Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups
Author(s)
Type
Journal Article
Abstract
Background
Evidence on long term effectiveness of public health strategies for lowering blood pressure
(BP) is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA) Trial, a 2 x 2
factorial, cluster randomized controlled trial, the combined home health education (HHE)
and trained general practitioner (GP) intervention delivered over 2 years was more effective
than no intervention (usual care) in lowering systolic BP among adults with hypertension in
urban Pakistan. However, it was not clear whether the effect would be sustained after the
cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention
period of COBRA trial participants to assess the effectiveness of the interventions
on BP during extended follow-up.
Methods
A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or
greater, diastolic BP 90 mm Hg or greater, or already receiving treatment) were followed by
trained research staff masked to randomization status. BP was measured thrice with a calibrated
automated device (Omron HEM-737 IntelliSense) in the sitting position after 5 minutes
of rest. BP measurements were repeated after two weeks. Generalized estimating
equations (GEE) were used to analyze the primary outcome of change in systolic BP from
baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at
baseline, sex, baseline systolic and diastolic BP, and presence of diabetes.
Findings
After 7 years of follow-up, systolic BP levels among those randomised to combined HHE
plus trained GP intervention were significantly lower (2.1 [4.1–0.1] mm Hg) compared to
those randomised to usual care, (P = 0.04). Participants receiving the combined intervention
compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6]
mg/dl.
Conclusions
The benefit in systolic BP reduction observed in the original cohort assigned to the combined
intervention was attenuated but still evident at 7- year follow-up. These findings highlight
the potential for scaling-up simple strategies for cardiovascular risk reduction in lowand
middle- income countries.
Evidence on long term effectiveness of public health strategies for lowering blood pressure
(BP) is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA) Trial, a 2 x 2
factorial, cluster randomized controlled trial, the combined home health education (HHE)
and trained general practitioner (GP) intervention delivered over 2 years was more effective
than no intervention (usual care) in lowering systolic BP among adults with hypertension in
urban Pakistan. However, it was not clear whether the effect would be sustained after the
cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention
period of COBRA trial participants to assess the effectiveness of the interventions
on BP during extended follow-up.
Methods
A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or
greater, diastolic BP 90 mm Hg or greater, or already receiving treatment) were followed by
trained research staff masked to randomization status. BP was measured thrice with a calibrated
automated device (Omron HEM-737 IntelliSense) in the sitting position after 5 minutes
of rest. BP measurements were repeated after two weeks. Generalized estimating
equations (GEE) were used to analyze the primary outcome of change in systolic BP from
baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at
baseline, sex, baseline systolic and diastolic BP, and presence of diabetes.
Findings
After 7 years of follow-up, systolic BP levels among those randomised to combined HHE
plus trained GP intervention were significantly lower (2.1 [4.1–0.1] mm Hg) compared to
those randomised to usual care, (P = 0.04). Participants receiving the combined intervention
compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6]
mg/dl.
Conclusions
The benefit in systolic BP reduction observed in the original cohort assigned to the combined
intervention was attenuated but still evident at 7- year follow-up. These findings highlight
the potential for scaling-up simple strategies for cardiovascular risk reduction in lowand
middle- income countries.
Date Issued
2015-11-05
Date Acceptance
2015-09-25
Citation
PLoS One, 2015, 10 (11)
ISSN
1932-6203
Publisher
PUBLIC LIBRARY SCIENCE
Journal / Book Title
PLoS One
Volume
10
Issue
11
Copyright Statement
© 2015 Jafar et al. This is an open
access article distributed under the terms of the
Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any
medium, provided the original author and source are
credited.
access article distributed under the terms of the
Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any
medium, provided the original author and source are
credited.
License URL
Sponsor
Imperial College Healthcare NHS Trust- BRC Funding
National Institute for Health Research
Grant Number
RDC02 79560
n/a
Subjects
Science & Technology
Multidisciplinary Sciences
Science & Technology - Other Topics
SYSTEMATIC ANALYSIS
GLOBAL BURDEN
MORTALITY
DISEASE
HYPERTENSION
POPULATION
PAKISTAN
SOCIETY
SODIUM
Publication Status
Published
Article Number
e0140550