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Date Published: 17/07/2022
Abstract Views: 543
Views PDF: 267
DOI: https://doi.org/10.51298/vmj.v516i1.2995
Issue
Vol. 516 No. 1 (2022)
Section
Các bài báo
How to Cite
Thị Thu Huyền, C. ., Quang Huân, Đỗ ., Vĩnh Nam, N., Nhật Long, N. ., Bích Việt, Đặng ., Đình Hòa, V. ., Quang Nam, T. ., Quỳnh Nga, V., Trung Quân, Đỗ ., Quang Toàn, L. ., Thị Thanh Phương, C. ., Nguyễn Thụy Khương, L. ., Thanh Phong, N., Lễ Trí, P. ., & Hoàng Anh, N. (2022). MONITORING ADVERSE EVENTS ASSOCIATED WITH DAPAGLIFLOZIN TREATMENT IN TYPE 2 DIABETES PATIENTS: A POST-MARKETING SURVEILANCE PROGRAM IN VIETNAM. Vietnam Medical Journal, 516(1). https://doi.org/10.51298/vmj.v516i1.2995

MONITORING ADVERSE EVENTS ASSOCIATED WITH DAPAGLIFLOZIN TREATMENT IN TYPE 2 DIABETES PATIENTS: A POST-MARKETING SURVEILANCE PROGRAM IN VIETNAM

Cao Thị Thu Huyền1,, Đỗ Quang Huân2, Nguyễn Vĩnh Nam3, Ngô Nhật Long4, Đặng Bích Việt1, Vũ Đình Hòa1, Trần Quang Nam5, Vũ Quỳnh Nga6, Đỗ Trung Quân7, Lê Quang Toàn8, Chu Thị Thanh Phương9, Lê Nguyễn Thụy Khương10, Nguyễn Thanh Phong11, Phương Lễ Trí12, Nguyen Hoàng Anh1
1 The National Centre of Drug Information and Adverse Drug Reactions Monitoring
2 Institut Du Coeur
3 Department of Pharmaceutical Administration and Economics, Hanoi University of Pharmacy
4 1Trung tâm Quốc gia về Thông tin thuốc & Theo dõi phản ứng có hại của thuốc
5 University Medical Center Ho Chi Minh City
6 Hanoi Heart Hospital
7 Bach Mai Hospital
8 National Hospital of Endocrinology
9 115 People’s Hospital, Ho Chi Minh City
10 Gia Dinh People's Hospital, Ho Chi Minh City
11 An Sinh Hospital
12 AstraZeneca vietnam Co., Ltd

Main Article Content

Abstract

To provide more evidence on the safety profile of dapagliflozin (ForxigaTM) in real-life settings, eight hospitals across Vietnam were involved to implement a post marketing surveillance program. Among 1001 subjects, 278 patients (27.8%) experienced at least 1 adverse event (AE) during 24 weeks of follow-up, 5 of those (0,5%) were serious adverse events (SAEs) and 29 (2.9%) led to modification of dapagliflozin treatment. Arthritis (2.4%) and hepatic enzyme increased (2.4%) were the most common, followed by urinary tract infection (1.9%). However, only 120 (12.0%) AEs were evaluated as dapagliflozin-related adverse events. The results revealed that dapagliflozin was well tolerated in Vietnamese adult patients with type 2 diabetes mellitus. Besides the databases of spontaneous ADR reports, this study provides additional data and did not find any new or significant risks of dapagliflozin (Forxiga), supporting its safety profile for the future users in Vietnam.

Article Details

Keywords

dapaglifozin, safety, pharmacovigilance, post marketing surveillance

References

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