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J-DOIT3 tests multifactorial treatment in CVD prevention for patients with type 2 diabetes
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In Japanese patients with type 2 diabetes at high risk for cardiovascular disease, strict multifactorial treatment may be effective in preventing cardiovascular disease, according to the hypothesis of the J-DOIT3 study.
In the multicenter, open-label, randomized, parallel-group trial, researchers evaluated 2,542 patients with type 2 diabetes and hypertension or dyslipidemia from 81 Japanese hospitals. Participants were randomly allocated 1:1 to an intensive therapy group (n = 1,271) with robust blood glucose, blood pressure and lipid control, or to a conventional therapy group (n = 1,271). The following targets were established for the two groups: HbA1c less than 6.2% for the intensive therapy group and 6.9% for the conventional therapy group; BP less than 120/75 mm Hg for intensive therapy group and 130/80 mm Hg for conventional therapy group; LDL less than 80 mg/dL for intensive therapy group (< 70 mg/dL in patients with history of CVD) and less than 120 mg/dL for the conventional therapy group (< 100 mg/dL in patients with CVD history). In both groups, participants are instructed to follow dietary and lifestyle guidelines.
At baseline, the mean age of the conventional therapy group was 59.1 years, and the mean age in the intensive therapy group was 58.9 years. The conventional therapy group consisted of 790 men and 481 women, whereas the intensive therapy group consisted of 784 men and 487 women. BMI was 24.9 kg/m2 in the conventional therapy group and 24.8 kg/m2 in the intensive therapy group. In the conventional therapy group, 10.8% of the participants had a history of CVD, whereas in the intensive therapy group, 11.2% had a history of CVD. The percentage of current smokers at baseline was higher in the intensive therapy group than in the conventional therapy group (25.8% vs. 21%).
The study’s primary endpoint was defined as the incidence of CVD events or any-cause mortality. The intensive therapy group patient population is scheduled to undergo intensifications of blood glucose, BP and lipid control medications until 250 primary endpoint events have occurred. Kaplan-Meier analysis will be used to calculate the event-free survival period as well as the yearly proportion of patients remaining event free, and Greenwood’s formula will be used to calculate 95% CIs.
The study is expected to end in March, resulting in a mean intervention duration of roughly 8 years.
“J-DOIT3 is a quite unique study not just because it is the first large-scale trial for East Asian patients with type 2 diabetes, who have many different characteristics from Caucasians, but because it also strives to achieve strict and safe control for all the risk factors of vascular complications,” the researchers wrote. “Thus, J-DOIT3 will provide novel therapeutic strategies to treat patients with type 2 diabetes for prevention of macrovascular and microvascular complications.” – by Jennifer Byrne
Disclosure: The study was supported by corporate donations from Asahi Kasei, Astellas, AstraZeneca, Bayer Yakuhin, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly Japan, Kissei, Kowa, Mitsubishi Tanabe, Merck, Nippon Boehringer Ingelheim, Novartis, Novo Nordisk, Ono, Pfizer, Shionogi, Sumitomo Dainippon and Takeda. Please see the full study for a list of all the researchers’ financial disclosures.
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