Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes

Abstract

Background: The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, but without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure of less than 120 mm Hg (intensive treatment) than among those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient-reported outcomes was uncertain; those results from the trial are reported here.

Methods: We randomly assigned 9361 participants with hypertension to a systolic blood-pressure target of less than 120 mm Hg or a target of less than 140 mm Hg. Patient-reported outcome measures included the scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Health Survey, the Patient Health Questionnaire 9-item depression scale (PHQ-9), patient-reported satisfaction with their blood-pressure care and blood-pressure medications, and adherence to blood-pressure medications. We compared the scores in the intensive-treatment group with those in the standard-treatment group among all participants and among participants stratified according to physical and cognitive function.

Results: Participants who received intensive treatment received an average of one additional antihypertensive medication, and the systolic blood pressure was 14.8 mm Hg (95% confidence interval, 14.3 to 15.4) lower in the group that received intensive treatment than in the group that received standard treatment. Mean PCS, MCS, and PHQ-9 scores were relatively stable over a median of 3 years of follow-up, with no significant differences between the two treatment groups. No significant differences between the treatment groups were noted when participants were stratified according to baseline measures of physical or cognitive function. Satisfaction with blood-pressure care was high in both treatment groups, and we found no significant difference in adherence to blood-pressure medications.

Conclusions: Patient-reported outcomes among participants who received intensive treatment, which targeted a systolic blood pressure of less than 120 mm Hg, were similar to those among participants who received standard treatment, including among participants with decreased physical or cognitive function. (Funded by the National Institutes of Health; SPRINT ClinicalTrials.gov number, NCT01206062 .).

Figure 1. Patient-Reported Outcomes in the Two Treatment Groups over Time

The data points represent the estimated mean based on a linear mixed model; I bars denote 95% confidence intervals. The values below each graph indicate the number of participants assessed at each trial visit. Scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Health Survey (VR-12) are standardized with a mean of 50 and a standard deviation of 10; scores range from 0 to 100, with higher scores denoting better physical health and mental health, respectively. Scores on the Patient Health Questionnaire 9-item depression scale (PHQ-9) range from 0 to 27, with higher scores indicating greater severity of depressive symptoms and scores of 10 or higher suggesting moderate-to-severe depressive symptoms.

Figure 2. Scores on the VR-12 over Time, According to Treatment Group and Number of Medical Coexisting Conditions

The burden of medical coexisting conditions was categorized as 2 or fewer, 3 or 4, 5 or 6, or 7 or more. The data points represent the estimated mean based on a linear mixed model, with I bars denoting 95% confidence intervals. The values below each graph indicate the number of participants assessed at each trial visit, according to the number of coexisting conditions participants had at baseline. Coexisting conditions were reported by the participants with the use of the Selim comorbidity index, which assesses 30 medical conditions and 6 mental health conditions. The physical score on the Selim comorbidity index was calculated as the sum of the number of these 30 possible medical conditions reported, and the mental score was the sum of the number of these 6 possible mental health conditions reported.

Figure 3. Scores on the VR-12 over Time, According to Treatment Group and Age Category

The data points represent the estimated mean based on a linear mixed model, with I bars denoting 95% confidence intervals. The values below each graph indicate the number of participants assessed at each trial visit, according to age category.