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).
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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.)
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NEWS HIGHLIGHTS
Published Studies Related to Vasotec (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 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.
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.
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.
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 phase I trial is studying giving enalapril maleate together with
doxorubicin hydrochloride to see how well it works in treating women with breast cancer.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Vasotec has an overall score of 7.67. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Vasotec review by 55 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | HTN |
| Dosage & duration: | | 10mg taken bid for the period of 1.5 yrs |
| Other conditions: | | chemo induced cardiomyopathy & CHF |
| Other drugs taken: | | carvedilol | | |
Reported Results |
| Benefits: | | The medication eliminated the symptoms of Congestive Heart Failure, lowered my blood pressure, I had no more shortness of breath, or edema of lower extremities, no more fatigue, palpitations are gone, no more racing pulse, tachycardia has been eliminated, I have no more sense of dis-ease |
| Side effects: | | none |
| Comments: | | I had to take medications as prescribed, change my diet to minimize sodium intake, I had to exercise as tolerated without over exertion, then maintain body weight by watching calories, keep cholesterol and fat intake low, be more selective in what I eat.
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| | 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 |
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| | 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 |
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Page last updated: 2009-10-20
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