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PubMed1995

Medical treatment to reduce total ischemic burden: total ischemic burden bisoprolol study (TIBBS), a multicenter trial comparing bisoprolol and nifedipine. The TIBBS Investigators.

OBJECTIVES: We compared the effects of bisoprolol on transient myocardial ischemia with those of nifedipine in patients with chronic stable angina. BACKGROUND: Both beta-adrenergic blocking agents and calcium antagonists reduce transient ischemic episodes, but comparisons of these agents have been made in only a few larger studies. METHODS: The Total Ischemic Burden Bisoprolol Study (TIBBS) was a randomized double-blind controlled study with two parallel groups; 330 patients from 30 centers in seven European countries with stable angina pectoris, a positive exercise test and more than two transient ischemic episodes during 48 h of Holter monitoring (central evaluation) were included. Of these patients 161 were randomized to receive bisoprolol and 169 to receive nifedipine slow release. There were two treatment phases of 4 weeks each, with 48-h Holter monitoring after each phase. During phase 1, patients received either 10 mg of bisoprolol daily or 2 x 20 mg of nifedipine slow release. During phase 2, they received either 20 mg of bisoprolol daily or 2 x 40 mg of nifedipine slow release. RESULTS: In phase 1 of the trial, 4 weeks of bisoprolol therapy (10 mg daily) reduced the mean [+/- SD] number of transient ischemic episodes from 8.1 +/- 0.6 to 3.2 +/- 0.4/48 h. Nifedipine (2 x 20 mg) reduced transient ischemic episodes from 8.3 +/- 0.5 to 5.9 +/- 0.4/48 h. Total duration of ischemia was reduced from 99.3 +/- 10.1 to 31.9 +/- 5.5 min/48 h with bisoprolol and from 101 +/- 9.1 to 72.6 +/- 8.1 min/48 h with nifedipine. Reductions were statistically significant for both drugs; the difference between bisoprolol and nifedipine was also significant (p < 0.0001). Bisoprolol reduced the heart rate at onset of episodes by 13.7 +/- 1.4 beats/min from a baseline value of 99.5 +/- 1.2 beats/min (p < 0.001). Heart rate was unchanged with nifedipine. Bisoprolol had significantly higher responder rates than nifedipine. Doubling of the dose in phase 2 of the trial had small additive effects. Only bisoprolol showed a marked circadian effect by reducing the morning peak of transient ischemic episodes (by 68% at peak time, 8:00 to 8:59 AM). CONCLUSIONS: Both bisoprolol and nifedipine reduced the number and duration of transient ischemic episodes in patients with chronic stable angina. Bisoprolol was significantly more effective than nifedipine in both doses tested and reduced the morning peak of ischemic activity.

Adult↗
PubMed1986

Haemodynamic effects of bisoprolol in patients with coronary heart disease: influence of various bisoprolol plasma concentrations.

The aim of this study was to investigate the haemodynamics of the beta 1-selective beta-blocker bisoprolol at plasma concentrations that would be expected to block completely the cardiac beta-receptors. Seven patients with stable exercise-dependent angina pectoris received 40 mg bisoprolol, and six patients received 10 mg bisoprolol orally as a single dose. Before and 1.5 h after administration, the following parameters were measured at rest and during physical exercise within the framework of an invasive diagnostic investigation: cardiac output, blood pressure in the systemic and pulmonary circulation, heart rate, and ST-segment change. Further haemodynamic factors were derived from these parameters. Before beta-blockade, the change from rest to exercise resulted in an increase in heart rate, blood pressure, and cardiac index, and also in an increase in pulmonary capillary wedge pressure as an indication of ischaemically induced left-ventricular dysfunction. After 40 mg bisoprolol, under exercise conditions, the cardiac index decreased as a consequence of reduced heart rate, and the mean pulmonary capillary wedge pressure increased slightly, compared with baseline. This finding was attributable to clearer changes in three patients; however, as an overall result, an improvement of oxygen consumption also was achieved in these patients. Measured by reduction in cardiac index, no appreciable increase in effect was achieved at bisoprolol plasma concentrations greater than 60 ng/ml. In angina pectoris patients, bisoprolol possesses the typical haemodynamic profile of a beta-adrenoceptor antagonist. There was no indication of a beta-blockade-independent negative inotropic effect of bisoprolol. Forty mg bisoprolol was shown to be an unnecessarily high dose. It may be deduced that the therapeutic dose range of bisoprolol is between 5 and 20 mg.

