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Lisinopril

Pronunciation

Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
Chemical Name: (S)-1-[N2-[(S-1- Carboxy-3-phenylpropyl]-l-lysyl-l-proline dihydrate
Molecular Formula: C21H31N3O5•2H2O
CAS Number: 83915-83-7
Brands: Prinivil, Prinzide, Zestoretic, Zestril

Warning(s)

  • May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 2 3 4 74 75 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  • If pregnancy is detected, discontinue lisinopril as soon as possible.1 2 3 4 75

Introduction

Non-sulfhydryl ACE inhibitor.1 2 3 4 5

Uses for Lisinopril

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 3 4 5 12 34

One of several preferred initial therapies in hypertensive patients with heart failure, post-MI, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.55

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Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.55

CHF

Management of symptomatic CHF, usually in conjunction with cardiac glycosides and diuretics.1 2

AMI

Used in conjunction with thrombolytic agents, aspirin, and/or β-adrenergic blocking agents to improve survival in patients with AMI who are hemodynamically stable.1 2 27 Usually initiated within 24 hours of MI.1 2 27

Diabetic Nephropathy

A first-line agent in the treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes mellitus.59 60

Lisinopril Dosage and Administration

General

Hypertension

  • Lisinopril/hydrochlorothiazide fixed combinations should not be used for initial treatment of hypertension.3 4

Administration

Oral Administration

Administer orally once daily without regard to meals.1 2 3 4 Administer as extemporaneously prepared oral suspension in patients unable to swallow tablets.67 69

Reconstitution

Preparation of extemporaneous suspension containing lisinopril 1 mg/mL: Add 10 mL of purified water USP to a polyethylene terephthalate (PET) bottle containing ten 20-mg lisinopril tablets; shake contents for ≥1 minute.1 2 67 69 Add 30 mL of sodium citrate dihydrate (Bicitra) and 160 mL of syrup (Ora-Sweet SF) to the PET bottle; gently shake for several seconds to disperse ingredients.1 2 67 69 Shake suspension before dispensing each dose.1 2 67 69

Dosage

Pediatric Patients

Hypertension
Oral

Children ≥6 years of age: Initially, 0.07 mg/kg (up to 5 mg) once daily.1 2 67 68 69 Adjust dosage until the desired BP goal is achieved (up to maximum dosage of 0.61 mg/kg or 40 mg daily).1 2 67 68 69

Adults

Hypertension
Oral

Initially, 10 mg once daily as monotherapy.1 2 55 Adjust dosage to achieve BP control.13

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating lisinopril.1 2 3 4 May cautiously resume diuretic therapy if BP not controlled adequately with lisinopril alone.1 2 3 4 If diuretic cannot be discontinued, increase sodium intake and initiate lisinopril at 5 mg daily under close medical supervision for at least 2 hours and until BP has stabilized for at least an additional hour.1 2 3 4

Usual dosage: 10–40 mg once daily.1 2 55

If effectiveness diminishes toward end of dosing interval in patients treated once daily (particularly likely with daily dosage of 10 mg), consider increasing dosage or administering drug in 2 divided doses.1 2 12

Lisinopril/Hydrochlorothiazide Combination Therapy
Oral

If BP is not adequately controlled by monotherapy with lisinopril or hydrochlorothiazide, can switch to the fixed-combination preparation containing lisinopril 10 mg and hydrochlorothiazide 12.5 mg or, alternatively, lisinopril 20 mg and hydrochlorothiazide 12.5 mg.3 4 Adjust dosage of either or both drugs according to patient’s response; however, dosage of hydrochlorothiazide should not be increased for about 2–3 weeks after initiation of therapy.3 4

Can switch to the fixed-combination preparation if stable dosages of lisinopril or hydrochlorothiazide have been achieved.3

If BP is controlled by monotherapy with hydrochlorothiazide 25 mg daily but potassium loss is problematic, can switch to fixed-combination preparation containing lisinopril 10 mg and hydrochlorothiazide 12.5 mg.3 4

CHF
Oral

Initially, 2.5–5 mg daily.1 43 Monitor closely (especially patients with systolic BP <100 mg Hg) until BP has stabilized.1 To minimize risk of hypotension, reduce diuretic dosage, if possible.1

