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.)
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)
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).
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.
A Study for Prevention of Kidney Disease in Diabetic Patients (BENEDICT) [Active, not recruiting]
Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery [Not yet recruiting]
Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and
including the morning of an intermediate risk surgery will experience more intraoperative
hypotension than those who hold their chronic ACEI perioperatively.
Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and
including the morning of an intermediate risk surgery will experience better postoperative
control of hypertension than those who hold their chronic ACEI perioperatively.
Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and
including the morning of an intermediate risk surgery will experience less acute renal
failure than those who hold their chronic ACEI perioperatively.
Secondary research hypothesis #3: Patients with a preoperative systolic blood pressure less
than 110 mmHg who are continued on their chronicACEI therapy perioperatively will have a
significant decrease in blood pressure during anesthesia compared to those who have a
preoperative systolic blood pressure greater than 110 who are continued on their chronic
Secondary research hypothesis #4: Patients above the age of 64 who are continued on their
chronic ACEI therapy perioperatively will have a significant decrease in blood pressure
during anesthesia compared to those aged 64 or younger who are continued on their chronic
Reports of Suspected Mavik (Trandolapril) Side Effects
Pulmonary Oedema (3),
Cardiac Failure Congestive (3),
Pericardial Drainage (3),
Cerebrovascular Accident (3),
Asthenia (3), more >>