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, ALTACE® should be discontinued as soon as possible. See WARNINGS: Fetal/neonatal morbidity and mortality.
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ALTACE SUMMARY
Ramipril and ramiprilat inhibit angiotensin-converting enzyme (ACE).
Altace is indicated for the ollowing:
REDUCTION IN RISK OF MYOCARDIAL INFARCTION, STROKE, AND DEATH FROM CARDIOVASCULAR CAUSES
Altace is indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Altace can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).
HYPERTENSION
ALTACE is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.
In using ALTACE, 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. Available data are insufficient to show that ALTACE does not have a similar risk. (See WARNINGS.)
In considering use of ALTACE, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. (See WARNINGS, Angioedema.)
HEART FAILURE POST MYOCARDIAL INFARCTION
Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure. (See CLINICAL PHARMACOLOGY, Heart Failure Post Myocardial Infarction for details and limitations of the survival trial.)
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ALTACE NEWS HIGHLIGHTS
Published Studies Related to Altace (Ramipril)
Effect of valsartan and ramipril on atrial fibrillation recurrence and P-wave dispersion in hypertensive patients with recurrent symptomatic lone atrial fibrillation. [2008.09]
BACKGROUND: This study compared the effect of antihypertensive treatment with valsartan or ramipril [generic for Altace] on atrial fibrillation (AF) recurrence, on P-wave dispersion, (PWD) and on serum procollagen type I carboxy terminal peptide (PIP)... CONCLUSIONS: Despite similar BP lowering, valsartan and ramipril were more effective than amlodipine in preventing new episodes of AF, but the effect of valsartan was greater than that of ramipril. This could be related to the greater PWD reduction observed with valsartan.
Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomised, double-blind, controlled trial. [2008.08.16]
BACKGROUND: Angiotensin receptor blockers (ARB) and angiotensin converting enzyme (ACE) inhibitors are known to reduce proteinuria. Their combination might be more effective than either treatment alone, but long-term data for comparative changes in renal function are not available. We investigated the renal effects of ramipril [generic for Altace] (an ACE inhibitor), telmisartan (an ARB), and their combination in patients aged 55 years or older with established atherosclerotic vascular disease or with diabetes with end-organ damage... INTERPRETATION: In people at high vascular risk, telmisartan's effects on major renal outcomes are similar to ramipril. Although combination therapy reduces proteinuria to a greater extent than monotherapy, overall it worsens major renal outcomes.
Utility of semiautomatic clinic and 24-h ambulatory blood pressure measurements to evaluate combination therapy: the Ramipril-Hydrochlorothiazide Hypertension Trial. [2008.08]
Angiotensin-converting enzyme inhibitors combined with higher doses of hydrochlorothiazide (HCT), that is, 25 mg daily, have been recognized as an effective form of antihypertensive therapy. To evaluate the coadministration of 20 mg ramipril [generic for Altace] with 25 mg HCT, we carried out a randomized, double-blind, controlled trial with two dose schedules of ramipril (20 mg q.d...
The PHARAO study: prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril in patients with high-normal blood pressure - a prospective, randomized, controlled prevention trial of the German Hypertension League. [2008.07]
BACKGROUND: The prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril [generic for Altace] in patients with high-normal blood pressure study addresses the issue of whether progression to manifest hypertension in patients with high-normal blood pressure can be prevented with treatment... INTERPRETATION: There is now good clinical evidence that patients with high-normal blood pressure (prehypertension) are more likely to progress to manifest hypertension than patients with optimal or normal blood pressure. Additional ambulatory blood pressure monitoring seems to be essential to achieve correct diagnosis. Treatment of patients with high-normal office blood pressure with the angiotensin-converting enzyme inhibitor was well tolerated, and significantly reduced the risk of progression to manifest hypertension.
Utility of semiautomatic clinic and 24-h ambulatory blood pressure measurements to evaluate combination therapy: the Ramipril-Hydrochlorothiazide Hypertension Trial. [2008.05.08]
Angiotensin-converting enzyme inhibitors combined with higher doses of hydrochlorothiazide (HCT), that is, 25 mg daily, have been recognized as an effective form of antihypertensive therapy. To evaluate the coadministration of 20 mg ramipril [generic for Altace] with 25 mg HCT, we carried out a randomized, double-blind, controlled trial with two dose schedules of ramipril (20 mg q.d...
Clinical Trials Related to Altace (Ramipril)
Higher Dose of Ramipril Versus Addition of Telmisartan-Ramipril in Hypertension and Diabetes [Terminated]
The purpose of this study is to determine if a dose of ramipril combined with a normal dose
of telmisartan 80 mg will be more effective than ramipril 20 mg in reducing microalbuminuria
in hypertensive patients with diabetes.
A 54 Week, Randomized, Double-Blind, Parallel-Group, Multicenter Study Evaluating the Long-Term Gastrointestinal (GI) Safety and Tolerability of Aliskiren (300 mg) Compared to Ramipril (10 mg) in Patients With Essential Hypertension [Recruiting]
This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren
(300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.
Mechanisms of Ramipril Reduction in the Onset of Type 2 Diabetes [Recruiting]
The study will be focused on determining the integrated in-vivo mechanisms responsible for
Ramipril's effects on delaying type 2 diabetes and restoring normal glycemia in patients with
impaired glucose tolerance.
Hypothesis - Ramipril effects will delay the onset of type 2 diabetes and restore normal
glycemia in patients with impaired glucose tolerance.
Comparison of Awakening Versus Bedtime Dosing of Ramipril in Subjects With Essential Hypertension [Recruiting]
This prospective chronotherapy trial will investigate the potential differing efficacy of
ramipril in doses from 5 to 10 mg/day when administered, as a monotherapy either upon
awakening from nighttime sleep or at bedtime, to diurnally active patients with grade 1 or 2
essential hypertension, who will be evaluated by 48-hour ABPM before and after pharmacologic
intervention. The benefits from this trial may be extremely important, taking into account 1)
the high prevalence of non-dipping among patients with essential hypertension, 2) the need
for a proper 24-hour BP control with particular emphasis on the regulation of nighttime
resting BP mean, and 3) the lacking information on the administration-time dependent effects
on BP of ramipril, a widely used ACEI in doses of 5-10 mg/day.
Efficacy and Safety Study of TAK-491 Compared to Ramipril for Treating Essential Hypertension [Recruiting]
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Page last updated: 2009-02-07
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