Usual dosage: 5–40 mg once daily.1 2 13 14

AMI
Oral

5 mg within 24 hours post-MI, followed by 5 mg 24 hours after initial dose, 10 mg 48 hours after initial dose, and then 10 mg daily.1 2 Recommended maintenance dosage: 10 mg daily for 6 weeks.1 2

If low SBP (≤120 mm Hg) observed when lisinopril therapy is initiated or during the first 3 days post-MI, give lower dose (i.e., 2.5 mg).1 2

If hypotension (SBP <100 mm Hg) occurs, reduce maintenance dosage to 5 mg daily; may temporarily reduce further to 2.5 mg daily if needed.1 2

If prolonged hypotension (SBP <90 mm Hg lasting >1 hour) occurs, discontinue lisinopril.1 2

Prescribing Limits

Pediatric Patients

Hypertension
Oral

Children ≥6 years of age: Maximum 0.61 mg/kg or 40 mg daily.67 68 69

Adults

Hypertension
Oral

Dosages up to 80 mg daily have been used, but no additional benefit observed.1 2

Dosage of lisinopril/hydrochlorothiazide fixed combination generally should not exceed lisinopril 80 mg and hydrochlorothiazide 50 mg daily.3

Special Populations

Renal Impairment

Hypertension

Initially, 5 mg once daily in adults with Clcr 10–30 mL/minute or 2.5 mg once daily in adults with Clcr <10 mL/minute (usually on hemodialysis).1 2 Titrate until BP is controlled or to maximum of 40 mg daily.1 2 Manufacturers do not recommend use in hypertensive pediatric patients with Clcr <30 mL/minute per 1.73 m2.67 69

Lisinopril/hydrochlorothiazide fixed combinations are not recommended in patients with severe renal impairment.3

CHF

Initially, 2.5 mg once daily in CHF patients with moderate to severe renal impairment (Clcr ≤30 mL/minute or Scr >3 mg/dL) under close medical supervision.1 2

AMI

Use with caution in AMI patients with Scr >2 mg/dL.1 2 If renal impairment (Scr >3 mg/dL or a doubling of baseline Scr) occurs during lisinopril therapy, consider discontinuing therapy.1 2

Volume- and/or Salt-depleted Patients

CHF

Initially, 2.5 mg once daily in CHF patients with hyponatremia (serum sodium concentration <130 mEq/L) under close medical supervision.1 2

Geriatric Patients

Generally titrate dosage carefully, initiate therapy at the low end of the dosage range.1 2 3

Cautions for Lisinopril

Contraindications

  • Known hypersensitivity (e.g., history of angioedema) to lisinopril or another ACE inhibitor.1 2 3 4 History of hereditary or idiopathic angioedema.1 3 4

Warnings/Precautions

Warnings

Hypotension

Possible symptomatic hypotension, sometimes associated with oliguria and/or progressive azotemia and, rarely, acute renal failure and/or death.1 2 3 4 Patients at particular risk include those with CHF with BP <100 mm Hg, intensive diuretic therapy or recent increase in diuretic dose, dialysis, or severe volume and/or salt depletion of any etiology.1 2 Risk of marked hypotension in patients with CHF.1 2

Potential for excessive hypotension to result in MI or stroke in patients with AMI1 2 or ischemic cardiovascular or cerebrovascular disease.1 2 3 4 Do not use in patients with AMI at risk of further serious hemodynamic deterioration following treatment with a vasodilator (e.g., those with SBP ≤100 mm Hg) or in those with cardiogenic shock.1 2

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.1 2

To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.1 2 May minimize potential for hypotension by withholding diuretic therapy, reducing diuretic dosage, and/or increasing sodium intake prior to initiation of lisinopril.1 2 (See Dosage under Dosage and Administration.)

In patients at risk of excessive hypotension, initiate therapy under close medical supervision; monitor closely for first 2 weeks following initiation of lisinopril or any increase in lisinopril or diuretic dosage.1 2

If excessive hypotension occurs, immediately place patient in a supine position and, if necessary, administer IV infusion of sodium chloride 0.9%.1 2 Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).1 2 If symptomatic hypotension develops, dosage reduction or discontinuance of lisinopril or diuretic may be necessary.1 2

Hematologic Effects

Neutropenia and agranulocytosis reported with captopril; risk appears to depend principally on presence of renal impairment and/or presence of collagen vascular disease.1 2 3 4 Data insufficient to rule out similar incidence of leukopenia, neutropenia, or agranulocytosis with lisinopril.1 2 3 4 67 69

