KCCQ total symptom score, clinical outcome measures, and adverse events associated with omecamtiv mecarbil for heart failure with reduced ejection fraction: a systematic review and meta-analysis of randomized controlled trials

Ibrahim, Ramzi; Olagunju, Abdulbaril; Terrani, Kristina; Takamatsu, Chelsea; Khludenev, George; William, Preethi

doi:10.1007/s00392-023-02172-w

Cited by 1 publication

(1 citation statement)

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“…Moreover, in severe HF where patients are often less prone to tolerate hypotensive effects of guidelinedirected medical therapies, myotropes such as OM might facilitate initiation and/or continuation. Although the overall relative reduction in risk of HF events or CV death was modest in GALACTIC-HF [28], and non-significant according to a meta-analysis [29], subgroup and post-hoc analyses from GALACTIC-HF have suggested a greater benefit with OM in patients with lower EF and greater HF severity [30,31]. In our analysis, these patients were also considerably more likely eligible for OM according to the trial as well as pragmatic criteria (EF<30%: 27% trial and 44% pragmatic eligibility; severe HF: 35% trial and 60% pragmatic eligibility).…”

Section: Discussionmentioning

confidence: 83%

Eligibility for omecamtiv mecarbil in a real-world heart failure population: Data from the Swedish Heart Failure Registry

Lindberg,

Øigaard,

Metra

et al. 2024

PLoS ONE

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Aims We assessed eligibility for omecamtiv mecarbil (OM) in a real-world cohort with heart failure with reduced ejection fraction (HFrEF) according to the selection criteria of the GALACTIC-HF trial (trial scenario) and selected trial´s criteria more likely to impact real-world use (pragmatic scenario). Methods and results We included 31,015 patients with HFrEF lasting ≥3 months and registered in the Swedish HF registry between 2000–2021. Trial eligibility was calculated by applying all the GALACTIC-HF selection criteria. The pragmatic scenario considered only the New York Heart Association class, history of worsening HF, N-terminal pro-B-type natriuretic peptides (NT-proBNP), blood pressure and renal failure criteria defined as in the trial. Eligibility for OM in chronic HFrEF was 21% and 36% in the trial and pragmatic scenarios, respectively. Eligibility was higher in those with EF<30% (trial: 27%, pragmatic: 44%), in-patients (trial:30%, pragmatic:57%), severe HF (trial: 35%, pragmatic: 60%), NYHA class III-IV (trial: 26%, pragmatic: 45%), and NT-proBNP≥5,000pg/mL (trial: 30%, pragmatic: 51%). The criteria that most limited eligibility were history of a recent worsening HF event (60% eligible in chronic HFrEF), elevated NT-proBNP (82% eligible), and deviating blood pressure (82% eligible). Overall, eligible patients were characterized by more severe HF and higher CV event-rates in both scenarios, and higher comorbidity burden in the pragmatic scenario. Conclusion Approximately 21% of real-world chronic HFrEF patients would be eligible for OM according to the GALACTIC-HF selection criteria, and 36% according to the criteria more likely to affect OM use in clinical practice. Criteria in both scenarios identified a patient-group with severe HF and high CV event-rates.

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