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Lowering systolic blood pressure to less than 120 mm Hg versus less than 140 mm Hg in patients with high cardiovascular risk with and without diabetes or previous stroke: an open-label, blinded-outcome, randomised trial
Abstract
Background Uncertainty exists about whether lowering systolic blood pressure to less than 120 mm Hg is superior to that of less than 140 mm Hg, particularly in patients with diabetes and patients with previous stroke. Methods In this open-label, blinded-outcome, randomised controlled trial, participants with high cardiovascular risk were enrolled from 116 hospitals or communities in China. We used minimised randomisation to assign participants to intensive treatment targeting standard office systolic blood pressure of less than 120 mm Hg or standard treatment targeting less than 140 mm Hg. The primary outcome was a composite of myocardial infarction, revascularisation, hospitalisation for heart failure, stroke, or death from cardiovascular causes, assessed by the intention-to-treat principle. This trial was registered with ClinicalTrials.gov, NCT04030234. Findings Between Sept 17, 2019, and July 13, 2020, 11 255 participants (4359 with diabetes and 3022 with previous stroke) were assigned to intensive treatment (n=5624) or standard treatment (n=5631). Their mean age was 64·6 years (SD 7·1). The mean systolic blood pressure throughout the follow-up (except the first 3 months of titration) was 119·1 mm Hg (SD 11·1) in the intensive treatment group and 134·8 mm Hg (10·5) in the standard treatment group. During a median of 3·4 years of follow-up, the primary outcome event occurred in 547 (9·7%) participants in the intensive treatment group and 623 (11·1%) in the standard treatmen…
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“The primary outcome, a composite of MI, revascularization, hospitalization for heart failure, stroke, or cardiovascular death, was significantly reduced by 12% in the intensive therapy group (HR 0.88, 95% CI 0.78–0.99) irrespective of the diagnosis of diabetes at baseline.”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [43]
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“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 [43]
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“The investigators reported a modest increase in adverse events, including syncope (0.4% vs. 0.1%, HR 3.00, 95% CI 1.35–6.68) (43).”
From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [43]
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X., Duan, R., Duan, X., Duan, X., Fan, D., Fan, X., Fan, X., Fang, F., Fang, J., Fang, X., Fang, Y., Feng, E., Feng, H., Feng, L., Feng, R., Feng, Z., Fu, H., Fu, Q., Gao, H., Gao, L., Gao, L., Gao, L., Gao, L., Gao, M., Gao, M., Gao, Q., Gao, Y., Gao, Y., Ge, J., Geng, H., Geng, H., Geng, L., Geng, L., Gou, H., Gu, Q., Guan, L., Guan, S., Guan, W., Guan, Z., Guang, B., Guo, A., Guo, C., Guo, G., Guo, L., Guo, Q., Guo, Q., Guo, Y., Guo, Z., Han, A., Han, M., Han, S., Han, X., Han, Y., Hao, F., Hao, J., Hao, S., He, C., He, D., He, M., He, M., He, S., He, W., He, X., He, Y., Hong, J., Hou, C., Hou, J., Hu, D., Hu, J., Hu, J., Hu, L., Hu, M., Hu, Z., Huang, A., Huang, C., Huang, H., Huang, J., Huang, S., Huang, S., Huang, W., Huang, W., Huang, X., Huang, X., Huang, X., Hui, J., Hui, L., Hui, Z., Huo, F., Ji, R., Ji, R., Jia, G., Jia, H., Jia, J., Jia, J., Jia, X., Jiang, H., Jiang, J., Jiang, Q., Jiang, X., Jiang, X., Jiang, Y., Jiao, Y., Jie, L., Jin, B., Jin, L., Jin, R., Jin, R., Jin, 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Z.
- Affiliations
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2024-07
- Volume
- 404
- Issue
- 10449
- Pages
- 245-255
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W4400066882
- Cited by
- 258
- References
- 29
- Citations by year
- 2026: 105 · 2025: 133 · 2024: 20
- FWCI
- 77.61
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Servier
- University of Oxford
- National Key Research and Development Program of China (2018YFC1312400, 2018YFC1312401, 2018YFC1312404)
- Tulane University
- Capital Medical University
- Ministry of Science and Technology of the People's Republic of China
- Chinese Academy of Medical Sciences (NCRC2021001)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Health Sciences › Nursing › Nutrition and Dietetics › Sodium Intake and Health
- Keywords
- intensive blood pressure lowering, systolic blood pressure target, high cardiovascular risk, diabetes mellitus, stroke history, cardiovascular events, myocardial infarction, syncope, antihypertensive therapy, China, primary prevention of cardiovascular disease, secondary stroke prevention, revascularization, stroke recurrence, cardiovascular mortality
- MeSH terms
- Heart Disease Risk Factors, Aged, Antihypertensive Agents, Blood Pressure, Cardiovascular Diseases, China, Diabetes Mellitus, Female, Humans, Hypertension, Male, Middle Aged, Myocardial Infarction, Treatment Outcome, Stroke
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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