Publication:
Real-World Safety of Intravitreal Bevacizumab and Ranibizumab Treatments for Retinal Diseases in Thailand: A Prospective Observational Study

Issued Date

2018-09-01

Resource Type

Article

ISSN

11791918
11732563

DOI

10.1007/s40261-018-0678-5

Other identifier(s)

2-s2.0-85051263294

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Mahidol University

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SCOPUS

Bibliographic Citation

Clinical Drug Investigation. Vol.38, No.9 (2018), 853-865

Suggested Citation

Sermsiri Sangroongruangsri, Usa Chaikledkaew, Suthasinee Kumluang, Olivia Wu, Claudia Geue, Tanapat Ratanapakorn, Pattara Leelahavarong, Lily Ingsrisawang, Paisan Ruamviboonsuk, Wongsiri Taweebanjongsin, Janejit Choovuthayakorn, Apichart Singalavanija, Prut Hanutsaha, Kittisak Kulvichit, Thitiporn Ratanapojnard, Warapat Wongsawad, Yot Teerawattananon Real-World Safety of Intravitreal Bevacizumab and Ranibizumab Treatments for Retinal Diseases in Thailand: A Prospective Observational Study. Clinical Drug Investigation. Vol.38, No.9 (2018), 853-865. doi:10.1007/s40261-018-0678-5 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/46419

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Title

Real-World Safety of Intravitreal Bevacizumab and Ranibizumab Treatments for Retinal Diseases in Thailand: A Prospective Observational Study

Author(s)

Sermsiri Sangroongruangsri
 Usa Chaikledkaew
 Suthasinee Kumluang
 Olivia Wu
 Claudia Geue
 Tanapat Ratanapakorn
 Pattara Leelahavarong
 Lily Ingsrisawang
 Paisan Ruamviboonsuk
 Wongsiri Taweebanjongsin
 Janejit Choovuthayakorn
 Apichart Singalavanija
 Prut Hanutsaha
 Kittisak Kulvichit
 Thitiporn Ratanapojnard
 Warapat Wongsawad
 Yot Teerawattananon

Other Contributor(s)

Chulalongkorn University
 Rangsit University
 Kasetsart University
 Khon Kaen University
 Faculty of Medicine, Ramathibodi Hospital, Mahidol University
 Thailand Ministry of Public Health
 Mahidol University
 Faculty of Medicine, Siriraj Hospital, Mahidol University
 Phramongkutklao College of Medicine
 University of Glasgow
 Chiang Mai University
 Mettapracharak (Wat Rai Khing) Hospital

Abstract

© 2018, The Author(s). Background: There is very limited evidence examining serious systemic adverse events (SSAEs) and post-injection endophthalmitis of intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) treatments in Thailand and low- and middle-income countries. Moreover, findings from the existing trials might have limited generalizability to certain populations and rare SSAEs. Objectives: This prospective observational study aimed to assess and compare the safety profiles of IVB and IVR in patients with retinal diseases in Thailand. Methods: Between 2013 and 2015, 6354 patients eligible for IVB or IVR were recruited from eight hospitals. Main outcomes measures were prevalence and risk of SSAEs, mortality, and endophthalmitis during the 6-month follow-up period. Results: In the IVB and IVR groups, 94 and 6% of patients participated, respectively. The rates of outcomes in the IVB group were slightly greater than in the IVR group. All-cause mortality rates in the IVB and IVR groups were 1.10 and 0.53%, respectively. Prevalence rates of endophthalmitis and non-fatal strokes in the IVB group were 0.04% of 16,421 injections and 0.27% of 5975 patients, respectively, whereas none of these events were identified in the IVR group. There were no differences between the two groups in the risks of mortality, arteriothrombotic events (ATE), and non-fatal heart failure (HF). Adjustment for potential confounding factors and selection bias using multivariable models for time-to-event outcomes and propensity scores did not alter the results. Conclusions: The rates of SAEs in both groups were low. The IVB and IVR treatments were not associated with significant risks of mortality, ATE, and non-fatal HF. Trial Registration: Thai Clinical Trial Registry identifier TCTR20141002001.

Keyword(s)

Medicine

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/46419

Collections

Scopus 2018