Artikel ; Online: Nicotine patches in patients on mechanical ventilation for severe COVID-19: a randomized, double-blind, placebo-controlled, multicentre trial.
2022 Band 48, Heft 7, Seite(n) 876–887
Abstract: Purpose: 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 ... ...
| Abstract | Purpose: 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. Methods: 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. Results: 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. Conclusion: 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. |
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| Mesh-Begriff(e) | Adult ; COVID-19/therapy ; Double-Blind Method ; Female ; Humans ; Intensive Care Units ; Male ; Nicotine/adverse effects ; Respiration, Artificial ; SARS-CoV-2 ; Treatment Outcome | |||||
| Chemische Substanzen | Nicotine (6M3C89ZY6R) | |||||
| Sprache | Englisch | |||||
| Erscheinungsdatum | 2022-06-09 | |||||
| Erscheinungsland | United States | |||||
| Dokumenttyp | Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't | |||||
| ZDB-ID | 80387-x | |||||
| ISSN | 1432-1238 ; 0340-0964 ; 0342-4642 ; 0935-1701 | |||||
| ISSN (online) | 1432-1238 | |||||
| ISSN | 0340-0964 ; 0342-4642 ; 0935-1701 | |||||
| DOI | 10.1007/s00134-022-06721-1 | |||||
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| Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
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