Relationships between blood pressure lowering therapy and cardiovascular events in hypertensive patients with coronary artery disease and type 2 diabetes mellitus: The HIJ-CREATE sub-study.

Objective: The effects of intensive blood pressure (BP) lowering for hypertensive patients with coronary artery disease (CAD) and diabetes mellitus on their clinical outcomes have not been fully evaluated. The aim was to explore the optimal systolic BP target in such patients in a substudy of a prospective, randomized trial.

Methods: Of a total of 2049 hypertensive patients with CAD who were enrolled in the HIJ-CREATE study, type 2 diabetes was diagnosed in 780 (38.1%). Titration of antihypertensive agents was performed to reach the target BP of <130/85 mmHg. The primary endpoint was the occurrence of a first major adverse cardiovascular event (MACE). Achieved BP was defined as the mean value of systolic BP in patients who did not develop MACEs and as the mean value of systolic BP prior to MACEs in those who developed MACEs during follow-up.

Results: During a median follow-up of 4.2 years, the primary outcome occurred in 259 (33.2%) diabetic patients and in 293 (23.1%) non-diabetic patients (p < 0.0001). The diabetic patients were divided into quartiles based on the mean systolic BP during follow-up. The relationships between achieved BP and the incidence of MACEs did not follow a J-shaped curve. Intensive systolic BP lowering to less than 120 mmHg did not correlate with an increased risk of MACEs.

Conclusions: Our results suggest that the intensive BP lowering may not impair patients' clinical courses even in a high-risk population. The establishment of an optimal management strategy for hypertensive patients with diabetes and CAD is essential.