Real-world safety of intravitreal bevacizumab and ranibizumab treatments for retinal diseases in Thailand: a prospective observational study

Sangroongruangsri, S. et al. (2018) Real-world safety of intravitreal bevacizumab and ranibizumab treatments for retinal diseases in Thailand: a prospective observational study. Clinical Drug Investigation, 38(9), pp. 853-865. (doi: 10.1007/s40261-018-0678-5) (PMID:30069864) (PMCID:PMC6153972)

Abstract

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.

• Item Type: Articles
• Additional Information: This study was funded by the Health Systems Research Institute (HSRI) (Grants 57-026 and 59-005). The HITAP is funded by the Thailand Research Fund (TRF) under a Grant for Senior Research Scholar (RTA5980011). HITAP’s International Unit and Mahidol University are supported by the International Decision Support Initiative (iDSI) to provide technical assistance on health intervention and technology assessment to governments in low- and middle-income countries. iDSI is funded by the Bill & Melinda Gates Foundation (OPP1134345), the UK’s Department for International Development, and the Rockefeller Foundation. SS and UC’s contribution to the study have been funded through the Royal Golden Jubilee Ph.D. Program (Grant no. PHD/0180/2554) provided by the TRF and Mahidol University
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Wu, Professor Olivia and Geue, Dr Claudia
• Authors: Sangroongruangsri, S., Chaikledkaew, U., Kumluang, S., Wu, O., Geue, C., Ratanapakorn, T., Leelahavarong, P., Ingsrisawang, L., Ruamviboonsuk, P., Taweebanjongsin, W., Choovuthayakorn, J., Singalavanija, A., Hanutsaha, P., Kulvichit, K., Ratanapojnard, T., Wongsawad, W., and Teerawattananon, Y.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment
• Journal Name: Clinical Drug Investigation
• Publisher: Adis
• ISSN: 1173-2563
• ISSN (Online): 1179-1918
• Published Online: 01 August 2018
• Copyright Holders: Copyright © 2018 The Authors
• First Published: First published in Clinical Drug Investigation 38(9): 853-865
• Publisher Policy: Reproduced under a Creative Commons License