Key result
High-dose influenza vaccine reduces pneumonia or flu hospitalizations and mortality vs standard-dose regardless of hypertension.
Why the study?
Patients with hypertension face increased risks of influenza complications and mortality, but evidence comparing high-dose with standard-dose inactivated influenza vaccines in this population is limited.
Does high-dose inactivated influenza vaccine reduce hospitalizations and mortality compared to standard-dose in older patients with hypertension?
RCT (n=12,477)
open-label
individually randomized
Does high-dose inactivated influenza vaccine reduce hospitalizations and mortality compared to standard-dose in older patients with hypertension?
High-dose influenza vaccination is associated with lower risks of hospitalizations and mortality compared to standard-dose in older adults, irrespective of hypertension status.
Answers are grounded in this paper and cite their sources.
Supports high-dose influenza vaccination in older adults with hypertension; extends RCT evidence irrespective of hypertension status.
Patients with hypertension (HTN) face an increased risk of complications and mortality from influenza; a risk that may be modified by influenza vaccination. There is limited evidence on the effectiveness of high‐dose (HD‐IIV) compared with standard‐dose (SD‐IIV) inactivated influenza vaccines in hypertensive individuals. This study, a post hoc analysis of DANFLU‐1, a pragmatic, and open‐label, individually randomized trial of HD‐IIV vs. SD‐IIV conducted during the 2021–2022 influenza season among participants aged 65–79 years. Prespecified outcomes in DANFLU‐1 included hospitalization for influenza or pneumonia, cardiovascular, cardiorespiratory, and respiratory hospitalizations, all‐cause hospitalization, and all‐cause mortality. Outcomes were analyzed as both time‐to‐first and recurrent events. DANFLU‐1 randomized 12 477 participants randomized to HD‐IIV or SD‐IIV, of these 6469 (51.9%) had a history of HTN. HD‐IIV was associated with lower hazards for hospitalizations for pneumonia or influenza, respiratory disease, and all‐cause mortality compared with SD‐IIV and these associations were consistent regardless of HTN status ( p interaction = 0.09, = 0.09, and = 0.59, respectively). HD‐IIV was associated with lower incidence rates of recurrent hospitalizations for pneumonia or influenza and all‐cause hospitalizations compared with SD‐IIV, irrespective of HTN status ( p interaction = 0.09 and = 0.75, respectively). There was evidence of potential effect modification of HD‐IIV vs. SD‐IIV in relation to recurrent respiratory hospitalizations, where the relative effect may be greater among those without vs. with HTN ( p interaction = 0.04). In conclusion, this post hoc analysis of a large‐scale pragmatic trial, HD‐IIV was associated with lower risk of clinical outcomes, including hospitalizations for pneumonia or influenza, all‐cause mortality, and all‐cause hospitalizations irrespective of the presence of HTN. Trial Registration : ClinicalTrials.gov identifier: NCT05048589
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Langhoff et al. (2025) conducted an RCT in Hypertension (n=12,477). Inactivated influenza vaccine vs. Standard-dose inactivated influenza vaccine was evaluated on Hospitalization for influenza or pneumonia, cardiovascular, cardiorespiratory, and respiratory hospitalizations, all-cause hospitalization, and all-cause mortality. High-dose influenza vaccine was associated with lower risk of hospitalizations for pneumonia or influenza and all-cause mortality compared to standard-dose, irrespective of hypertension status.
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