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Nicotine patches in patients on mechanical ventilation for severe COVID-19: a randomized, double-blind, placebo-controlled, multicentre trial

2022; Springer Science+Business Media; Volume: 48; Issue: 7 Linguagem: Inglês

10.1007/s00134-022-06721-1

1432-1238

Guylaine Labro, Florence Tubach, Lisa Belin, Jean‐Louis Dubost, David Osman, Grégoire Müller, Jean‐Pierre Quenot, Daniel Silva, Jonathan Zarka, Matthieu Turpin, Julien Mayaux, Christian Lamer, Denis Doyen, Guillaume Chevrel, Gaëtan Plantefève, Sophie Demeret, Gaël Piton, C. Manzon, Evelina Ochin, Raphaël Gaillard, Bertrand Dautzenberg, Mathieu Baldacini, Saïd Lebbah, Makoto Miyara, Marc Pineton de Chambrun, Zahir Amoura, Alain Combes, Jessica Palmyre, Linda Gimeno, Assitan Kone, Cedric Vialette, Ouramdane Slimi, Juliette Chommeloux, Lucie Lefèvre, Matthieu Schmidt, Guillaume Hékimian, Charles‐Édouard Luyt, Laure Stiel, Anne‐Florence Dureau, Khaldoun Kuteifan, Hanna Eid, Matthieu Baldacini, Cecile Zyberfajn, Julien Manson, Nathanaël Charrier, Angelique Balabanian, Damien Contou, Olivier Pajot, Megan Fraissé, Paul Desaint, Florence Sarfati, Muriel Fartoukh, Guillaume Voirot, Alexandre Elabbabi, Michel Djibré, Cyrielle Desnos, Pierre Garçon, Ly Van Vong, Andréa Issad, Bertrand Pillot, Delphine Reither, Patrick Rouge, Pascale Foliot, Lynda Bendjamar, Valentin Pointurier, Hadrien Winiszewski, Gilles Capellier, Jean-Christophe Navellou, Romain Tapponnier, Émilie Panicucci, L. Morand, Jean Dellamonica, Clément Saccheri, Nicolas Weiss, Clémence Marois, Loïc Le Guennec, Benjamin Rohaut, Luis Ensenat, Cecilia Billiou, María Aroca, Marie Baron, Alexandre Demoule, Alexandra Beurton, Côme Bureau, Maxens Decavèle, Martin Dres, Frédérique Bayle, Quốc Việt Lê, Lionel Liron, Jean-Baptiste Putegnat, François Salord, Pascal Andreu, Hakim Slimani, Baptiste Roudeau, Marie Labruyère, Marine Jacquier, Nadia Anguel, S. Ayed, Edgard Durand, Laurent Guérin, Christopher Lai, Jérôme Aboab, Sophie Alviset, Laurent Lainé, Mathilde Azzi, T. Issoufaly, Laurent Tric, Lyes Knani, Chahrazad Bey Boumezrag, Nicolas Viault, François Barbier, Thierry Boulain, Toufik Kamel, Mai-Anh Nay, Sophie Tollec, An Hung Nguyen,

Long-Term Effects of COVID-19

Epidemiologic studies have documented lower rates of active smokers compared to former or non-smokers in symptomatic patients affected by coronavirus disease 2019 (COVID-19). We assessed the efficacy and safety of nicotine administered by a transdermal patch in critically ill patients with COVID-19 pneumonia.In this multicentre, double-blind, placebo-controlled trial conducted in 18 intensive care units in France, we randomly assigned adult patients (non-smokers, non-vapers or who had quit smoking/vaping for at least 12 months) with proven COVID-19 pneumonia receiving invasive mechanical ventilation for up to 72 h to receive transdermal patches containing either nicotine at a daily dose of 14 mg or placebo until 48 h following successful weaning from mechanical ventilation or for a maximum of 30 days, followed by 3-week dose tapering by 3.5 mg per week. Randomization was stratified by centre, non- or former smoker status and Sequential Organ Function Assessment score (< or ≥ 7). The primary outcome was day-28 mortality. Main prespecified secondary outcomes included 60-day mortality, time to successful extubation, days alive and free from mechanical ventilation, renal replacement therapy, vasopressor support or organ failure at day 28.Between November 6th 2020, and April 2nd 2021, 220 patients were randomized from 18 active recruiting centers. After excluding 2 patients who withdrew consent, 218 patients (152 [70%] men) were included in the analysis: 106 patients to the nicotine group and 112 to the placebo group. Day-28 mortality did not differ between the two groups (30 [28%] of 106 patients in the nicotine group vs 31 [28%] of 112 patients in the placebo group; odds ratio 1.03 [95% confidence interval, CI 0.57-1.87]; p = 0.46). The median number of day-28 ventilator-free days was 0 (IQR 0-14) in the nicotine group and 0 (0-13) in the placebo group (with a difference estimate between the medians of 0 [95% CI -3-7]). Adverse events likely related to nicotine were rare (3%) and similar between the two groups.In patients having developed severe COVID-19 pneumonia requiring invasive mechanical ventilation, transdermal nicotine did not significantly reduce day-28 mortality. There is no indication to use nicotine in this situation.