Altace (Ramipril) - Summary

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)

Randomised trial of ramipril in repaired tetralogy of Fallot and pulmonary regurgitation: the APPROPRIATE study (Ace inhibitors for Potential PRevention Of the deleterious effects of Pulmonary Regurgitation In Adults with repaired TEtralogy of Fallot). [2012]
ramipril and its effects on cardiovascular function in these patients... CONCLUSIONS: Ramipril is a well tolerated therapy, improves biventricular

Effect of pioglitazone and ramipril on biomarkers of low-grade inflammation and vascular function in nondiabetic patients with increased cardiovascular risk and an activated inflammation: results from the PIOace study. [2011.07.01]
CONCLUSIONS: Our 3-month study in nondiabetic hypertensive patients showed a decrease in biomarkers of IR and chronic systemic inflammation with the PIO monotherapy and the PIRA combination only, which may help to explain some findings in other cardiovascular outcome trials. (c) 2011 Diabetes Technology Society.

Antihypertensive efficacy and safety of olmesartan and ramipril in elderly patients with mild to moderate systolic and diastolic essential hypertension. [2011.04]
OBJECTIVE: To compare the efficacy and safety of olmesartan medoxomil (O) and ramipril (R) in elderly patients with essential arterial hypertension... CONCLUSIONS: In elderly patients with essential arterial hypertension, O provides an effective, prolonged and well tolerated blood pressure control, with significantly better blood pressure normalization than R and represents a useful option among first-line drug treatments of hypertension in this age group.

Cardiovascular and renal outcomes with telmisartan, ramipril, or both in people at high renal risk: results from the ONTARGET and TRANSCEND studies. [2011.03.15]
CONCLUSIONS: This post hoc analysis does not support dual therapy over monotherapy in high-vascular risk patients with low glomerular filtration rate or albuminuria. This observation is a post hoc comparison and should be interpreted appropriately. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov Identifier: NCT00153101.

Different actions of losartan and ramipril on adipose tissue activity and vascular remodeling biomarkers in hypertensive patients. [2011.01]
We planned a randomized, double blind clinical trial to evaluate whether an antihypertensive intervention at the proximal or distal level of the renin-angiotensin-aldosterone system could have different effects on a broad range of innovative cardiovascular risk biomarkers... In conclusion, we observed that short-term treatment with losartan improved several metabolic parameters (M-value, ADN, RBP-4, r and visfatin) and decreased vascular remodeling biomarkers (MMP-2 and MMP-9) in hypertensive subjects, whereas ramipril did not.

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Clinical Trials Related to Altace (Ramipril)

Ramipril and Clopidogrel in Oxidative Stress, Vascular Inflammation and Endothelial Dysfunction in Type 2 Diabetes and Diabetic Nephropathy [Recruiting]
The purpose of this study is to determine whether the combination with ramipril and clopidogrel leads to further improvement of endothelial function, reduction of oxidative stress and reduction of vascular inflammation, compared with ramipril monotherapy, in patients with Diabetes Mellitus type 2 and diabetic nephropathy.

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 (blood sugar levels) 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.

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.

Studying the Effects of Antihypertensives on Individuals at Risk for Alzheimer's [Recruiting]
Angiotensin converting enzyme inhibitors (ACE-I) are a group of blood pressure-lowering medicines. Some studies suggest that ACE-I, such as ramipril, may help prevent Alzheimer's disease (AD). The purpose of the research is to see how ramipril affects a substance in the body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting Alzheimer's disease. This study will see if ramipril can lower the amount of beta-amyloid in the spinal fluid. This study will also see if ramipril affects blood vessel function and memory and thinking. The investigators hope that future studies will show whether ramipril might prevent memory loss and decrease the chance of developing Alzheimer's disease.

Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome [Recruiting]
This is a phase III, multi-centre, randomised, placebo-controlled, patient and investigator-blind study in paediatric patients with early stages of Alport syndrome to assess the safety and efficacy of the ACEi ramipril in slowing disease progression.

Alport syndrome stages that describe the extent of renal damage and loss of function are defined as:

- 0 Microhaematuria without microalbuminuria (usually at birth)

- I Microalbuminuria (30-300 mg albumin/gCrea)

- II Proteinuria >300 mg albumin/gCrea

- III > 25% decline of normal renal function (creatinine clearance)

- IV End stage renal failure (ESRF)

Eligible patients with Alport stages 0 and I will be randomly assigned at a 1: 1 ratio to receive once daily ramipril or placebo. Eligible patients who, or whose parents/legal guardian refuse randomisation after eligibility is confirmed, and patients who have been treated with ramipril prior to the study, may be treated open-label with ramipril as per protocol. The total number of patients will not exceed 120, with the number of randomised patients not exceeding 80, and the number of patients treated open label from Day 1 of the study aimed to be approximately 40.

Randomised patients whose disease progresses to the next disease level during the 3 year treatment period will be unblinded, and open label ramipril treatment will be initiated and continued, respectively, depending on prior treatment randomisation.

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Reports of Suspected Altace (Ramipril) Side Effects

Drug Interaction (46),  Dyspnoea (37),  Renal Failure Acute (36),  Drug Ineffective (35),  Hyponatraemia (24),  Hypotension (23),  Oedema Peripheral (21),  Cough (21),  Angioedema (21),  Palpitations (20), more >>