Effects of high‐dose versus standard‐dose quadrivalent influenza vaccine among patients with diabetes: A post‐hoc analysis of the DANFLU ‐1 trial
Authors' conclusion
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.
Study context
- Population
- Adults aged 65–79 years, 2021/22 influenza season; 1162 (9.3%) had diabetes at baseline1,162 with diabetes
- Participants
- 12,477 adults
- Comparison
- High-dose quadrivalent influenza vaccine (QIV-HD) vs standard-dose (QIV-SD), by diabetes status
Methodological detailspragmatic, open-label, randomized 1:1
- Pragmatic
- Open-label
- Randomized 1:1
Primary result
As reported in the abstract
Total all-cause hospitalizations (first + recurrent), by diabetes status
QIV-HD vs QIV-SDIncidence rate ratio (95% CI)P value
Overall: 647vs 742 events
0.87(0.76–0.99)
Diabetes: 93vs 118 events
0.80(0.55–1.15)
Without diabetes: 554vs 624 events
0.88(0.76–1.01)
P = 0.62for interactionFurther findings
Events
| Outcome | QIV-HD | QIV-SD | HR (95% CI) | |
|---|---|---|---|---|
| Composite of all-cause mortality and hospitalization for pneumonia or influenza, patients with diabetes | 2 | 11 | 0.18 (0.04–0.83) | |
| Incident diabetesDid not affect risk | 1.18 (0.94–1.47) | |||
| 0.050.21520Hazard ratio (log scale) |
| Outcome | Adjusted mean difference (mmol/mol) (95% CI) |
|---|---|
| ∆HbA1c, patients with diabetesNo effect on ∆HbA1c | + 0.2 (−0.9 to 1.2) |
Original publication
Effects of high‐dose versus standard‐dose quadrivalent influenza vaccine among patients with diabetes: A post‐hoc analysis of the DANFLU ‐1 trial. Diabetes Obes Metab. Published 8 April 2024. doi:10. 1111/ dom. 15498
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