Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial

Ueki, Kohjiro; Sasako, Takayoshi; Okazaki, Yukiko; Kato, Masayuki; Okahata, Sumie; Katsuyama, Hisayuki; Haraguchi, Mikiko; Morita, Ai; Ohashi, Ken; Hara, Kazuo; Morise, Atsushi; Izumi, Kazuo; Ishizuka, Naoki; Ohashi, Yasuo; Noda, Mitsuhiko; Kadowaki, Takashi; Haneda, Masakazu; Iwashima, Yasunori; Suda, Toshio; Tamasawa, Naoki; Daimon, Makoto; Satoh, Jo; Takebe, Noriko; Ishigaki, Yasushi; Watanabe, Tsuyoshi; Satoh, Hiroaki; Kasai, Kikuo; Aso, Yoshimasa; Ishibashi, Shun; Katayama, Shigehiro; Ishikawa, San‐e; Kakei, Masafumi; Namai, Kazuyuki; Hashimoto, Naotake; Suzuki, Yoshiyuki; Onishi, Shunichiro; Yokote, Koutaro; Matsuda, Masafumi; Masuzawa, Masahiro; Hayashi, Yuzo; Saitô, Satoshi; Ogihara, Norikazu; Ishihara, Hideharu; Tajima, Naoko; Utsunomiya, Kazunori; Itoh, Hiroshi; Kawamori, Ryuzo; Watada, Hirotaka; Hayashi, Michio; Mori, Yusaku; Shiba, Teruo; Isogawa, Akihiro; Sakura, Hiroshi; Odawara, Masato; Tobe, Kazuyuki; Tsukamoto, Kazuhisa; Yamauchi, Toshimasa; Teramoto, Tamio; Hirata, Yukio; Uchimura, Isao; Ogawa, Yoshihiro; Yoshino, Gen; Hirose, Takahisa; Kajio, Hiroshi; Atsumi, Yoshihito; Shimada, Akira; Oikawa, Yoichi; Araki, Atsushi; Ueki, Akio; Ohno, Atsushi; Kitaoka, Masafumi; Fujita, Yoshikuni; Moriya, Takuya; Tojo, Taiki; Shichiri, Masayoshi; Suzuki, Daisuke; Toyoda, Masao; Hamano, Kumiko; Komi, Rieko; Terauchi, Yasuo; Kuzuya, Nobuaki; Yamada, Masayo; Takamura, Toshinari; Imura, Mitsuo; Tanaka, Hiroshi; Hayashi, Masayuki; Kato, Yasuhisa; Itoh, Mitsuyasu; Suzuki, Atsushi; Nakayama, Mikihiro; Sano, Takahisa; Nakashima, Eitaro; Sumida, Yasuhiro; Yano, Yutaka; Tanaka, Tsuyoshi; Murata, Kazuya; Kashiwagi, Atsunori; Maegawa, Hiroshi; Kono, Shigeo; Inagaki, Nobuya; Kosugi, Ken’ichirou; Yasuda, Tetsuyuki; Yoshimasa, Yasunao; Kishimoto, Ichiro; Satô, Toshihiko; Hosoi, Masayuki; Yamasaki, Tomoyuki; Matsuhisa, Munehide; Shimomura, Iichiro; Taniguchi, Ataru; Kuroe, Akira; Kurose, Takeshi; Ohara, Takeshi; Sakaguchi, Kazuhiko; Namba, Mitsuyoshi; Kaku, Kohei; Fujiwara, Masazumi; Shimizu, Ikki; Ono, Kouji; Ebisui, Osamu; Tanizawa, Yukio; Okada, Yosuke; Kodera, Takehiko; Sato, Naoichi; Ide, Makoto; Yamada, Kentaro; Umeda, Fumio; Natori, Shoichi; Eto, Tomoaki; Mimura, Kazuo; Hiramatsu, Shinsuke; Inoue, Tomoaki; Takei, Ryoko; Ogo, Atsushi; Eguchi, Katsumi; Kawasaki, Eiji; Koide, Yuji; Araki, Eiichi; Jinnouchi, Hideaki; Yamamoto, H.; Motoyoshi, Mitsutaka; Hiyoshi, Toru; Tanaka, Yasushi; Momoki, Tadahisa; Sato, Koichiro; Yoneyama, Akihiko; Ito, Kenichi; Sano, Hiroshi; Ikegami, Hiroshi; Ikeda, Masaki; Ikeda, Hiroki; Takahashi, Kenji; Makino, Hírofumi; Ueda, Yasuo; Nakazato, Masamitsu

doi:10.1016/s2213-8587(17)30327-3

Cited by 248 publications

(204 citation statements)

