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1995 - Coreg has now been tested in more than 1,900 heart failure patients. Coreg has multiple actions: One is blocking beta-receptors in the heart, protecting it against over-stimulation by adrenaline. Easing this stimulation without also easing the work load of the heart would be risky. Coreg balances this by blocking alpha-receptors in artery walls, causing vasodilation. The resulting drop in blood pressure allows the heart to pump against less resistance.
Coreg's effects have now been thoroughly studied in large trials in the USA. Coreg - compared to placebo - reduced the risk of death across all the trials by 67% when added to current drug therapy of digoxin, diuretics, and ACE inhibitors. Patients were followed for an average of 6-1/2 months after they were randomly assigned to treatment groups.
Coreg also reduced hospitalizations for heart-related reasons by 40% and slowed progression of failure. The most common side effect of Coreg was dizziness, which usually stopped when dose of Coreg or diuretics was lowered.
Source: 68th Scientific Sessions of the American Heart Association, November, 1995.
May, 1995 - We studied the effectiveness and safety of Coreg use in heart failure patients with idiopathic or ischemic cardiomyopathy. Sixty heart failure patients from class 2 to class 4, with EF of 35% or less, were in the study. Coreg dose was raised over one month from 6.25 to 25mg twice a day or 50mg twice a day for patients over 165 pounds. Coreg was continued for 3 months.
Coreg lowered heart rate and the resistance against which the heart must pump. EF increased 52% in Coreg patients. Coreg patients also reported improved heart failure symptoms. Peak oxygen consumption during exercise (Vo2max) did not change.
Long-term Coreg therapy improves "at-rest" heart function and symptoms in heart failure patients.
Title: Carvedilol improves left ventricular function and symptoms in chronic heart failure: a double-blind randomized study.
Author: Olsen SL, Gilbert EM, Renlund DG, Taylor DO, Yanowitz FD, Bristow MR
Source: J Am Coll Cardiol 1995 May;25(6):1225-1231
PMID: 7722114, UI: 95238741
December 31, 1996 - Three randomized, placebo-controlled studies show that Coreg helps CHFers. Each trial involved about 300 patients and tested adding Coreg to standard therapy, including ACE inhibitors. Symptoms, ability to exercise, quality of life, progression of heart failure and mortality were studied. Coreg increased ejection fraction in all 3 studies.
The first trial showed that patients with moderate to severe heart failure improved in symptoms and heart class, and had a lower death rate. The second study showed a 48% reduction in worsening of mild heart failure, hospitalization and death due to heart failure. The third study found that Coreg reduced death and hospitalization in patients with moderate, stable, chronic heart failure.
These studies support adding Coreg to standard therapy for patients with mild as well as more severe heart failure.
Title: Double-blind, placebo-controlled study of the effects of Coreg in patients with moderate to severe heart failure: the PRECISE trial
Authors: Packer M; et al
Source: Circulation 1996 Dec 1; 94:2793-2799
Title: Coreg inhibits clinical progression in patients with mild symptoms of heart failure
Authors: Colucci WS; et al
Source: Circulation 1996 Dec 1; 94:2800-2806
Title:Coreg produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure
Authors: Bristow MR; et al
Source: Circulation 1996 Dec 1; 94:2807-2816
May 23, 1996 - This manufacturer-sponsored trial studied Coreg use in 1,197 patients with chronic CHF. Coreg is a nonselective beta-blocker that also blocks alpha-1 receptors. Of the 1,197 patients, 1,094 tolerated Coreg in a 2-week evaluation. Seven patients died during this period and 17 developed worsening heart failure.
The study was stopped early by the Safety Monitoring Board because of a 65% relative reduction in mortality in Coreg patients compared to placebo patients. Coreg also reduced hospitalizations 27%. More patients in the placebo group than the Coreg group stopped taking the drug (8% versus 6%) because of adverse reactions.
This study supports use of beta-blockers in heart failure but its results cannot be accepted as definite. The 7 deaths in the 2 week run-in period are a concern.
Title: The effect of Carvedilol on morbidity and mortality in patients with chronic heart failure.
Authors: Packer M et al
Source: N Engl J Med 1996 May 23; 334:1349-1355
Editorial: Pfeffer MA and Stevenson LW
Source: N Engl J Med 1996 May 23; 334:1396-1397
December, 1996 - Three hundred and forty-five people with mild to moderate, stable, chronic heart failure took either Coreg or placebo, at 6.25mg BID, 12.5mg BID, or 25mg BID. After 2 to 4 weeks to get them all up to full dose, they stayed on study medication for 6 months. Primary endpoint was exercise ability, as measured by 6 minute walk test and 9 minute treadmill test.
Coreg did not affect exercise as measured by either test. However, heart function improved in the Coreg group. The low dose group's EF went up an average of 5%, the medium dose group 6% and the high dose group 8%, while the placebo group's EF went up by an average of 2%.
Coreg patients also had higher survival rates. The low dose group had 6% mortality, the medium dose group 7%, and the high dose group 1%, compared with 16% mortality in the placebo group. Coreg also lowered the hospitalization rate by 61% and was generally well tolerated.
In people with mild to moderate heart failure from systolic dysfunction, Coreg improved heart function, mortality and hospitalization rate, but not ability to exercise.
Title:Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure
Authors: Bristow MR, Gilbert EM, Abraham WT, Adams KF, Fowler MB, Hershberger RE, Kubo SH, Narahara KA, Ingersoll H, Krueger S, Young S, Shusterman N
Source: Circulation 1996 Dec 1;94(11):2807-2816
PMID: 8941106, UI: 97096082
December, 1996 - We studied 278 patients with moderate to severe heart failure and an EF less than 36%. Each patient took either placebo (145 patients) or Coreg (133 patients). The dose was 25 to 50mg twice a day for 6 months. Regular drug therapy of digoxin, diuretics and an ACE inhibitor continued.
Coreg patients had more symptom improvement and less worsening of CHF. Coreg raised EF and lowered risk of death. In contrast, Coreg therapy had little effect on exercise tolerance or quality of life scores. The effects of the drug were about the same whether patients had ischemic heart disease or idiopathic DCM as cause of heart failure.
Title: Double-blind, placebo-controlled study of the effects of carvedilol in patients with moderate to severe heart failure. The PRECISE Trial. Prospective Randomized Evaluation of Carvedilol on Symptoms and Exercise
Authors: Packer M, Colucci WS, Sackner-Bernstein JD, Liang CS, Goldscher DA, Freeman I, Kukin ML, Kinhal V, Udelson JE, Klapholz M, Gottlieb SS, Pearle D, Cody RJ, Gregory JJ, Kantrowitz NE, LeJemtel TH, Young ST, Lukas MA, Shusterman NH
Source: Circulation 1996 Dec 1;94(11):2793-2799
PMID: 8941104, UI: 97096080
All information on this site is opinion only. All concepts, explanations, trials, and studies have been re-written in plain English and may contain errors. I am not a doctor. Use the reference information at the end of each article to search MedLine for more complete and accurate information. All original copyrights apply. No information on this page should be used by any person to affect their medical, legal, educational, social, or psychological treatment in any way. I am not a doctor. This web site and all its pages, graphics, and content copyright © 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004 Jon C.