Intensive Blood-Pressure Control in Patients with Type 2 Diabetes.
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Bi Yufang, Li Mian, Liu Yan, Li Tingzhi, Lu Jieli, Duan Peng, Xu Fengmei, Dong Qijuan, Wang Ailiang, Wang Tiange, Zheng Ruizhi, Chen Yuhong, Xu Min, Wang Xiaohu, Zhang Xinhuan, Niu Yanbo, Kang Zhiqiang, Lu Chunru, Wang Jing, Qiu Xinwen, Wang An, Wu Shujing, Niu Jingya, Wang Jingya, Zhao Zhiyun, Pan Huanfeng, Yang Xiaohua, Niu Xiaohong, Pang Shuguang, Zhang Xiaoliang, Dai Yuancheng, Wan Qin, Chen Shihong, Zheng Qidong, Dai Shaoping, Deng Juan, Liu Leshan, Wang Guixia, Zhu Huiqi, Tang Weidong, Liu Haixia, Guo Zhenfang, Ning Guang, He Jiang, Xu Yu, Wang Weiqing, BPROAD Research Group
Аннотация
METHODS: We enrolled patients 50 years of age or older with type 2 diabetes, elevated systolic blood pressure, and an increased risk of cardiovascular disease at 145 clinical sites across China. Patients were randomly assigned to receive intensive treatment that targeted a systolic blood pressure of less than 120 mm Hg or standard treatment that targeted a systolic blood pressure of less than 140 mm Hg for up to 5 years. The primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes. Multiple imputation was used for missing outcome data, with an assumption that the data were missing at random.
RESULTS: Of 12,821 patients (6414 patients in the intensive-treatment group and 6407 in the standard-treatment group) enrolled from February 2019 through December 2021, 5803 (45.3%) were women; the mean (±SD) age of the patients was 63.8±7.5 years. At 1 year of follow-up, the mean systolic blood pressure was 121.6 mm Hg (median, 118.3 mm Hg) in the intensive-treatment group and 133.2 mm Hg (median, 135.0 mm Hg) in the standard-treatment group. During a median follow-up of 4.2 years, primary-outcome events occurred in 393 patients (1.65 events per 100 person-years) in the intensive-treatment group and 492 patients (2.09 events per 100 person-years) in the standard-treatment group (hazard ratio, 0.79; 95% confidence interval, 0.69 to 0.90; P<0.001). The incidence of serious adverse events was similar in the treatment groups. However, symptomatic hypotension and hyperkalemia occurred more frequently in the intensive-treatment group than in the standard-treatment group.
CONCLUSIONS: Among patients with type 2 diabetes, the incidence of major cardiovascular events was significantly lower with intensive treatment targeting a systolic blood pressure of less than 120 mm Hg than with standard treatment targeting a systolic blood pressure of less than 140 mm Hg. (Funded by the National Key Research and Development Program of the Ministry of Science and Technology of China and others; BPROAD ClinicalTrials.gov number, NCT03808311.).