Consider monitoring leukocyte counts in patients with collagen vascular disease and renal disease.1 2

Hepatic Effects

Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.1 2 3 4

If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.1 2 3 4

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 2 3 4 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.75

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.74 75

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.75 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.76 77

Sensitivity Reactions

Anaphylactoid reactions and/or head and neck angioedema possible; if associated with laryngeal edema, may be fatal.1 2 3 4 67 69 Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.1 2 3 4 Antihistamines and corticosteroids may not provide sufficient relief; prolonged observation may be necessary.1 2 3 Use caution in patients with history of angioedema unrelated to ACE inhibitor therapy.1 2 3 4

Intestinal angioedema possible; consider in differential diagnosis of patients who develop abdominal pain.1 2 3 67 68 69 Manifestations include abdominal pain (with or without nausea or vomiting).1 2 3 67 68 69 Consider intestinal angioedema in the differential diagnosis of patients receiving ACE inhibitors and presenting with abdominal pain.1 2 3 67 68 69

Sudden and potentially life-threatening anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing dialysis with high-flux membranes (e.g., AN69).1 67 69 If anaphylactoid reactions occur, immediately stop dialysis and initiate aggressive therapy (symptoms not relieved by antihistamines).1 67 69 Consider using a different type of dialysis membrane or a different class of antihypertensive agent.1 67 69

Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption.1 2 3 4

Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.1 2 3 4

Not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitors.1 2 3 4

General Precautions

Aortic Stenosis/Hypertrophic Cardiomyopathy

Use with caution in patients with obstruction in the outflow tract of the left ventricle (e.g., aortic stenosis, hypertrophic cardiomyopathy).1 2 3 4

Renal Effects

Transient increases in BUN and Scr possible; more likely to occur in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.1 2 3 4 Possible increases in BUN and Scr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of ACE inhibitor and/or diuretic.1 2 3 4

Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe CHF.1 2 3 4

Closely monitor renal function for the first few weeks of therapy in hypertensive patients with unilateral or bilateral renal-artery stenosis.1 2 Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic.1 2

In patients with AMI who develop renal impairment (Scr >3 mg/dL or a doubling of baseline Scr), consider discontinuing therapy.1 2

Hyperkalemia

Possible hyperkalemia, especially in patients with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).1 2 3 4 (See Specific Drugs under Interactions.)

Cough

Persistent and nonproductive cough; resolves after drug discontinuance.1 2 3 4

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.3 4

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).1 2 3 4 (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)

Lactation

Distributed into milk in rats; not known whether lisinopril is distributed into milk in humans.1 2 3 4 Discontinue nursing or the drug.1 2 3 4

Pediatric Use

Safety and efficacy not established in children <6 years of age or in those with Clcr <30 mL/minute per 1.73 m2.1 2 67 68 69

Geriatric Use

Response in patients ≥65 years of age does not appear to differ from that in younger adults; however, use with caution due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.1 2 3 (See Geriatric Patients under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Renal Impairment

Deterioration of renal function may occur in susceptible patients.1 (See Renal Effects under Cautions.)

Increased lisinopril concentrations, particularly in patients with GFR <30 mL/minute.1 Initial dosage adjustment recommended in patients with severe renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Lisinopril/hydrochlorothiazide fixed combinations are not recommended in patients with severe renal impairment.3

Blacks

BP reduction may be smaller in black patients compared with nonblack patients;1 2 3 4 29 30 53 54 70 71 however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.12 29 31 32 34 Use in combination with a diuretic.12 34

Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.33 54 67 69

Common Adverse Effects

Patients with hypertension: Headache, dizziness, cough, fatigue, diarrhea, upper respiratory tract infection, nausea.1 2 3 4 With fixed combination preparation, muscle cramps, asthenia, orthostatic effects, paresthesia.1 2 3 4

Patients with CHF: Dizziness, hypotension, headache, diarrhea, chest pain, nausea, abdominal pain, rash, upper respiratory tract infection.1 2

Patients with AMI: Hypotension, renal dysfunction.1 2

Interactions for Lisinopril

Specific Drugs

Drug

Interaction

Comments

Digoxin

Interaction unlikely1 2

Diuretics

Increased hypotensive effect1 2 3 4

If possible, discontinue diuretic before initiating lisinopril1 2 3 4 (See Dosage under Dosage and Administration)

