Drugs for chronic heart failure

Some Drugs for Chronic Heart Failure Page 71 Treatment Guidelines Published by The Medical Letter, Inc.. Some of the drugs commonly used now for treatment of chronic heart failure are li

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Drugs for Chronic Heart Failure p 69

Drugs for Chronic Heart Failure

Tables

1 Some Drugs for Chronic Heart Failure Page 71

Treatment Guidelines

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Volume 10 (Issue 121) September 2012

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Chronic systolic heart failure is usually associated with

a left ventricular ejection fraction (LVEF) of <40%

Many patients with symptoms of heart failure have

higher ejection fractions, but there is no evidence that

drug treatment of heart failure with preserved systolic

function (LVEF >40%) improves clinical outcomes

Some of the drugs commonly used now for treatment of

chronic heart failure are listed in the table on page 71

(ACE) INHIBITORS — Most experts recommend

prescribing an ACE inhibitor for all patients with

symptomatic heart failure and for asymptomatic

patients with a decreased LVEF or a history of

myocardial infarction (MI) Patients should be titrated

to the highest tolerated dose, targeting the maximum

daily dosages listed in Table 1 on page 71.1,2 ACE

inhibitors improve symptoms in patients with heart

failure (sometimes within the first 48 hours, but more

commonly over 4-12 weeks), decrease the incidence of

hospitalization and MI, and prolong survival

Cautions – ACE inhibitors should be used cautiously

in patients with systolic blood pressure <90 mm Hg, creatinine levels >3 mg/dL, or potassium levels >5.5 mEq/L (>5.0 mEq/L in diabetics) They should not be used in patients with a history of angioedema or with bilateral renal artery stenosis ACE inhibitors cause increased fetal mortality and should not be used dur-ing pregnancy (first trimester, category C [risk cannot

be ruled out]; second and third trimesters, category D [positive evidence of risk])

Adverse Effects – The most common adverse effects

of ACE inhibitors are thought to be related to inhibit-ing breakdown of endogenous kinins (cough and, less commonly, angioedema), suppression of angiotensin II (hyperkalemia, hypotension and renal insufficiency), and reduction of aldosterone production (hyper-kalemia) Cough and angioedema can usually be relieved by replacing the ACE inhibitor with an angiotensin receptor blocker (ARB); ARBs do not increase concentrations of kinins to the same degree

Formulary Considerations – A few ACE inhibitors are

not approved for treatment of heart failure, but no data are available showing that any ACE inhibitor is more effective than any other for treatment of heart failure

ANGIOTENSIN RECEPTOR BLOCKERS (ARBs) — Long-term therapy with an ARB reduces

the risk of death, MI and other cardiovascular events

in patients with systolic heart failure; results appear to

be similar to those obtained with ACE inhibitors ARBs should be used in patients with heart failure and LVEF <40% who cannot tolerate the common ACE-inhibitor-induced cough

Cautions – As with ACE inhibitors, blood pressure,

renal function and serum potassium concentrations should be monitored in patients taking ARBs They also should not be used during pregnancy Pregnancy ratings for ARBs are the same as those for ACE inhibitors

RECOMMENDATIONS — Unless there is a

spe-cific contraindication, all patients with heart failure

and systolic dysfunction (LVEF <40%) should take

both an ACE inhibitor and a beta blocker, and if

vol-ume overloaded, a diuretic as well An angiotensin

receptor blocker (ARB) is recommended for

patients who cannot tolerate an ACE inhibitor

Addition of an aldosterone antagonist can be

bene-ficial for patients with symptomatic heart failure or

for patients with left ventricular dysfunction after a

myocardial infarction A combination of

hydralazine and isosorbide dinitrate added to

stan-dard therapy has been effective in

African-American patients with class III-IV heart failure

Digoxin can decrease symptoms and lower the rate

of hospitalization for heart failure, but does not

decrease mortality There is no evidence that any

drug improves clinical outcomes in patients with

heart failure with preserved systolic function

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Drugs for Chronic Heart Failure

Treatment Guidelines from The Medical Letter • Vol 10 ( Issue 121) • September 2012

