Efficacy and safety of intravenous levosimendan compared with dobutamine in severe low-output heart failure (the LIDO study): a randomised double-blind trial

Folláth, Ferenc; Cleland, John G.F.; Just, Hanjörg; Jg, Papp; Scholz, Hasso; Peuhkurinen, Keijo; Harjola, Veli‐Pekka; Mitrović, Veselin; Abdalla, Mona; Sandell, Esa-Pekka; Lehtonen, Lasse

doi:10.1016/s0140-6736(02)09455-2

Cited by 1,059 publications

(849 citation statements)

References 24 publications

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“…There are no previous data about the levosimendan effect in patients with advanced but stable chronic HF; however, two previous studies have shown improvement in haemodynamic function measured by invasive haemodynamic monitoring in patients with decompensated HF 12, 28. Moreover, we confirmed findings from previous studies documenting that levosimendan also reduces NT‐pro‐BNP, MAP, and eTPR 29, 30, 31.…”

Section: Discussionsupporting

confidence: 89%

“…Levosimendan was first approved in Sweden in the year 2000 and subsequently throughout Europe, and the early LIDO12 and RUSSLAN13 trials were promising. However, the larger SURVIVE14 and REVIVE15 trials were not confirmatory, and levosimendan is not licensed in the USA.…”

Section: Discussionmentioning

confidence: 99%

“…In early studies in ADHF, levosimendan improved haemodynamics and mortality compared with dobutamine12 and placebo 13. In later studies, it was not superior to dobutamine,14 and it improved symptoms but increased hypotension and arrhythmia compared with placebo 15…”

Section: Introductionmentioning

confidence: 99%

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Haemodynamic effects of levosimendan in advanced but stable chronic heart failure

et al. 2018

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AimsLevosimendan improves haemodynamics in acute decompensated heart failure (HF). However, it is increasingly used for repetitive or intermittent infusions in advanced but stable chronic HF, without clear indication, selection criteria, or effect. We tested the hypotheses that (1) levosimendan improves haemodynamics in stable chronic HF and (2) that the response is dependent on baseline clinical and haemodynamic factors.Methods and resultsTwenty‐three patients [median age 56 (49–64) years, four (17%) women] with stable New York Heart Association (NYHA) III and IV HF received a single 24 h levosimendan infusion. Non‐invasive haemodynamics (inert gas re‐breathing technique), estimated glomerular filtration rate, and N‐terminal pro‐brain natriuretic peptide were assessed before and after infusion. Levosimendan had the following effects (median change): a significant increase in cardiac output (+9.8 ± 21.6%; P = 0.026) and decrease in N‐terminal pro‐brain natriuretic peptide (−28.1 ± 16.3%, P < 0.001), estimated total peripheral resistance (−16.9 ± 18.3%, P = 0.005), and mean arterial pressure (−5.9 ± 8.2%, P = 0.007), but no change in estimated glomerular filtration rate (+0.89 ± 14.0%, P = 0.955). There were no significant associations between baseline clinical and/or haemodynamic factors and the levosimendan effect on cardiac output.ConclusionsLevosimendan was associated with improved haemodynamics in patients with stable chronic HF, but we could not identify any predictors of the magnitude of haemodynamic response.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

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Haemodynamic effects of levosimendan in advanced but stable chronic heart failure

et al. 2018

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“…In an updated meta‐analysis comprising six trials, we found no statistically significant difference in short‐term mortality,27, 28, 29, 30, 31, 32 long‐term mortality,27, 30, 31, 33, 34, 35 ischemic events,30, 34 acute kidney injury,31 dysrhythmias,30, 36 or hospital length‐of‐stay37 in patients with cardiogenic shock treated with dobutamine vs. levosimendan (Fig. 3, Fig.…”

Section: Resultsmentioning

confidence: 94%

Scandinavian SSAI clinical practice guideline on choice of inotropic agent for patients with acute circulatory failure

