Safety of beta-blocker therapy with and without thrombolysis:A comparison of bisoprolol and atenolol in acute myocardial infarction

In the current era of widely used thrombolytic therapy, the new betablocker bisoprolol was compared with the well-established betablocker atenolol in the treatment of acute myocardial infarction (AMI), A total of 334 patients were enrolled in this international, multicenter, randomized, double-masked, controlled study of 7 days' duration in two parallel groups, The purpose of the study was to compare the tolerability and safety of the two beta-blockers given to patients with AMIs who either were (281 patients) or were not (53) given concurrent thrombolytic agents, A statistically significant decrease in heart rate was seen with both bisoprolol and atenolol, Beta-blocker therapy had to be interrupted in 70 patients, 36 receiving bisoprolol and 34 atenolol, because of serious adverse effects, The difference in incidence of adverse events between groups was not significant, A logistic regression analysis based on conditions at admission predicted an increase in the risk of critical events occurring during the first week after an AMI for patients with a positive family history of AMI, a moderate-sized myocardial infarction, or a heart rate >70 beats/min, and for patients pretreated with dihydropyridine calcium antagonists, Bisoprolol was found to be as effective as atenolol in reducing heart rate, an important goal of intervention in AMI. Furthermore, some characteristics that might influence the decision to use beta-blockers in addition to thrombolytic agents were identified

Reduced costs with bisoprolol treatment for heart failure - An economic analysis of the second Cardiac Insufficiency Bisoprolol Study (CIBIS-II)

Background Beta-blockers, used as an adjunctive to diuretics, digoxin and angiotensin converting enzyme inhibitors, improve survival in chronic heart failure. We report a prospectively planned economic analysis of the cost of adjunctive beta-blocker therapy in the second Cardiac Insufficiency BIsoprolol Study (CIBIS II). Methods Resource utilization data (drug therapy, number of hospital admissions, length of hospital stay, ward type) were collected prospectively in all patients in CIBIS . These data were used to determine the additional direct costs incurred, and savings made, with bisoprolol therapy. As well as the cost of the drug, additional costs related to bisoprolol therapy were added to cover the supervision of treatment initiation and titration (four outpatient clinic/office visits). Per them (hospital bed day) costings were carried out for France, Germany and the U.K. Diagnosis related group costings were performed for France and the U.K. Our analyses took the perspective of a third party payer in France and Germany and the National Health Service in the U.K. Results Overall, fewer patients were hospitalized in the bisoprolol group, there were fewer hospital admissions perpatient hospitalized, fewer hospital admissions overall, fewer days spent in hospital and fewer days spent in the most expensive type of ward. As a consequence the cost of care in the bisoprolol group was 5-10% less in all three countries, in the per them analysis, even taking into account the cost of bisoprolol and the extra initiation/up-titration visits. The cost per patient treated in the placebo and bisoprolol groups was FF35 009 vs FF31 762 in France, DM11 563 vs DM10 784 in Germany and pound 4987 vs pound 4722 in the U.K. The diagnosis related group analysis gave similar results. Interpretation Not only did bisoprolol increase survival and reduce hospital admissions in CIBIS II, it also cut the cost of care in so doing. This `win-win' situation of positive health benefits associated with cost savings is Favourable from the point of view of both the patient and health care systems. These findings add further support for the use of beta-blockers in chronic heart failure

BISOPROLOL PILOT-STUDIES IN MYOCARDIAL-INFARCTION

The efficacy of beta-blockade after myocardial infarction (MI) has been investigated in a series of studies. When beta-blockers are used during the first hours after the onset of MI, a reduction in infarct size, mortality, and nonfatal reinfarction may occur. Bisoprolol is a highly beta-1-selective beta-blocker, without intrinsic sympathomimetic activity (ISA), and with a plasma elimination half-life of 10-12 h, permitting treatment with one daily dose. Because no experience with bisoprolol was available in MI, its safety and efficacy were studied in two open, uncontrolled pilot studies. The first study was a dose-finding study in 37 patients with a 3-day-old MI. Bisoprolol was given intravenously and carefully titrated in steps of 1 mg up to a cumulative maximum dose of 5 mg. Subsequently, the patients received 10 mg of oral bisoprolol once daily (o.d.) until the end of the study. Based on the results of this first pilot study, a second pilot study was performed in which bisoprolol was given within the first 6 h after the onset of MI. Intravenous (i.v.) bisoprolol was titrated in two steps of 2.5 mg each, directly followed by 10 mg of oral bisoprolol o.d. The aim of this study was to investigate the influence of i.v. and subsequent oral bisoprolol on central hemodynamics. The results of these studies demonstrate that i.v. and subsequent oral administration of bisoprolol is well tolerated and indicate that the selected dose regimen is hemodynamically safe

Reduced costs with bisoprolol treatment for heart failure - An economic analysis of the second Cardiac Insufficiency Bisoprolol Study (CIBIS-II)

Background Beta-blockers, used as an adjunctive to diuretics, digoxin and angiotensin converting enzyme inhibitors, improve survival in chronic heart failure. We report a prospectively planned economic analysis of the cost of adjunctive beta-blocker therapy in the second Cardiac Insufficiency BIsoprolol Study (CIBIS II). Methods Resource utilization data (drug therapy, number of hospital admissions, length of hospital stay, ward type) were collected prospectively in all patients in CIBIS . These data were used to determine the additional direct costs incurred, and savings made, with bisoprolol therapy. As well as the cost of the drug, additional costs related to bisoprolol therapy were added to cover the supervision of treatment initiation and titration (four outpatient clinic/office visits). Per them (hospital bed day) costings were carried out for France, Germany and the U.K. Diagnosis related group costings were performed for France and the U.K. Our analyses took the perspective of a third party payer in France and Germany and the National Health Service in the U.K. Results Overall, fewer patients were hospitalized in the bisoprolol group, there were fewer hospital admissions perpatient hospitalized, fewer hospital admissions overall, fewer days spent in hospital and fewer days spent in the most expensive type of ward. As a consequence the cost of care in the bisoprolol group was 5-10% less in all three countries, in the per them analysis, even taking into account the cost of bisoprolol and the extra initiation/up-titration visits. The cost per patient treated in the placebo and bisoprolol groups was FF35 009 vs FF31 762 in France, DM11 563 vs DM10 784 in Germany and pound 4987 vs pound 4722 in the U.K. The diagnosis related group analysis gave similar results. Interpretation Not only did bisoprolol increase survival and reduce hospital admissions in CIBIS II, it also cut the cost of care in so doing. This 'win-win' situation of positive health benefits associated with cost savings is Favourable from the point of view of both the patient and health care systems. These findings add further support for the use of beta-blockers in chronic heart failure. (C) 2001 The European Society of Cardiology