Adverse Effects – ARBs, like ACE inhibitors, block

the effects of angiotensin II and may cause

hypoten-sion, renal insufficiency and hyperkalemia They do

not cause cough Angioedema has occurred, but less

commonly than with ACE inhibitors

Formulary Considerations – Candesartan and

valsar-tan are the only ARBs approved by the FDA for

treatment of heart failure; losartan, which is available

generically, has also been widely used.3,4 Many

Medical Letter reviewers believe that all ARBs could

be effective for this indication

BETA-ADRENERGIC BLOCKERS — Most

guide-lines recommend use of a beta blocker in addition to an

ACE inhibitor for patients with symptomatic systolic

heart failure and for asymptomatic patients with a

decreased LVEF Use of bisoprolol, carvedilol or

sus-tained-release metoprolol succinate consistently leads

to a 30-40% reduction in mortality and hospitalization

in adults with New York Heart Association (NYHA)

class II–IV heart failure These results are less certain

in children and adolescents.5

Cautions – Beta blockers should be started at a low

dose Dosage should be increased gradually, usually at

2-week intervals, to the highest tolerated dose, targeting

the maximum daily dosages listed in Table 1 on page

71 Full clinical benefits may not occur for 3-6 months

or more Beta blockers should be used cautiously, if at

all, in patients with asthma or severe bradycardia

Adverse Effects – Fatigue, hypotension,

asympto-matic fluid retention, and worsening heart failure may

occur during the first 2-4 weeks of treatment

Increasing the dose of a concurrent diuretic may be

helpful for fluid retention

Formulary Considerations – There is no published

evidence supporting the effectiveness of beta blockers

other than bisoprolol, carvedilol, sustained-release

metoprolol succinate or nebivolol for treatment of heart

failure Bisoprolol and nebivolol are not approved for

treatment of heart failure by the FDA, and nebivolol

appears to be the least effective of the four.6

ALDOSTERONE ANTAGONISTS — Some

guide-lines recommend the addition of an aldosterone

antagonist only in selected patients with moderately

severe to severe symptoms of heart failure and reduced

ejection fraction, but addition of eplerenone to standard

therapy in mildly symptomatic heart failure patients

(NYHA class II) with systolic dysfunction has

signifi-cantly reduced both the risk of death and the risk of

hospitalization.7When used in addition to standard

ther-apy in patients with LVEF <40% and heart failure after

MI, one study found that eplerenone significantly

70

reduced the primary endpoints of all-cause mortality and mortality or hospitalization for cardiovascular reasons.8

Adverse Effects – Hyperkalemia may occur,

especial-ly in patients also taking potassium supplements or an ACE inhibitor or ARB, and in those with renal impair-ment Aldosterone antagonists should be avoided in patients with a baseline serum creatinine concentration higher than 2.0 (women) or 2.5 (men) mg/dL (or crea-tinine clearance <30 mL/min) or a serum potassium concentration >5.0 mEq/L Spironolactone has anti-androgenic activity and can cause painful gyneco-mastia and erectile dysfunction in men and menstrual irregularities in women; the incidence of these effects has been reported to be lower with eplerenone

Formulary Considerations – Eplerenone may be

similar in effectiveness to spironolactone and may have less anti-androgenic activity, but it costs much more Comparative studies of their use in heart failure are lacking

VASODILATORS — Concurrent use of two oral

vasodilators, hydralazine and isosorbide dinitrate, may

be helpful for patients who cannot tolerate or continue

to have significant symptoms with standard therapy The addition of a fixed-dose combination of

hydralazine and isosorbide dinitrate (BiDil) to standard

therapy in African-American patients with NYHA class III-IV heart failure significantly lowered mortal-ity and the rate of first hospitalization for heart failure while improving quality-of-life scores.9

Adverse Effects – Hydralazine/isosorbide dinitrate

can cause headache and dizziness Hydralazine alone can cause tachycardia, peripheral neuritis and a lupus-like syndrome A phosphodiesterase inhibitor such as

sildenafil (Viagra, Revatio), vardenafil (Levitra,

Staxyn, and others) or tadalafil (Cialis, Adcirca) should

not be taken concurrently with hydralazine/isosorbide dinitrate because of the risk of additive hypotension