Diuretics, potassium-sparing (amiloride, spironolactone, triamterene)

Enhanced hyperkalemic effect1 2 3 4

Use with caution; monitor serum potassium concentrations frequently.1 2 3 4 Concomitant therapy generally not recommended in patients with CHF1 2

Nitrates (nitroglycerin)

Clinically important interaction not observed1 2

NSAIAs

Possible decreased antihypertensive response to lisinopril1 2 3 4 (slightly decreased response observed with concomitant indomethacin)1 2

Potential for acute reduction of renal function in patients with impaired renal function1 3 4

Lithium

Increased serum lithium concentrations; possible toxicity1 2 3 4

Monitor serum lithium concentrations frequently1

Potassium supplements or potassium-containing salt substitutes

Enhanced hyperkalemic effect1

Use with caution; monitor serum potassium concentrations frequently1

Lisinopril Pharmacokinetics

Absorption

Bioavailability

About 25% of oral dose is absorbed.1 2 Absolute bioavailability is about 16% in patients with CHF.1 2

Peak plasma concentrations achieved within 7 hours; time to reach peak plasma concentrations slightly delayed in patients with AMI.1 2

Onset

Following a single oral dose, antihypertensive effects are observed within 1 hour, with peak BP reduction at 6 hours.1 2

During chronic therapy, maximum antihypertensive effect is achieved after 2–4 weeks.1 2

Duration

Antihypertensive effect of a single dose persists for about 24 hours; effect at 24 hours substantially smaller than at 6 hours after dosing.1 2

Food

Food does not affect absorption.1 2

Distribution

Extent

Crosses the blood-brain barrier poorly.1 2

Crosses the placenta and is distributed into milk in rats.1 2

Plasma Protein Binding

Not bound to serum proteins other than ACE.1 2

Elimination

Metabolism

Not metabolized.1 2

Elimination Route

Eliminated principally in urine as unchanged drug.1 2

Removed by hemodialysis.1 2

Half-life

12 hours.1 2

Special Populations

In patients with renal impairment (GFR <30 mL/minute), clearance is decreased, plasma concentrations increased; in patients with GFR ≥30 mL/minute, elimination half-life is minimally altered.1 2

In geriatric patients, peak plasma concentrations and AUCs increased (i.e., may be doubled).1 2

Stability

Storage

Oral

Extemporaneous Suspension

1-mg/mL preparation of lisinopril tablets in syrup (Ora-Sweet SF) (see Oral Administration under Dosage and Administration): Stable up to 4 weeks at ≤25°C.1 2 67 69

Tablets

Conventional tablets: 15–30°C.1 2 Protect from moisture, freezing, and excessive heat.1 2

Fixed combination tablets: 15–30°C.3 Protect from excessive light and moisture.3

Actions

  • Suppresses the renin-angiotensin-aldosterone system.1 2 3 4

Advice to Patients

  • Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.1 2 3 4 Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.1 2 3 4

  • Importance of reporting signs of infection (e.g., sore throat, fever).1 2

  • Risk of hypotension.1 2 3 4 Importance of informing clinicians promptly if lightheadedness or fainting occurs.1 2

  • Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.1 2

  • Risks of use during pregnancy.1 2 3 4 (See Boxed Warning)

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).1 2

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2

  • Importance of advising patients of other important precautionary information.1 2 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Lisinopril

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

2.5 mg*

Zestril

AstraZeneca

5 mg*

Prinivil

Merck

Zestril

AstraZeneca

10 mg*

Prinivil

Merck

Zestril

AstraZeneca

20 mg*

Prinivil

Merck

Zestril

AstraZeneca

30 mg*

Zestril

AstraZeneca

40 mg*

Prinivil

Merck

Zestril

AstraZeneca

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Lisinopril Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

10 mg with Hydrochlorothiazide 12.5 mg*

Prinzide

Merck

Zestoretic

AstraZeneca

20 mg with Hydrochlorothiazide 12.5 mg*

Prinzide

Merck

Zestoretic

AstraZeneca

20 mg with Hydrochlorothiazide 25 mg*

Prinzide

Merck

Zestoretic

AstraZeneca

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Lisinopril 10MG Tablets (LUPIN PHARMACEUTICALS): 30/$13.99 or 90/$32.97

