Abstract | Background: Methods: Nationwide retrospective cohort study of Danish specialist diagnosed outpatients with COPD treated with promethazine or an active comparator ( melatonin). Patients with collection of promethazine or melatonin were propensity score matched 1:1. The primary outcome was a composite of severe COPD exacerbations and death from all causes analyzed by Cox proportional hazards regression. We performed an interaction analysis for comorbid asthma. Results: In our registry of 56,523 patients with COPD, 5,661 collected promethazine (n = 3,723) or melatonin (n = 1,938). A cohort of 3,290 promethazine- or melatonin-treated patients matched 1:1 was available for the primary analysis.Within 1-year patients treated with promethazine were at higher risk of the primary outcome than matched controls with a Hazard Ratio (HR) of 1.42 (CI 1.27-1.58, p < 0.0001). Similarly, the risk of death was higher for promethazine-treated patients (HR 1.53, CI 1.32-1.77, p < 0.0001). An interaction analysis for comorbid asthma showed no interaction between comorbid asthma and the likelihood of a primary outcome when collecting promethazine (p = 0.19). Adjusted Cox analysis on the entire population indicated a further increased risk with more promethazine (HR for primary outcome among patients collecting ≥ 400 promethazine tablets/year=2.15, CI 1.94-2.38, p<0.0001). Conclusions:
Promethazine-treated patients with COPD had a concerning excess risk of a composite outcome of severe exacerbations and death from all causes compared to melatonin.
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Authors | Barbara Bonnesen, Valdemar Rømer, Sidse Graff Jensen, Jon Torgny Wilcke, Julie Janner, Jens Bak, Sofie Johansson, Christian B Laursen, Lars Pedersen, Josefin Eklof, Pradeesh Sivapalan, Jens-Ulrik Stæhr Jensen |
Journal | European clinical respiratory journal
(Eur Clin Respir J)
Vol. 10
Issue 1
Pg. 2250604
( 2023)
ISSN: 2001-8525 [Print] United States |
PMID | 37680536
(Publication Type: Journal Article)
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Copyright | © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. |