Adrenergic beta-Antagonists↗
PubMed2001

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 II. 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 diem (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 per patient 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 diem 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 pound4987 vs pound4722 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.

Adrenergic beta-Antagonists↗
PubMed1986

Management of chronic stable angina with once-daily bisoprolol or atenolol and long-term efficacy of bisoprolol.

The efficacy of once-daily bisoprolol (10 mg) and atenolol (100 mg) was assessed in 19 patients with stable angina, using a double-blind randomized crossover protocol and computer-assisted treadmill exercise testing with continuous monitoring of leads CM5 and CC5, the test being carried out 22-24 h after the last dose. The mean +/- SEM exercise time on placebo was 6.5 +/- 0.4 min increasing to 7.8 +/- 0.5 min on bisoprolol (p less than 0.02) and 8.6 +/- 0.6 min on atenolol (p less than 0.001). The increase in exercise time with atenolol was significantly greater than with bisoprolol (p less than 0.02). The time to 1 mm ST-depression in CM5 and CC5 was also prolonged significantly with both drugs compared to placebo, but with no difference between the two active treatments. The mean resting heart rate of 84 +/- 4 beats/min decreased to 63 +/- 2 beats/min on bisoprolol (p less than 0.001) and 64 +/- 2 beats/min on atenolol (p less than 0.001) with a significant decrease in the peak exercise heart rate seen with both drugs (p less than 0.001). The peak rate-pressure product (beats/min X mm Hg X 10(-2)) was 175 +/- 8 after placebo, 146 +/- 7 (p less than 0.001) after bisoprolol and 149 +/- 5 (p less than 0.01) after atenolol. One patient was withdrawn because he suffered a myocardial infarction. After completion of the crossover phase, 18 of the patients were prescribed bisoprolol 10 mg once a day for 6 weeks. Twelve patients were treated for 12 weeks. An exercise test was performed at the end of each 6-week period. The effects of bisoprolol on all parameters were maintained. In conclusion, bisoprolol is an effective antianginal agent, comparable in efficacy and duration of action with atenolol, and is suitable for once daily administration.

Adrenergic beta-Antagonists↗
PubMed2003

Effect of bisoprolol on perioperative complications in chronic heart failure after surgery (Cardiac Insufficiency Bisoprolol Study II (CIBIS II)).

In patients with coronary artery disease undergoing noncardiac surgery, beta-blockers decrease perioperative mortality and nonfatal myocardial infarction. It is presently unknown whether beta-blockers reduce perioperative risk in patients with chronic heart failure. Thus, data of the CIBIS II study were analyzed regarding the effect of bisoprolol on perioperative outcome in patients with moderate to severe heart failure. A total of 2647 patients with heart failure in New York Heart Association (NYHA) class III-IV and left ventricular ejection fraction < or =35% were randomized to bisoprolol or placebo in a double-blind randomized study. Of these patients, 165 underwent surgery (bisoprolol, n = 87; placebo, n = 78). In patients undergoing surgery, mortality was not different between the placebo- and bisoprolol-treated group (7.7% vs 5.8%, p = 0.76). Neither postoperative hospital admission (placebo, 24.4%; bisoprolol, 34.5%, p = 0.17) nor time to postoperative hospital admission (placebo, < or =30 days, n = 2; 31-180 days, n=11; >180 days, n = 6; bisoprolol, n = 9/ 10/11; p = 0.14) were reduced by bisoprolol. Compared to coronary artery disease, perioperative beta-blockade has little effect in patients with chronic heart failure. Therefore, a controlled randomized trial with perioperative beta-blocker treatment in heart failure patients is warranted to further test this hypothesis.

Adrenergic beta-Antagonists↗
PubMed1998

A cost-minimization of heart failure therapy with bisoprolol in the French setting: an analysis from CIBIS trial data. Cardiac Insufficiency Bisoprolol Study.

