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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
Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes
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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NEWS HIGHLIGHTS
Published Studies Related to Altace (Ramipril)
Effect of angiotensin-converting enzyme inhibition on C-reactive protein levels: the ramipril C-reactive pRotein randomized evaluation (4R) trial results. [2009.07]
BACKGROUND: Plasma levels of the inflammatory biomarker C-reactive protein (CRP) predict cardiovascular risk and may represent a target for treating and/or monitoring risk-reduction strategies. The effect of angiotensin-converting enzyme inhibitors on CRP levels has not been adequately studied... CONCLUSIONS: A 12-week ramipril treatment protocol for healthy middle-aged volunteers did not lower CRP levels compared with placebo. However, because of the inherent variability of CRP levels, a much larger study is required to exclude a small treatment effect.
Prognostic value of blood pressure in patients with high vascular risk in the Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial study. [2009.07]
BACKGROUND: Hypertension guidelines advise aggressive blood pressure (BP) lowering in patients with diabetes or high cardiovascular risk, but supporting evidence is limited. We analysed the impact of BP on cardiovascular events in well treated high-risk patients enrolled in a large clinical trial (Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial)... CONCLUSION: In high-risk patients, the benefits from SBP lowering below 130 mmHg are driven mostly by a reduction of stroke; myocardial infarction is unaffected and cardiovascular mortality is unchanged or increased. Future trials should be designed to test the value of SBP lowering in high-risk patients with SBP in the range of 130-150 mmHg.
Chronotherapy with the angiotensin-converting enzyme inhibitor ramipril in essential hypertension: improved blood pressure control with bedtime dosing. [2009.07]
Clinical studies have demonstrated a different effect on blood pressure of some angiotensin-converting enzyme inhibitors when administered in the morning versus the evening. Their administration at bedtime resulted in a higher effect on nighttime blood pressure as compared with morning dosing... The change in the dose-response curve, increased proportion of controlled patients, and improved efficacy on nighttime blood pressure with administration of ramipril at bedtime should be taken into account when prescribing this angiotensin-converting enzyme inhibitor for treatment of essential hypertension.
Effect of ramipril and of rosiglitazone on carotid intima-media thickness in people with impaired glucose tolerance or impaired fasting glucose: STARR (STudy of Atherosclerosis with Ramipril and Rosiglitazone). [2009.06.02]
OBJECTIVES: The aim of this study was to evaluate effects of the angiotensin-converting enzyme (ACE) inhibitor ramipril and the thiazolidinedione (TZD) rosiglitazone on carotid intima-media thickness (CIMT) in people with impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG). BACKGROUND: People with IGT and/or IFG are at increased long-term risk for cardiovascular disease. Effects of ACE inhibitors and of TZDs on vascular disease in this population are unknown... CONCLUSIONS: In people with IGT and/or IFG without cardiovascular disease and diabetes, treatment with ramipril had a neutral effect on CIMT, whereas rosiglitazone modestly reduced CIMT progression. (The Study of Atherosclerosis With Ramipril and Rosiglitazone; NCT00140647).
Comparison of the effects of ramipril versus telmisartan on high-sensitivity C-reactive protein and endothelial progenitor cells after acute coronary syndrome. [2009.06.01]
To compare the anti-inflammatory and endothelial progenitor cell mobilizing effects of ramipril and telmisartan in patients presenting with acute coronary syndrome (ACS), 42 patients with ACS were randomized after successful percutaneous coronary intervention to ramipril 5 mg/day (22 patients) or telmisartan 80 mg/day (20 patients)...
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: 2009-10-20
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