tetano
Editor, Senior Moderator
Pharmacoepidemiol Drug Saf
. 2021 Dec 8.
doi: 10.1002/pds.5392. Online ahead of print.
Comparison of the incidence of bleeding between baloxavir marboxil and other anti-influenza drugs among outpatients with influenza virus infection: a retrospective cohort study using an employment-based health insurance claims database in Japan
Azusa Hara[SUP] 1 [/SUP], Kanae Hara[SUP] 2 [/SUP], Takuji Komeda[SUP] 3 [/SUP], Eriko Ogura[SUP] 2 [/SUP], Shogo Miyazawa[SUP] 2 [/SUP], Chiduru Kobayashi[SUP] 2 [/SUP], Masakazu Fujiwara[SUP] 2 [/SUP], Manami Yoshida[SUP] 2 [/SUP], Hisashi Urushihara[SUP] 1 [/SUP]
Affiliations
Abstract
Purpose: Alerts for bleeding events are included in the Japanese package inserts of some anti-influenza drugs, including baloxavir marboxil and oseltamivir. However, there are few reports on the incidence of bleeding events during treatment with anti-influenza drugs. This large-scale quantitative assessment compared the incidence of bleeding events in influenza patients treated with baloxavir and other anti-influenza drugs and in untreated patients.
Methods: This retrospective cohort study used a large-scale Japanese employment-based health insurance claims database provided by JMDC Inc. and included outpatients diagnosed with influenza between 1 October 2018 and 11 April 2019. Bleeding events were identified by ICD-10 codes. Incidences were compared between patients treated with baloxavir or neuraminidase inhibitors and untreated patients. Odds ratios were calculated after exact matching to adjust for potential confounders.
Results: Among 529 201 influenza episodes, 30 964 were untreated and 498 237 were treated with anti-influenza drugs: baloxavir, 207 630; oseltamivir, 143 722; zanamivir, 28 208; peramivir, 5304; laninamivir, 113 373. Crude incidence proportions for total bleeding up to 20 days after influenza diagnosis were similar among treated groups, with a slightly higher value for peramivir (0.21% vs. 0.19% for baloxavir, oseltamivir, zanamivir and laninamivir), and 0.30% in untreated patients. After exact matching, the incidence of bleeding for baloxavir was similar to that for other anti-influenza treatments (odds ratios for baloxavir were 0.90-0.99 compared to other therapies).
Conclusions: Based on real-world observation using a large-scale claims database, a similar incidence of bleeding events was observed in recipients of the different anti-influenza drugs. This article is protected by copyright. All rights reserved.
Keywords: Influenza; baloxavir marboxil; bleeding; neuraminidase inhibitors.
. 2021 Dec 8.
doi: 10.1002/pds.5392. Online ahead of print.
Comparison of the incidence of bleeding between baloxavir marboxil and other anti-influenza drugs among outpatients with influenza virus infection: a retrospective cohort study using an employment-based health insurance claims database in Japan
Azusa Hara[SUP] 1 [/SUP], Kanae Hara[SUP] 2 [/SUP], Takuji Komeda[SUP] 3 [/SUP], Eriko Ogura[SUP] 2 [/SUP], Shogo Miyazawa[SUP] 2 [/SUP], Chiduru Kobayashi[SUP] 2 [/SUP], Masakazu Fujiwara[SUP] 2 [/SUP], Manami Yoshida[SUP] 2 [/SUP], Hisashi Urushihara[SUP] 1 [/SUP]
Affiliations
- PMID: 34881477
- DOI: 10.1002/pds.5392
Abstract
Purpose: Alerts for bleeding events are included in the Japanese package inserts of some anti-influenza drugs, including baloxavir marboxil and oseltamivir. However, there are few reports on the incidence of bleeding events during treatment with anti-influenza drugs. This large-scale quantitative assessment compared the incidence of bleeding events in influenza patients treated with baloxavir and other anti-influenza drugs and in untreated patients.
Methods: This retrospective cohort study used a large-scale Japanese employment-based health insurance claims database provided by JMDC Inc. and included outpatients diagnosed with influenza between 1 October 2018 and 11 April 2019. Bleeding events were identified by ICD-10 codes. Incidences were compared between patients treated with baloxavir or neuraminidase inhibitors and untreated patients. Odds ratios were calculated after exact matching to adjust for potential confounders.
Results: Among 529 201 influenza episodes, 30 964 were untreated and 498 237 were treated with anti-influenza drugs: baloxavir, 207 630; oseltamivir, 143 722; zanamivir, 28 208; peramivir, 5304; laninamivir, 113 373. Crude incidence proportions for total bleeding up to 20 days after influenza diagnosis were similar among treated groups, with a slightly higher value for peramivir (0.21% vs. 0.19% for baloxavir, oseltamivir, zanamivir and laninamivir), and 0.30% in untreated patients. After exact matching, the incidence of bleeding for baloxavir was similar to that for other anti-influenza treatments (odds ratios for baloxavir were 0.90-0.99 compared to other therapies).
Conclusions: Based on real-world observation using a large-scale claims database, a similar incidence of bleeding events was observed in recipients of the different anti-influenza drugs. This article is protected by copyright. All rights reserved.
Keywords: Influenza; baloxavir marboxil; bleeding; neuraminidase inhibitors.