Beta-blocker-induced benefit in heart failure is under intense evaluation. Several large-scale mortality trials are currently being performed, with CIBIS II evaluating bisoprolol. The economic impact of beta-blocker therapy in heart failure has not been previously determined. The present study is a cost-effectiveness evaluation of bisoprolol treatment based on CIBIS I data. It considers direct costs, that is, the bisoprolol medication cost and the cost of hospitalization related to heart failure and its complications. Hospitalization costs were calculated from the French system of classification (PMSI), which provides costs according to homogeneous groups of patients (GHM). The cost difference between bisoprolol and placebo in the entire CIBIS population and the trial duration result from an increase in cost caused by bisoprolol treatment (+ 2018 Frs/patient) and a decrease in cost related to reduced hospitalization (6349 Frs/patient). A total savings per patient of about 4330 Frs was produced by bisoprolol. Cost reduction is still more pronounced in patients not having a history of myocardial infarction. We conclude that heart failure therapy with bisoprolol lowers medical healthcare costs, mainly due to the reduced rate of hospital admissions for heart failure.

Adrenergic beta-Antagonists↗
PubMed1997

Prognostic value of bisoprolol-induced hemodynamic effects in heart failure during the Cardiac Insufficiency BIsoprolol Study (CIBIS).

BACKGROUND: To further evaluate the mechanism of beta-blocker-induced benefits in heart failure, the relationships between bisoprolol-induced hemodynamic effects and survival were studied during the Cardiac Insufficiency BIsoprolol Study (CIBIS). METHODS AND RESULTS: In 557 patients studied, bisoprolol significantly reduced heart rate (-16.3+/-15.3 versus -1.6+/-13.4 bpm, respectively; P<.001) compared with placebo at 2 months after inclusion in the study. Heart rate change over time had the highest predictive value for survival (P<.01). Left ventricular fractional shortening (LVFS) significantly increased in the bisoprolol group compared with the placebo group 5 months after inclusion (+0.04+/-0.06 versus -0.001+/-0.05, respectively; P<.001; n=160). LVFS change over time was also significantly correlated with further survival (P<.02 by Cox analysis). Using a nonparametric approach, we demonstrated a significant interaction between study treatment group and LVFS over time. Patients who demonstrated improvement of LVFS over time (82% and 51% of patients in the bisoprolol and the placebo groups, respectively; P<.02) were at lower risk, but the hazard did not further decrease with a further increase of fractional shortening, and there was no significant difference between study treatment groups. Finally, it could be demonstrated that each of the three factors (heart rate change over time, LVFS change over time, and bisoprolol treatment) made a specific contribution to mortality rate. CONCLUSIONS: Preservation of left ventricular function appears to play a key role in the bisoprolol-induced beneficial effects on prognosis in heart failure. Short-term beta-blocker-induced cardiac effects could provide a means to identify those patients who will experience improved survival over the long term.

Adrenergic beta-Antagonists↗
PubMed2005

Effect on survival and hospitalization of initiating treatment for chronic heart failure with bisoprolol followed by enalapril, as compared with the opposite sequence: results of the randomized Cardiac Insufficiency Bisoprolol Study (CIBIS) III.

BACKGROUND: In patients with chronic heart failure (CHF), a beta-blocker is generally added to a regimen containing an angiotensin-converting-enzyme (ACE) inhibitor. It is unknown whether beta-blockade as initial therapy may be as useful. METHODS AND RESULTS: We randomized 1010 patients with mild to moderate CHF and left ventricular ejection fraction < or =35%, who were not receiving ACE inhibitor, beta-blocker, or angiotensin receptor blocker therapy, to open-label monotherapy with either bisoprolol (target dose 10 mg QD; n=505) or enalapril (target dose 10 mg BID; n=505) for 6 months, followed by their combination for 6 to 24 months. The 2 strategies were blindly compared with regard to the combined primary end point of all-cause mortality or hospitalization and with regard to each of these end point components individually. Bisoprolol-first treatment was noninferior to enalapril-first treatment if the upper limit of the 95% confidence interval (CI) for the absolute between-group difference was <5%, corresponding to a hazard ratio (HR) of 1.17. In the intention-to-treat sample, the primary end point occurred in 178 patients allocated to bisoprolol-first treatment versus 186 allocated to enalapril-first treatment (absolute difference -1.6%, 95% CI -7.6 to 4.4%, HR 0.94; 95% CI 0.77 to 1.16). In the per-protocol sample, 163 patients allocated to bisoprolol-first treatment had a primary end point, versus 165 allocated to enalapril-first treatment (absolute difference -0.7%, 95% CI -6.6 to 5.1%, HR 0.97; 95% CI 0.78 to 1.21). With bisoprolol-first treatment, 65 patients died, versus 73 with enalapril-first treatment (HR 0.88; 95% CI 0.63 to 1.22), and 151 versus 157 patients were hospitalized (HR 0.95; 95% CI 0.76 to 1.19). CONCLUSIONS: Although noninferiority of bisoprolol-first versus enalapril-first treatment was not proven in the per-protocol analysis, our results indicate that it may be as safe and efficacious to initiate treatment for CHF with bisoprolol as with enalapril.

