Zestril (Lisinopril) - Summary

ZESTRIL SUMMARY

ZESTRIL
(lisinopril)

Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor.

ZESTRIL is indicated for the following:

Hypertension

ZESTRIL is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.

Heart Failure

ZESTRIL is indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis.

Acute Myocardial Infarction

ZESTRIL is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta blockers.

In using ZESTRIL, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that ZESTRIL does not have a similar risk. (See WARNINGS.)

In considering the use of ZESTRIL, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients (see WARNINGS, Anaphylactoid and Possibly Related Reactions).

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NEWS HIGHLIGHTS

Published Studies Related to Zestril (Lisinopril)

Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial. [2011.06.15]
BACKGROUND: High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective... The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke.

Potential pharmacodynamic drug-drug interaction between concomitantly administered lisinopril and diclofenac sodium: a call for appropriate management in hypertensive osteoarthritic patients. [2011]
Abstract Background: The present study was designed as an open label, multiple-dose, randomized, parallel trial to evaluate the pharmacodynamic drug-drug interaction of lisinopril and concomitantly administered diclofenac sodium in non-diabetic and diabetic, mild to moderate hypertensive, osteoarthritic patients...

Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial. [2011]
BACKGROUND: High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective... The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke.

Carotid artery hemodynamics: observing patient-specific changes with amlodipine and lisinopril by using MR imaging computation fluid dynamics. [2010.12]
PURPOSE: To assess whether using magnetic resonance (MR) imaging combined with computational fluid dynamics (CFD) could reveal changes in common carotid artery (CCA) flow and wall shear stress (WSS) that might contribute to differences in CCA remodeling between amlodipine, a calcium channel blocker, and lisinopril, an angiotensin-converting enzyme inhibitor, despite similar reductions in blood pressure (BP)... CONCLUSION: Amlodipine causes increased blood flow and increased time-averaged WSS in the CCA compared with lisinopril, despite similar reductions in BP. Differences in the subacute hemodynamic effects of amlodipine and lisinopril could contribute to the differences in CCA remodeling seen in long-term studies. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100788/-/DC1. (c) RSNA, 2010

Comparison of the influence of angiotensin-converting enzyme inhibitor lisinopril and angiotensin II receptor antagonist losartan in patients with idiopathic membranous nephropathy and nephrotic syndrome. [2010.09]
CONCLUSION: Treatment with lisinopril and losartan in nephrotic patients with idiopathic membranous nephropathy results in similar (and significant) effects on renal function, hypoalbuminaemia, proteinuria and blood pressure.

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Clinical Trials Related to Zestril (Lisinopril)

Antiproteinuric Effect of Valsartan and Lisinopril [Completed]
Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3: 3:1), double blind, parallel group, controlled trial, 5 months follow-up.

Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo treatment in no-diabetic and diabetic patients.

Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin ratio more than monotherapies.

Design: Multicentric, randomized, double blind, parallel group, active controlled.

Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20

Antialbuminuric Effects of Valsartan and Lisinopril [Terminated]
Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3: 3:1), open label, parallel group, 20 weeks follow-up.

Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril vs combo treatment in non-diabetic and diabetic patients.

Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more than monotherapies..

Design: Multicentric, randomized, open label, parallel group, active controlled.

Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20

Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up. Description % of change in albuminuria from baseline at 20 weeks.

Secondary Endpoint : To investigate the effect of 5 months treatment with valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus lisinopril on blood pressure and the effect on left ventricular mass index using electrocardiogram and Cornell-Sokolow method.

A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril [Recruiting]
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effect of aleglitazar on renal function, the renin-angiotensin system and the pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to lisinopril for 4 weeks.

Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant [Recruiting]
The drug lisinopril is approved by the U. S. Food and Drug Administration for the treatment of high blood pressure, heart failure, and acute heart attacks in adult patients. In children over 6 years of age, lisinopril is approved for the treatment of high blood pressure. Lisinopril is in a group of medications called angiotensin-converting enzyme inhibitors (ACE). ACE inhibitors such as lisinopril work by decreasing certain chemicals that tighten the blood vessels so blood flows more smoothly and the heart can pump blood more efficiently.

There is some information available about how children with high blood pressure absorb, distribute, metabolize, and eliminate lisinopril (this information about medication processing by the body is called pharmacokinetic data). However, there is no information about how children with high blood pressure who have received a kidney transplant process lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril may help kidney transplants work longer by reducing the activity of chemicals made by cells in kidney transplants that can lead to inflammation and injury. Such benefits have not been found with another group of blood pressure medications called calcium channel blockers, which are the most commonly used medication group to control high blood pressure in children after a kidney transplant. A clinical trial will be conducted in the future to compare which medication group helps kidney transplants in children last longer. To guide the selection of the best dose to test in future studies, investigators in this study will try to determine the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and adolescents (2-17 years of age) who have received a kidney transplant and have high blood pressure.

VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria [Completed]
The purpose of this study is to compare if the combination of valsartan 320 mg/lisinopril 20 mg versus the monotherapies of lisinopril 40 mg or valsartan 320 mg will result in a greater decrease of urinary albumin excretion measured as urinary albumin/creatinine ratio (UACR) in the first morning urine of hypertensive subjects with previously diagnosed microalbuminuria (MAU).

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Reports of Suspected Zestril (Lisinopril) Side Effects

Hypertension (21),  Drug Ineffective (18),  Drug Hypersensitivity (17),  Cough (15),  Dyspnoea (13),  Cataract (11),  Headache (10),  Bronchitis (10),  Drug Dose Omission (9),  Pain (8), more >>