Randomised control trial of early use of a simplified treatment regimen incorporating a half -dose, three-in-one blood pressure lowering pill vs. usual care for improving hypertension control in India

Background

Hypertension is a major contributor to the cardiovascular disease burden in India, particularly in urban settings where prevalence may be as high as 40%,with control of hypertension as low as 38%. The use of multiple medications and complex up-titration regimes to achieve BP likely represents a significant barrier to patient adherence, frequently relating to issues of cost and complexity. Additionally, such regimens are likely to contribute to clinician inertia. Combination BP lowering therapy has been shown to be effective in improving BP control to target and improving patient compliance and adherence to prescribed medications. Simplified treatment regimes for up-titrating BP lowering medications have also been shown to be effective in improving BP control by addressing clinician inertia as well as improving patient acceptability. There are also sound pharmacological principles to expect an improved benefit to side effect ratio from low-dose triple combinations, compared to incremental use of full dose drugs . However, there are concerns that any advantages in adherence and reduction in side effects are counterbalanced by less ability to individually tailor anti-hypertensive drugs. This question had not been addressed in a clinical trial.

Aims

To investigate effectiveness, cost-effectiveness, and acceptability of Triple pill (Triple BP lowering therapy) compared to usual care for early management of high BP in India and Sri Lanka.

Project plan

• Design
  Randomised Controlled Trial, Economic Evaluation, and Process Evaluation.

• Participants
  Adults with high BP despite diet and lifestyle advice or single drug therapy.

• Intervention
  Triple pill vs. usual care.

• Outcome
  Proportion of participant achieving target BP at 6 months follow-up.

Publications and output

GACD have published an end-of-programme report, providing a comprehensive summary of the programme and outcomes.

Funding organisations

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