DIURETICS — Most patients with heart failure have

fluid retention In these patients, diuretics relieve symptoms, but their effect on survival is unknown Diuretics provide symptomatic relief of pulmonary and peripheral edema more rapidly than other drugs used for the treatment of heart failure Diuretics that act on the loop of Henle, such as furosemide, bumetanide or torsemide, are more effective than thi-azide diuretics, such as hydrochlorothithi-azide, which act

on the distal tubule

Dosage – Diuretics should be started at a low dose,

which can be titrated upward until urine output

increas-es and weight decreasincreas-es Patients with renal dysfunc-tion or prior refractoriness to loop diuretics can be

start-ed at higher doses Intravenous (IV) administration,

concurrent use of 2 diuretics (1 loop, 1 thiazide-like) or

addition of an aldosterone antagonist can sometimes

overcome diuretic resistance

Adverse Effects – The most common adverse effect of

diuretic therapy is hypokalemia Diuretics can also

cause worsening of renal function

Formulary Considerations – Torsemide is better

absorbed than furosemide and has a longer duration of

action, but there is no clinical evidence that torsemide

or bumetanide is more effective than furosemide, which has been used longer

DIGITALIS — Digoxin can decrease the symptoms

of heart failure, increase exercise tolerance and decrease the rate of hospitalization, but it does not increase survival.10

Dosage – A low dose of digoxin (0.125 mg/d) is

gener-ally recommended for patients with chronic systolic

Initial Maximum

Angiotensin-Converting Enzyme (ACE) Inhibitors

Angiotensin Receptor Blockers (ARBs)

Beta-Adrenergic Blockers

Metoprolol succinate ext release – generic 12.5-25 mg once 200 mg once 53.70

Aldosterone Antagonists

Vasodilators

Isosorbide dinitrate/hydralazine –

Loop Diuretics

in divided doses

Digitalis Glycosides

* Not approved by the FDA for treatment of heart failure.

1 Wholesale acquisition cost (WAC) for 30 days' treatment at the lowest maximum dosage Source: PricePointRx™ Reprinted with permission by FDB All rights reserved ©2012 http://www.firstdatabank.com/support/drug-pricing-policy.aspx Accessed August 7, 2012 Actual retail prices may be higher.

2 A 30-day supply costs $4.00 at some large discount pharmacies.

3 Cost of two 20-mg tablets of isosorbide dinitrate plus 3 25-mg tablets of hydralazine given tid.

4 BiDil is a fixed-dose combination that contains 20 mg isosorbide dinitrate and 37.5 mg hydralazine in each tablet.

Table 1 Some Drugs for Chronic Heart Failure

Treatment Guidelines from The Medical Letter • Vol 10 ( Issue 121) • September 2012

72

Drugs for Chronic Heart Failure

heart failure Dose adjustments based on renal function,

age, and concomitant medications may be required

Adverse Effects – The most common adverse effects

of digitalis glycosides are conduction disturbances,

cardiac arrhythmias, nausea, vomiting, confusion and

visual disturbances

NEW APPROACHES — n-3 polyunsaturated fatty

acids (PUFA) have potent anti-inflammatory actions A

large trial in patients with NYHA class II-IV systolic

heart failure (GISSI-HF) found that PUFA 1 gram daily

added to standard therapy for a median of 3.9 years

modestly reduced all-cause mortality and

hospitaliza-tions for cardiovascular reasons compared to placebo.11

Aliskiren (Tekturna) is a direct renin inhibitor

approved for treatment of systemic hypertension

Whether aliskiren should replace or be added to ACE

inhibitors in patients with systolic heart failure is

under investigation An observed increase in adverse

events in patients with type 2 diabetes and renal

impairment treated with aliskiren in addition to an

ACE inhibitor or ARB has raised safety concerns.12

Ivabradine is a selective If current inhibitor that

slows heart rate It is available in Europe, but not in

the US or Canada Added to standard therapy for

patients with NYHA class II-III systolic heart failure,

ivabradine reduced the incidence of death due to heart

failure and hospital admission for heart failure The

benefit diminished for patients with lower baseline

resting heart rates and those taking higher doses of

beta blockers.13

1 J Lindenfeld et al Executive summary: HFSA 2010 comprehensive

heart failure practice guideline J Card Fail 2010; 16:475 Available at

onlinejcf.com Accessed August 8, 2012.

2 M Jessup et al 2009 Focused update: ACCF/AHA guidelines for the

diagnosis and management of heart failure in adults: a report of the

American College of Cardiology Foundation/American Heart

Association Task Force on Practice Guidelines: developed in

collabo-ration with the International Society for Heart and Lung

Transplantation Circulation 2009; 119:1977.

3 H Svanström et al Association of treatment with losartan vs candesartan

and mortality among patients with heart failure JAMA 2012; 307:1506.

