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Various studies have highlighted the importance of ethnic differences. The consideration of ethnic differences in the field of individualized pharmacotherapy is imperative. Therefore, various organizations and networks across countries should aim to conduct multicountry and multiregional clinical trials (MRCTs). If there is solid evidence available to evaluate the existence of ethnic differences between the same regional areas, it will lead to an increase in the efficiency of drug development. The purpose of this paper was to compare the approval dosing regimen among four Asian countries (Korea, Japan, China, and Taiwan) and elucidate the readiness and current status of the implementation of the International Conference on Harmonization (ICH) E17 guidelines on MRCTs. Reducing unnecessary clinical trials via multinational clinical trials in East Asian countries is also suggested. The approved dosing regimens for some drugs in the four Asian countries were similar; however, some differences might be caused by differences in legislation, even though there were no ethnic differences. This indicates that there are several roles to be expected of the Asia Clinical Pharmacology study network for exploratory MRCTs, which would lead to the accumulation of evidence for MRCTs, ultimately accelerating the efficiency of drug development in East Asian countries. The exposure of the new treatment to the necessary patients through collaborative research coordination and simultaneous multinational subject recruitment would serve its role in providing East Asia with specific personalized medicine with a high treatment success rate., (© 2021 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.)

Obesity and overweight have been associated with better clinical outcomes in different populations with a diverse spectrum of cardiovascular disease (obesity paradox). However, conflicting data exist about the relation between body mass index (BMI) and outcomes after transcatheter aortic valve implantation (TAVI). The aim of this study is to evaluate the association of body mass index with clinical outcomes in patients with severe aortic stenosis (AS) who underwent TAVI. The study cohort included 379 consecutive patients with symptomatic severe AS who underwent TAVI between March 2010 and February 2017 in 3 centers in East Asia. Patients were grouped into tertiles of baseline BMI (first tertile: ≤22.3 kg/m 2 , second tertile: 22.4 to 24.8 kg/m 2 , and third tertile: ≥24.9 kg/m 2 ). The primary outcome was a composite of death from any causes or stroke at 1 year. The median (interquartile range) BMI was 23.5 (21.8 to 26.1) kg/m 2 . During the median follow-up of 18.4 months, there were 69 deaths and 23 strokes. At 1 year, the primary outcome occurred in 21.9% in the first tertile, 18.7% in the second tertile, and 7.8% in the third tertile, respectively (p = 0.009). After adjustment for confounding variables, an inverse relation was observed between BMI and primary outcome: with the third BMI tertile as the reference category, the adjusted hazard ratios were 2.51 (95% confidence interval, 1.20 to 5.26) for the second BMI tertile and 2.61 (95% confidence interval, 1.20 to 5.66) for the first BMI tertile. In conclusion, in patients with severe AS who underwent TAVI, an inverse association between BMI and the risk of death or stroke was observed., (Copyright © 2018. Published by Elsevier Inc.)