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Safety Assessment of Dapagliflozin in Patients with Type 2 Diabetes
J. Kor. Soc. Health-syst. Pharm. 2019;36:223-231
Published online May 31, 2019;  https://doi.org/10.32429/jkshp.2019.36.2.005
© 2019 Korean Society of Health-System Pharmacists

Young Hyun Hana,†, Hye Jeong Choia, Mi Na Minb, Ok Yeon Hana and Shin Yi Hwangboc

Department of Pharmacy, The Catholic University of Korea, ST. Paul’s Hospital 180 Wangsanro, Dongdaemun-gu, Seoul, 02559, Koreaa, Administration of IRB, The Catholic University of Korea, Seoul ST. Mary’s Hospital 222 Banpo-daero, Seocho-gu, Seoul, 06591, Koreab, Department of Pharmacy, The Catholic University of Korea, Seoul ST. Mary’s Hospital 222 Banpo-daero, Seocho-gu, Seoul, 06591, Koreac
Correspondence to: 한영현 Tel:02-2030-3396 E-mail:hyh0402@cmcnu.or.kr
Received September 28, 2018; Revised October 15, 2018; Accepted March 15, 2019.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background : Dapagliflozin, an Sodium-glucose co-transporter 2 inhibitor, is an oral antidiabetic agent that controls plasma glucose levels by facilitating the excretion of glucose in the urine and its usage is on the rise. However, safety concerns with dapagliflozin have increased because of reports of adverse events, such as dehydration and acute kidney failure. Therefore, We studied the pattern of adverse events and the therapeutic effects of dapagliflozin for the safe use of the antidiabetic agent.
Methods : A retrospective analysis was performed by reviewing the electronic medical record of type 2 diabetes patients who had been prescribed dapagliflozin in endocrinology medicine at St. Mary's Hospital between January 1st and December 31st, 2015. We reviewed records of adverse events and changes in hemoglobin A1c (HbA1c), fasting glucose levels, body weight and estimated glomerular filtration rate (eGFR).
Results : There were a total of 589 patients in this study. Ninety-three patients experienced adverse events. Among these, 91 patients had taken dapagliflozin with other antidiabetic agents. Fifty-seven patients experienced adverse events within six months after taking dapagliflozin. The proportion of adverse events occurred in patients with metabolic and nutritional disorders, urinary system disorders, skin and appendage disorders, gastrointestinal system disorders at frequencies of 26.3%, 18.4%, 12.3%, and 12.3% respectively. Skin and appendages disorders and reproductive disorders were more common in females than in males (P< 0.05). There were no serious adverse events. HbA1c, fasting plasma glucose, body weight and eGFR decreased by 0.65%, 25.66 mg/dl, 2.27kg, 0.73 mL/min/1.73 m2, respectively, from baseline to the first visit.
Conclusions :Dapagliflozin was effective with no serious adverse drug effects. This study found that skin and appendage disorders and reproductive disorders were more common in females. In terms of effectiveness, dapagliflozin decreased body weight, as well as plasma glucose.
Keywords : Dapagliflozin, SGLT2 inhibitor, ADR (Adverse Drug Reaction), HbA1c