Effects of high-dose versus standard-dose quadrivalent influenza vaccine among patients with diabetes: A post-hoc analysis of the DANFLU-1 trial
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Effects of high-dose versus standard-dose quadrivalent influenza vaccine among patients with diabetes : A post-hoc analysis of the DANFLU-1 trial. / Lassen, Mats C.Højbjerg; Johansen, Niklas Dyrby; Modin, Daniel; Nealon, Joshua; Samson, Sandrine; Dufournet, Marine; Loiacono, Matthew M.; Larsen, Carsten Schade; Jensen, Anne Marie Reimer; Landler, Nino Emanuel; Claggett, Brian L.; Solomon, Scott D.; Landray, Martin J.; Gislason, Gunnar H.; Køber, Lars; Jensen, Jens Ulrik Stæhr; Sivapalan, Pradeesh; Vestergaard, Lasse Skafte; Krause, Tyra Grove; Biering-Sørensen, Tor.
I: Diabetes, Obesity and Metabolism, Bind 26, Nr. 5, 2024, s. 1821-1829.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Effects of high-dose versus standard-dose quadrivalent influenza vaccine among patients with diabetes
T2 - A post-hoc analysis of the DANFLU-1 trial
AU - Lassen, Mats C.Højbjerg
AU - Johansen, Niklas Dyrby
AU - Modin, Daniel
AU - Nealon, Joshua
AU - Samson, Sandrine
AU - Dufournet, Marine
AU - Loiacono, Matthew M.
AU - Larsen, Carsten Schade
AU - Jensen, Anne Marie Reimer
AU - Landler, Nino Emanuel
AU - Claggett, Brian L.
AU - Solomon, Scott D.
AU - Landray, Martin J.
AU - Gislason, Gunnar H.
AU - Køber, Lars
AU - Jensen, Jens Ulrik Stæhr
AU - Sivapalan, Pradeesh
AU - Vestergaard, Lasse Skafte
AU - Krause, Tyra Grove
AU - Biering-Sørensen, Tor
N1 - Publisher Copyright: © 2024 John Wiley & Sons Ltd.
PY - 2024
Y1 - 2024
N2 - Aim: High-dose quadrivalent influenza vaccine (QIV-HD) has been shown to be more effective than standard-dose (QIV-SD) in reducing influenza infection, but whether diabetes status affects relative vaccine effectiveness (rVE) is unknown. We aimed to assess rVE on change in glycated haemoglobin [HbA1c (∆HbA1c)], incident diabetes, total all-cause hospitalizations (first + recurrent), and a composite of all-cause mortality and hospitalization for pneumonia or influenza. Methods: DANFLU-1 was a pragmatic, open-label trial randomizing adults (65-79 years) 1:1 to QIV-HD or QIV-SD during the 2021/22 influenza season. Cox proportional hazards regression was used to estimate rVE against incident diabetes and the composite endpoint, negative binomial regression to estimate rVE against all-cause hospitalizations, and ANCOVA when assessing rVE against ∆HbA1c. Results: Of the 12 477 participants, 1162 (9.3%) had diabetes at baseline. QIV-HD, compared with QIV-SD, was associated with a reduction in the rate of all-cause hospitalizations irrespective of diabetes [overall: 647 vs. 742 events, incidence rate ratio (IRR): 0.87, 95% CI (0.76-0.99); diabetes: 93 vs. 118 events, IRR: 0.80, 95% CI (0.55-1.15); without diabetes: 554 vs. 624 events, IRR: 0.88, 95% CI (0.76-1.01), pinteraction = 0.62]. Among those with diabetes, QIV-HD was associated with a lower risk of the composite outcome [2 vs. 11 events, HR: 0.18, 95% CI (0.04-0.83)] but had no effect on ∆HbA1c; QIV-HD adjusted mean difference: ∆ + 0.2 mmol/mol, 95% CI (−0.9 to 1.2). QIV-HD did not affect the risk of incident diabetes [HR 1.18, 95% CI (0.94-1.47)]. Conclusions: In this post-hoc analysis, QIV-HD versus QIV-SD was associated with an increased rVE against the composite of all-cause death and hospitalization for pneumonia/influenza, and the all-cause hospitalization rate irrespective of diabetes status.
AB - Aim: High-dose quadrivalent influenza vaccine (QIV-HD) has been shown to be more effective than standard-dose (QIV-SD) in reducing influenza infection, but whether diabetes status affects relative vaccine effectiveness (rVE) is unknown. We aimed to assess rVE on change in glycated haemoglobin [HbA1c (∆HbA1c)], incident diabetes, total all-cause hospitalizations (first + recurrent), and a composite of all-cause mortality and hospitalization for pneumonia or influenza. Methods: DANFLU-1 was a pragmatic, open-label trial randomizing adults (65-79 years) 1:1 to QIV-HD or QIV-SD during the 2021/22 influenza season. Cox proportional hazards regression was used to estimate rVE against incident diabetes and the composite endpoint, negative binomial regression to estimate rVE against all-cause hospitalizations, and ANCOVA when assessing rVE against ∆HbA1c. Results: Of the 12 477 participants, 1162 (9.3%) had diabetes at baseline. QIV-HD, compared with QIV-SD, was associated with a reduction in the rate of all-cause hospitalizations irrespective of diabetes [overall: 647 vs. 742 events, incidence rate ratio (IRR): 0.87, 95% CI (0.76-0.99); diabetes: 93 vs. 118 events, IRR: 0.80, 95% CI (0.55-1.15); without diabetes: 554 vs. 624 events, IRR: 0.88, 95% CI (0.76-1.01), pinteraction = 0.62]. Among those with diabetes, QIV-HD was associated with a lower risk of the composite outcome [2 vs. 11 events, HR: 0.18, 95% CI (0.04-0.83)] but had no effect on ∆HbA1c; QIV-HD adjusted mean difference: ∆ + 0.2 mmol/mol, 95% CI (−0.9 to 1.2). QIV-HD did not affect the risk of incident diabetes [HR 1.18, 95% CI (0.94-1.47)]. Conclusions: In this post-hoc analysis, QIV-HD versus QIV-SD was associated with an increased rVE against the composite of all-cause death and hospitalization for pneumonia/influenza, and the all-cause hospitalization rate irrespective of diabetes status.
KW - diabetes
KW - influenza
KW - pragmatic
KW - randomized controlled trial
KW - registry
KW - vaccine
U2 - 10.1111/dom.15498
DO - 10.1111/dom.15498
M3 - Journal article
C2 - 38586966
AN - SCOPUS:85190100081
VL - 26
SP - 1821
EP - 1829
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
SN - 1462-8902
IS - 5
ER -
ID: 389311929