COREG SUMMARY
COREG ® (carvedilol) Tablets
Carvedilol is a nonselective (beta)-adrenergic blocking agent with (alpha)1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. It is a racemic mixture.
Carvedilol is indicated for the following:
Congestive Heart Failure: COREG 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 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 is also 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 (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.
Bisoprolol vs. carvedilol in elderly patients with heart failure: rationale and design of the CIBIS-ELD trial. [2008.09] BACKGROUND: Chronic heart failure (CHF) is a widespread disease with severe quality of life impairment and a poor prognosis... Besides determining which of two standard beta-blockers is best tolerated in elderly patients with systolic or diastolic CHF, we expect to gain further insight into the treatment of the particular population of patients with diastolic CHF.
Clinical Trials Related to Coreg (Carvedilol)
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.
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 Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL. [Completed]
This study will be a randomized study investigating the bioequivalence of COREG CR to its
components, COREG and Lisinopril (ZESTRIL). PK samples will be obtained throughout the study
to investigate the PK of COREG CR FDC to COREG and Lisinopril
Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its Components [Completed]
This study will be a randomized study investigating the bioequivalence of COREG CR and
Lisinopril to COREG CR and ZESTRIL
Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's carvedilol 12. 5
mg tablets to GSK's Coreg® 12. 5 mg tablets following a single, oral 12. 5 mg (1 x 12. 5 mg)
dose administered under fasting conditions.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Coreg has an overall score of 6. The effectiveness score is 8 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
| | Coreg review by 49 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | | Treatment Info |
| Condition / reason: | | HEART |
| Dosage & duration: | | 25MG taken tid for the period of 2 YEARS |
| Other conditions: | | high blood pressure |
| Other drugs taken: | | BP | | | Reported Results |
| Benefits: | | HEART WORKS BETTER -NO PVCS- less shortness of breath able to do physical activities again |
| Side effects: | | DRY SKIN wrinkles decreased appetite takes the body a long time to adapt to such a radical change to the heart and lungs |
| Comments: | | took the pill and get checkups? congestive heart failure first confirmed by an echocardiogram wore a holter for 24 hours to detect pvc's |
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Page last updated: 2009-10-20
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