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<p>Evidence is lacking for guiding optimal combination hypertension therapy in South Asian patients. Here we investigated the blood pressure (BP)-lowering efficacy and safety of three commonly recommended antihypertensive dual combinations in a multicenter, single-blinded trial conducted in India. We randomized Indians aged 30–79 years (mean age, 52 years) with mean sitting systolic blood pressure (SBP) of 150–179 mmHg on no treatment or an SBP of 140–159 mmHg on monotherapy 1:1:1 to a single-pill combination of amlodipine–perindopril, perindopril–indapamide or amlodipine–indapamide. 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 &lt; 140/90 mmHg) were achieved in approximately 70% of participants in all three groups. Furthermore, no significant differences in secondary outcomes, such as mean day and night ambulatory and office BPs and hypertension control rates, were observed among the study groups. Thus, 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 (ClinicalTrials.gov registration: <a href="https://clinicaltrials.gov/study/NCT05683301">NCT05683301</a>).</p>

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Comparison of dual therapies for hypertension treatment in India: a randomized clinical trial

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  • 发表日期：

    2025年7月25日

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  • Dorairaj Prabhakaran,
  • Ambuj Roy,
  • Ambalam M. Chandrasekaran,
  • Dimple Kondal,
  • Somnath Mukherjee,
  • Gaia Kiru,
  • Kavita Singh,
  • Hyndavi Salwa,
  • Edmin Christa Sobitharaj,
  • Ameeka Shereen Lobo,
  • Gayatri Mahajan,
  • Bishav Mohan,
  • Aman Khanna,
  • Amit Malviya,
  • Satish G. Patil,
  • Vinod K. Abichandani,
  • Bhupinder Singh,
  • Bal Kishan Gupta,
  • Balsubramaiam Yellapantula,
  • Shailendra Dandge,
  • Shantanu Sengupta,
  • Sunil Kumar,
  • Neil Bardoloi,
  • Nagendra Boopathy Senguttuvan,
  • Rakesh Kumar Sahay,
  • Suvarna Patil,
  • Surender Deora,
  • Rajpurohit Prahalad,
  • Vijaya Parthasaradhi Sarvepalli,
  • Justin Paul Gnanaraj,
  • Mallika Khanna,
  • Animesh Mishra,
  • Kiran Aithal,
  • Vipul Chavda,
  • Victoria R. Cornelius,
  • Kyrshanglang G. Lynrah,
  • Gurpreet Singh Wander,
  • Gautam Singal,
  • Akash Batta,
  • Ankush Mittal,
  • Suraj Kumar,
  • Deepak Chaudhary,
  • Maninder Kansal,
  • B. K. Gupta,
  • Jigyasa Gupta,
  • Balsubramaniam Yellapantula,
  • Ankita Kapse,
  • D. Shailendra,
  • M. Sneha Manju,
  • M. Suchitra Uikey,
  • Aniket Wazade,
  • Prathibha Pereira,
  • K. M. Srinath,
  • K. C. Shashidhara,
  • Vinay Kumar,
  • Ajay Hanumamthu,
  • K. S. Poornima,
  • Dhanjit Nath,
  • Amitava Misra,
  • Mohini Singh,
  • S. Lekshmi,
  • Said Jabir,
  • Sachin Surnar,
  • Pranav Shamraj,
  • Jyoti L. Iyer,
  • Deepti Mathur,
  • M. B. Shalini,
  • S. V. Partha Saradhi,
  • Rajendran Velayudham,
  • Sudha Kulur Mukhyaprana,
  • Hariharan Chellapandy,
  • Vivek Jaganathan,
  • Ramadevi Kanakasabapathi,
  • E. Theranirajan,
  • Debomallya Bhuyan,
  • Barnali Bhuyan,
  • Shoubhik Bhattacharjee,
  • Sindhuja Kunapareddy,
  • Ambuj Roy,
  • Sandeep Singh,
  • Sayavir Yadav,
  • Kamar Ali,
  • P. B. Jayagopal,
  • Vinit Kr Shah,
  • L. Sreenivasa Murthy,
  • G. Pramod Bagali,
  • P. V. Raghav Sarma,
  • Chinta Srinivasarao,
  • Sharan Badiger,
  • Avinash V. Jugati,
  • Saptarshi Bhattacharya,
  • O. R. Kumaran,
  • Anitha Kolukula,
  • Harika Menti,
  • H. C. Kalita,
  • Hemant Thacker,
  • Abhishek Subhas,
  • Sudhir Varma,
  • Harpreet Kalra,
  • Sanchit Sood,
  • Navjot Kaur,
  • Prabh Simranpal,
  • Taniya Aggarwal,
  • Jabir Abdullakutty,
  • Prashant Kr Sahoo,
  • Sharmila Moharana,
  • Yusuf A. Kumble,
  • P. N. Sandhya Rani,
  • Neil R. Poulter

摘要

Evidence is lacking for guiding optimal combination hypertension therapy in South Asian patients. Here we investigated the blood pressure (BP)-lowering efficacy and safety of three commonly recommended antihypertensive dual combinations in a multicenter, single-blinded trial conducted in India. We randomized Indians aged 30–79 years (mean age, 52 years) with mean sitting systolic blood pressure (SBP) of 150–179 mmHg on no treatment or an SBP of 140–159 mmHg on monotherapy 1:1:1 to a single-pill combination of amlodipine–perindopril, perindopril–indapamide or amlodipine–indapamide. 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. Furthermore, no significant differences in secondary outcomes, such as mean day and night ambulatory and office BPs and hypertension control rates, were observed among the study groups. Thus, 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 (ClinicalTrials.gov registration: NCT05683301).