- 著者
-
奥山 治美
浜 六郎
大櫛 陽一
浜崎 智仁
内野 元
- 出版者
- 日本脂質栄養学会
- 雑誌
- 脂質栄養学 (ISSN:13434594)
- 巻号頁・発行日
- vol.27, no.1, pp.30-38, 2018 (Released:2018-07-16)
An open-label, randomized controlled trial in type 2 diabetics with hypertension,
dyslipidemia, or both was reported (J-DOIT3 study).The participants were
randomly assigned to receive conventional or intensive therapy with respect to
HbA1c, blood pressure and LDL-C (n=1,271 in each group),and were followed for
8.5 years at 81 clinical sites. Both the participants and doctors in charge were aware
of the group assigned. The experimental design was essentially as recommended
in the [Comprehensive risk management chart for the prevention of cerebro- and
cardiovascular diseases 2015] from the Joint Committee consisted of 13 internal
medicine-related societies in Japan, and the Japan Atherosclerotic Society Guidelines
2017. Therefore, the conclusion from the J-DOIT3 study is expected in medical field
to affect the current and future medications for the prevention of atherosclerotic
cerebro- and cardiovascular diseases (ASCVD).While analyzing the results of this
study,we encountered serious problems associated with the methodology, logics and
its interpretations, which were summarized in this review. The follow-up study appears
to be in progress as described in the Discussion, but we interpret that the intensive
therapy used in the J-DOIT3 study is risky in view of currently available evidence.
We propose the authors of the study to let the participants know of the results on its
objective endpoint, and newly obtain Informed Consents including the potential risks
of the intensive intervention based on the progress in this field after the start of this
study.