Coreg CR (Carvedilol Phosphate) - Summary

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)

Randomized controlled trial of carvedilol versus variceal band ligation for the prevention of the first variceal bleed. [2009.09]
Current therapy for preventing the first variceal bleed includes beta-blocker and variceal band ligation (VBL). VBL has lower bleeding rates, with no differences in survival, whereas beta-blocker therapy can be limited by side effects... Carvedilol is an option for primary prophylaxis in patients with high-risk esophageal varices.

Beta-receptor selectivity of carvedilol and metoprolol succinate in patients with heart failure (SELECT trial): a randomized dose-ranging trial. [2009.08]
STUDY OBJECTIVE: To determine whether metoprolol succinate (a beta(1)-selective beta-blocker) remains beta(1)-selective compared with carvedilol (a nonselective beta-blocker) during upward titration of doses in patients with American College of Cardiology (ACC) stage C heart failure... CONCLUSION: In this ACC stage C heart failure population, carvedilol was nonselective at all clinically relevant doses, whereas metoprolol succinate was beta(1)-selective at low doses and became progressively nonselective at higher doses.

Adherence with once daily versus twice daily carvedilol in patients with heart failure: the Compliance And Quality of Life Study Comparing Once-Daily Controlled-Release Carvedilol CR and Twice-Daily Immediate-Release Carvedilol IR in Patients with Heart Failure (CASPER) Trial. [2009.06]
CONCLUSIONS: Compliance among chronic HF patients in the CASPER trial was high at baseline and unaffected by QD versus BID dosing. Over the 5-month follow-up period, there were no differences in adverse events among patients switching from carvedilol IR to CR.

The comparative effects of long-term carvedilol versus bisoprolol therapy on QT dispersion in patients with chronic heart failure. [2009]
OBJECTIVES: Carvedilol and bisoprolol reduce QT dispersion (QTD) in chronic heart failure (CHF). However, it is unclear whether there is a difference between the effects of the two drugs. The aim of the present study was to compare the long-term effects of carvedilol and bisoprolol on QTD in patients with CHF... CONCLUSIONS: Carvedilol and bisoprolol decrease HR and QTcD in patients with CHF, and there is no meaningful difference between the two beta-blockers as regards their effects on these parameters. Copyright 2008 S. Karger AG, Basel.

Levosimendan versus dobutamine in heart failure patients treated chronically with carvedilol. [2008.09]
CONCLUSIONS: Dobutamine and levosimendan have different effects on LV functions in patients treated chronically with carvedilol. These differences should be considered when selecting inotropic therapy for decompensated HF receiving long-term carvedilol.

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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.

Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-Daily or Twice-Daily Coreg [Active, not recruiting]
The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release carvedilol (Coreg) twice a day.

The CLEVER Study - Coreg And Left Ventricular Mass Regression [Active, not recruiting]
This study is designed to compare the effects of COREG MR (carvedilol modified release formulation) to atenolol on indices of left ventricular dimensions when added to standardized angiotensin converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone. Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The primary endpoint will be the change in left ventricular mass index (LVMI) characterized by magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints include the change in LV (left ventricular) mass, LV wall thickness, diastolic left ventricular filling parameters, and left ventricular ejection fraction by echocardiographic methods at Treatment Month 12. Composite outcomes and individual event data will also be evaluated by treatment group.

Carvedilol Versus Metoprolol for the Prevention of Atrial Fibrillation After Off-Pump Coronary Bypass Surgery [Completed]
Postoperative new-onset atrial fibrillation (AF) is the most common complication stemming from coronary artery bypass graft surgery, and is associated with increased early and late mortality risk. Standard guidelines recommend β blockers for the prevention of AF; however, no prospective study has compared the relative efficacy of β-blocking agents. We hypothesize that carvedilol, a non-selective adrenergic blocker with both anti-inflammatory and antioxidant properties, is more effective than metoprolol, a conventional β1-selective antagonist, in suppressing new-onset AF following off-pump coronary bypass surgery. We have designed the Carvedilol or Metoprolol Post-Revascularization Atrial Fibrillation Controlled Trial (COMPACT) to test our hypothesis in a multi-center, open-label, and randomized controlled trial.

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