Influenza vaccination and vitamin K antagonist treatment: A placebo-controlled, randomized, double-blind crossover study

Alfonso Iorio, Michela Basileo, Maura Marcucci, Francesco Guercini, Barbara Camilloni, Elisa Paccamiccio, Maria Vecchioli, Anna Maria Iorio

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background: Among millions of persons vaccinated against influenza virus each year, many are older patients treated with several drugs, including vitamin K antagonists (VKAs), among which warfarin is the most commonly used. Due to high interpatient and intrapatient variability, the therapeutic dose of VKA has to be individualized by monitoring of international normalized ratio (INR) values. The objectives of this study were to evaluate variation in the INR and warfarin weekly dose variation after influenza vaccination administration and to follow up patients for related hemorrhagic and thrombotic events to evaluate the safety of the influenza vaccine and to assess the immunogenicity of the influenza vaccination in patients receiving VKAs. Methods: One hundred four patients on a stable VKA regimen and with an indication for influenza vaccination were randomized to receive influenza vaccination and subsequent placebo administration, or vice versa. All patients were tested for coagulation variables, clinical events, and antibody response against vaccine components. Results: Similar mean prothrombin times, expressed as the INR and VKA weekly dose, were found in patients after receiving vaccine or placebo. The absence of any vaccination effect on VKA treatment was confirmed using a linear mixed-effects model. The percentages of time that patients were in therapeutic range were 70.7% after receiving vaccine and 72.4% after receiving placebo (P=.57). There were no fatal or major bleeding events and 11 minor mucocutaneous hemorrhagic events. After vaccination, the percentage of seroprotected patients ranged from 92.0% to 100.0% depending on the vaccine antigen examined. Conclusions: Influenza vaccination had no significant effect on INR values or warfarin sodium weekly doses. Close monitoring of INR values is not required after influenza vaccination in patients on stable long-term VKA regimens. Trial Registration: clinicaltrials.gov Identifier: NCT00222638.

Original languageEnglish
Pages (from-to)609-616
Number of pages8
JournalArchives of Internal Medicine
Volume170
Issue number7
DOIs
Publication statusPublished - Apr 12 2010

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Vitamin K
Double-Blind Method
Cross-Over Studies
Human Influenza
Vaccination
Placebos
International Normalized Ratio
Warfarin
Vaccines
Therapeutics
Influenza Vaccines
Prothrombin Time
Orthomyxoviridae
Antibody Formation
Hemorrhage
Safety
Antigens

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Influenza vaccination and vitamin K antagonist treatment : A placebo-controlled, randomized, double-blind crossover study. / Iorio, Alfonso; Basileo, Michela; Marcucci, Maura; Guercini, Francesco; Camilloni, Barbara; Paccamiccio, Elisa; Vecchioli, Maria; Iorio, Anna Maria.

In: Archives of Internal Medicine, Vol. 170, No. 7, 12.04.2010, p. 609-616.

Research output: Contribution to journalArticle

Iorio, Alfonso ; Basileo, Michela ; Marcucci, Maura ; Guercini, Francesco ; Camilloni, Barbara ; Paccamiccio, Elisa ; Vecchioli, Maria ; Iorio, Anna Maria. / Influenza vaccination and vitamin K antagonist treatment : A placebo-controlled, randomized, double-blind crossover study. In: Archives of Internal Medicine. 2010 ; Vol. 170, No. 7. pp. 609-616.
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AU - Iorio, Alfonso

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AU - Marcucci, Maura

AU - Guercini, Francesco

AU - Camilloni, Barbara

AU - Paccamiccio, Elisa

AU - Vecchioli, Maria

AU - Iorio, Anna Maria

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N2 - Background: Among millions of persons vaccinated against influenza virus each year, many are older patients treated with several drugs, including vitamin K antagonists (VKAs), among which warfarin is the most commonly used. Due to high interpatient and intrapatient variability, the therapeutic dose of VKA has to be individualized by monitoring of international normalized ratio (INR) values. The objectives of this study were to evaluate variation in the INR and warfarin weekly dose variation after influenza vaccination administration and to follow up patients for related hemorrhagic and thrombotic events to evaluate the safety of the influenza vaccine and to assess the immunogenicity of the influenza vaccination in patients receiving VKAs. Methods: One hundred four patients on a stable VKA regimen and with an indication for influenza vaccination were randomized to receive influenza vaccination and subsequent placebo administration, or vice versa. All patients were tested for coagulation variables, clinical events, and antibody response against vaccine components. Results: Similar mean prothrombin times, expressed as the INR and VKA weekly dose, were found in patients after receiving vaccine or placebo. The absence of any vaccination effect on VKA treatment was confirmed using a linear mixed-effects model. The percentages of time that patients were in therapeutic range were 70.7% after receiving vaccine and 72.4% after receiving placebo (P=.57). There were no fatal or major bleeding events and 11 minor mucocutaneous hemorrhagic events. After vaccination, the percentage of seroprotected patients ranged from 92.0% to 100.0% depending on the vaccine antigen examined. Conclusions: Influenza vaccination had no significant effect on INR values or warfarin sodium weekly doses. Close monitoring of INR values is not required after influenza vaccination in patients on stable long-term VKA regimens. Trial Registration: clinicaltrials.gov Identifier: NCT00222638.

AB - Background: Among millions of persons vaccinated against influenza virus each year, many are older patients treated with several drugs, including vitamin K antagonists (VKAs), among which warfarin is the most commonly used. Due to high interpatient and intrapatient variability, the therapeutic dose of VKA has to be individualized by monitoring of international normalized ratio (INR) values. The objectives of this study were to evaluate variation in the INR and warfarin weekly dose variation after influenza vaccination administration and to follow up patients for related hemorrhagic and thrombotic events to evaluate the safety of the influenza vaccine and to assess the immunogenicity of the influenza vaccination in patients receiving VKAs. Methods: One hundred four patients on a stable VKA regimen and with an indication for influenza vaccination were randomized to receive influenza vaccination and subsequent placebo administration, or vice versa. All patients were tested for coagulation variables, clinical events, and antibody response against vaccine components. Results: Similar mean prothrombin times, expressed as the INR and VKA weekly dose, were found in patients after receiving vaccine or placebo. The absence of any vaccination effect on VKA treatment was confirmed using a linear mixed-effects model. The percentages of time that patients were in therapeutic range were 70.7% after receiving vaccine and 72.4% after receiving placebo (P=.57). There were no fatal or major bleeding events and 11 minor mucocutaneous hemorrhagic events. After vaccination, the percentage of seroprotected patients ranged from 92.0% to 100.0% depending on the vaccine antigen examined. Conclusions: Influenza vaccination had no significant effect on INR values or warfarin sodium weekly doses. Close monitoring of INR values is not required after influenza vaccination in patients on stable long-term VKA regimens. Trial Registration: clinicaltrials.gov Identifier: NCT00222638.

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