MAVIK SUMMARY
Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat.
MAVIK is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide.
In considering the use of MAVIK, it should be noted that in controlled trials ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. (See Warnings: Angioedema.)
When using MAVIK, 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 MAVIK does not have a similar risk. (See WARNINGS.)
MAVIK is indicated in stable patients who have evidence of left-ventricular systolic dysfunction (identified by wall motion abnormalities) or who are symptomatic from congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of trandolapril to Caucasian patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risk of heart failure-related hospitalization (See CLINICAL PHARMACOLOGY, Heart Failure or Left-Ventricular Dysfunction Post Myocardial Infarction for details of the survival trial.)
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NEWS HIGHLIGHTS
Published Studies Related to Mavik (Trandolapril)
Effect of verapamil, trandolapril and their combination on vascular function and structure in essential hypertensive patients. [2009.07]
AIM: The aim of the present study is to evaluate the effect of treatment with verapamil, trandolapril and their combination on peripheral microcirculation vasoreactivity... CONCLUSION: The present study demonstrates that chronic treatment with verapamil ameliorates endothelial function in the forearm microcirculation of essential hypertensive patients, while trandolapril protects microcirculation from structural alterations. The combination of the two drugs is potentially a powerful tool to counteract hypertension-related microvascular dysfunction and damage.
Pulse pressure and risk of cardiovascular outcomes in patients with hypertension and coronary artery disease: an INternational VErapamil SR-trandolapril STudy (INVEST) analysis. [2009.06]
CONCLUSION: In CAD patients with hypertension, PP (on anti-hypertensive treatment) is a weaker predictor of cardiovascular outcomes than SBP, DBP, or MAP.
Alpha-adducin polymorphism associated with increased risk of adverse cardiovascular outcomes: results from GENEtic Substudy of the INternational VErapamil SR-trandolapril STudy (INVEST-GENES). [2008.08]
BACKGROUND: The alpha-adducin (ADD1) Gly460Trp polymorphism has been associated with hypertension and response to diuretic therapy, but controversy exists... CONCLUSIONS: In hypertensive patients with coronary artery disease, black ADD1 variant carriers showed a 2.6-fold excess risk for a primary outcome event and an 8-fold increase risk of death. White and Hispanic ADD1 variant carriers showed an increased but nonsignificant excess risk. However, the effect of diuretic use on risk of cardiovascular outcomes did not vary by ADD1 carrier status.
Verapamil-sustained release-based treatment strategy is equivalent to atenolol-based treatment strategy at reducing cardiovascular events in patients with prior myocardial infarction: an INternational VErapamil SR-Trandolapril (INVEST) substudy. [2008.08]
BACKGROUND: In patients with prior myocardial infarction (MI), beta-blockers reduce mortality by 23% to 40%. However, despite this favorable effect, adverse effects limit compliance to this medication. The purpose of the study was to compare a beta-blocker-based strategy with a heart rate-lowering calcium antagonists-based strategy in patients with prior MI... CONCLUSIONS: In hypertensive patients with prior MI, a verapamil-SR-based strategy was equivalent to a beta-blocker-based strategy for blood pressure control and prevention of cardiovascular events, with greater subjective feeling of well-being and a trend toward lower incidence of angina pectoris and stroke in the verapamil-SR-based group.
Blood pressure control and improved cardiovascular outcomes in the International Verapamil SR-Trandolapril Study. [2007.08]
Uncontrolled blood pressure (BP) increases cardiovascular risk, independent of type of treatment. In this posthoc International Verapamil SR-Trandolapril Study analysis, we determined whether adverse outcomes are related to consistency of BP control, defined as the proportion of visits in which BP was in control...
Clinical Trials Related to Mavik (Trandolapril)
Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL) [Active, not recruiting]
The TRAIL study was conducted to examine the effects of escalating doses of an ACE inhibitor,
trandolapril, on lowering blood pressure in Stage 1-2 hypertensive patients.
INVEST: INternational VErapamil SR Trandolapril STudy [Completed]
Because blood pressure affects the heart, blood vessels, kidneys, and the entire body, it is
important to keep it as normal as possible. There are several different ways to control
blood pressure and to prevent or limit the development of heart disease due to high blood
pressure. The purpose of this study is to compare two treatments to see how well they work
and the difference in their side effects. One treatment includes the use of a calcium
antagonist drug (Isoptin sustained release [SR] or Verapamil SR). The other treatment
excludes the calcium antagonist and may include a non-calcium antagonist drug called a beta
blocker (Tenormin or Atenolol). Both treatments may also include medication called
angiotensin converting enzyme (ACE) inhibitors and water pills. None of the drugs in this
study are experimental, they are all approved by the Food and Drug Administration (FDA).
A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT) [Active, not recruiting]
Acute Haemodynamic Effects of Treatment With Angiotensin Converting Enzyme (ACE)-Inhibitors in Patients With Symptomatic Aortic Stenosis [Recruiting]
Abundant evidence suggests that Angiotensin Converting Enzyme (ACE) inhibition potentially
could reduce the hazardous effects of aortic stenosis and improve haemodynamics. The
treatment seems safe even in patients with severe stenosis. There are however no randomised
clinical trials that can confirm this hypothesis.
Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives [Completed]
To study the effect of sibutramine treatment on weight reduction and blood pressure
improvement in three groups with antihypertensive therapy whose blood pressure was not
adequately controlled with antihypertensive combination treatment.
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Page last updated: 2009-10-20
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