CHICAGO – Intensive therapy to lower systolic blood pressure to 120 mm Hg in patients with type 2 diabetes reduced the risk of cardiovascular events compared with a standard treatment approach in the trial BPROAD.
In the new Chinese clinical trial, the relative risk of a major cardiovascular event was 21% lower with intensive treatment than with standard treatment during the 4-year follow-up period.
“These results strongly support the idea of a more intensive systolic blood pressure goal in people with type 2 diabetes for the prevention of major cardiovascular events,” said study author Dr. Dr Guang NingMD and PhD, from Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, China, at the 2024 Scientific Sessions of the American Heart Association (AHA). The results were simultaneously published online in the New England Journal of Medicine.
Blood pressure goals for patients with type 2 diabetes have not been clearly defined, the authors explain. The American essay SPRINT the landmark study, showed that intensive treatment with a systolic target of 120 mm Hg resulted in a significant reduction in cardiovascular events compared to the standard target of 140 mm Hg, but this trial did not include diabetic patients.
The test ACCORDolder, failed to show a significant reduction in cardiovascular events after similar intensive blood pressure reduction in people with diabetes. However, this trial was underpowered to evaluate the blood pressure intervention and the results may have been confounded by the factorial design of the glucose intervention used in the trial, the researchers report.
Consistent with SPRINT
The BPROAD trial provides “compelling evidence of the benefits of lowering systolic blood pressure to a target value below 120 mm Hg in patients with type 2 diabetes,” the researchers report. This result is consistent with the findings of the SPRINT study, “which showed a significant 27% reduction in the risk of major cardiovascular events in non-diabetic patients who received intensive blood pressure reduction.”
Furthermore, the test ESPRIT “recently showed a 12% reduction in the risk of major vascular events in diabetic and non-diabetic patients” who received intensive blood pressure lowering treatment, they add.
With intensive blood pressure goals, patients should be monitored for hypotension and hyperkalemia
The BPROAD trial has important implications for blood pressure management in clinical practice, they explain. Although the Eighth Joint National Committee recommends a systolic blood pressure less than 140 mm Hg in patients with type 2 diabetes based on results from the ACCORD trial, most current recommendations recommend a systolic blood pressure less than 130 mm Hg in patients with diabetes. However, evidence supporting this recommendation is lacking.
These results “argue in favor of more intensive control of systolic blood pressure in diabetic patients for the prevention of major cardiovascular diseases. However, with intensive blood pressure goals, patients should be monitored for hypotension and hyperkalemia, they add.
The BPROAD study
In the BPROAD trial, 12,821 patients aged 50 years and older with type 2 diabetes and elevated systolic blood pressure and increased risk of cardiovascular disease were recruited from 145 clinical centers across the world. China.
Patients were randomized to receive intensive treatment, with a systolic blood pressure goal less than 120 mm Hg, or standard treatment, with a goal less than 140 mm Hg, for up to 5 years.
Lower average SBP with intensive treatment
The primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, and cardiovascular death.
After one year of follow-up, mean systolic blood pressure was lower with intensive treatment than with standard treatment (121.6 versus 133.2 mm Hg).
After a median follow-up of 4.2 years, fewer patients in the intensive treatment group than in the standard treatment group experienced a primary event (393 vs. 492 patients; 1.65 vs. 2.09 events per 100 person-years hazard ratio, 0.79; 95% CI, 0.69 to 0.90;
The incidence of serious adverse events was similar in the two treatment groups. However, symptomatic hypotension occurred more frequently in the intensive treatment group than in the standard treatment group (8 of 6414 patients versus 1 of 6407 patients; P = 0.05). In addition, elevated serum potassium (>5.5 mmol/L) was more common with intensive treatment than with standard treatment (2.8% versus 2.0%; P = 0.003).
The BPROAD study filled an important gap in our knowledge, namely whether the results of the SPRINT study would also apply to diabetic patients
Dr Amit Khera
Among secondary outcomes, stroke occurred less frequently in the intensive treatment group than in the standard treatment group (1.19 versus 1.50 events per 100 person-years). “Stroke is the most common type of cardiovascular disease among Chinese people, and hypertension is the main contributing factor to stroke and stroke-related death,” the authors report.
Filling a knowledge gap
“The BPROAD study filled an important gap in our knowledge, namely whether the results of the SPRINT study would also apply to diabetic patients. The answer is definitely yes. We must now implement these important results in the millions of diabetic patients around the world,” said the Dr Amit Kheradirector of preventive cardiology at UT Southwestern Medical Center in Dallas, Texas, and chair of the AHA 2024 Council on Scientific Session Programming.
The study confirms that diabetics respond similarly to non-diabetics in terms of benefits from more aggressive blood pressure reduction, added the Dre Shawna Nesbittwhich was uncertain due to unclear results from the ACCORD trial.
“The fact that the ACCORD study is positive for non-diabetics but negative for diabetics has been somewhat misinterpreted. This goes against what you would think, because the risk of cardiovascular events in diabetics is obviously much higher,” said Dr. Nesbitt, who also works at UT Southwestern Medical Center.
In clinical practice, however, “although we are very pleased to see that intensive blood pressure reduction reduces events, we must be concerned about the serious adverse effects that these blood pressure changes can cause, particularly in people elderly,” she said.
BPROAD study confirms that diabetic patients should have the same blood pressure goals as non-diabetic patients
Dre Jane Leopold
The AHA generally advises lowering systolic blood pressure to less than 130 mm Hg and diastolic blood pressure to 80 mm Hg. Additionally, nonpharmacologic treatment should initially be used for people whose systolic blood pressure is between 130 and 139 mm Hg and diastolic blood pressure between 80 and 89 mm Hg.
“However, the patient’s age and condition should be taken into account when deciding whether to lower blood pressure, as we know that in older people the risk of falls or hypotension may be slightly increased. We also need to be careful to monitor electrolytes and kidney function to minimize adverse effects,” explained Dr. Nesbitt.
The BPROAD study confirms that diabetic patients should have the same blood pressure goals as non-diabetic patients, explained the Dre Jane Leopolddirector of the Women’s Interventional Cardiology Health Initiative at Brigham and Women’s Hospital in Boston, Massachusetts, and associate editor of the New England Journal of Medicinein an audio interview published on the newspaper’s website.
“In fact, it is more important to reduce blood pressure in patients with diabetes because they are at higher risk of cardiovascular events,” she said.
However, getting patients to achieve these blood pressure-lowering goals is extremely difficult, Leopold noted.
“It often requires multiple medications, which have many side effects, and patients don’t like taking lots of different medications. This is something we must continue to work on. We need to explain to patients the benefits of lowering blood pressure, while balancing those benefits with the risks of polypharmacy,” she said.
This article was translated from Medscape.com part of the Medscape professional network, using several editorial tools, including AI, in the process. The content was reviewed by the editorial staff before publication.
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