Lisinopril 2.5MG Tablets (LUPIN PHARMACEUTICALS): 30/$12.99 or 60/$23.98

Lisinopril 20MG Tablets (LUPIN PHARMACEUTICALS): 30/$14.99 or 90/$33.97

Lisinopril 30MG Tablets (SANDOZ): 30/$20.99 or 90/$56.97

Lisinopril 40MG Tablets (LUPIN PHARMACEUTICALS): 30/$17.99 or 90/$39.97

Lisinopril 5MG Tablets (LUPIN PHARMACEUTICALS): 30/$14.89 or 60/$17.98

Lisinopril-Hydrochlorothiazide 10-12.5MG Tablets (LUPIN PHARMACEUTICALS): 30/$23.99 or 60/$39.98

Lisinopril-Hydrochlorothiazide 20-12.5MG Tablets (LUPIN PHARMACEUTICALS): 30/$21.99 or 90/$59.97

Lisinopril-Hydrochlorothiazide 20-25MG Tablets (LUPIN PHARMACEUTICALS): 30/$21.99 or 90/$59.97

Prinivil 10MG Tablets (MERCK SHARP &amp; DOHME): 60/$75.99 or 180/$205.96

Prinivil 20MG Tablets (MERCK SHARP &amp; DOHME): 30/$45.99 or 90/$119.97

Prinivil 5MG Tablets (MERCK SHARP &amp; DOHME): 90/$102.98 or 180/$195.96

Prinzide 10-12.5MG Tablets (MERCK SHARP &amp; DOHME): 30/$46.99 or 90/$125.96

Zestoretic 10-12.5MG Tablets (ASTRAZENECA): 30/$56.78 or 90/$147.40

Zestoretic 20-12.5MG Tablets (ASTRAZENECA): 30/$60.05 or 90/$163.77

Zestril 10MG Tablets (ASTRAZENECA): 30/$55.11 or 90/$143.27

Zestril 2.5MG Tablets (ASTRAZENECA): 30/$37.99 or 90/$91.97

Zestril 20MG Tablets (ASTRAZENECA): 30/$52.99 or 90/$149.97

Zestril 30MG Tablets (ASTRAZENECA): 30/$71.99 or 90/$199.98

Zestril 5MG Tablets (ASTRAZENECA): 30/$50.99 or 90/$129.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions April 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Merck. Prinivil (lisinopril) tablets prescribing information. Whitehouse Station, NJ; 2004 Nov.

2. AstraZeneca. Zestril (lisinopril) tablets prescribing information. Wilmington, DE: 2005 Jun.

3. Merck. Prinzide (lisinopril and hydrochlorothiazide) tablets prescribing information. Whitehouse Station, NJ; 2004 Nov.

4. AstraZeneca. Zestoretic (lisinopril and hydrochlorothiazide) tablets prescribing information. Wilmington, DE: 2002 Jan.

5. McAreavey D, Robertson JI. Angiotensin converting enzyme inhibitors and moderate hypertension. Drugs. 1990; 40:326-345. [PubMed 2226219]

6. Squibb. Capoten (captopril) tablets prescribing information. In: Physician’s desk reference. 47th ed. Montvale, NJ: Medical Economics Company Inc; 1993: 2356-62.

7. Reviewer’s comments in Enalaprilat/Enalapril (personal observations).

8. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]

9. Anon. Drugs for hypertension. Med Lett Drugs Ther. 1984; 26:107-12. [PubMed 6150424]

10. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148: 1023-38.

11. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.

12. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

13. Giles TD. Clinical experience with lisinopril in congestive heart failure: focus on the older patient. Drugs. 1990; 39(Suppl. 2):17-22. [PubMed 2160883]

14. Giles TD, Katz R, Sullivan JM et al. Short- and long-acting angiotensin-converting enzyme inhibitors: a randomized trial of lisinopril versus captopril in the treatment on congestive heart failure. J Am Coll Cardiol. 1989; 13:1240-7. [PubMed 2539403]

15. Lancaster SG, Todd PA. Lisinopril, a preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in hypertension and congestive heart failure. Drugs. 1988;35:646-69.

