Cardio-oncology & otherSecondary analysis
High-Dose Versus Standard-Dose Influenza Vaccine and Cardiovascular Outcomes in Older Adults: The FLUNITY-HD Prespecified Pooled Analysis
- Prespecified secondary analysis of the FLUNITY-HD pooled randomised trials
- individual-level pooled data
- 2 pragmatic, individually randomised trials
- Denmark and Spain
- Data primarily from routine health care databases
Authors' conclusion
In a prespecified pooled analysis of 466 320 individually randomized older adults, HD-IIV reduced the incidence of a wide range of severe cardiovascular and respiratory outcomes compared with SD-IIV, with consistent findings regardless of previous history of CVD. Among cardiovascular outcomes, the protective effect of HD-IIV versus SD-IIV was particularly pronounced against hospitalization for heart failure.
Study context
- Population
- Adults ≥65 years of age, with or without pre-existing cardiovascular disease (CVD)107,700 (23.1%) with CVD history
- Participants
- 466,320 adults
- Comparison
- High-dose vs standard-dose inactivated influenza vaccine
- Primary endpoint
- Relative vaccine effectiveness against severe CV outcomes, by pre-existing CVD
- Follow-up
- From 14 days after vaccination to May 31 the following year
Primary result
Hospitalization for any CVD
Relative vaccine effectiveness
6.6%
95% CI 1.6–11.4
P = 0.010
By group
As reported in the abstract
Further findings
Hospitalization for HF
relative vaccine effectiveness 21.3% (7.6–33.0) · P = 0.003
Hospitalization for any respiratory disease
relative vaccine effectiveness 6.5% (0.7–11.9) · P = 0.027
Hospitalization for influenza or pneumonia, cardiorespiratory disease, laboratory-confirmed influenza and any cause, by pre-existing CVD
- Reduced with high-dose inactivated influenza vaccine (HD-IIV) vs standard-dose inactivated influenza vaccine (SD-IIV) irrespective of pre-existing CVD
- Pinteraction>0.66 for all outcomes
Original publication
Summarised from the published abstract; every number is checked against it