| 1. |
- Funck-Brentano, Christian, et al.
(författare)
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Influence of order and type of drug (bisoprolol vs. enalapril) on outcome and adverse events in patients with chronic heart failure: a post hoc analysis of the CIBIS-III trial
- 2011
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Ingår i: European Journal of Heart Failure. - : Wiley. - 1879-0844 .- 1388-9842. ; 13:7, s. 765-772
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Tidskriftsartikel (refereegranskat)abstract
- Aims Angiotensin-converting enzyme inhibitors (ACE-Is) and beta-blockers are associated with improved outcome in patients with chronic heart failure (CHF). In this post hoc analysis of the CIBIS III trial, we examined the influence of the order of drug administration on clinical events and achieved dose. We also assessed the relations between dose levels and baseline variables or adverse events. Methods and results In the CIBIS III trial, 1010 patients (mean age: 72.4 years; mean ejection fraction: 28.8%; male: 68.2%) with stable CHF were randomized to up-titration of monotherapy with either bisoprolol (target dose 10 mg o.d.) or enalapril (target dose 10 mg b.i.d.) for 6 months, followed by their combination for 6-24 months. Endpoints were mortality or all-cause hospitalization, mortality alone and mortality or cardiovascular hospitalization. The study drug (ACE-I or beta-blocker) was last prescribed at >= 50% of target dose to significantly more patients for the first initiated drug in both treatment groups (both P < 0.001). Sixty per cent of endpoints were reached during the monotherapy phase and randomized treatment during monotherapy was not a predictor of the three assessed outcomes. Monotherapy phase was the strongest independent predictor of outcome (P < 0.0001 for all endpoints). Older age, NYHA class III, impaired renal function, lower body weight and blood pressure at baseline, and hypotension, bradycardia and heart failure during treatment were associated with the inability to reach high dose of both study drugs. Conclusion The order of drug administration plays an important role in whether CHF patients reach target doses of bisoprolol and enalapril. For both study drugs, the dose level reached was associated with baseline characteristics and adverse events. In CHF patients not treated with an ACE-I or a beta-blocker, the duration of monotherapy with either type of drug should be shorter than 6 months.
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| 2. |
- Van de Ven, Louis L. M., et al.
(författare)
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The effect of treatment with bisoprolol-first versus enalapril-first on cardiac structure and function in heart failure
- 2010
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Ingår i: International Journal of Cardiology. - : Elsevier BV. - 0167-5273. ; 144:1, s. 59-63
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Tidskriftsartikel (refereegranskat)abstract
- Background: In CIBIS III, initiating chronic heart failure (CHF) treatment with bisoprolol (target dose 10 mg q.d.) followed by combination therapy with enalapril (target dose 10 mg b.i.d.), compared to the opposite order, showed similar effects on survival and hospitalization. By echocardiography, we evaluated the effects of these treatment strategies on cardiac structure and function. Methods: In a single-centre substudy, we compared the impact on left ventricular (LV) dimensions and ejection fraction (EF) of treatment with bisoprolol-first (n = 21) and enalapril-first (n = 19) in 40 beta-blocker and angiotensin-converting-enzyme-inhibitor naive patients, with stable, mild or moderate CHF (NYHA II-III) and LVEF <= 35%. Echocardiography was performed at baseline, after the 6-month monotherapy phase and after 12 months, i.e. after 6 months combination therapy. Results: Baseline characteristics were similar across treatment groups. After 6 months LVEF increased by 5.1 +/- 4.0 EF-% (P<0.0001) with Bisoprolol and 4.0 +/- 4.0 EF-% (P = 0.0005), with enalapril (between-group P = 0.47). LV end-diastolic volume (LVEDV) decreased by 8.1 +/- 4.7 ml (P<0.0001) with bisoprolol and by 4.6 +/- 8.2 ml (P = 0.03) with enalapril (between-group P = 0.16). Mean wall thickness (WT) decreased by 0.31 +/- 0.43 mm (P = 0.004) with bisoprolol and by 0.18 +/- 0.48 mm (P = 0.11) with enalapril (between-group P = 0.29). From baseline to 12 months, LVEF increased by 7.5 +/- 4.0 EF-% (P<0.0001) in Bisoprolol first group and 6.0 +/- 4.6 EF-% (P<0.0001), in the enalapril first group (between-group P = 0.31). LVEDV decreased by 12.9 +/- 6.3 ml (P<0.0001) with bisoprolol-first and by 7.9 +/- 7.7 ml (P = 0.0006) with enalapril-first (between-group P = 0.16) and WT decreased by 0.38 +/- 0.44 mm (P = 0.0008) and 0.59 +/- 0.54 mm (P = 0.0004), respectively (between-group P = 0.10). Conclusion: During both monotherapy and combined therapy, bisoprolol-first and enalapril-first similarly reversed cardiac remodelling and improved LVEF. (C) 2009 Elsevier Ireland Ltd. All rights reserved.
