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New clinical outcome of Fimasartan on reducing proteinuria in Korean diabetic nephropathy patients: FANTASTIC trial
Jieun Oh
2021 ; 2021(1):
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춘계학술대회 초록집
Chronic kidney disease (CKD) is common in people with both type 1 and type 2 diabetes. It is defined by the presence of reduced glomerular filtration rate (GFR) and/or increased urinary albumin excretion for at least three months. Globally, diabetic kidney disease (DKD) is a major cause of CKD and is the most common cause of end-stage kidney disease (ESKD). As an example, Lee et al. reported the epidemiology of ESKD in Korea using the nationwide NHIS-NHS database, which revealed that the incidence of ESKD with diabetes was 13.8 times higher than the incidence of ESKD without DM in 20151. In patients with diabetes, the goal of blood pressure control is suggested as follows; a goal blood pressure of 120 to 125/<80 mmHg (using the non-routine [preferred] measurement methods including standardized office-based measurement, AOBPM, home blood pressure, and ABPM) or 125 to 130/<80 mmHg (using routine office measurements)2. FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC) trial (Clinicaltrials.gov, NCT02620306) was designed to assess the reno-protective effects of fimasartan compared to those of losartan as a primary outcome3. This study is a prospective, phase III, randomized, double-blind, active- controlled, non-inferiority, four-parallel group, dose-titration, multicenter trial. Patients with hypertensive diabetic CKD with albuminuria were enrolled. Participants were randomized into four groups (1:1:1:1): fimasartan standard SBP control (SBP < 140 mmHg); fimasartan strict SBP control (SBP < 130 mmHg); losartan standard SBP control; and losartan strict SBP control. The primary endpoint is the rate of change in proteinuria at 24 weeks, which is assessed using the spot urine albumin–creatinine ratio. A total of 341 patients participated in the study, with a mean age of 61.96 years old, and mean baseline SBP of 154.58 mmHg. Baseline spot urine albuminuria was 1,396 vs 1,521 mg/g for each fimasartan group vs losartan group. Fimasartan was noninferior to losartan for the primary endpoint, with a decrease rate of albuminuria at 24 weeks of - 37.6 % vs -20.6 % from the baseline, respectively (P<0.0001 for non-inferiority). Fimasartan was superior to losartan for primary endpoint; -17% more albuminuria reduction. Based on the results of the FANTASTIC study, fimasartan has acquired an indication for “reduction of proteinuria in patients with type 2 diabetic kidney disease with hypertension” as of December 30, 2020. 1. Lee, M.-J., Ha, K. H., Kim, D. J. & Park, I. Trends in the Incidence, Prevalence, and Mortality of End-Stage Kidney Disease in South Korea. Diabetes Metab. J. 44, 933– 937 (2020). 2. Johannes FE Mann & Karl F Hilgers. Goal blood pressure in adults with hypertension. UpToDate https://www.uptodate.com/contents/goal-blood-pressure- in-adults-with- hypertension?sectionName=Patients%20with%20diabetes%20mellitus&topicRef=3 052&anchor=H2839714254&source=see_link#H2710374071 (2021). 3. Kim, J.-Y. et al. FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial. Trials 18, 632 (2017).
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