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Vasotec (Enalapril Maleate) - Summary

 
 



USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, VASOTEC should be discontinued as soon as possible. (See WARNINGS, Fetal/Neonatal Morbidity and Mortality).

 

VASOTEC SUMMARY

TABLETS
VASOTEC®
(ENALAPRIL MALEATE)

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, Angioedema.)


See all Vasotec indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Vasotec (Enalapril)

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...

Effects of telmisartan on markers of ventricular remodeling in patients with acute myocardial infarction: comparison with enalapril. [2010.11]
Enalapril is effective in the suppression of left ventricular remodeling after acute myocardial infarction (AMI), but the effect of telmisartan is unclear. The consecutive 163 AMI patients underwent primary percutaneous coronary intervention and were randomized to telmisartan (n = 82) or enalapril (n = 81)...

more studies >>

Clinical Trials Related to Vasotec (Enalapril)

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.

Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer [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.

Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in Patients With Chronic Heart Failure [Recruiting]
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity

and mortality in patients with chronic heart failure (NYHA Class II - IV.

An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age [Recruiting]
The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active

comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th

percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).

The Effect of Enalapril and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients [Recruiting]
A prospective, randomized, open-label, Single-center clinical trial to determine whether Enalapril or Enalapril plus Losartan effect on Peritoneal membrane transportation.

more trials >>

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

Based on a total of 4 ratings/reviews, Vasotec has an overall score of 8.25. The effectiveness score is 8.50 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

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

See all Vasotec reviews / ratings >>

Page last updated: 2011-12-09

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