Adrenergic beta-Antagonists↗
PubMed2002

Bisoprolol for the treatment of chronic heart failure: a meta-analysis on individual data of two placebo-controlled studies--CIBIS and CIBIS II. Cardiac Insufficiency Bisoprolol Study.

BACKGROUND: Despite the available evidence from randomized clinical trials, beta-blockers are often not used optimally in patients with congestive heart failure (CHF). This meta-analysis aims at providing a precise and quantitative estimate of the benefit and risks of long-term bisoprolol on major clinical events in patients with CHF, both overall and in selected subgroups. This may help clinicians in their decisions as to whether to prescribe bisoprolol for their individual patients. METHODS: Meta-analysis was performed of results from the 2 randomized, controlled clinical studies in which bisoprolol was compared with placebo (Cardiac Insufficiency Bisoprolol Study [CIBIS and CIBIS II]), which included 3288 patients with proven CHF. The main outcomes were total death, cardiovascular death, sudden death, hospitalization for heart failure, and myocardial infarction. RESULTS: A highly significant 29.3% relative reduction of death (17%, 40%; P =.00003) was observed, as well as significant risk reduction in cardiovascular death and sudden death in favor of bisoprolol. Also, a highly significant relative reduction of 18.4% (25%, 11%; P =.00001) in hospital admission or death was observed. A similar relative reduction of death was consistently observed in selected subgroups of patients. CONCLUSIONS: Bisoprolol prevents major cardiovascular events in patients with CHF with a high benefit-to-risk ratio and can be recommended for these patients.

Adrenergic beta-Antagonists↗
PubMed1986

Double-blind comparison of the cardioselective beta-blockers bisoprolol and atenolol in hypertension: the Bisoprolol International Multicenter Study (BIMS).

The antihypertensive efficacy and tolerability of bisoprolol and atenolol were compared in the Bisoprolol International Multicenter Study (BIMS). In 104 patients with essential hypertension (21 to 70 years of age and diastolic blood pressures (DBP) of 100-120 mm Hg in the sitting position), after a four-week placebo period, the active drug was given in a random double-blind crossover design (10 to 20 mg bisoprolol, 50 to 100 mg atenolol) for eight weeks each, with a 2 to 6 week placebo wash-out phase between active therapy. All blood pressures were recorded 24 h after drug intake. Of the 104 patients, 10 were withdrawn during the study because of unwanted effects, unsatisfactory blood pressure response, or intercurrent disease, leaving 94 for intraindividual comparisons. After 8 weeks active treatment with individually titrated dose, there were slightly, but significantly greater falls in blood pressure with bisoprolol (p less than or equal to 0.05). Diastolic target pressures of less than or equal to 95 mm Hg were reached in 68% with bisoprolol and 56% with atenolol (p less than or equal to 0.05; Mc Nemar). There was no between treatment group difference in the patients' self-assessed well-being. For both drugs, response rates were greater in patients below the age of 60 years than in those above 60 years. Better antihypertensive responses were observed with bisoprolol in patients regularly smoking cigarettes.

Adrenergic beta-Antagonists↗
PubMed2001

Cost effectiveness of bisoprolol in the treatment of chronic congestive heart failure in Sweden: analysis using data from the Cardiac Insufficiency Bisoprolol Study II trial.

