Trials find intensive control reduced cardiovascular events in high-risk, diagnosed patients.
High blood pressure leads to cardiovascular disease, which is the leading cause of death among patients with type 2 diabetes. This study was a subgroup analysis of ACCORD-BP (Action to Control Cardiovascular Risk in Diabetes Blood Pressure) participants. Participants were studied if they were in standard glucose control group of ACCORD-BP and had CVD risk factors required for SPRINT (systolic blood pressure intervention trial) eligibility. In both the ACCORD-BP and SPRINT trial, they compared an intensive blood pressure control strategy (goal of systolic blood pressure (SBP) <120 mmHg) against standard blood pressure control (goal SBP <140 mmHg) in patients who were at increased cardiovascular risk. Inclusion and exclusion criteria for ACCORD-BP and SPRINT were very similar. Both trials recommended ACE inhibitors, angiotensin receptor blockers, thiazide and loop diuretics, calcium channel blockers, a-blockers, and beta blockers for blood pressure control. However in SPRINT, direct vasodilators and potassium-sparing diuretics were also permitted.
The main outcomes studied in these trials included myocardial infarction (MI), stroke, heart failure, cardiovascular death, nonfatal myocardial infarction, non-fatal stroke, and coronary revascularization. Out of a total of 4,733 ACCORD-BP participants, 2,592 met inclusion criteria for SPRINT. 652 participants were randomized to the intensive blood pressure control and 632 participants were randomized to standard blood pressure control. The baseline characteristics were very similar between SPRINT-eligible ACCORD-BP participants in the standard and intensive glucose control groups.
The baseline mean Framingham 10-year CVD risk scores were 14.5% and 14.8% in the intensive and standard blood pressure control groups, respectively (p=0.56). There was a significant difference observed in aspirin use between the intensive blood pressure control participants and the standard blood pressure control participants (p=0.02). The mean SBP in the intensive blood pressure control group was 120.1 ± 14.0 and 133.5 ± 15.5 in the standard blood pressure control group (p<0.001).
In SPRINT-eligible ACCORD-BP participants with type 2 diabetes, it was found that intensive blood pressure control was significantly able to reduce risk of cardiovascular death, nonfatal MI, nonfatal stroke, revascularization, and heart failure by 21% compared to the standard blood pressure control group. It was also noted that treatment-related serious adverse events were significantly higher in intensive blood pressure control participants compared to standard blood pressure control participants (p=0.003).
When comparing original SPRINT participants with SPRINT-eligible ACCORD-BP participants, it was found that there was a non-significant difference observed in cardiovascular death, nonfatal MI, nonfatal stroke, any revascularization, or heart failure between participants with and without type 2 diabetes in intensive blood pressure control group(p=0.76).
Based on these results, the optimal blood pressure management strategy for patients with type 2 diabetes remains controversial. Without type 2 diabetes status, the SPRINT-eligible ACCORD-BP trial found that intensive blood pressure control significantly reduced the risk of cardiovascular events. However, intensive blood pressure control was not different in its effect on cardiovascular outcomes between patients with and without type 2 diabetes. A meta-analysis of 19 clinical trials found that there was a non-significant difference in reduction in cardiovascular outcomes in patients with and without type 2 diabetes (p=0.76). Based on previous studies and results from this study, it is safe to say that the intensive blood pressure control goal should be chosen for high-risk patients with type 2 diabetes in order to reduce cardiovascular events. The results from this study were controversial. It was found that patients with type 2 diabetes can benefit from intensive BP control. However, results were non-significant. So, basically they found that the benefits of intensive BP control are higher in patients with pre-existing cardiovascular risk factors. Patients with type 2 diabetes and cardiovascular risk factors will benefit more from intensive BP control than just patients with type 2 diabetes. These patients will benefit more from intensive blood pressure control than patients without cardiovascular risk factors.
In addition, it was noted that the benefits of intensive blood pressure control was most evident in SPRING-eligible ACCORD-BP patients who were not receiving intensive glucose control. In the original ACCORD-BP analysis, it was found that there was interaction between intensive glucose control and intensive blood pressure control. Intensive blood pressure control was beneficial only in the standard glucose control group. In conclusion, intensive blood pressure control is beneficial in high risk patients with type 2 diabetes by allowing for reduction in cardiovascular risk.
- Intensive blood pressure control reduces cardiovascular outcomes in patients with type 2 diabetes better than standard blood pressure control.
- Treatment related adverse events are higher in participants receiving intensive blood pressure control.
- The overall effect of intensive blood pressure control on cardiovascular outcomes was not significantly different between patients with and without type 2 diabetes.
Buckley L, Dixon D, Wohlford G et al. Intensive Versus Standard Blood Pressure Control in SPRINT-Eligible Participants of ACCORD-BP. Diabetes Care. 2017; 40:1733-1738.
Vidhi Patel, Pharm. D. Candidate 2018, LECOM School of Pharmacy