https://doi.org/10.55788/596ea84f
“Macitentan is an orally active, non-peptide, potent, dual endothelin receptor antagonist (ERA), approved for the treatment of PAH,” said Prof. Adriaan Voors (University of Groningen, the Netherlands) [1]. The multicentre, phase 2b SERENADE trial (NCT03153111) originally aimed to enrol 300 patients with HFpEF and pulmonary vascular disease to be randomised 1:1 to placebo or macitentan for 52 weeks after a 4-week placebo run-in and a 5-week macitentan run-in. The run-in periods aimed to identify and exclude participants who were susceptible to developing fluid retention. The recruitment stopped early due to slow enrolment, and the double-blind phase of the trial was cut down to 24 weeks. Notably, approximately 12% and 30% of the participants dropped out during the placebo and macitentan run-in periods, respectively. The main reason for treatment failure was, the exceeding of fluid retention restrictions the study sought to avoid. In the end, only 71 participants in each arm could be analysed for the primary endpoint, which was the change in NT-proBNP from baseline.
After 24 weeks, the study groups showed no difference regarding the primary endpoint (geometric mean ratio 1.02; P=0.79). Similarly, the time to worsening HF was similar in the placebo arm and macitentan arm (HR 1.48; P=0.24). Furthermore, 88.7% and 85.9% of the participants in the macitentan and placebo groups displayed at least 1 adverse event. Fluid retention was still more frequently observed in the active arm than in the placebo arm (22.5% vs 14.1%).
“Despite a novel enrichment trial designed to target PAH associated with HFpEF and exclude treatment-related fluid retention, macitentan neither lowered NT-proBNP nor improved heart failure outcomes in patients with HFpEF and pulmonary vascular disease,” concluded Prof. Voors.
- Voors A, et al. SERENADE: Macitentan in heart failure with preSERved ejEction fractioN and pulmonAry vascular DiseasE. LBT Pharmacotherapy, Heart Failure 2022, 21–24 May, Madrid, Spain.
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Table of Contents: HFA 2022
Featured articles
Phase 3 and 4 Trials
GALACTIC-HF: Omecamtiv mecarbil as option for HFrEF patients with low SBP
HELIOS-A: Vutrisiran meets exploratory endpoints
Patiromer helps HFrEF patients to optimise RAAS inhibitors without hyperkalaemia
FIDELITY: Cardiorenal benefits of finerenone, regardless of LVH status
DAPA-VO2: Rapid effect of dapagliflozin on peak VO2 in stable HFrEF
Phase 1/2 Trials
Significant improvement in BP from istaroxime, a novel non-adrenergic agent
SERENADE: Macitentan fails in HFpEF plus PAH
Combination of filgrastim and dutogliptin appears safe in STEMI
Therapeutic Devices
Cardiac contractility modulation therapy promising for patients with HFpEF
REBALANCE-HF: Encouraging observations for splanchnic nerve ablation in HFpEF
Updates on SGLT2 Inhibitors
DAPA-HF: Dapagliflozin is safe and efficacious in frail patients
EMPEROR-Preserved: Empagliflozin stable across age groups
EMPULSE: Empagliflozin delivers rapid and clinically meaningful decongestion
Dapagliflozin performs consistently across LVEF in HF
Miscellaneous Topics
Cardiac wasting relevant for clinical outcomes in cancer
Urocortin-2 a potential treatment target for HFpEF
Should ATTR-CM be added to the differential diagnosis of patients with HF?
Delayed initiation of novel GDMTs associated with adverse outcomes in HF patients
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