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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PRINIVIL NEWS HIGHLIGHTS

Published Studies Related to Prinivil (Lisinopril)

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 [generic for Prinivil] 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 [generic for Prinivil] (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 [generic for Prinivil] 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.

Lisinopril for the treatment of hypertension within the first 24 hours of acute ischemic stroke and follow-up. [2007.03]
BACKGROUND: Hypertension immediately after acute ischemic stroke is associated with impaired morbidity and mortality, although there are few data on antihypertensive use immediately after ictus. This randomized, double-blinded, placebo-controlled, parallel-group study explored the hemodynamic effect and safety of oral lisinopril [generic for Prinivil] initiated within 24 h after an ictus... CONCLUSIONS: Lisinopril, even at small dosages, is well tolerated and an effective hypotensive agent after acute ischemic stroke, gradually reducing BP by 4 h after oral first-dose administration. Oral lisinopril is now being studied in a larger outcome-based trial in acute hypertensive stroke patients.

Clinical effects produced by a standardized herbal medicinal product of Hibiscus sabdariffa on patients with hypertension. A randomized, double-blind, lisinopril-controlled clinical trial. [2007.01]
Hibiscus sabdariffa L... Further studies are necessary for evaluating the dose-dependency of HsHMP and for detecting lower effective doses.

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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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PRINIVIL PATIENT REVIEWS / RATINGS / COMMENTS

Prinivil review by 51 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Nocturnal Myoclonus (like Restless Leg Syndrome)
Dosage & duration:		10 mg taken nightly for the period of 14 years
Other conditions:		Many conditions, including eventual heart attack
Other drugs taken:		too numerous to mention, but took many
		Reported Results
Benefits:		Nocturnal myoclonus (similar to restless leg syndrome) causes severe jerking of the legs every 15 seconds for up to 7 hours. Lisinopril allowed both myself and my partner to sleep at night. Somehow, the drug works without the adverse effects the other sleeping pills, neuro transmiter pills and anti-depressants had.
Side effects:		No adverse side effects, but it did keep my blood pressure down.
Comments:		Though it is a blood pressure medication, I have never had high blood pressure. I have taken Xanax, Ativan, Clonipin, and many other medications to allow me to sleep, but did not stop the nocturnal myoclonus(similar to restless leg syndrome). This meant I did not remain awake to experience the effects, but my partners did get kicked violently, kept awake with my movements and dirupted sleep. Though it is not known by many doctors, the research was down many years ago on this treatment by a VA doctor while in medical school in the 70s. It has been effective for so many years when I went 15 years without getting acceptable relief.

Prinivil review by 55 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		High Blood Pressure
Dosage & duration:		20mg taken once a day for the period of 3 yrs now
Other conditions:		Low Thyroid
Other drugs taken:		Synthroid
		Reported Results
Benefits:		It did lower my BP some
Side effects:		I'm not sure if the drugs did this, but I have severe tinnitus now, and it's driving me crazy!
Comments:		I definitely have to have synthroid, because once I stopped taking it, and I couldn't get out of bed I was so tired. I have not stopped the lisinopril, continue to take it with no side effects, except I wonder about the ear ringing.

Prinivil review by 65 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		high-normal hypertension
Dosage & duration:		10mg taken once daily for the period of 3 months
Other conditions:		blood clots in vein in eye
Other drugs taken:		Coreg 20 mg. once at night
		Reported Results
Benefits:		Lowered blood pressure
Side effects:		Extreme lethargy, coughing all day and during the night. Dry mouth and gagging at night. Nausea and the feeling of a weight on my chest. Sneezing, sore throat. Because I have allergies, I thought they were just giving me more trouble than usual. Constipation/diarrhea. The feeling of being winded with only a moderate amount of activity. I am only 15 lbs. overweight and am used to a very active life but feel down and depressed a lot and have problems getting to sleep at night.
Comments:		I had an average of 135 to 145 over 80 or 90 that is called high-normal. But because I had a stroke in my eye, my doctor felt that I had had a spike in blood pressure that caused the problem. I was given Coreg which brought the numbers down a bit, but then my Dr. felt that lisinopril would help take it down lower along with the Coreg-which it did. But then, my allergies seem to get really horrible and my breathing got worse and worse until I mentioned all of my symptoms at my three month check up today. It wasn't my allergies, it was the medication. We stopped the lisinoprol. I have never had such bad affects from a medication. I hope the new medication will be better, but you can bet I will check it out thoroughly before taking it.