OBJECTIVE: To investigate the cost effectiveness of adding the beta-blocker bisoprolol to standard treatment in patients with congestive heart failure (CHF). DESIGN AND SETTING: A cost-effectiveness study was based on the Cardiac Insufficiency Bisoprolol Study II (CIBIS-II), a randomised clinical trial investigating the efficacy of adding bisoprolol to standard therapy of CHF. The cost-effectiveness analysis was carried out from a societal perspective. METHODS: Health effects were measured in terms of years of life gained. On the cost side, treatment costs for pharmaceuticals and hospitalisations were included. Data on healthcare resource consumption from CIBIS-II were used and were combined with average Swedish retail prices for medicines, and average costs for hospitalisations based on hospital admissions, in the base case. The costs of added years of life, i.e. consumption net of production during life-years gained were also included. RESULTS: If costs of added years of life were not included, then bisoprolol therapy increased life expectancy at an incremental cost of Swedish kronor (SEK) 13 094 (1999 values) per year of life gained. If costs of added years of life were included, then the incremental cost-effectiveness ratio of bisoprolol therapy was SEK 168 858 per year of life gained. CONCLUSIONS: For patients with CHF with the characteristics of those in CIBIS-II, the cost effectiveness of bisoprolol therapy compares favourably with that of other cardiovascular therapies.

Aged↗
PubMed1993

Comparison of bisoprolol with atenolol for systemic hypertension in four population groups (young, old, black and nonblack) using ambulatory blood pressure monitoring. Bisoprolol Investigators Group.

The antihypertensive effects of drugs are partly determined by characteristics of the patients treated. A randomized, double-blind study used 24-hour ambulatory blood pressure (BP) monitoring to compare the effects of 2 beta blockers, bisoprolol (10 to 20 mg; n = 107) and atenolol (50 to 100 mg; n = 96), administered once daily in 4 population groups. After a 4-week placebo period, patients with an office diastolic BP between 95 and 114 mm Hg were stratified according to race and age, and were randomly assigned to treatment with bisoprolol or atenolol for 8 weeks. BP averages measured by automated monitoring for the 24-hour periods were compared between groups. In elderly patients, the reductions in both average 24-hour systolic and diastolic BP were greater with bisoprolol than with atenolol (13 +/- 3/13 +/- 1 mm Hg [n = 23] vs 4 +/- 2/6 +/- 1 mm Hg [n = 30]; p < 0.01). Similarly, bisoprolol produced greater reductions in average 24-hour diastolic BP than did atenolol in nonblack patients (16 +/- 2/12 +/- 1 mm Hg [n = 85] vs 12 +/- 2/9 +/- 1 mm Hg [n = 83]; p = 0.02). Bisoprolol and atenolol were similar in the black (10 +/- 5/9 +/- 3 mm Hg [n = 22] and 10 +/- 6/6 +/- 3 mm Hg [n = 13], respectively) and young (15 +/- 1/11 +/- 1 mm Hg [n = 84] and 16 +/- 2/10 +/- 1 mm Hg [n = 66], respectively) groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2003

Bisoprolol dose-response relationship in patients with congestive heart failure: a subgroup analysis in the cardiac insufficiency bisoprolol study(CIBIS II).

AIMS: Whether all patients with congestive heart failure (CHF) need to reach the target dose of beta-blocker to obtain a benefit in terms of survival remains uncertain. METHODS AND RESULTS: We classified by tertile the 2647 patients enrolled in CIBIS II according to the last tolerated dose: low dose (LD: 1.25, 2.5 or 3.75mg/day, n=434), moderate dose (MD: 5 or 7.5mg/day, n=328) and high dose (HD: 10mg/day, n=565) of bisoprolol or placebo (LD=234, MD=278 and HD=808). In both groups, patients tolerating only low doses were significantly older with more severe New York Heart Association (NYHA) functional class and higher frequency of co-morbidities. Treatment withdrawal was associated with a significant increase of mortality in the bisoprolol group (relative hazard (RH)=2.13, 95% confidence interval (CI)=1.43-3.17, p=0.0002). After adjustment, all-cause mortality was significantly reduced in the bisoprolol group compared to placebo regardless of the dose level considered: LD (RH=0.66, 95% CI=0.48-0.92), MD (RH=0.33, 95% CI=0.21-0.51) or HD (RH=0.59, 95% CI=0.40-0.89). CONCLUSIONS: Bisoprolol reduces mortality in CHF patients at all tolerated dose levels and its withdrawal increases the risk of mortality. Efforts should be made to maintain bisoprolol therapy based on the individual patient's tolerability.

