Intensive Blood-Pressure Control in Patients with Type 2 Diabetes
Abstract
BACKGROUND: Effective targets for systolic blood-pressure control in patients with type 2 diabetes are unclear. 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.).
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There were similar incidences of CKD progression and CKD development between intensive and standard SBP groups.
“There were similar incidences of CKD progression and CKD development.”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [82]
In the BPROAD trial, intensive SBP goal of ≤120 mmHg produced a 21% reduction in nonfatal stroke, nonfatal myocardial infarction, heart failure, or cardiovascular death compared with standard treatment targeting SBP ≤140 mmHg.
“Blood Pressure Control Target in Diabetes (BPROAD), an open-label trial that randomized 12,821 individuals with diabetes and elevated CVD risk to an intensive SBP goal of ≤120 mmHg or standard treatment that targeted an SBP of ≤140 mmHg for up to 5 years, noted a 21% reduction in nonfatal stroke, nonfatal myocardial infarction, heart failure, or cardiovascular death in the intensive SBP group (82)”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [82]
Incident albuminuria was reduced in the intensive-treatment group compared with the standard-treatment group (11.29 vs. 13.84 events per 100 person-years) (HR 0.87; 95% CI 0.77-0.97).
“Incident albuminuria was also reduced in the intensive-treatment group compared with the standard-treatment group (11.29 vs. 13.84events per 100 person-years) (HR 0.87; 95% CI 0.77-0.97).”
From 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [82]
BPROAD randomized individuals with diabetes and elevated CVD risk to an intensive systolic blood pressure goal of <120 mmHg and noted a 21% reduction in nonfatal stroke, nonfatal MI, heart failure, or cardiovascular death compared with a standard systolic blood pressure goal of <140 mmHg.
“The primary outcome of nonfatal stroke, nonfatal MI, treatment or hospitalization for heart failure, or death from cardiovascular causes was reduced by 21% in the intensive treatment group (hazard ratio [HR] 0.79, 95% CI 0.69–0.90)”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [42]
Targeting an on-treatment systolic blood pressure goal of <120 mmHg in people with high cardiovascular risk is associated with reduction in cardiovascular events compared with systolic blood pressure <140 mmHg.
“The results of BPROAD and ESPRIT highlight that targeting an on-treatment systolic blood pressure goal of <120 mmHg in people with high cardiovascular risk is associated with reduction in cardiovascular events compared with systolic blood pressure <140 mmHg.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [42]
In BPROAD, adverse event rates were similar in the two groups, although symptomatic hypotension and hyperkalemia were more frequent in the intensive therapy group.
“Adverse event rates were similar in the two groups, although symptomatic hypotension and hyperkalemia were more frequent in the intensive therapy group (42).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [42]
BPROAD provides the strongest evidence to support a systolic blood pressure treatment goal of <120 mmHg.
“BPROAD provides the strongest evidence to support a systolic blood pressure treatment goal of <120 mmHg, as it enrolled people with type 2 diabetes and increased cardiovascular risk with a baseline systolic blood pressure ≥140 mmHg (or 130–180 mmHg if already taking antihypertensive medication).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [42]
In the SPRINT trial, the risk for development of incident heart failure decreased by 36%.
“Intensive treatment of hypertension in people with diabetes in the BPROAD trial led to a 34% reduction in treatment or hospitalization for heart failure (HR 0.66, 95% CI 0.41–1.04), a finding that parallels observations from the SPRINT trial where the risk for development of incident heart failure decreased by 36% (42,274).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [42]
In the BPROAD trial, intensive treatment of hypertension in people with diabetes led to a 34% reduction in treatment or hospitalization for heart failure (HR 0.66, 95% CI 0.41-1.04).
“Intensive treatment of hypertension in people with diabetes in the BPROAD trial led to a 34% reduction in treatment or hospitalization for heart failure (HR 0.66, 95% CI 0.41–1.04), a finding that parallels observations from the SPRINT trial where the risk for development of incident heart failure decreased by 36% (42,274).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [42]
There is strong evidence from clinical trials of the value of treating hypertension in older adults.
