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Originally published in NEJM, 16 November 2024, and presented at AHA Scientific Sessions 2024. This summary does not represent the original research, nor is it intended to replace the original research. Content Disclaimer
People with Type 2 diabetes are twice as likely to develop high blood pressure, with as many as 75% of diabetic patients also experiencing elevated blood pressure, substantially increasing their risk for cardiovascular, renal and other complications.
Recent research presented at the American Heart Association’s Scientific Sessions 2024 showed that an intensive approach to managing systolic blood pressure (SBP) could substantially reduce the risk of cardiovascular events and other complications in individuals with Type 2 diabetes.
About the Study
The BROAD trial (NCT03808311) was a multi-center, open-label, parallel-group, randomized controlled trial conducted across mainland China.
The primary hypothesis was whether an intensive treatment strategy, targeting a systolic blood pressure of <120 mmHg, would be more effective than a standard treatment strategy (targeting <140 mmHg) in reducing the risk of major cardiovascular events including non-fatal stroke, non-fatal myocardial infarction, heart failure hospitalisation or treatment, and cardiovascular deaths.
Secondary objectives included assessing the impact of intensive versus standard treatment on cognitive function, individual components of the primary outcome, all-cause mortality, kidney outcomes, quality of life, and the incidence of dangerous falls.
Participants
The study enrolled participants between February 2019 and December 2021.
A total of 12,821 patients, aged 50 or older, with Type 2 diabetes, elevated systolic blood pressure, and increased cardiovascular risk were enrolled from 145 clinical sites across China.
Participants were randomly assigned to receive either intensive treatment (targeting an SBP <120 mmHg) or standard treatment (targeting SBP <140 mmHg).
The mean age of the participants was 63.8 years, and 45.3% of the participants were women.
The study enrolled participants between February 2019 and December 2021.
Results
After one year of follow-up, the mean systolic blood pressure in the intensive treatment group was 121.6 mmHg (median 118.3 mmHg), compared to 133.2 mmHg (median 135.0 mmHg) in the standard treatment group.
Over a median follow-up period of 4.2 years, the incidence of primary outcome events was 1.65 events per 100 person-years in the intensive-treatment group, compared to 2.09 events per 100 person-years in the standard-treatment group (hazard ratio, 0.79; 95% CI, 0.69 to 0.90; P<0.001).
The incidence of serious adverse events was similar across both groups. However, symptomatic hypotension and hyperkalaemia were more frequently observed in the intensive treatment group.
Investigator Comment
Speaking to the AHA Newsroom team, Dr. Guang Ning, the lead author of the study, commented:
“Our study results are consistent with another study of patients with hypertension but without diabetes, which found a significant 27% reduction in the incidence of cardiovascular diseases. Future clinical practice guidelines will hopefully consider these results when making recommendations for blood pressure targets for people with Type 2 diabetes. Beneficial future research could focus on profiling those with the largest benefit and the lowest harm in an intensive blood pressure treatment group.”
Conclusion
The BROAD trial provides strong evidence that intensive management of systolic blood pressure to a target of <120 mmHg significantly reduces the risk of major cardiovascular events in patients with Type 2 diabetes compared to the standard treatment target of <140 mmHg. This supports the consideration of more aggressive blood pressure management in clinical practice guidelines for people with Type 2 diabetes to prevent cardiovascular complications.
However, further research is needed to identify which patients will benefit the most from intensive BP treatment while minimizing potential risks.
Limitations
Several limitations were noted in the study. The participants and study physicians were not blinded, which could introduce bias. Additionally, while other cardiovascular risk factors were similar between the groups during follow-up, telephone interviews were used to maintain data collection, especially during the COVID-19 lockdown, when in-person visits were limited. Furthermore, the findings may not be fully generalizable to non-Chinese populations or those with different baseline characteristics.
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