Vasotec (Enalapril Maleate) - Summary

VASOTEC SUMMARY

VASOTEC^® (Enalapril Maleate) is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat.

Hypertension

VASOTEC is indicated for the treatment of hypertension.

VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive.

Heart Failure

VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials).

Asymptomatic Left Ventricular Dysfunction

In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), VASOTEC decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials).

In using VASOTEC 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 VASOTEC does not have a similar risk (see WARNINGS).

In considering use of VASOTEC, 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, Head and Neck Angioedema).

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NEWS HIGHLIGHTS

Published Studies Related to Vasotec (Enalapril)

Effects of enalapril/lercanidipine combination on some emerging biomarkers in cardiovascular risk stratification in hypertensive patients. [2014]
CONCLUSION: The combination enalapril/lercanidipine seems to be

Prevention of chemotherapy-induced left ventricular dysfunction with enalapril and carvedilol: rationale and design of the OVERCOME trial. [2011.08]
BACKGROUND: The current treatment of hematologic malignancies includes diverse potentially cardiotoxic chemotherapy agents, including high-dose myeloablative regimens used in autologous hematopoietic stem cell transplantation (HSCT). Many of these treatments could induce left ventricular dysfunction (LVD), and limit their efficacy. Angiotensin-converting enzime inhibitors and beta-blockers prevent LVD and prolong survival after infarction, and recent animal and pilot clinical studies suggest that they can prevent the development of chemotherapy-induced cardiac toxicity... CONCLUSIONS: The OVERCOME study will be the first clinical trial to test the preventive efficacy on LVD of combined treatment with enalapril and carvedilol administered to patients with hematologic malignancies submitted to current treatment with intensive chemotherapy. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Influence of order and type of drug (bisoprolol vs. enalapril) on outcome and adverse events in patients with chronic heart failure: a post hoc analysis of the CIBIS-III trial. [2011.07]
CONCLUSION: The order of drug administration plays an important role in whether CHF patients reach target doses of bisoprolol and enalapril. For both study drugs, the dose level reached was associated with baseline characteristics and adverse events. In CHF patients not treated with an ACE-I or a beta-blocker, the duration of monotherapy with either type of drug should be shorter than 6 months.

Enalapril improves endothelial function in patients with migraine: A randomized, double-blind, placebo-controlled trial. [2011.01]
BACKGROUND: There are increasing evidences of endothelial dysfunction in migraine. The ACE-inhibitors have previously been shown to be effective in migraine prophylaxis. Furthermore, ACE inhibitors have beneficial effects on endothelial dysfunction. We therefore investigated whether Enalapril is effective in endothelial function improvement... CONCLUSIONS: These results indicate that ACE inhibition can improve endothelial function in patients with migraine, as it has been shown by both FMD and serum levels of nitric oxide. The mechanism could be either that Enalapril limits the angiotensin IIinduced production of superoxide radicals which would normally inactivate nitric oxide, or that it may increase bradykinin-mediated nitric oxide release.

Effect of combined spironolactone-beta-blocker +/- enalapril treatment on occurrence of symptomatic atrial fibrillation episodes in patients with a history of paroxysmal atrial fibrillation (SPIR-AF study). [2010.12.01]
Angiotensin II and aldosterone are key factors responsible for the structural and neurohormonal remodeling of the atria and ventricles in patients with atrial fibrillation (AF). The aim of the present study was to evaluate the antiarrhythmic effects of spironolactone compared to angiotensin-converting enzyme inhibitors in patients with recurrent AF...

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Clinical Trials Related to Vasotec (Enalapril)

Relative Bioavailability Study With Enalapril in Healthy Volunteers [Active, not recruiting]
Phase I study in healthy adult male and female volunteers to compare the bioavailability of enalapril administered in orodispersible Minitablets with or without water in comparison to the standard galenic tablet formulation of enalapril. The standard pharmacokinetic parameters will be calculated from the bioanalytical results for enalapril and enalaprilat and compared in a descriptive statistical analysis.

Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Enalapril maleate may help protect heart cells from the side effects of chemotherapy. It is not yet known whether giving enalapril maleate before or after doxorubicin hydrochloride is more effective in treating women with breast cancer. PURPOSE: This randomized clinical trial is studying giving enalapril maleate together with doxorubicin hydrochloride to see how well it works in treating women with breast cancer.

A Fixed Dose Combination Amlodipine + Enalapril Bioavailability Study [Completed]
The study is designed to estimate the bioavailability of amlodipine and enalapril maleate fixed dose combination (FDC) relative to co-administration of amlodipine and enalapril maleate tablets. The rational for this study is to provide a more convenient dosing regimen for patients. This is an open-label, randomized, single dose, two-way crossover study, in which 16 healthy adult male and female subjects will be enrolled and dosed under fasting conditions. Each subject will participate in two treatment periods of 7 days each. There will be at least 14 days of wash out period between the two dosing periods and a follow-up period of up to 21 days after treatment period 2. The total duration of study will be approximately 35 days from the start of the first treatment.

Comparison of the Antihypertensive Efficacy of Valsartan and Enalapril After Missing One Dose [Completed]
This study was designed in order to evaluate the blood pressure lowering effect of valsartan compared to enalapril over 24 hours after skipping one daily dose. Both drugs act on the renin-angiotensin-aldosterone system (RAAS) and are widely use for the treatment of hypertension. Previous studies had a significant limitation: the effect of a missing dose was not evaluated after the whole 24 hours post missing dose period (48 hours after last taken dose), and as a result, it does not imitate the real life situation of a missing dose.

China Stroke Primary Prevention Trial [Completed]
The purpose of this trial is to confirm that enalapril maleate and folic acid tablets is more effective in preventing stroke among the patients with primary hypertension when compared to enalapril maleate.

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Reports of Suspected Vasotec (Enalapril) Side Effects

Nausea (6),  Pruritus (4),  Muscle Spasms (4),  Drug Hypersensitivity (4),  Tremor (4),  Pharyngeal Oedema (3),  Blood Pressure Increased (3),  Nightmare (3),  Angioedema (3),  Agitation (2), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Vasotec review by 51 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		hypertension
Dosage & duration:		10 mg taken once daily for the period of 18 mo
Other conditions:		none
Other drugs taken:		mvi
		Reported Results
Benefits:		i had elevated blood pressure which was treated with different medications in the past. initially i was treated with norvasc which caused constipation. then i was treated with cozaar which did not control blood pressure well , instead it caused fluctuation of the blood pressure going from high to low over the course of the day, which made me very uncomfortable because i will sense both high and low blood pressure and have headache whether it was low or high. vasotec even in the small dose that i am taking now normalized my blood pressure , so i do not have fluctuation of the blood pressure any more.
Side effects:		none
Comments:		medication is taken once daily for blood pressure control. blood pressure is very well controlled. no side effects.

Vasotec review by care giver of 32 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		high blood pressure
Dosage & duration:		10mg taken once a day for the period of since jan 2006- 2 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		kept the high blood pressure normal. of course patient has also changed lifestyle - exercising four times a week, eating light sodium and low calorie foods. diet of vegetables and fish or white chicken, fruits and grains, no red meats. we believe it is both lifestyle and medication that have lowered the high blood pressure.
Side effects:		none that we can tell.
Comments:		one tablet of 10mg once a day

Vasotec review by care giver of 32 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		high blood pressure
Dosage & duration:		10mg taken once a day for the period of since jan 2006- 2 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		kept the high blood pressure normal. of course patient has also changed lifestyle - exercising four times a week, eating light sodium and low calorie foods. diet of vegetables and fish or white chicken, fruits and grains, no red meats. we believe it is both lifestyle and medication that have lowered the high blood pressure.
Side effects:		none that we can tell.
Comments:		one tablet of 10mg once a day