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Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes
Dan R Berlowitz1, Capri G Foy1, Lewis E Kazis1
1From the Center for Healthcare Organization and Implementation Research, Bedford Veterans Affairs (VA) Hospital, Bedford (D.R.B., L.E.K.), and Boston University Schools of Medicine and Public Health (D.R.B., L.E.K.) and Tufts Medical Center (D.E.W.), Boston - all in Massachusetts; Wake Forest School of Medicine, Winston-Salem (C.G.F., J.N., N.M.P.), and East Carolina University College of Nursing (L.P.B.) and Brody School of Medicine (J.P.), East Carolina University, Greenville - both in North Carolina; the University of Pittsburgh, Pittsburgh (M.B.C.); Mayo Clinic Florida, Jacksonville (P.F.); the Ohio State Wexner Medical Center, Columbus (T.R.G.); the National Institute of Diabetes and Digestive and Kidney Diseases (P.L.K.) and the National Heart, Lung, and Blood Institute (J.S.), Bethesda, MD; the G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS (K.K.); UCLA Fielding School of Public Health, Los Angeles (D.E.M.); Minneapolis VA Medical Center, Minneapolis (C.O.); University of Alabama at Birmingham, Birmingham (S.O., T.R.); University of Utah School of Medicine (D.L.S., M.A.S.) and VA Geriatric Research, Education and Clinical Center (M.A.S.), Salt Lake City; and the Clement J. Zablocki VA Medical Center, Milwaukee (J.W.).
Insights
Intensive blood pressure treatment targeting <120 mm Hg did not significantly alter patient-reported outcomes compared to standard treatment (<140 mm Hg). This includes physical and mental health scores, depression, and medication adherence in hypertensive patients.
Area of Science:
- Cardiology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- The Systolic Blood Pressure Intervention Trial (SPRINT) previously demonstrated reduced cardiovascular events with intensive systolic blood pressure (SBP) treatment (<120 mm Hg) versus standard treatment (<140 mm Hg) in high-risk hypertensive patients without diabetes.
- Uncertainty remained regarding the impact of intensive SBP treatment on patient-reported outcomes (PROs).
Purpose of the Study:
- To evaluate the effect of intensive SBP treatment versus standard SBP treatment on PROs in the SPRINT trial.
- To assess PROs across different strata of physical and cognitive function.
Main Methods:
- 9361 hypertensive participants were randomized to an SBP target of <120 mm Hg (intensive) or <140 mm Hg (standard).
- PROs included Veterans RAND 12-Item Health Survey (PCS/MCS), Patient Health Questionnaire (PHQ-9), satisfaction with care, and medication adherence.
- Analyses compared PROs between groups, stratified by baseline physical and cognitive function.
Main Results:
- Intensive treatment lowered SBP by 14.8 mm Hg more than standard treatment, with an additional antihypertensive medication used on average.
- Mean scores for Physical Component Summary (PCS), Mental Component Summary (MCS), and PHQ-9 remained stable with no significant between-group differences over a median of 3 years.
- No significant differences in PROs were observed when stratifying by baseline physical or cognitive function. Satisfaction and adherence were similar in both groups.
Conclusions:
- Intensive SBP treatment targeting <120 mm Hg did not adversely affect patient-reported outcomes compared to standard treatment.
- These findings suggest that intensive blood pressure management is acceptable from a patient-reported perspective, even for those with impaired physical or cognitive function.
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 .).
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