16. Packer M, Lee WH, Kessler PD. Preservation of glomerular filtration rate in human heart failure by activation of the renin-angiotensin system. Circulation. 1986; 74:766-74. [IDIS 224939] [PubMed 3019586]

17. Packer M, Lee WH, Medina N. Functional renal insufficiency during long-term therapy with captopril and enalapril in severe chronic heart failure. Ann Intern Med. 1987; 106:346-54. [IDIS 226752] [PubMed 3028221]

18. Packer M, Lee WH, Yushak M et al. Comparison of captopril and enalapril in patients with severe chronic heart failure. N Engl J Med. 1986; 315:847-53. [IDIS 221364] [PubMed 3018566]

19. Bach R, Zardini P. Long-acting angiotensin-converting enzyme inhibition: once daily lisinopril versus twice daily captopril in mild to moderate heart failure. Am J Cardiol. 1992; 70:70-7C.

20. Zannad F, van den Broek SA, Bory M. Comparison of treatment with lisinopril versus enalapril for congestive heart failure. Am J Cardiol. 1992; 70:78-83C. [PubMed 1377441]

21. Oster JR, Materson BL. Renal and electrolyte complications of congestive heart failure and effects of therapy with angiotensin-converting enzyme inhibitors. Arch Intern Med. 1992; 152:704-10. [IDIS 295733] [PubMed 1558426]

22. Mason N. Angiotensin-converting enzyme inhibitors and renal function. DICP. 1990; 24:496-505. [IDIS 266588] [PubMed 2188438]

23. Baker DW, Konstam MA, Bottorff M. Management of heart failure. JAMA. 1994; 272:1361-6. [IDIS 337704] [PubMed 7933398]

24. Young JB. Angiotensin-converting enzyme inhibitors in heart failure: new strategies justified by recent clinical trials. Int J Cardiol. 1994; 43:151-63. [PubMed 8181869]

25. Sharpe N. ACE inhibitors versus diuretics: when to choose which drug? Cardiovasc Drugs Ther. 1993; 7:877-9. Abstract.

26. Riegger GA. The effects of ACE inhibitors on exercise capacity in the treatment of congestive heart failure. J Cardiovasc Pharmacol. 1990; 15(Suppl 2):S41-6.

27. Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico. GISSI-3: effects of lisinopril and transdermal glyceryl trinitrate single and together on 6-week mortality and ventricular function after acute myocardial infarction. Lancet. 1994; 343:1115-22. [IDIS 329049] [PubMed 7910229]

28. 1988 Joint National Committee. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

29. Saunders E. Tailoring treatment to minority patients. Am J Med. 1990; 88(Suppl 3B):21-3S. [PubMed 2294761]

30. Chrysant SG, Danisa K, Kem DC et al. Racial differences in pressure, volume and renin interrelationships in essential hypertension. Hypertension. 1979; 1:136-41. [PubMed 399939]

31. Holland OB, Kuhnert L, Campbell WB et al. Synergistic effect of captopril with hydrochlorothiazide for the treatment of low-renin hypertensive black patients. Hypertension. 1983; 5:235-9. [PubMed 6337951]

32. Ferguson RK, Vlasses PH, Rotmesch HH. Clinical applications of angiotensin-enzyme inhibitors. Am J Med. 1984; 77:690-8. [IDIS 191617] [PubMed 6091446]

33. Hoechst Marion Roussel. Altace (ramipril) capsules prescribing information. Sommerville, NJ; 1995 Jul.

34. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

35. Rey E, LeLorier J, Burgess E et al. Report of the Canadian Hypertension Society consensus conference: 3. pharmacologic treatment of hypertensive disorders in pregnancy. CMAJ. 1997; 157:1245-54. [IDIS 396283] [PubMed 9361646]

36. American College of Obstetricians and Gynecologists. ACOG technical bulletin No. 219: hypertension in pregnancy. 1996 Jan.

37. Hanssens M, Keirse MJ, Van Assche FA. Fetal and neonatal effects of treatment with angiotensin-converting enzyme inhibitors in pregnancy. Obstet Gynecol. 1991; 78:128-35. [IDIS 284531] [PubMed 2047053]

38. Brent Rl, Beckman D. Angiotensin-converting enzyme inhibitors, an embryopathic class of drugs with unique properties: information for clinical teratology counselors. Teratology. 1991; 43:543-6. [PubMed 1882342]

39. Piper JM, Ray WA, Rosa FW. Pregnancy outcome following exposure to angiotensin-converting enzyme inhibitors. Obstet Gynecol. 1992; 80:429-32. [IDIS 300973] [PubMed 1495700]

40. Sibai BM. Treatment of hypertension in pregnant women. N Engl J Med. 1996; 335:257-65. [IDIS 369138] [PubMed 8657243]

41. Barr M, Cohen MM. ACE inhibitor fetopathy and hypocalvaria: the kidney-skull connection. Teratology. 1991; 44:485-95. [PubMed 1771591]

42. US Food and Drug Administration. Dangers of ACE inhibitors during pregnancy. FDA Med Bull. 1992; 22:2.

43. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9A-38A.

