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<\/a>Study: High-Dose vs Standard-Dose Influenza Vaccine in Older Adults With Diabetes<\/a>. Image credit: Andrew Angelov\/Shutterstock.com<\/p>\nA study published in\u00a0JAMA Internal Medicine<\/a> suggests that high-dose influenza vaccine is associated with lower rates of selected influenza-related hospitalization outcomes than standard-dose vaccine in older adults with or without diabetes.<\/p>\n Diabetes heightens risk of influenza complications<\/p>\n Influenza, commonly known as flu, is an acute respiratory infection caused by influenza viruses. Approximately 1 billion influenza cases occur annually worldwide, including 3 to 5 million severe cases. Approximately 290,000 to 650,000 deaths occur each year due to severe infections.<\/p>\n Although the infection remains mild in most cases, children under 5 years of age, older adults, and those with comorbidities such as diabetes are at higher risk of developing severe respiratory and cardiovascular complications.<\/p>\n Seasonal influenza vaccines are primary preventive interventions against severe outcomes. However, the standard-dose inactivated influenza vaccine has been found to provide suboptimal protection, particularly in high-risk individuals.<\/p>\n Given the substantial burden of influenza, the high-dose inactivated influenza vaccine has been developed, containing 4-fold higher antigen<\/a> levels than the standard vaccine. Currently, high-dose vaccination is preferred for adults aged 65 years or older in the US. However, only a few randomized trials have so far analyzed the protective efficacy of high-dose vaccination in susceptible older adults with diabetes.<\/p>\n In the current study, researchers conducted a prespecified secondary analysis of the DANFLU-2 randomized clinical trial in Denmark to compare the protective efficacy of high-dose and standard-dose influenza vaccines in older adults with or without diabetes.<\/p>\n Trial compares high-dose versus standard vaccination<\/p>\n The study included 332,438 older adults, including 43,881 with diabetes. Participants were randomly assigned to two groups, one receiving high-dose vaccination and the other receiving standard-dose vaccination.<\/p>\n Participants were followed up from 14 days after vaccination to May 31 of the following year. The efficacy of<\/a> the two tested vaccines on prespecified cardiorespiratory, cardiovascular, and influenza-related hospitalization outcomes was analyzed in participants with or without diabetes.<\/p>\n High-dose vaccine linked to fewer influenza hospitalizations<\/p>\n The study analysis revealed that the high-dose influenza vaccine was associated with lower rates of hospitalization for several outcomes, most notably influenza-related hospitalizations, among older adults, with a consistent effect across diabetes status.<\/p>\n No overall differences were observed in hospitalization rates for any respiratory disease or myocardial infarction, suggesting that the benefits of high-dose vaccination were not uniform across all endpoints.<\/p>\n Among different diabetes subgroups, diabetes duration was found to modify the association between vaccine type and cardiorespiratory hospitalization. A lower incidence of cardiorespiratory hospitalizations was observed with high-dose vaccination among participants with diabetes of longer duration, but not among those with shorter duration.<\/p>\n Exploratory results highlight potential for targeted prevention<\/p>\n The study highlights a potential incremental benefit of high-dose influenza vaccine over standard-dose influenza vaccine in reducing hospitalizations for some, but not all, cardiorespiratory and cardiovascular outcomes, including influenza and laboratory-confirmed influenza, in older adults, irrespective of diabetes status.<\/p>\n These findings should be interpreted in the context of the DANFLU-2 trial\u2019s neutral primary endpoint, hospitalization for influenza or pneumonia, and the authors emphasize that the secondary and subgroup analyses are exploratory.<\/p>\n Global public health authorities widely recommend annual influenza vaccination, particularly for individuals with chronic conditions, such as diabetes, due to their high vulnerability to complications, including cardiovascular complications.<\/p>\n The study finds a higher risk of hospitalization due to cardiorespiratory and cardiovascular complications in participants with diabetes than those without diabetes. These findings highlight the importance of optimizing preventive strategies for this high-risk population. Consistent with this higher baseline risk, the absolute benefit of high-dose vaccination was greater in individuals with diabetes, as reflected by lower numbers needed to vaccinate.<\/p>\n Moreover, the study reports a generally consistent direction of association between high-dose vaccination and reduced hospitalizations for cardiorespiratory disease, cardiovascular disease, and heart failure. However, several diabetes-specific estimates were imprecise and not statistically significant. Notably, no overall reduction in cardiovascular death was observed, reinforcing the need for cautious interpretation.<\/p>\n The observed influence of different diabetes characteristics, including diabetes duration, presence of diabetes-related complications, and glycated hemoglobin levels, a measure of glycemic control, on vaccine associations with hospitalization outcomes, suggests that the protective benefits of high-dose vaccination over standard-dose vaccination may be more prominent in individuals with more advanced diabetes, although these subgroup findings are hypothesis-generating.<\/p>\n The authors hypothesize that these findings may reflect a more pronounced suboptimal immune response to standard-dose vaccination in individuals with greater disease burden, as well as higher susceptibility to influenza-related complications associated with longer disease duration and a greater comorbidity burden.<\/p>\n Overall, the study findings highlight that high-dose influenza vaccination may offer superior benefits against selected severe outcomes in vulnerable populations through a single annual intervention that imposes no additional burden on the patients.<\/p>\n The DANFLU-2 trial data analyzed in this study were not specifically powered for subgroup analyses. These findings should therefore be considered as exploratory.<\/p>\n The trial did not have access to follow-up laboratory data, such as follow-up glycated hemoglobin levels, or to the Danish prescription registries, which limited the inclusion of data on filled prescriptions in baseline or endpoint definitions.<\/p>\n The study, therefore, could not determine the treatment patterns, including the use of glucose-independent cardiorenal protective and weight-lowering agents, such as glucagon<\/a>-like peptide 1 receptor agonists and sodium-glucose cotransporter-2 inhibitors, and the balance between the groups.<\/p>\n