“There is strong evidence from clinical trials of the value of treating hypertension in older adults”
From 13. Older Adults: Standards of Care in Diabetes—2026 (2026) · cites this paper as [81]
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- Authors
- Bi, Y., Li, M., Liu, Y., Li, T., Lu, J., Duan, P., Xu, F., Dong, Q., Wang, A., Wang, T., Zheng, R., Chen, Y., Xu, M., Wang, X., Zhang, X., Niu, Y., Kang, Z., Lu, C., Wang, J., Qiu, X., Wang, A., Wu, S., Niu, J., Wang, J., Zhao, Z., Pan, H., Yang, X., Niu, X., Pang, S., Zhang, X., Dai, Y., Wan, Q., Chen, S., Zheng, Q., Dai, S., Deng, J., Liu, L., Wang, G., Zhu, H., Tang, W., Liu, H., Guo, Z., Ning, G., He, J., Xu, Y., & Wang, W.
- Affiliations
- Shanghai Jiao Tong University (CN)
- Department of Endocrine and Metabolic Diseases, Third People’s Hospital of Datong, Datong, China
- Department of Endocrine and Metabolic Diseases, First People’s Hospital of Loudi, Loudi, China
- Department of Endocrine and Metabolic Diseases, Shanghai Institute of Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Third Hospital of Nanchang (CN)
- Department of Endocrine and Metabolic Diseases, General Hospital of Hebi Coal Industry Group, Hebi, China
- Zhengzhou People's Hospital (CN)
- Nanjing Drum Tower Hospital (CN)
- Department of Endocrine and Metabolic Diseases, People’s Hospital of Anyang City, Anyang, China
- Weifang People's Hospital (CN)
- Department of Endocrine and Metabolic Diseases, Tieli People’s Hospital, Tieli, China
- Zhengzhou Central Hospital (CN)
- Department of Endocrine and Metabolic Diseases, Yi’an County Hospital of Traditional Chinese Medicine, Qiqihar, China
- Department of Endocrine and Metabolic Diseases, People’s Hospital of Liuyang, Liuyang, China
- People 's Hospital of Jilin Province (CN)
- Department of Endocrine and Metabolic Diseases, Hai’an People’s Hospital, Hai’an, China
- Changzhi Medical College (CN)
- Jinan Central Hospital (CN)
- Department of Endocrine and Metabolic Diseases, Sheyang County Diabetes Hospital, Yancheng, China
- Southwest Medical University (CN)
- Second Hospital of Shandong University (CN)
- Department of Endocrine and Metabolic Diseases, Yuhuan Second People’s Hospital, Yuhuan, China
- Department of Endocrine and Metabolic Diseases, Lai’an Jianing Hospital, Chuzhou, China
- First Hospital of Jilin University (CN)
- Department of Endocrine and Metabolic Diseases, Pingmei Shenma Medical Group General Hospital, Pingdingshan, China
- Department of Endocrine and Metabolic Diseases, Wuchang People’s Hospital, Wuchang, China
- Dalian Medical University (CN)
- Department of Endocrine and Metabolic Diseases, Shanghe County People’s Hospital, Jinan, China
- The University of Texas Southwestern Medical Center (US)
- ORCID
- Bi, Yufang
- Li, Mian
- Lu, Jieli
- Duan, Peng
- Wang, Tiange
- Zheng, Ruizhi
- Chen, Yuhong
- Xu, Min
- Wang, Xiaohu
- Zhang, Xinhuan
- Kang, Zhiqiang
- Wang, Jing
- Niu, Jingya
- Wang, Jingya
- Pang, Shuguang
- Zhang, Xiaoliang
- Wan, Qin
- Chen, Shihong
- Zheng, Qidong
- Deng, Juan
- Wang, Guixia
- Zhu, Huiqi
- Tang, Weidong
- Liu, Haixia
- Ning, Guang
- He, Jiang
- Wang, Weiqing
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2025-03-27
- Volume
- 392
- Issue
- 12
- Pages
- 1155-1167
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4404436453
- Cited by
- 224
- References
- 21
- Citations by year
- 2026: 97 · 2025: 123 · 2024: 4
- FWCI
- 59.93
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Natural Science Foundation of China (82088102)
- National Key Research and Development Program of China (2017YFC1310700, 2021YFA1301100, 2023YFC2506700)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- intensive blood pressure control, type 2 diabetes, systolic blood pressure, cardiovascular events, stroke, myocardial infarction, heart failure, cardiovascular mortality, older adults, antihypertensive therapy, hypotension, hyperkalemia, adverse events, blood pressure targets, China
- MeSH terms
- Aged, Antihypertensive Agents, Blood Pressure, Cardiovascular Diseases, China, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Hospitalization, Humans, Hyperkalemia, Hypertension, Hypotension, Male, Middle Aged, Incidence, Treatment Outcome
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