한빛사논문
- 조회213
Jae-Kwan Song MD a, Sahmin Lee MD a, Yong-Jin Kim MD b, Hyung-Kwan Kim MD b, Jong-Won Ha MD c, Eui-Young Choi MD d, Seung-Woo Park MD e, Sung-Ji Park MD e, Yong-Hyun Park MD f, Jae-Hyeong Park MD g, Dong Heon Yang MD h, Kye Hun Kim MD i, Dong Hyun Yang MD j, Sangwon Han MD k, Sun Young Chae MD l, Ji Sung Lee PhD m, Jong-Min Song MD a, Goo-Yeong Cho MD n
aDivision of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
bDivision of Cardiology, Seoul National University Hospital, Seoul, Republic of Korea
cDivision of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
dDivision of Cardiology, Gangnam Severance Hospital, Seoul, Republic of Korea
eDivision of Cardiology, Samsung Medical Center, Seoul, Republic of Korea
fDivision of Cardiology, Pusan National University Yangsan Hospital, Busan, Republic of Korea
gChungnam National University Hospital, Daejeon, Republic of Korea
hDivision of Cardiology, Kyungpook National University Hospital, Daegu, Republic of Korea
iChonnam National University Hospital, Gwangju, Republic of Korea
jDepartment of Radiology, Asan Medical Center, Seoul, Republic of Korea
kDepartment of Nuclear Medicine, Asan Medical Center, Seoul, Republic of Korea
lDepartment of Nuclear Medicine, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Uijeongbu, Republic of Korea
mClinical Research Center, Asan Institute for Life Science, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
nDivision of Cardiology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea
Address for correspondence: Dr Jae-Kwan Song
Abstract
Background: Medical therapy for aortic stenosis (AS) remains an elusive goal.
Objectives: This study sought to establish whether evogliptin, a dipeptidyl peptidase-4 inhibitor, could reduce AS progression.
Methods: A total of 228 patients (age 67 ± 11 years; 33% women) with AS were randomly assigned to receive placebo (n = 75), evogliptin 5 mg (n = 77), or evogliptin 10 mg (n = 76). The primary endpoint was the 96-week change in aortic valve calcium volume (AVCV) on computed tomography. Secondary endpoints included the 48-week change in active calcification volume measured using 18F-sodium fluoride positron emission tomography (18F-NaF PET).
Results: There were no significant differences in the 96-week changes in AVCV between evogliptin 5 mg and placebo (-5.27; 95% CI: -55.36 to 44.82; P = 0.84) or evogliptin 10 mg and placebo (-18.83; 95% CI: -32.43 to 70.10; P = 0.47). In the placebo group, the increase in AVCV between 48 weeks and 96 weeks was higher than that between baseline and 48 weeks (136 mm3; 95% CI: 108-163 vs 102 mm3; 95% CI: 75-129; P = 0.0485). This increasing trend in the second half of the study was suppressed in both evogliptin groups. The 48-week change in active calcification volume on 18F-NaF PET was significantly lower in both the evogliptin 5 mg (-1,325.6; 95% CI: -2,285.9 to -365.4; P = 0.008) and 10-mg groups (-1,582.2; 95% CI: -2,610.8 to -553.5; P = 0.0038) compared with the placebo group.
Conclusions: This exploratory study did not demonstrate the protective effect of evogliptin on AV calcification. Favorable 18F-NaF PET results and possible suppression of aortic valve calcification with longer medication use in the evogliptin groups suggest the need for larger confirmatory trials. (A Multicenter, Double-blind, Placebo-controlled, Stratified-randomized, Parallel, Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-1229 in Patients With Calcific Aortic Valve Disease; NCT04055883).
논문정보
- Research article
- 2024년 09월 (BRIC 등록일 2024-09-23)
- 국내 연구진
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