TOPSPIN

Treatment Optimisation for blood Pressure with Single-Pill combinations in India

30%

Hypertension Prevalence

↓ ~30/14 mmHg

Blood Pressure Reduction

~70%

Patients Achieving Control

Overview

Globally, high systolic blood pressure (SBP) was reported as the leading risk factor for morbidity and mortality. Hypertension is also a leading cause of death and disability in India with a prevalence of 30%. Significant variation was noted in hypertension prevalence among rural (28%) and urban (34%) patients in India. More importantly, hypertension control rates in India are low at 11% and 20% among rural and urban patients respectively.

Reducing BP to target levels is a major priority in preventing cardiovascular events in patients with hypertension, and typically, this requires more than one BP lowering medication in the majority of patients. Single BP lowering drug therapy may help only around 30% of hypertensive patients to achieve the optimal BP control as recommended in recent guidelines. Current guidelines therefore recommend the use of combination therapy as first-line treatment or early in the management of hypertensive patients with co-morbidities that require prompt BP reduction. The latest European guidelines for treating hypertension in adults recommends initiating treatment for most patients with two anti-hypertensive drugs. The combinations recommended in these guidelines are an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) with a calcium channel blocker (CCB) or a thiazide/thiazide-like diuretic for management of high blood pressure in people without other comorbidities such as cardiovascular disease or chronic kidney disease. The latest Indian hypertension guidelines recommend combining low doses of two or more drugs in order to achieve the target BP control. In addition, initial treatment with two anti-hypertensive medications was suggested for those with BP greater than 20/10 mmHg above the goal pressure by international guidelines.

Aim

Aim to compare the efficacy of amlodipine plus perindopril, amlodipine plus indapamide and perindopril plus indapamide in reducing the BP of Indian patients aged 30–79 years with hypertension.

Objectives

To compare the efficacy of three single-pill combinations of antihypertensive agents on 24-hour ambulatory systolic blood pressure among hypertensive patients across multiple sites in India. The combinations studied were amlodipine plus perindopril, perindopril plus indapamide, and amlodipine plus indapamide. Safety and efficacy were assessed at 2, 4, and 6 months of follow-up.

Project Status and Outcomes

The study was initiated on 29 August 2024. A total of 86 participants were randomized, and 83 completed follow-up, achieving a retention rate of 97 percent. The study was successfully completed with site closeout on 8 August 2024, and the completion report has been submitted. 

Results

The primary outcome was the mean change in 24-hour ambulatory SBP at 6 months. Of the 1,981 participants (42% females) enrolled in the trial, 1,637 completed a 24-hour ambulatory BP measurement. All three drug combinations produced similar large reductions in the primary outcome, namely ambulatory (~14/8 mmHg) and office (~30/14 mmHg) BPs after 6 months, such that hypertension control rates (sitting BP < 140/90 mmHg) were achieved in approximately 70% of participants in all three groups.

Conclusion

In Indian patients, amlodipine–perindopril, perindopril–indapamide and amlodipine–indapamide were all equally well tolerated and equally highly effective in reducing 24-hour ambulatory and office BPs.

Investigators

Dr. D. Shailendra, MBBS, MD

Dr. Tilak Ram, MBBS, MD

Funding sources

Imperial College London and CCDC, New Delhi.

Thank You for Your Support

Your support helped advance research on hypertension prevalence and management in India, contributing to evidence-based guidelines and improved cardiovascular care.