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, enalapril maleate should be discontinued as soon as possible. See WARNINGS, Fetal / Neonatal Morbidity and Mortality
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ENALAPRIL SUMMARY
Enalapril maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat.
Hypertension
Enalapril maleate is indicated for the treatment of hypertension.
Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.
Heart Failure
Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate 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), enalapril maleate 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 enalapril maleate, 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 enalapril maleate does not have a similar risk. (See WARNINGS.)
In considering use of enalapril maleate, 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 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...
Clinical Trials Related to 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.
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.
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.
Reports of Suspected Enalapril Side Effects
Dementia (4),
Drug Interaction (3),
Completed Suicide (3),
Renal Failure Acute (3),
Intraocular Pressure Increased (2),
Hypertension (2),
Rhabdomyolysis (1),
Intentional Overdose (1),
Blood Triglycerides Increased (1),
Headache (1), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Enalapril has an overall score of 5. The effectiveness score is 8 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst.
| | Enalapril review by 55 year old male patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Moderately Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | high blood pressure |
| Dosage & duration: | | 10 mg X 1 p/d taken 1 p/d for the period of 5 yrs |
| Other conditions: | | none |
| Other drugs taken: | | dizothiazide | | |
Reported Results |
| Benefits: | | The treatment reulted in significantly lower blood pressure - in total a drop of over 30 points on both the upper and lower readings. |
| Side effects: | | none |
| Comments: | | The pharmaceutical therapy was combined with moderate excercise (eg. walking 3 miles 3-4 times a week) and life style modification such as meditation, enhanced body-mind awareness and diet changes, such as cutting eliminating red meat and cutting down on hot spices, wheat, processed grains and sugar and milk products, while significantly increasing complex carbohydrates, lentils, and dietary fiber. |
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| | Enalapril review by 26 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | management of Congestive heart failure |
| Dosage & duration: | | 2.5mg/day taken 2 doses for the period of one month |
| Other conditions: | | mental health and liver problems |
| Other drugs taken: | | aspirin | | |
Reported Results |
| Benefits: | | slowed the progression of left ventricular dysfunction into overt heart failure
alone or with other agents in the managment of hypertension
mangagement of congestive heart failur |
| Side effects: | | cough, hypotension , proteinuria, impotence , renal failure , angina pectoris , tachycardia , eosinophilic pneumonitis, tastes disturbances , anusease anorecia , weakness fatigue insominca weakness |
| Comments: | | monitor blood pressure , weight and asses for resolution of fluid |
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Page last updated: 2015-08-10
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