COREG CR SUMMARY
COREG CR®
Carvedilol phosphate is a nonselective β-adrenergic blocking agent with α1-blocking activity.
COREG CR is indicated for the following:
Heart Failure
COREG CR is indicated for the treatment of mild-to-severe heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitor, and digitalis, to increase survival and, also, to reduce the risk of hospitalization (see CLINICAL TRIALS).
Left Ventricular Dysfunction Following Myocardial Infarction
COREG CR is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤40% (with or without symptomatic heart failure) (see CLINICAL TRIALS).
Hypertension
COREG CR is indicated for the management of essential hypertension. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics (see PRECAUTIONS, Drug Interactions).
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NEWS HIGHLIGHTS
Published Studies Related to Coreg CR (Carvedilol)
Endothelial function is unaffected by changing between carvedilol and metoprolol in patients with heart failure-a randomized study. [2011.10.15] ABSTRACT: BACKGROUND: Carvedilol has been shown to be superior to metoprolol tartrate to improve clinical outcomes in patients with heart failure (HF), yet the mechanisms responsible for these differences remain unclear. We examined if there were differences in endothelial function, insulin stimulated endothelial function, 24 hour ambulatory blood pressure and heart rate during treatment with carvedilol, metoprolol tartrate and metoprolol succinate in patients with HF... CONCLUSION: Endothelial function remained unchanged when switching the beta blocker treatment from carvedilol to either metoprolol tartrate or metoprolol succinate in this study, where blood pressure and heart rate also remained unchanged in patients with mild HF. TRIAL REGISTRATION: Current Controlled Trials NCT00497003.
Prevention of chemotherapy-induced left ventricular dysfunction with enalapril and carvedilol: rationale and design of the OVERCOME trial. [2011.08] BACKGROUND: The current treatment of hematologic malignancies includes diverse potentially cardiotoxic chemotherapy agents, including high-dose myeloablative regimens used in autologous hematopoietic stem cell transplantation (HSCT). Many of these treatments could induce left ventricular dysfunction (LVD), and limit their efficacy. Angiotensin-converting enzime inhibitors and beta-blockers prevent LVD and prolong survival after infarction, and recent animal and pilot clinical studies suggest that they can prevent the development of chemotherapy-induced cardiac toxicity... CONCLUSIONS: The OVERCOME study will be the first clinical trial to test the preventive efficacy on LVD of combined treatment with enalapril and carvedilol administered to patients with hematologic malignancies submitted to current treatment with intensive chemotherapy. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Comparison of antihypertensive efficacy of carvedilol and nebivolol in mild-to-moderate primary hypertension: a randomized trial. [2011.06] OBJECTIVE: The aim of the present study is to compare the antihypertensive effects of carvedilol and nebivolol in mild-to-moderate hypertensive patients... CONCLUSION: Although both carvedilol and nebivolol effectively decreased blood pressure compared to placebo, they showed similar efficacy for lowering blood pressure.
Titration to target dose of bisoprolol vs. carvedilol in elderly patients with heart failure: the CIBIS-ELD trial. [2011.06] CONCLUSION: Overall tolerability to target doses was comparable. The pattern of intolerance, however, was different: bradycardia occurred more often in the bisoprolol group, whereas pulmonary adverse events occurred more often in the carvedilol group. This study is registered with controlled-trials.com, number ISRCTN34827306.
Effects of Beta-Blockade on Exercise Performance at High Altitude: A Randomized, Placebo-Controlled Trial Comparing the Efficacy of Nebivolol versus Carvedilol in Healthy Subjects. [2011.03.11] Aims: Exposure to high altitude (HA) hypoxia decreases exercise performance in healthy subjects. Although beta-blockers are known to affect exercise capacity in normoxia, no data are available comparing selective and nonselective beta-adrenergic blockade on exercise performance in healthy subjects acutely exposed to HA hypoxia...
Clinical Trials Related to Coreg CR (Carvedilol)
A Study to Compare COREG CR to COREG CR Fixed-Dose Combination in Patients With High Blood Pressure [Completed]
Carvedilol controlled release is a marketed drug to treat high blood pressure. This study is
to compare carvedilol controlled release to carvedilol controlled release plus lisinopril
(fixed-dose combination) after repeat dosing in patients with high blood pressure. This is to
make sure that when carvedilol controlled release is given with lisinopril it acts the same
in the body as when given alone. The study will also assess the safety and tolerability of
the fixed-dose combination.
A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure [Active, not recruiting]
The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in
improving heart function in subjects with stable chronic heart failure.
Efficacy and Safety of Carvedilol SR Versus Carvedilol IR in Patients With Essential Hypertension [Recruiting]
Coreg CR, Blood Vessel Stiffness and Blood Vessel Function [Recruiting]
We are comparing the blood pressure-lowering effects of two marketed medications, Coreg CR
and Toprol XL. Although both drugs reduce blood pressure by blocking the action of
noradrenaline on beta-receptors in the blood vessels, Coreg CR also blocks alpha-receptors,
which may provide added blood pressure-lowering. In addition, Coreg CR may have anti-oxidant
actions. Cells which line blood vessels (termed "endothelial cells") make nitric oxide (NO),
which relaxes the muscle cells encircling the blood vessels, causing a reduction in blood
pressure. When body cells use oxygen, they normally produce "free radicals", which can
destroy NO,leading to high blood pressure, heart damage and worsenimg of diabetes.
Antioxidants remove free radicals and prevent or repair this damage. In this study we will
measure endothelial cell function, blood vessel wall stiffness, NO in exhaled breath, and
blood levels of substances which reflect NO production and destruction to determine if a
pure beta-blocker (Toprol XL) differs from an alpha/beta blocker (Coreg CR) in these
effects. We will also examine the mechanism by which such differences might occur.
Cocaine Withdrawal and Pharmacotherapy Response [Recruiting]
A total of 20 male and female opioid dependent cocaine users will participate in this study.
This study will be a 8 - week open label study examining the dose-dependent effects of
carvedilol (up to 50mg/day) in methadone stabilized patients. The design will have two
phases: 1) a four-week "treatment " phase; and 2) a 4 week " taper and detoxification or
transfer" phase. Subjects will be cocaine users who are on stable doses of methadone (60 to
140mg/day). Carvedilol dose will be increased from 12. 5mg/day to the target dose of 50mg/day
as tolerated. At the end of the treatment-phase, subjects will undergo detoxification from
methadone over a 2 to 4-week period based on an individual's needs, and they will
concurrently be tapered off carvedilol.
Reports of Suspected Coreg CR (Carvedilol) Side Effects
Drug Ineffective (17),
Blood Pressure Increased (10),
Fatigue (8),
Rash (7),
Dizziness (6),
Pruritus (5),
Headache (4),
Treatment Noncompliance (4),
Weight Increased (4),
Blood Pressure Inadequately Controlled (4), more >>
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Page last updated: 2011-12-09
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