WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue MAVIK as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (See WARNINGS: Fetal Toxicity).
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.
Heart Failure Post Myocardial Infarction or Left-Ventricular Dysfunction Post Myocardial Infarction
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).
Published Studies Related to Mavik (Trandolapril)
Trandolapril, but not verapamil nor their association, restores the physiological renal hemodynamic response to adrenergic activation in essential hypertension. [2011.06]
The purpose of this study was to evaluate the effects of antihypertensive drugs on renal hemodynamics in hypertensive patients during an adrenergic activation by mental stress (MS), which induces renal vasoconstriction in healthy subjects. Renal hemodynamics was assessed twice in 30 middle-aged essential hypertensive patients (57+/-6 years)-after 15 days of pharmacological wash-out and after 15 days of treatment with Trandolapril (T, 4 mg, n=10), Verapamil (V, 240 mg, n=10), or both (T 2 mg+V 180 mg, n=10)...
Effects of verapamil added-on trandolapril therapy in hypertensive type 2 diabetes patients with microalbuminuria: the BENEDICT-B randomized trial. [2011.02]
OBJECTIVES: To address whether nondihydropyridine calcium-channel blocker added-on angiotensin-converting-enzyme inhibitor therapy ameliorates albuminuria and cardiovascular outcomes in type 2 diabetes patients... CONCLUSION: In hypertensive type 2 diabetes patients with microalbuminuria, verapamil added-on trandolapril did not improve renal or cardiovascular outcomes. Independent of verapamil, trandolapril normalized albuminuria in half of patients and this translated into significant cardioprotection.
Genetic variation in the beta2 subunit of the voltage-gated calcium channel and pharmacogenetic association with adverse cardiovascular outcomes in the INternational VErapamil SR-Trandolapril STudy GENEtic Substudy (INVEST-GENES). [2010.12]
CONCLUSIONS: These data suggest that genetic variation within CACNB2 may influence treatment-related outcomes in high-risk patients with hypertension.
Coronary revascularization strategy and outcomes according to blood pressure (from the International Verapamil SR-Trandolapril Study [INVEST]). [2010.08.15]
The optimal blood pressure (BP) to prevent major adverse outcomes (death, myocardial infarction, and stroke) for patients with hypertension and coronary artery disease who have undergone previous revascularization is unknown but might be influenced by the type of revascularization procedure...
Changes of matrix metalloproteinase-9 level is associated with left ventricular remodeling following acute myocardial infarction among patients treated with trandolapril, valsartan or both. [2010.06]
BACKGROUND: Inhibition of the renin-angiotensin system (RAS) with angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) can suppress left ventricular (LV) remodeling after acute myocardial infarction (AMI), possibly through the modifications of matrix metalloproteinase (MMP)-9...
Clinical Trials Related to Mavik (Trandolapril)
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fed Conditions [Completed]
Bioequivalence Study of Trandolapril 4 mg Tablets of Dr. Reddy's Under Fasting Conditions [Completed]
Trandolapril 4 mg Tablet Under Fasting Conditions [Completed]
Trandolapril 4 mg Tablet Under Non-Fasting Conditions [Completed]
The objective of this study is to evaluate the comparative bioavailability between
trandolapril 4 mg tablets (test) and MavikŪ 4 mg Tablets (reference) after a single-dose in
healthy subjects under fed conditions.
Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL) [Completed]
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.
Reports of Suspected Mavik (Trandolapril) Side Effects
Pulmonary Oedema (3),
Cardiac Failure Congestive (3),
Pericardial Drainage (3),
Cerebrovascular Accident (3),
Asthenia (3), more >>
Page last updated: 2011-12-09