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      Use of levosimendan in acute and advanced heart failure: short review on available real-world data

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          Abstract

          Published data have shown potential advantages of levosimendan in the management of acute decompensated heart failure and advanced heart failure when standard medical therapies threaten hemodynamics and organ perfusion are unable to alleviate clinical symptoms. Levosimendan distinguishes itself from other catecholaminergic inotropes by its three mechanisms of action: positive inotropy, vasodilation, and cardioprotection. In addition, its pharmacokinetics allow for a longer duration of action from the metabolite OR1896 allowing for further cardiovascular therapeutic effects for several days, even after discontinuation of the parent drug.

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          Most cited references 54

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          Burden of systolic and diastolic ventricular dysfunction in the community: appreciating the scope of the heart failure epidemic.

          Approximately half of patients with overt congestive heart failure (CHF) have diastolic dysfunction without reduced ejection fraction (EF). Yet, the prevalence of diastolic dysfunction and its relation to systolic dysfunction and CHF in the community remain undefined. To determine the prevalence of CHF and preclinical diastolic dysfunction and systolic dysfunction in the community and determine if diastolic dysfunction is predictive of all-cause mortality. Cross-sectional survey of 2042 randomly selected residents of Olmsted County, Minnesota, aged 45 years or older from June 1997 through September 2000. Doppler echocardiographic assessment of systolic and diastolic function. Presence of CHF diagnosis by review of medical records with designation as validated CHF if Framingham criteria are satisfied. Subjects without a CHF diagnosis but with diastolic or systolic dysfunction were considered as having either preclinical diastolic or preclinical systolic dysfunction. The prevalence of validated CHF was 2.2% (95% confidence interval [CI], 1.6%-2.8%) with 44% having an EF higher than 50%. Overall, 20.8% (95% CI, 19.0%-22.7%) of the population had mild diastolic dysfunction, 6.6% (95% CI, 5.5%-7.8%) had moderate diastolic dysfunction, and 0.7% (95% CI, 0.3%-1.1%) had severe diastolic dysfunction with 5.6% (95% CI, 4.5%-6.7%) of the population having moderate or severe diastolic dysfunction with normal EF. The prevalence of any systolic dysfunction (EF < or =50%) was 6.0% (95% CI, 5.0%-7.1%) with moderate or severe systolic dysfunction (EF < or =40%) being present in 2.0% (95% CI, 1.4%-2.5%). CHF was much more common among those with systolic or diastolic dysfunction than in those with normal ventricular function. However, even among those with moderate or severe diastolic or systolic dysfunction, less than half had recognized CHF. In multivariate analysis, controlling for age, sex, and EF, mild diastolic dysfunction (hazard ratio, 8.31 [95% CI, 3.00-23.1], P<.001) and moderate or severe diastolic dysfunction (hazard ratio, 10.17 [95% CI, 3.28-31.0], P<.001) were predictive of all-cause mortality. In the community, systolic dysfunction is frequently present in individuals without recognized CHF. Furthermore, diastolic dysfunction as rigorously defined by comprehensive Doppler techniques is common, often not accompanied by recognized CHF, and associated with marked increases in all-cause mortality.
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            National and regional trends in heart failure hospitalization and mortality rates for Medicare beneficiaries, 1998-2008.

            It is not known whether recent declines in ischemic heart disease and its risk factors have been accompanied by declines in heart failure (HF) hospitalization and mortality. To examine changes in HF hospitalization rate and 1-year mortality rate in the United States, nationally and by state or territory. From acute care hospitals in the United States and Puerto Rico, 55,097,390 fee-for-service Medicare beneficiaries hospitalized between 1998 and 2008 with a principal discharge diagnosis code for HF. Changes in patient demographics and comorbidities, HF hospitalization rates, and 1-year mortality rates. The HF hospitalization rate adjusted for age, sex, and race declined from 2845 per 100,000 person-years in 1998 to 2007 per 100,000 person-years in 2008 (P < .001), a relative decline of 29.5%. Age-adjusted HF hospitalization rates declined over the study period for all race-sex categories. Black men had the lowest rate of decline (4142 to 3201 per 100,000 person-years) among all race-sex categories, which persisted after adjusting for age (incidence rate ratio, 0.81; 95% CI, 0.79-0.84). Heart failure hospitalization rates declined significantly faster than the national mean in 16 states and significantly slower in 3 states. Risk-adjusted 1-year mortality decreased from 31.7% in 1999 to 29.6% in 2008 (P < .001), a relative decline of 6.6%. One-year mortality rates declined significantly in 4 states but increased in 5 states. The overall HF hospitalization rate declined substantially from 1998 to 2008 but at a lower rate for black men. The overall 1-year mortality rate declined slightly over the past decade but remains high. Changes in HF hospitalization and 1-year mortality rates were uneven across states.
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              Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial.

              Because acute decompensated heart failure causes substantial morbidity and mortality, there is a need for agents that at least improve hemodynamics and relieve symptoms without adversely affecting survival. To assess the effect of a short-term intravenous infusion of levosimendan or dobutamine on long-term survival. The Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support (SURVIVE) study was a randomized, double-blind trial comparing the efficacy and safety of intravenous levosimendan or dobutamine in 1327 patients hospitalized with acute decompensated heart failure who required inotropic support. The trial was conducted at 75 centers in 9 countries and patients were randomized between March 2003 and December 2004. Intravenous levosimendan (n = 664) or intravenous dobutamine (n = 663). All-cause mortality at 180 days. All-cause mortality at 180 days occurred in 173 (26%) patients in the levosimendan group and 185 (28%) patients in the dobutamine group (hazard ratio, 0.91; 95% confidence interval, 0.74-1.13; P = .40). The levosimendan group had greater decreases in B-type natriuretic peptide level at 24 hours that persisted through 5 days compared with the dobutamine group (P<.001 for all time points). There were no statistical differences between treatment groups for the other secondary end points (all-cause mortality at 31 days, number of days alive and out of the hospital, patient global assessment, patient assessment of dyspnea at 24 hours, and cardiovascular mortality at 180 days). There was a higher incidence of cardiac failure in the dobutamine group. There were higher incidences of atrial fibrillation, hypokalemia, and headache in the levosimendan group. Despite an initial reduction in plasma B-type natriuretic peptide level in patients in the levosimendan group compared with patients in the dobutamine group, levosimendan did not significantly reduce all-cause mortality at 180 days or affect any secondary clinical outcomes. clinicaltrials.gov Identifier: NCT00348504.
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                Author and article information

                Journal
                Ther Clin Risk Manag
                Ther Clin Risk Manag
                TCRM
                tcriskman
                Therapeutics and Clinical Risk Management
                Dove
                1176-6336
                1178-203X
                17 June 2019
                2019
                : 15
                : 765-772
                Affiliations
                [1 ] Division of Cardiology, Department of Medicine, Westchester Medical Center and New York Medical College , Valhalla, NY 10595, USA
                Author notes
                Correspondence: Wilbert S Aronow Cardiology Research, Westchester Medical Center and New York Medical College , 100 Woods Road, Valhalla, NY10595, USATel +1 914 493 5311Fax +1 914 235 6274Email wsaronow@ 123456aol.com
                Article
                188761
                10.2147/TCRM.S188761
                6588712
                © 2019 Pashkovetsky et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                References: 60, Pages: 8
                Categories
                Review

                Medicine

                inotropic therapy, heart failure, levosimendan

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