Midazolam versus morphine in acute cardiogenic pulmonary oedema: results of a multicentre, open‐label, randomized controlled trial

Autor: Alberto, Domínguez-Rodríguez, Coral, Suero-Mendez, Guillermo, Burillo-Putze, Victor, Gil, Rafael, Calvo-Rodriguez, Pascual, Piñera-Salmeron, Pere, Llorens, Francisco J, Martín-Sánchez, Pedro, Abreu-Gonzalez, Òscar, Miró, Bárbara, Peña-Pardo
Přispěvatelé: Suero Méndez, Coral, Burillo-Putze, Guillermo, Gil, Víctor, Calvo Rodríguez, Rafael, Piñera Salmerón, Pascual, Llorens, Pere, Martín Sánchez, Francisco Javier, Abreu González, Pedro, Miró, Òscar, MIMO (MIdazolam versus MOrphine)
Rok vydání: 2022
Předmět:
Zdroj: European Journal of Heart Failure. 24:1953-1962
ISSN: 1879-0844
1388-9842
DOI: 10.1002/ejhf.2602
Popis: Aims: Benzodiazepines have been used as safe anxiolytic drugs for decades and some authors have suggested they could be an alternative for morphine for treating acute cardiogenic pulmonary oedema (ACPE). We compared the efficacy and safety of midazolam and morphine in patients with ACPE. Methods and results: A randomized, multicentre, open-label, blinded endpoint clinical trial was performed in seven Spanish emergency departments (EDs). Patients >18 years old clinically diagnosed with ACPE and with dyspnoea and anxiety were randomized (1:1) at ED arrival to receive either intravenous midazolam or morphine. Efficacy was assessed by in-hospital all-cause mortality (primary endpoint). Safety was assessed through serious adverse event (SAE) reporting, and the composite endpoint included 30-day mortality and SAE. Analyses were made on an intention-to-treat basis. The trial was stopped early after a planned interim analysis by the safety monitoring committee. At that time, 111 patients had been randomized: 55 to midazolam and 56 to morphine. There were no significant differences in the primary endpoint (in-hospital mortality for midazolam vs. morphine 12.7% vs. 17.9%; risk ratio[RR] 0.71, 95% confidence interval [CI] 0.29–1.74; p = 0.60). SAE were less common with midazolam versus morphine (18.2% vs. 42.9%; RR 0.42, 95% CI 0.22–0.80; p = 0.007), as were the composite endpoint (23.6% vs. 44.6%; RR 0.53, 95% CI 0.30–0.92; p = 0.03). Conclusion: Although the number of patients was too small to draw final conclusions and there were no significant differences in mortality between midazolam and morphine, a significantly higher rate of SAEs was found in the morphine group. Instituto de Salud Carlos III supported with funds from the Spanish Ministry of Health and FEDER (PI17/01590) No data IDR 2020 18.174 JCR (2021) Q1, 7/143 Cardiac & Cardiovascular Systems 5.231 SJR (2021) Q1, 7/356 Cardiology and Cardiovascular Medicine No data IDR 2021 UEC
Databáze: OpenAIRE
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