modification will optimize management of hypertension . This measure will lower blood pressure and prevent complications from high blood pressure, it will also reduce the need for additional medication. Some of the important life style changes that Mr G needs are : weight loss. When people think about losing weight, they sometimes make it more complicated than it really is. To lose weight, Mr G should either eat less or move more. If he does both of those things, it’s even better. But there is no single weight-loss diet or activity that’s better than any other. When it comes to weight loss, the most effective plan is the one that he will stick with.

Reduction in alcohol intake to no more than 2 standard drinks a day and smoking cessation are also advised. Information on hotline for smoking cessation can be provided

Clinical Course

DG two month follow up appointment, he states that he has been walking 2 miles a day, and has been adherent to his medications as prescribed He states that he is having difficulty with healthy eating. His average blood pressure is 140/82.

What instructions should you give the patient at this point in his therapy. 5pts

At this point , Mr G has shown a n improvement in his blood pressure, He has made some progress in some of his life style, He is able to walk and is compliant with his medication but continues to have problem adhering to eating healthy. These positive changes have to be recognized while encouragement on healthy diet is needed. He may be referred to a Nutritionist to address the problem.

What changes in therapy would you recommend if the patient now complains of intolerable adverse effects due to the current antihypertensive drug therapy. Outline an appropriate change to his current therapy. Include rationale and clinical guideline used to support the change.

10pts

Thiazide diuretics is an option in managing Mr G if he can not tolerate a calcium channel blocker. The preferred thiazide diuretic in patients with primary hypertension is chlorgalidone since major trials such as ALLHAT have shown benefit with this regimen. There is little, if any, evidence that hydrochlorothiazide improves cardiovascular outcomes. Hydrochlorothiazide is both less potent and shorter acting than chlorthalidone and indapamide. (Roush GC, Ernst ME, Kostis JB, et al 2015)

According to Roush GC , et al (2015)One problem with low-dose chlorthalidone that there is no 12.5 mg tablet. Thus, 25 mg tablets of generic chlorthalidone need to be cut in half; however, these tablets are not scored, and attempts to halve them may result in uneven dosing. In addition, in patients who require combination therapy, fixed-dose combination pills of chlorthalidone with ACE inhibitors and long-acting calcium channel blockers are not available (in contrast to hydrochlorothiazide. Indapamide, an alternative to chlorthalidone, has both a low-dose option available (1.25 mg) and a fixed-dose combination with an ACE inhibitor .

What changes in therapy would you recommend if the patient is tolerating the current drug therapy but had not achieved the desire BP control (average BP162/88)? Outline an appropriate change to her current therapy. Include rationale and clinical guideline used to support the change.

10pts

When amlodipine failed to control Mr G’s blood pressure, another group of antihypertensive should be introduced, a term known by clinicians as combination therapy. Two major issues related to combination therapy include the use of combination therapy as first-line therapy and addition of a second drug when the goal blood pressure is not achieved with monotherapy.

Recommendations for combination therapy were made by the European Society of Hypertension/European Society of Cardiology (ESH/ESC), by the Joint National Committee 8 panel (JNC-8), and by the American and International Societies of Hypertension (ASH/ISH) ( Chow CK , 2017).

First-line combination therapy — Administering two drugs as initial therapy should be considered when the blood pressure is more than 20/10 mmHg above goal, as recommended by the ESH/ESC, the ASH/ISH, and by some members of the JNC-8 panel (Chow, CK,2017). This strategy may increase the likelihood that target blood pressures are achieved in a reasonable time period. Fixed-dose combination preparations are available that may improve patient compliance, blood pressure control, and, if both drugs are given at lower doses, reduce side effects

Based upon the results of the ACCOMPLISH trial , I will recommend the use of a long-acting dihydropyridine calcium channel blocker plus a long-acting angiotensin-converting enzyme (ACE) inhibitor/ARB (such as amlodipine plus benazepril plus as used in ACCOMPLISH)

References

Muntner P, Carey RM, Gidding S, et al. Potential US Population Impact of the 2017 ACC/AHA High Blood Pressure Guideline. Circulation 2018; 137:109.

https://www.cdc.gov/nchs/data/ahcd/namcs_summary/2014_namcs_web_tables.pdf.

Siu AL, U.S. Preventive Services Task Force. Screening for high blood pressure in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2015; 163:778.

Reboussin DM, Allen NB, Griswold ME, et al. Systematic Review for the 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension 2018; 71:e116.

American College of Obstetricians and Gynecologists (ACOG), Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists’ Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. [PubMed 24150027]

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52. doi: 10.1002/cpt.377. [PubMed 27060684]

Funder JW, Carey RM, Mantero F, et al. The management of primary aldosteronism: case detection, diagnosis, and treatment: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016;101(5):1889-1916. doi: 10.1210/jc.2015-4061. [PubMed 26934393]

Go AS, Bauman M, King SM, et al. An effective approach to high blood pressure control: a science advisory from the American Heart Association, the American College of Cardiology, and the Centers for Disease Control and Prevention [published online November 15, 2013]. Hypertension. [PubMed 24243703]

Packer M, Carson P, Elkayam U et al. Effect of amlodipine on the survival of patients with severe chronic heart failure due to a nonischemic cardiomyopathy: results of the PRAISE-2 study (prospective randomized amlodipine survival evaluation 2). JACC Heart Fail 2013;1:308–14. doi:10.1016/j.jchf.2013.04.004 [PubMed]

ESH/ESC Task Force for the Management of Arterial Hypertension. 2013 Practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens 2013; 31:1925.

Mancia G, Fagard R, Narkiewicz K, et al. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens 2013; 31:1281.

Roush GC, Ernst ME, Kostis JB, et al. Head-to-head comparisons of hydrochlorothiazide with indapamide and chlorthalidone: antihypertensive and metabolic effects. Hypertension 2015; 65:1041.

Chow CK, Thakkar J, Bennett A, et al. Quarter-dose quadruple combination therapy for initial treatment of hypertension: placebo-controlled, crossover, randomised trial and systematic review. Lancet 2017; 389:1035.