J Korean Diabetes > Volume 18(4); 2017 > Article
The Journal of Korean Diabetes 2017;18(4):275-283.
DOI: https://doi.org/10.4093/jkd.2017.18.4.275    Published online January 10, 2018.
당뇨병 환자에서 Dapagliflozin 투여 전후의 혈당변화: 단일 기관 신약 안전성 모니터 결과
이형우, 문선준, 한희심, 신은정, 백진희, 한현주, 조영민, 김귀숙
The Effect and Safety of Dapagliflozin in Patients with Type 2 Diabetes: A Single-Institution Pharmacovigilance Review.
Hyung Woo Lee, Sun Joon Moon, Hee Sim Han, Eun Jeong Shin, Jin Hee Baek, Hyun Joo Han, Young Min Cho, Kwi Suk Kim
1Department of Pharmacy, Seoul National University Hospital, Seoul, Korea. kimks@snuh.org
2Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Dapagliflozin, a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, lowers blood glucose by reducing glucose reabsorption at the proximal renal tubule in an insulin-independent manner. We aimed to evaluate the efficacy and safety of dapagliflozin and to identify the risk factors of adverse drug events in patients with type 2 diabetes. METHODS: As an institutional pharmacovigilance review activity, we reviewed data from medical records of 455 patients with type 2 diabetes who received dapagliflozin therapy from July 2014 to August 2015 in Seoul National University Hospital. We analyzed the changes in laboratory data and examined the characteristics of dapagliflozin users who showed adverse effects. RESULTS: Mean changes in HbA1c and fasting serum glucose level from baseline to second visit were −0.42% (8.07 ± 1.51% to 7.65 ± 1.31%, P < 0.001) and −22.9 mg/dL (167.8 ± 48.5 mg/dL to 144.9 ± 37.6 mg/dL, P < 0.001), respectively. Adverse drug events observed during this study were lower urinary tract symptoms (7.7%), dehydration-related symptoms (6.1%), ketonuria (3.4%), hypoglycemia (3.4%), and urogenital infection (4.2%). Thiazide use, age, insulin use, number of anti-diabetic drugs, gender and history of urogenital infection were the risk factors for adverse drug events (P < 0.05). CONCLUSION: Dapagliflozin significantly improved hyperglycemia in patients with type 2 diabetes without serious adverse drug events. The incidences of adverse drug events were was similar to those ofthat in the previous studies.
Key Words: Dapagliflozin, Diabetes mellitus, Risk factors, Sodium-glucose co-transporter 2 inhibitor

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