4 MA Konstam et al Effects of high-dose versus low-dose losartan on

clinical outcomes in patients with heart failure (HEAAL study): a

ran-domized, double-blind trial Lancet 2009; 374:1840.

5 RE Shaddy et al Carvedilol for children and adolescents with heart

failure: a randomized controlled trial JAMA 2007; 298:1171.

6 Nebivolol (Bystolic) for hypertension Med Lett Drugs Ther 2008;

50:17.

7 F Zannad et al Eplerenone in patients with systolic heart failure and

mild symptoms N Engl J Med 2011; 364:11.

8 B Pitt et al Eplerenone, a selective aldosterone blocker, in patients

with left ventricular dysfunction after myocardial infarction N Engl J

Med 2003; 348:1309.

9 AL Taylor et al Early and sustained benefit on event-free survival and

heart failure hospitalization from fixed-dose combination of

isosor-bide dinitrate/hydralazine Circulation 2007; 115:1747.

10 The Digitalis Investigation Group The effect of digoxin on mortality and

morbidity in patients with heart failure N Engl J Med 1997; 336:525.

11 GISSI-HF Investigators Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial Lancet 2008; 372:1223.

12 In brief: aliskiren trial terminated Med Lett Drugs Ther 2012; 54:5.

13 K Swedberg et al Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study Lancet 2010; 376:875.

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Treatment Guidelines

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1 Explain the current approach to the management of chronic heart failure.

2 Discuss the pharmacologic options available for treatment of chronic heart failure and compare them based on their efficacy, dosage and administration, potential adverse effects and drug interactions.

3 Determine the most appropriate therapy given the clinical presentation of an individual patient.

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Treatment Guidelines from The Medical Letter • Vol 10 ( Issue 121) • September 2012

1 Chronic heart failure is associated with a left ventricular ejection

fraction of:

a <50%

b <40%

c <30%

d <20%

Issue 121

2 In patients with symptomatic heart failure, ACE inhibitors:

a improve symptoms

b decrease hospitalizations

c prolong survival

d all of the above

Issue 121

3 The most common adverse effect of ACE inhibitors is:

a cough

b angioedema

c hypokalemia

d dizziness

Issue 121

4 ARBs:

a are less effective than ACE inhibitors for treatment of chronic

heart failure

b have been shown to cause more hyperkalemia than ACE

inhibitors

c do not cause cough

d all of the above

Issue 121

5 A 30-40% reduction in heart failure mortality in adults has been

demonstrated with which of the following beta-blockers?

a bisoprolol

b carvedilol

c sustained-release metoprolol succinate

d all of the above

Issue 121

6 Hyperkalemia can occur with:

a ACE inhibitors

b ARBs

c aldosterone antagonists

d all of the above

Issue 121

7 A combination of hydralazine and isosorbide dinitrate has been

shown to be helpful particularly in heart failure patients who are:

a unable to tolerate an ACE inhibitor

b African-American

c >65 years old

d all of the above

Issue 121

8 Because of the risk of additive hypotension, patients taking a combination of hydralazine and isosorbide dinitrate should not take:

a vitamin B12 supplements

b Viagra

c St John’s wort

d eplerenone

Issue 121

9 A 66-year-old man with NYHA class III heart failure being treated with losartan and carvedilol comes to your office complaining of shortness of breath On physical examination, he has bilateral rales and edema in both lower extremities The most effective treatment for symptomatic relief probably would be:

a a combination of hydralazine and isosorbide dinitrate

b a thiazide diuretic

c a loop diuretic

d spironolactone

Issue 121

10 In patients with heart failure, digoxin has not been shown to:

a improve symptoms

b decrease hospitalizations

c increase survival

d any of the above

Issue 121

11 A 46-year-old Caucasian man presents post-MI with NYHA class

IV heart failure and a LVEF of 29% He is currently being treated with an ACE inhibitor and metoprolol succinate Addition of which

of the following may improve survival in this patient?

a digoxin

b hydrochlorothiazide

c an aldosterone antagonist

d hydralazine and isosorbide dinitrate

Issue 121

12 A 79-year-old woman presents with mild symptoms of heart fail-ure and a LVEF of 51% You could tell her that:

a drug treatment of heart failure probably will not increase her life expectancy

b low doses of digoxin will increase her life expectancy

c taking an ARB will lower her risk of being hospitalized

d the combination of hydralazine and isosorbide dinitrate has been shown to benefit patients like her

Issue 121

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