In the previously reported Action to Control Cardiovascular Risk in Diabetes study, intensive BP control with a goal of achieving systolic BP < 120 mm Hg, as opposed to 130 to 139 mm Hg (standard BP control) did not reduce the main prespecificed, composite macrovascular outcome, or reduce mortality or myocardial infarctions, but it did reduce the rate of stroke.
Given the “mixed” clinical results, the ACCORD BP HRQL substudy was designed to prospectively quantify the impact of intensive versus standard BP treatment on validated measures of depression and HRQL in adults with type 2 diabetes over four years of follow-up.
The impact of BP interventions on HRQL “may inform the selection of optimal BP targets by clinicians and patients,” Dr. Patrick J. O’Connor from HealthPartners Research Foundation, Minneapolis, Minnesota and the ACCORD study team notes in their report.
The substudy included 1,028 patients who completed baseline and one or more HRQL evaluations at 12, 36 or 48 months. The researchers used multivariable linear regression analysis to assess the impact of BP treatment assignment on change in HRQL.
They failed to see any differences between intensive and standard BP in the Patient Health Questionnaire-9 (PHQ-9) scores, Short-Form health survey (SF36) mental components scores, number of symptoms, mean symptom distress, or treatment satisfaction.
However, between baseline and followup, those assigned to intensive BP treatment had statistically significant worsening in SF36 physical component scores (-0.8 vs -0.2;p=0.02), “suggesting worse perceived physical function over time in the intensive BP treatment group.”
But the magnitude of change (less than one point out of 100 on the SF36 physical component score) was not clinically significant, the researchers say.
In their paper, Dr. O’Connor and colleagues point out that the Treatment of Mild Hypertension Study (TOMHS) showed that among adults with hypertension and no diabetes, actively treated patients had better HRQL than those treated with placebo, although the effects of specific classes of hypertensive medications were mixed.
“However, HRQL data for those with diabetes and comorbid hypertension are limited,” they point out.
“The few observational studies examining the effects of coexisting morbidities (e.g., diabetes and other non-BP cardiovascular risk factors) have shown no consistent pattern of association for BP (and/or hypertension) and HRQL. Furthermore, no prior, large, randomized trial has achieved SBP < 120 mm Hg, so no prior assessment of the impact of such low BP levels on the HRQL of patients with hypertension is available. Whether the results presented may change with longer-term follow-up is of interest, and follow-up of ACCORD subjects is underway,” the authors say.