Møller

Granholm

Junttila

et al. 2018

Acta Anaesthesiol Scand

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BackgroundAdult critically ill patients often suffer from acute circulatory failure and those with low cardiac output may be treated with inotropic agents. The aim of this Scandinavian Society of Anaesthesiology and Intensive Care Medicine guideline was to present patient‐important treatment recommendations on this topic.MethodsThis guideline was developed according to GRADE. We assessed the following subpopulations of patients with shock: (1) shock in general, (2) septic shock, (3) cardiogenic shock, (4) hypovolemic shock, (5) shock after cardiac surgery, and (6) other types of shock, including vasodilatory shock. We assessed patient‐important outcome measures, including mortality and serious adverse reactions.ResultsFor all patients, we suggest against the routine use of any inotropic agent, including dobutamine, as compared to placebo/no treatment (very low quality of evidence). For patients with shock in general, and in those with septic and other types of shock, we suggest using dobutamine rather than levosimendan or epinephrine (very low quality of evidence). For patients with cardiogenic shock and in those with shock after cardiac surgery, we suggest using dobutamine rather than milrinone (very low quality of evidence). For the other clinical questions, we refrained from giving any recommendations or suggestions.ConclusionsWe suggest against the routine use of any inotropic agent in adult patients with shock. If used, we suggest using dobutamine rather than other inotropic agents for the majority of patients, however, the quality of evidence was very low, implying high uncertainty on the balance between the benefits and harms of inotropic agents.

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“…Among these 59 surrogate endpoint trials that had a subsequent clinical endpoint trial, in 24 cases the clinical endpoint trial results validated the positive surrogate trials, while in 20 the subsequent clinical endpoint trial was negative (Table 3). 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 A negative surrogate endpoint trial was less likely to be followed by a positive outcome trial and we identified only 3 such examples ( P =0.02, Figure 2). …”

Section: Resultsmentioning

confidence: 99%

Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011

Bikdeli

Punnanithinont

Akram

et al. 2017

JAHA

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BackgroundSurrogate endpoint trials test strategies more efficiently but are accompanied by uncertainty about the relationship between changes in surrogate markers and clinical outcomes.Methods and ResultsWe identified cardiovascular trials with primary surrogate endpoints published in the New England Journal of Medicine, Lancet, and JAMA: Journal of the American Medical Association from 1990 to 2011 and determined the trends in publication of surrogate endpoint trials and the success of the trials in meeting their primary endpoints. We tracked for publication of clinical outcome trials on the interventions tested in surrogate trials. We screened 3016 articles and identified 220 surrogate endpoint trials. From the total of 220 surrogate trials, 157 (71.4%) were positive for their primary endpoint. Only 59 (26.8%) surrogate trials had a subsequent clinical outcomes trial. Among these 59 trials, 24 outcomes trial results validated the positive surrogates, whereas 20 subsequent outcome trials were negative following positive results on a surrogate. We identified only 3 examples in which the surrogate trial was negative but a subsequent outcomes trial was conducted and showed benefit. Findings were consistent in a sample cohort of 383 screened articles inclusive of 37 surrogate endpoint trials from 6 other high‐impact journals.ConclusionsAlthough cardiovascular surrogate outcomes trials frequently show superiority of the tested intervention, they are infrequently followed by a prominent outcomes trial. When there was a high‐profile clinical outcomes study, nearly half of the positive surrogate trials were not validated. Cardiovascular surrogate outcome trials may be more appropriate for excluding benefit from the patient perspective than for identifying it.

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Efficacy and safety of intravenous levosimendan compared with dobutamine in severe low-output heart failure (the LIDO study): a randomised double-blind trial

Cited by 1,059 publications

References 24 publications

Haemodynamic effects of levosimendan in advanced but stable chronic heart failure

Haemodynamic effects of levosimendan in advanced but stable chronic heart failure

Scandinavian SSAI clinical practice guideline on choice of inotropic agent for patients with acute circulatory failure

Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990–2011

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