— Benefit did not persist after completing 12-month intensive intervention
Blood pressure (BP) reductions (relative to usual care) obtained in a 12-month intensive antihypertensive intervention were not maintained in longer-term follow-up, researchers said, suggesting that patients who achieve their BP goals with such regimens must still be managed closely.
Assessments of 326 participants in a cluster-randomized trial -- in which patients were assigned to either intensive monitoring and management or to usual care -- conducted over an additional 42 months showed that the intensive approach's benefits over usual care dissipated after the randomized phase had ended, reported Karen Margolis, MD, MPH, of HealthPartners Institute for Education and Research in Minneapolis, and colleagues in JAMA Network Open.
By month 54 (that is, 42 months after the initial 12-month study concluded), differences between treatment arms in terms of reduction from baseline were no longer significant (systolic BP: -2.5 mm Hg, 95% CI -6.3 to 1.2, P=0.18; and diastolic BP: -1.00 mm Hg, 95% CI -3.2 to 1.2, P=0.37).
Interventions in the trial included telemonitored at-home BP measurement (six times per week) and pharmacist management of patients' medications. Initial enrollment was 450; all patients had uncontrolled hypertension at baseline. Randomization was by primary care clinic at which patients were seen (16 in all). After the 12-month intervention ended, BP readings from clinic visits continued to be recorded in patients' electronic records and were the basis for the current analysis.
The study results aren't surprising considering trends in adherence and patients participation in care, George L. Bakris, MD, of the University of Chicago, told MedPage Today regarding the study, to which he did not contribute.
"It is important to provide both short-term and long-term goals and make patients accountable for the management of their disease," Bakris explained. "This is one of the longest-term studies done and for that reason is even more encouraging than shorter-term studies providing similar results."
The telemonitoring intervention (TI) group and the usual care (UC) group had the following average differences in systolic BP:
- From baseline to 6 months: -10.7 mm Hg (95% CI -14.3 to -7.3, P<0.001)
- From baseline to 12 months: -9.7 mm Hg (95% CI -13.4 to -6.0, P<0.001)
- From baseline to 18 months: -6.6 mm Hg (95% CI -10.7 to -2.5, P= 0.004)
Between the telemonitoring intervention group and the usual care group the average differences in diastolic pressure were as follows:
- From baseline to 6 months: -6.0 mm Hg (95% CI, -8.6 to -3.4 mm Hg) (P<0.001)
- From baseline to 12 months: -5.1 mm Hg (95% CI, -7.4 to -2.8 mm Hg) (P<0.001)
- From baseline to 18 months: -3.0 mm Hg (94% CI, -6.3 to 0.3 mm Hg) (P=0.07)
Notably, however, both groups showed clinically relevant reductions from baseline in both systolic and diastolic BP at month 54.
"Data sharing and better communication clearly improves patient adherence and will help maintain the reduction in [cardiovascular] risk factors, at least BP, and should be strongly encouraged for future care of patients," noted Bakris.
The researchers acknowledge several limitations of their work. Only 72% of the study's original participants completed the 54-month follow-up. But sensitivity analyses indicated that the losses to follow-up did not markedly affect the overall results.
"The specific reasons for lack of follow-up and their similarity by treatment group did not lead us to doubt the results or the assumptions of BP as missing or random," explained Margolis and co-authors.
Going forward, Margolis and colleagues said they would like to see more work used to determine the duration, intensity, and content "that are needed for maintaining intervention benefits over a longer period." "The EHR is a promising tool for measuring intervention effects and for detecting deterioration of BP control after initial successful control," they concluded.
This study was supported by the National Heart, Lung, and Blood Institute.
Margolis reported relationships with the National Institutes of Health/National Heart, Lung, and Blood Institute and the Patient-Centered Outcomes Research Institute (PCORI).
Bakris did not report any relevant conflicts of interest.
- Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner
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JAMA Network Open
Source Reference: Margolis K, et al “Long-term outcomes of the effects of home blood pressure telemonitoring and pharmacist management on blood pressure among adults with uncontrolled hypertension follow-up of a cluster randomized clinical trial” JAMA Network Open 2018; DOI: 10.1001/jamanetworkopen.2018.1617.
Read the original article on Medpage Today: Long-Term Attention Needed to Maintain Blood Pressure Reductions