Randomized trial of an increased dose of calcium channel blocker or angiotensin II type 1 receptor blocker as an add-on intensive depressor therapy in type 2 diabetes mellitus patients with uncontrolled essential hypertension: the ACADEMIE Study

Abstract

There is a lack of data on how to treat hypertensive patients with diabetes when treatment with medium doses of calcium channel blocker and angiotensin II type 1 receptor blocker (ARB) is insufficient to achieve the target blood pressure (BP). A total of 121 participants with type 2 diabetes and uncontrolled essential hypertension, who were receiving medium doses of amlodipine (5 mg/day) and ARB, were enrolled. Participants were randomized to receive either a high dose of amlodipine (10 mg/day) plus a medium dose of ARB (high-AML) or a medium dose of amlodipine (5 mg/day) plus a high dose of ARB (high-ARB). The depressor effects of these two regimens were monitored using a telemonitoring home BP-measuring system. Fifty-four patients were excluded after an observation period, and the remaining 67 eligible participants were randomized into the two groups; 42 which had a record of their home BP for analysis. The change in morning home systolic and diastolic BP was greater in the high-AML than in the high-ARB (systolic BP; − 7.9 mmHg vs. + 2.7 mmHg; p = 0.0002, diastolic BP; − 3.9 mmHg vs. + 0.6 mmHg; p = 0.0007). In addition, the home systolic and diastolic BP before going to bed and office systolic BP were significantly reduced from week 0 only in the high-AML. An increased dose of amlodipine, but not ARB, reduced home morning BP in hypertensive patients with type 2 diabetes who were already receiving combination therapy with medium doses of amlodipine and ARB.

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Change history

  • 10 April 2019

    In the Original publication of the article, the legend appearing inside the flow chart has been incorrectly published.

  • 10 April 2019

    In the Original publication of the article, the legend appearing inside the flow chart has been incorrectly published.

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Acknowledgements

ACADEMIE Investigators (Munehito Ideishi, Atsushi Iwata, Keita Noda, Kanta Fujimi, Akira Kawamura, Sen Adachi, Hiroaki Nishikawa, Takao Fukushima, Nobuhide Tanaka, Kazuhiro Fujisawa, Yosuke Takamiya, Hiroaki Arishima, Toshihiro Shimokawa, Hiroshi Seto, Asao Inoue, Takemasa Midorikawa, Hiroshi Shijo)

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Correspondence to Shin-ichiro Miura.

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Conflict of interest

The ACADEMIE trial was sponsored by Sumitomo Dainippon Pharma Co., Ltd. K.S. is a Chief Director and S.M. is a Director of NPO Clinical and Applied Science, Fukuoka, Japan. K.S. has an Endowed “Department of Molecular Cardiovascular Therapeutics” supported by MSD, Co. LTD. S.M. belongs to the Department of Molecular Cardiovascular Therapeutics, which is supported by MSD, Co. LTD. K.S. and S.M. have received grants and lecture honoraria from Daiichi-Sankyo Co, Takeda Pharm. Co. Ltd., Bayer Yakuhin Pharm., and Astellas Pharma Inc.

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Imaizumi, S., Shiga, Y., Ogawa, M. et al. Randomized trial of an increased dose of calcium channel blocker or angiotensin II type 1 receptor blocker as an add-on intensive depressor therapy in type 2 diabetes mellitus patients with uncontrolled essential hypertension: the ACADEMIE Study. Heart Vessels 34, 698–710 (2019). https://doi.org/10.1007/s00380-018-1286-2

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Keywords

  • Angiotensin II type 1 receptor blocker
  • Calcium channel blocker
  • Essential Hypertension
  • Home blood pressure
  • Type 2 diabetes mellitus