Adrenergic beta-Antagonists↗
PubMed2003

Comparison of the new cardioselective beta-blocker nebivolol with bisoprolol in hypertension: the Nebivolol, Bisoprolol Multicenter Study (NEBIS).

OBJECTIVES: The aim of the present study was to evaluate the antihypertensive efficacy of the highly beta(1)-selective adrenergic antagonist nebivolol in comparison with bisoprolol in the treatment of mild to moderate essential hypertension. METHODS: This multicenter, single-blind, randomized, parallel-group 16-week study involved a 4-week placebo run-in, followed by a 12-week treatment period (5 mg nebivolol or 5 mg bisoprolol). Patients (n = 273) eligible for the study had a sitting diastolic blood pressure (DBP) between 95 and 110 mm Hg and a systolic blood pressure (SBP) </=180 mm Hg at the end of the placebo run-in period. The primary endpoint of the study was the percentage of responders achieving DBP normalization (</=90 mm Hg) or a DBP reduction of at least 10 mm Hg. RESULTS: The baseline SBP and DBP were similar in the two groups. Both SBP and DBP decreased gradually and significantly upon treatment. The two treatments had similar effects on the mean change from the baseline for both DBP (nebivolol -15.7 +/- 6.4 mm Hg vs. bisoprolol -16.0 +/- 6.8 mm Hg) and SBP. A high proportion of responders was noted in both groups (nebivolol 92.0% vs. bisoprolol 89.6%) and there was no significant difference between the treatments. The overall number and incidence of spontaneously reported adverse events were slightly, but not significantly lower for nebivolol (8 events; 5.8%) than for bisoprolol (12 events; 8.9%). CONCLUSIONS: The findings of the present trial indicate that 5 mg nebivolol once daily is an effective antihypertensive agent. It can therefore be recommended as a useful alternative first-line treatment option for the management of patients with mild to moderate essential hypertension.

Adrenergic beta-Antagonists↗
PubMed1997

[Cost effectiveness of bisoprolol in heart failure. Economic evaluation of the Cardiac Insufficiency Bisoprolol Study (CIBIS) for Germany].

BACKGROUND: The Cardiac Insufficiency Bisoprolol Study (CIBIS) demonstrates that, for patients with heart failure of different etiologies, the administration of the beta(1)-adrenoceptor blocker bisoprolol adjuvant to the standard therapy leads to a significant avoidance of hospital admissions. PHARMACOECONOMIC EVALUATION: The results of the CIBIS were evaluated pharmacoeconomically for the Federal Republic of Germany, and were restricted to direct costs only. The costs of bisoprolol medication and in-patient treatment of heart failure were considered, the latter forming the major part of costs incurred. CONCLUSION: Adjunctive therapy with bisoprolol is not only clinically beneficial to the patient with heart failure, but also economically advantageous.

Adrenergic beta-Antagonists↗
PubMed1990

Beta-adrenoceptor-binding studies of the cardioselective beta blockers bisoprolol, H-I 42 BS, and HX-CH 44 BS to heart membranes and intact ventricular myocytes of adult rats: two beta 1-binding sites for bisoprolol.

beta-Adrenoceptor binding of cardioselective drugs to intact ventricular myocytes was performed using [3H]CGP-12177, a hydrophilic non-beta 1/beta 2-selective antagonist radioligand. The beta-adrenoceptor density on the intact cardiomyocytes was about 2 x 10(5) molecules/cell. The beta 1-selective antagonists H-I 42 BS and HX-CH 44 BS competed for [3H]CGP-12177 binding sites on the ventricular myocytes in an essentially monophasic manner with Ki = 72.6 nM and Ki = 76.7 nM, respectively. This is in contrast to the results of binding data from heart membranes, where these beta 1-antagonists bind in a biphasic manner with about 30% of an additional low affinity site, presumably corresponding to the beta 2-adrenoceptor. The beta 1-selective antagonist bisoprolol revealed two binding sites at the heart membranes and at the myocytes as well with Ki(1) = 34.2 and 20.0 nM and Ki(2) = 3,014 and 918 nM, respectively. Our results suggest that viable adult rat ventricular myocytes may contain two beta 1-adrenoceptor binding sites exhibiting different affinities for bisoprolol, whereas beta 2-adrenergic receptors are completely absent.

