San Diego, CA—Intensive blood pressure control failed to improve health-related quality of life (HRQOL) compared with standard blood pressure control in patients with type 2 diabetes, according to an analysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial presented at the 2011 Scientific Sessions of the American Diabetes Association (ADA). However, those randomized to intensive blood pressure control had significantly worse physical function at the end of the trial, which was unexpected.
“Intensive blood pressure control in the ACCORD trial did not have a benefit over standard blood pressure control in terms of cardiovascular events or mortality and did not improve or worsen HRQOL or depression. The statistically significant change in physical function [in the intensive arm] was not clinically meaningful, in my opinion,” stated Patrick O’Connor, MD, MPH, HealthPartners, Minneapolis, MN.
ACCORD was a large randomized, controlled trial that included 10,000 participants with type 2 diabetes randomized to intensive versus standard blood pressure control, intensive versus standard lipid-lowering therapy, and intensive versus standard glycemic control. At the ADA meeting, Dr O’Connor presented results of a substudy of HRQOL in 4000 patients from the blood pressure component of the trial; patients were randomized to aggressive blood pressure control (ie, systolic blood pressure [SBP] 120 mm Hg) versus standard blood pressure control (SBP 130-139 mm Hg).
HRQOL was the same in both arms, as assessed by the 36-Item Short Form Survey (SF-36) physical and mental health questionnaire, Patient Health Questionnaire, Symptom Distress in Diabetes Questionnaire, and Diabetes Treatment and Satisfaction Questionnaire. The only exception was significantly worse physical function on the SF-36 in the intensive arm (change of –0.8 in intensive care arm vs –0.2 in the standard care arm, P = .02). “Although statistically significant, this is not an important difference,” Dr O’Connor emphasized.
An unexpected finding was that participants who took more medications at baseline and who were assigned to intensive therapy had more symptoms than their counterparts assigned to standard control. “This is not a headline, however,” he said.
Dr O’Connor presented a second substudy of 2053 patients enrolled in the HRQOL study of ACCORD, showing that depression was an independent predictor of mortality, regardless of treatment arm. Excess mortality was only partially mediated by worse blood pressure control, hemoglobin A1c, lipid levels, aspirin use, body mass index, and tobacco use. A borderline association was found for depression and macrovascular complications, and there was no association between depression and microvascular complications.
“Depression is a strong predictor of increased mortality, and may increase the risk of cardiovascular events in type 2 diabetes,” Dr O’Connor told listeners. “This finding suggests that detection and management of depression is important in people with type 2 diabetes.”