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 TABLETS USP 2.5 mg, 5 mg, 10 mg and 20 mg
Enalapril Maleate is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin converting enzyme inhibitor, enalaprilat.
Hypertension
Enalapril maleate tablets are 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, Angioedema.)
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NEWS HIGHLIGHTS
Published Studies Related to Enalapril
Renal and retinal effects of enalapril and losartan in type 1 diabetes. [2009.07.02]
BACKGROUND: Nephropathy and retinopathy remain important complications of type 1 diabetes. It is unclear whether their progression is slowed by early administration of drugs that block the renin-angiotensin system... CONCLUSIONS: Early blockade of the renin-angiotensin system in patients with type 1 diabetes did not slow nephropathy progression but slowed the progression of retinopathy. (ClinicalTrials.gov number, NCT00143949.) 2009 Massachusetts Medical Society
Effects of enalapril or nifedipine on muscle strength or functional capacity in elderly subjects. A double blind trial. [2009.06]
INTRODUCTION: The inhibition of angiotensin-converting enzyme could be useful to avoid sarcopenia in the elderly... CONCLUSION: In this group of elderly subjects, enalapril was not superior to nifedipine with regard to the age-related decline of muscle performance.
Effects of enalapril, candesartan or both on neurohumoral activation and LV volumes and function in patients with heart failure not treated with a beta-blocker. [2009.04]
BACKGROUND: The long-term effects of the angiotensin-receptor blocker candesartan, the angiotensin-converting enzyme inhibitor enalapril or their combination have been incompletely studied in a large cohort of patients with heart failure not treated with beta-blockers. The objective of this study was to investigate the changes in neurohormones and LV volumes and ejection fraction in patients treated with enalapril, candesartan, or enalapril plus candesartan without concomitant beta-blocker therapy... CONCLUSION: We conclude that angiotensin-II modulation, with enalapril and candesartan, without concomitant utilization of beta-blocker lead to a decrease in BNP and an attenuation of the increase in LV end-diastolic and end-systolic volumes without a reversal of this process in the long term.
Efficacy of exercise, losartan, enalapril, atenolol and rilmenidine in subjects with blood pressure hyperreactivity at treadmill stress test and left ventricular hypertrophy. [2009.04]
High levels of activity of the renin-angiotensin system (RAS) and sympathetic nervous system (SNS) are related to left ventricular hypertrophy (LVH). A percentage of subjects with hyperactivity to treadmill stress test show LVH to echocardiogram... In conclusion, drugs that block RAS were more efficient in reducing LVH than physical exercise and drugs that block SNS, and such reduction took place regardless of SBP level reduction at rest and peak effort.
Effects of antihypertensive treatment on ultrasound measures of myocardial fibrosis in hypertensive patients with left ventricular hypertrophy: results of a randomized trial comparing the angiotensin receptor antagonist, candesartan and the angiotensin-converting enzyme inhibitor, enalapril. [2009.03]
OBJECTIVE: To compare the effects of the angiotensin II receptor antagonist candesartan with the angiotensin-converting enzyme inhibitor enalapril on myocardial fibrosis evaluated by echoreflectivity analysis... CONCLUSION: In hypertensive patients with left ventricular hypertrophy, both candesartan and enalapril induce a moderate but statistically significant reduction in an echoreflectivity index of myocardial fibrosis.
Clinical Trials Related to 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.
Effect of Enalapril Plus Folic Acid on Blood Pressure and Glycometabolism [Completed]
Combinded therapy with folic acid and enalapril may significantly decrease plasma total
homocysteine level and had beneficial effect on blood pressure reduction and
glycometabolism.
Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril [Completed]
The majority of hypertensive patients require antihypertensive associations to control their
blood pressure. Most of clinical trials don’t compare different associations using
Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using
doses that are not equivalent.
This randomized trial where patients and investigators are blinded and compares the
effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and
Enalapril.
Long Term Safety, Tolerability and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension [Recruiting]
The purpose of this extension study is to evaluate in children the long-term (up to 6 months
total) safety and tolerability of valsartan in comparison with enalapril. In addition it will
evaluate proteinuria reduction, renopreservation, and tolerability of valsartan and enalapril
combination vs. enalapril monotherapy alone in patients with chronic kidney disease.
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.
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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: 2009-10-20
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