Adrenergic beta-Antagonists↗
PubMed2006

CHARITY: Chagas cardiomyopathy bisoprolol intervention study: a randomized double-blind placebo force-titration controlled study with Bisoprolol in patients with chronic heart failure secondary to Chagas cardiomyopathy [NCT00323973].

BACKGROUND: Chagas' disease is the major cause of disability secondary to tropical diseases in young adults from Latin America, and around 20 million people are currently infected by T. cruzi. Heart failure due to Chagas cardiomyopathy is the main clinical presentation in Colombia. Heart failure due to Chagas' disease may respond to digoxin, diuretics and vasodilator therapy. Beta-adrenoreceptor antagonism seems to protect against the increased risk of cardiac arrhythmia and sudden death due to chronic sympathetic stimulation. The aim of this study is to evaluate the effects of the selective beta-adrenergic receptor blocker Bisoprolol on cardiovascular mortality, hospital readmission due to progressive heart failure and functional status in patients with heart failure secondary to Chagas' cardiomyopathy. METHODS/DESIGN: A cohort of 500 T. cruzi seropositive patients (250 per arm) will be selected from several institutions in Colombia. During the pretreatment period an initial evaluation visit will be scheduled in which participants will sign consent forms and baseline measurements and tests will be conducted including blood pressure measurements, twelve-lead ECG and left ventricular ejection fraction assessment by 2D echocardiography. Quality of life questionnaire will be performed two weeks apart during baseline examination using the "Minnesota living with heart failure" questionnaire. A minimum of two 6 minutes corridor walk test once a week over a two-week period will be performed to measure functional class. During the treatment period patients will be randomly assigned to receive Bisoprolol or placebo, initially taking a total daily dose of 2.5 mgrs qd. The dose will be increased every two weeks to 5, 7.5 and 10 mgrs qd (maximum maintenance dose). Follow-up assessment will include clinical check-up, and blood collection for future measurements of inflammatory reactants and markers. Quality of life measurements will be obtained at six months. This study will allow us to explore the effect of beta-blockers in chagas' cardiomyopathy.

Journal Article↗
PubMed1990

Beta-blockade treatment in heart failure: the cardiac insufficiency bisoprolol study (CIBIS) project. CIBIS Committees and Investigators. Cardiac Insufficiency Bisoprolol Study.

The efficacy of treatment with diuretics and vasodilators in heart failure has shown that compensatory mechanisms may induce vicious circles that can precipitate the deterioration of congestive heart failure (CHF). By counteracting sympathetic stimulation of cardiac beta-receptors, beta-blocking drugs could provide some benefit in CHF. Indeed, the sympathetic stimulation enhances metabolic costs and could lead to a further deterioration of myocardial fiber function. This could be counteracted by beta-blockade. On the contrary, the loss of adrenergic responsiveness due to beta-adrenergic downregulation and depletion of norepinephrine stores from sympathetic nerves could be responsible for the progressive deterioration of cardiac function. Moderate doses of beta-blocking agents could restore such a catecholamine sensitivity by upregulation of beta-receptors and restoration of norepinephrine stores. Results of clinical trials with beta-blockade in CHF are so far controversial. Most studies enrolled patients with cardiomyopathy and included small numbers of patients or were uncontrolled. The CIBIS trial (Cardiac Insufficiency Bisoprolol Study) has been launched in Europe to answer the question of the potential benefit on prognosis of beta-blockade therapy in heart failure from any etiology, especially ischemic CHF. It is a randomized, placebo-controlled, double-blind multicentric trial involving two parallel groups of patients (300 in each group) followed over a 2-year period. Results from the CIBIS trial should provide conclusive information concerning the use of beta-blocking therapy in CHF.

Adrenergic beta-Antagonists↗