Prinivil (Lisinopril) - Summary

PRINIVIL SUMMARY

PRINIVIL (Lisinopril), a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor.

PRINIVIL is indicated for the following:

Hypertension

PRINIVIL 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

PRINIVIL 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

PRINIVIL 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 PRINIVIL, 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 PRINIVIL does not have a similar risk. (See WARNINGS.)

In considering use of PRINIVIL, 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, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks (see WARNINGS, Anaphylactoid and Possibly Related Reactions, Angioedema).

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NEWS HIGHLIGHTS

Published Studies Related to Prinivil (Lisinopril)

Pleural effusions, water balance mediators and the influence of lisinopril after completion Fontan procedures. [2009.07]
OBJECTIVE: To investigate whether the duration of pleural drainage after Fontan completion operations can be influenced by postoperative lisinopril administration or can be related to water balance hormone levels... CONCLUSIONS: The Fontan completion induces significant changes in the levels of antidiuretic hormone, aldosteron and renin. Prolonged drainage correlates significantly with elevated levels of aldosteron, renin and antidiuretic hormone postoperatively, and with longer bypass time, but is not influenced by lisinopril. The eventual adjunct therapy with aldosteron antagonists warrants further study.

Irbesartan improves arterial compliance more than lisinopril. [2009]
BACKGROUND: Antihypertensive agents can reduce arterial stiffness. We hypothesized that an angiotensin receptor blocker (ARB) irbesartan and an angiotensin converting enzyme inhibitor (ACEI) lisinopril improved arterial compliance... CONCLUSIONS: Irbesartan improved arterial compliance in elastic and muscular arteries, whereas lisinopril improved it only in elastic arteries.

Cost-effectiveness of chlorthalidone, amlodipine, and lisinopril as first-step treatment for patients with hypertension: an analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). [2008.05]
OBJECTIVE: To evaluate the cost-effectiveness of first-line treatments for hypertension. BACKGROUND: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) found that first-line treatment with lisinopril or amlodipine was not significantly superior to chlorthalidone in terms of the primary endpoint, so differences in costs may be critical for optimizing decision-making... CONCLUSIONS: Initial treatment with chlorthalidone is less expensive than lisinopril or amlodipine, but amlodipine provided a nonsignificantly greater survival benefit and may be a cost-effective alternative. A randomized trial with power to exclude "clinically important" differences in survival will often have inadequate power to determine the most cost-effective treatment.

Bioequivalence evaluation of two brands of lisinopril tablets by in vitro comparative dissolution test and in vivo bioequivalence test. [2008]
The bioequivalence of a test formulation (Nanopril, "test") and a reference formulation ("reference") of lisinopril (CAS 83915-83-7) was demonstrated by in vivo and in vitro tests. The in vivo bioequivalence study in 26 healthy volunteers was designed as a single dose, randomized, double-blind trial with a 2-week washout period between the doses...

Effects of candesartan and lisinopril on the fibrinolytic system in hypertensive patients. [2007.06]
The effects of the angiotensin II receptor blocker candesartan and the angiotensin-converting enzyme inhibitor lisinopril on the fibrinolytic system were investigated in a double-blinded, prospective, randomized study. Seventy-seven hypertensive patients taking candesartan (n=41) and lisinopril (n=36) with a systolic blood pressure >130 mm Hg and/or a diastolic blood pressure >80 mm Hg obtained by 24-hour ambulatory blood pressure measurement were included in the study.

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Clinical Trials Related to Prinivil (Lisinopril)

A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL. [Completed]
This study will be a randomized study investigating the bioequivalence of COREG CR to its components, COREG and Lisinopril (ZESTRIL). PK samples will be obtained throughout the study to investigate the PK of COREG CR FDC to COREG and Lisinopril

Research Study To Test Coreg CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure [Active, not recruiting]
Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2 essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline. Subjects will be randomized to received either COREG CR + lisinopril or lisinopril + placebo. Subjects will be uptitrated over a 6 week period until target blood pressure (<140/90mmHg) is met. The primary objective of the study is to compare the proportion of subjects who achieve target blood pressure after 6 weeks of treatment.

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.

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

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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PATIENT REVIEWS / RATINGS / COMMENTS

Prinivil review by 65 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		HBP
Dosage & duration:		10-20mg taken once a day for the period of 27 years
Other conditions:		none
Other drugs taken:		Maxide, Atenolol
		Reported Results
Benefits:		After starting on a diuretic and a beta blocker without significant results, adding the ACE inhibitor worked wonders, and has continued to do so for 27 years. The next step, if one becomes necessary will be to add a sartan. Based on my previous response. I expect it to be a happy experience.
Side effects:		For no apparent reason the dosage needs to be adjusted, up or down from time to time. Fortunately hypertension is not asymptomatic in this patient: have a headache, it's up, raise the dose; feel wiped out, it's down, lower the dose. All this has been confirmed by home, office, and pharmacy readings.
Comments:		I never expected to live this long, let alone feel as healthy as I do. My mother died at age 53, and the last years of her life were marred by pain, discomfort and significant disability due to cardiovascular disease. My experience is one more validation of the benefits of early and aggressive intervention in the case of mild hypertension.

Prinivil review by 49 year old male patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Hypertension
Dosage & duration:		5 mg / day taken daily for the period of 1 month
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		the low dosage of Lisinopril reduced my blood pressure from 138/96 to 127/90.
Side effects:		Soon after starting treatment I developed moderate tinnitus, (ringing in the ears) in both ears but the ringing is more severe in the left ear. I also have dry mouth and dry throat with a slight cough and minor throat discomfort.
Comments:		I take 1 tablet per day, first thing in the morning.

Prinivil review by 48 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		blood pressure
Dosage & duration:		20 mg taken once daily for the period of 2 wks
Other conditions:		hypothyroid
Other drugs taken:		thyroid
		Reported Results
Benefits:		decreased bp
Side effects:		After three to four day started experiencing diarrhea and abdominal pain. The abdominal pain increased in severity over several days, starting in lower GI and moving up to include mid and upper abdomen. The drug was stopped for a few weeks. Thinking the GI pain may have been caused by a GI "bug", the lisinopril was restarted with the same reaction after two to three days. Drug discontinued.
Comments:		stopped drug. rechallenged few weeks later with same results