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High-Dose vs. Standard-Dose Influenza Vaccine and Cardiopulmonary Hospitalization or Mortality: Emulating the
Mehdi NajafZadeh1, HoJin Shin1, Sebastian Schneeweiss1
1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Clinical Pharmacology and Therapeutics
|October 19, 2023
Summary
High-dose (HD) flu vaccines did not benefit patients in the INVESTED trial. However, real-world evidence showed HD vaccines reduced hospitalization and mortality risk in older heart patients.
Area of Science:
- Cardiology
- Vaccinology
- Real-World Evidence (RWE) Studies
Background:
- The INVESTED trial found no benefit of high-dose (HD) versus standard-dose (SD) influenza vaccines for patients with recent myocardial infarction or hospitalization for heart failure (HHF).
- Discrepancies between clinical trial results and real-world effectiveness necessitate further investigation.
Purpose of the Study:
- To emulate the INVESTED trial using Medicare claims data to assess real-world effectiveness of HD versus SD influenza vaccines.
- To compare findings from the real-world evidence (RWE) study with the original trial results, including a re-analysis of trial data restricted to a population similar to the RWE cohort.
Main Methods:
- Propensity score (PS)-matched analysis of Medicare beneficiaries aged over 65 with prior HHF, vaccinated with HD or SD flu vaccines during 2016-2019.
- Re-analysis of the INVESTED trial data, restricting to participants over 65 with prior HHF.
- Comparison of hazard ratios (HRs) for the primary composite outcome (cardiopulmonary hospitalization or all-cause mortality) and its components between the RWE and trial data.
Main Results:
- In the RWE study, HD vaccines were associated with a lower risk of the primary composite outcome (HR=0.96) and all-cause mortality (HR=0.93) compared to SD vaccines.
- Cardiopulmonary hospitalization risk was similar between HD and SD vaccines in the RWE study (HR=0.98).
- The re-analyzed trial data, restricted to older patients with HHF, showed results more concordant with the RWE findings than the main trial results.
Conclusions:
- Real-world evidence suggests potential benefits of HD influenza vaccines in reducing mortality and hospitalization for older heart failure patients, contrary to the main INVESTED trial findings.
- The alignment of RWE with a subset of trial data highlights the importance of considering patient population characteristics when interpreting trial results and applying them to real-world settings.
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