44. Packer M, Poole-Wilson PA, Armstrong PW et al. Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. Circulation. 1999; 100:2312-8. [IDIS 440440] [PubMed 10587334]

45. Pitt B, Zannad F, Remme WJ et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med. 1999; 341:709-17. [IDIS 431313] [PubMed 10471456]

46. Weber KT. Aldosterone and spironolactone in heart failure. N Engl J Med. 1999; 341:753-4. [IDIS 431314] [PubMed 10471464]

47. Anon. Spironolactone for heart failure. Med Lett Drugs Ther. 1999; 41:81-2. [PubMed 10505071]

48. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

49. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

50. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

51. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.

52. Hunt SA, Baker DW, Chin MH et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure).

53. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-42. [IDIS 490723] [PubMed 12479770]

54. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2022; 288:2981-97.

55. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (Also published in JAMA. 2003; 289.

56. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2.

57. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.

58. Novartis. Diovan (valsartan) tablets prescribing information. East Hanover, NJ; 2002 Aug.

59. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2002; 25:134-47. [IDIS 479088] [PubMed 11772914]

60. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2002; 25(Suppl 1):S33-43.

61. American Diabetes Association. Clinical Practice Recommendations 2002. Position Statement. Diabetic nephropathy. Diabetes Care. 2002; 25(Suppl 1):S85-9.

62. Lewis EJ, Hunsicker LG, Bain RP et al. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1993; 329:1456-62. [IDIS 321612] [PubMed 8413456]

63. Remuzzi G. Slowing the progression of diabetic nephropathy. N Engl J Med. 1993; 329:1496-7. [PubMed 8413463]

64. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]

65. Viberti G, Mogensen CE, Groop LC et al. Effect of captopril on progression to clinical proteinuria in patients with insulin-dependent diabetes mellitus and microalbuminuria. JAMA. 1994; 271:275-9. [IDIS 324307] [PubMed 8295285]

66. Fournier A. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1994; 330:937. [PubMed 8114873]

67. AstraZeneca. Zestril (lisinopril) tablets prescribing information. Wilmington, DE; 2003 Jul.

68. National High Blood Pressure Education Program Working Group on Hypertension Control in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004; 114(Suppl 2):555-76. [PubMed 15286277]

69. Merck & Co., Inc. Prinivil (lisinopril) tablets prescribing information. Whitehouse Station, NJ; 2003 Apr.

70. Wright JT, Dunn JK, Cutler JA et al. Outcomes in hypertensive black and nonblack patients treated with chlorthalidone, amlodipine, and lisinopril. JAMA. 2005; 293:1595-607. [IDIS 531054] [PubMed 15811979]

71. Neaton JD, Kuller LH. Diuretics are color blind. JAMA. 2005; 293:1663-6. [IDIS 531056] [PubMed 15811986]

72. Leenen FHH, Nwachuku CE, Black HR et al. Clinical events in high-risk hypertensive patients randomly assigned to calcium-channel blocker versus angiotensin-converting enzyme inhibitor in the Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial. Hypertension. 2006; 48:374-84. [PubMed 16864749]

73. Messerli FH, Staessen JA. Amlodipine better than lisinopril: how one randomized clinical trial ended fallacies from observational studies? Hypertension . 2006; 48:359-61. Editorial..

74. Cooper WO, Hernandez-Diaz S, Arbogast PG et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med. 2006; 354:2443-51. [PubMed 16760444]

75. Food and Drug Administration. FDA public health advisory: angiotensin-converting enzyme inhibitor (ACE inhibitor) drugs and pregnancy. From FDA website.

76. Sibai BM. Treatment of hypertension in pregnant women. N Engl J Med. 1996; 335:257-65. [IDIS 369138] [PubMed 8657243]

77. US Food and Drug Administration. Dangers of ACE inhibitors during pregnancy. FDA Med Bull. 1992; 22:2.

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