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| 3. |
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| 4. |
- Willenheimer, Ronnie, et al.
(författare)
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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.
- 2005
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Ingår i: Circulation. - 1524-4539. ; 112:16, s. 2426-2435
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Tidskriftsartikel (refereegranskat)abstract
- 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 <= 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). Conclusion - 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.
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| 5. |
- Dobre, Daniela, et al.
(författare)
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Clinical effects of initial 6 months monotherapy with bisoprolol versus enalapril in the treatment of patients with mild to moderate chronic heart failure. Data from the CIBIS III trial
- 2008
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Ingår i: Cardiovascular Drugs and Therapy. - : Springer Science and Business Media LLC. - 0920-3206 .- 1573-7241. ; 22:5, s. 399-405
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Tidskriftsartikel (refereegranskat)abstract
- Purpose To assess the clinical effects and safety profile of initial monotherapy with either bisoprolol or enalapril in elderly patients with heart failure (HF). Methods In CIBIS III, 1010 patients with mild to moderate HF and age >= 65 years were randomized to monotherapy with either bisoprolol or enalapril for 6 months. Results Bisoprolol had a similar effect as enalapril on the combined end-point of all-cause mortality or hospitalization (HR 1.02; p=0.90), as well as on each of the individual end-points. A trend towards fewer sudden deaths was observed with bisoprolol (NS). On the other hand, more cases of worsening HF requiring hospitalization or occurring while in hospital were observed in the bisoprolol group (HR 1.67; p=0.03). The two groups were similar with regard to treatment cessations and early introduction of the second drug. Conclusions Bisoprolol and enalapril had a similar effect on the combined end-point of mortality or hospitalization during 6 months monotherapy. However, more worsening HF events were observed in the bisoprolol group.
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| 6. |
- Krum, Henry, et al.
(författare)
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Effect on Mode of Death of Heart Failure Treatment Started with Bisoprolol Followed by Enalapril, Compared to the Opposite Order: Results of the Randomized CIBIS III Trial
- 2011
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Ingår i: Cardiovascular Therapeutics. - : Wiley. - 1755-5914. ; 29:2, s. 89-98
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Tidskriftsartikel (refereegranskat)abstract
- P>Background: Mode of death in chronic heart failure (CHF) may be of relevance to choice of therapy for this condition. Sudden death is particularly common in patients with early and/or mild/moderate CHF. beta-Blockade may provide better protection against sudden death than ACE inhibition (ACEI) in this setting. Methods: We randomized 1010 patients with mild or moderate, stable CHF and left ventricular ejection fraction < 35%, without ACEI, beta-blocker or angiotensin-receptor-blocker therapy, to either bisoprolol (n = 505) or enalapril (n = 505) for 6 months, followed by their combination for 6-24 months. The two strategies were blindly compared regarding adjudicated mode of death, including sudden death and progressive pump failure death. Results: During the monotherapy phase, 8 of 23 deaths in the bisoprolol-first group were sudden, compared to 16 of 32 in the enalapril-first group: hazard ratio (HR) for sudden death 0.50; 95% confidence interval (CI) 0.21-1.16; P = 0.107. At 1 year, 16 of 42 versus 29 of 60 deaths were sudden: HR 0.54; 95% CI 0.29-1.00; P = 0.049. At study end, 29 of 65 versus 34 of 73 deaths were sudden: HR 0.84; 95% CI 0.51-1.38; P = 0.487. Comparable figures for pump failure death were: monotherapy, 7 of 23 deaths versus 2 of 32: HR 3.43; 95% CI 0.71-16.53; P = 0.124, at 1 year, 13 of 42 versus 5 of 60: HR 2.57; 95% CI 0.92-7.20; P = 0.073, at study end, 17 of 65 versus 7 of 73: HR 2.39; 95% CI 0.99-5.75; P = 0.053. There were no significant between-group differences in any other fatal events. Conclusion: Initiating therapy with bisoprolol compared to enalapril decreased the risk of sudden death during the first year in this mild systolic CHF cohort. This was somewhat offset by an increase in pump failure deaths in the bisoprolol-first cohort.
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