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Abstract
BackgroundEvidence 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.MethodsA 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.FindingsAfter 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.ConclusionsThe 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 low- and middle- income countries.Trial RegistrationClinicalTrials.gov NCT00327574
Highlights
Hypertension is the leading attributable risk factor for death globally, including in South Asia where it accounts for a third of age-standardized deaths. [1] About 1 in 4 adults suffers from hypertension Pakistan. [2]We previously reported 2-year outcomes of the Wellcome Trust funded Control of Blood Pressure and Risk Attenuation-(COBRA) trial (2004 to 2007) in Karachi, Pakistan. [3] The main trial was designed to assess the impact of family-based home health education (HHE) delivered every three months to households in randomized clusters, and a second approach of training general practitioners (GP) to manage hypertension optimally
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 in lowering systolic blood pressure (BP) among adults with hypertension in urban Pakistan
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
Summary
Hypertension is the leading attributable risk factor for death globally, including in South Asia where it accounts for a third of age-standardized deaths. [1] About 1 in 4 adults suffers from hypertension Pakistan. [2]We previously reported 2-year outcomes of the Wellcome Trust funded Control of Blood Pressure and Risk Attenuation-(COBRA) trial (2004 to 2007) in Karachi, Pakistan. [3] The main trial was designed to assess the impact of family-based home health education (HHE) delivered every three months to households in randomized clusters, and a second approach of training general practitioners (GP) to manage hypertension optimally. 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. 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
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