References 35 publications

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“…Furthermore, the patients undergoing intensive therapy required more glucose‐lowering agents at higher doses, which led to more frequent adverse events, including hypoglycemia, than those undergoing standard therapy. Another trial comparing Japanese patients with T2D in the standard therapy group and those in the intensive therapy group, the Japan Diabetes Optimal Integrated Treatment study for three major risk factors of cardiovascular diseases (J‐DOIT3), also failed to show a reduction in macrovascular events by intensive therapy.…”

Section: Conflicting Findings With Regard To the Use Of Hba1c As A Thmentioning

confidence: 99%

Challenges to hemoglobin A1c as a therapeutic target for type 2 diabetes mellitus

Ikeda

Shimazawa

2019

J of Gen and Family Med

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Glycated hemoglobin (HbA1c) is widely accepted as the most reliable measure of long‐term glycemia. However, there is disagreement among professional medical societies on a proper glycemic target for long‐term benefits in type 2 diabetes (T2D). The use of some glucose‐lowering drugs was associated with heart failure despite substantial lowering of HbA1c. The failure of intensive glycemic control to reduce cardiovascular risk in some trials again brought into question the usefulness of HbA1c as a therapeutic target in T2D. In large cardiovascular outcome trials, some newer glucose‐lowering drugs were associated with higher risks of heart failure or amputation despite comparable glycemic control between the test and placebo groups. Here, we provide evidence that variation in hemoglobin glycation between individuals is responsible for these inconsistencies. We suggest that further research be conducted in this area and that the findings be applied to clinical trials and practice.

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Section: Conflicting Findings With Regard To the Use Of Hba1c As A Thmentioning

confidence: 99%

Challenges to hemoglobin A1c as a therapeutic target for type 2 diabetes mellitus

Ikeda

Shimazawa

2019

J of Gen and Family Med

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“…Compared with the baseline values, body mass index was not increased and remained at 24.8 kg/m 2 in each group7. This is of note, as some of the intensive intervention in other clinical studies, especially in those using sulfonylurea, insulin or pioglitazone, showed a greater increase of bodyweight compared with a placebo or the conventional intervention.…”

mentioning

confidence: 58%

“…Recently, Ueki et al 6, 7. reported the effect of intensive multifactorial intervention on the prevention of cardiovascular complications and mortality in Japanese patients with type 2 diabetes.…”

mentioning

confidence: 99%

“…In addition to these values, target values of high‐density lipoprotein cholesterol and triglyceride should also be investigated, as there was a small, but significant, increase of high‐density lipoprotein cholesterol in the intensive intervention group. The triglyceride data was not described in the initial report7, and this should also be mentioned in future. Therefore, the detailed analysis of these parameters in J‐DOIT3 and/or a longer period of follow up of J‐DOIT3 should be very interesting.…”

mentioning

confidence: 99%

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Impacts of tight multifactorial intervention in patients with type 2 diabetes: Implications from the Japan Diabetes Outcome Intervention Trial 3

Araki

Senokuchi

Furukawa

2018

J of Diabetes Invest

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“…In this study, it was specifically verified if surrogate endpoints can also be applied for DKD. For DKD, the management of blood glucose and blood pressure is obviously important [19]. There is a need to raise the awareness that even during the clinical trial of new drugs, their strict management is a major prerequisite.…”

Section: Introductionmentioning

confidence: 99%

Guidelines for clinical evaluation of chronic kidney disease

et al. 2018

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Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial

Cited by 248 publications

References 35 publications

Challenges to hemoglobin A1c as a therapeutic target for type 2 diabetes mellitus

Challenges to hemoglobin A1c as a therapeutic target for type 2 diabetes mellitus

Impacts of tight multifactorial intervention in patients with type 2 diabetes: Implications from the Japan Diabetes Outcome Intervention Trial 3

Guidelines for clinical evaluation of chronic kidney disease

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