Kiru Gaia, Roy Ambuj, Kondal Dimple, Chandrasekaran Ambalam M, Mukherjee Somnath, Mohan Bishav, Singh Kavita, Salwa Hyndavi, Christa Edmin, Lobo Ameeka Shereen, Mahajan Gayatri, Khanna Aman, Malviya Amit, Patil Satish G, Abichandani Vinod K, Singh Bhupinder, Gupta Bal Kishan, Yellapantula Balsubramaiam, Shailendra Dandge, Sengupta Shantanu, Kumar Sunil, Bardoloi Neil, Khanna Mallika, Mishra Animesh, Aithal Kiran, Chavda Vipul, Cornelius Victoria R, Prabhakaran Dorairaj, Poulter Neil
Imperial Clinical Trials Unit, Imperial College London, 1st Floor, Stadium House, 68 Wood Lane, London, W12 7RH, UK, United Kingdom.
Department of Cardiology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.
Int J Cardiol Cardiovasc Risk Prev. 2024 Oct 24;23:200346. doi: 10.1016/j.ijcrp.2024.200346. eCollection 2024 Dec.
The burden of over 300 million individuals living with hypertension in India is increasing steadily. Most current guidelines recommend initial combination therapy for effective blood pressure (BP) control. However, there is no randomised evidence to inform which combinations to use in the South Asian population, who account for over one-quarter of the world's population.
This multi-centre, single-blind, randomised, three-arm trial recruited men and women aged 30-79 years with hypertension. The trial compares the efficacy of commonly recommended single pill combinations (SPCs) of three drug classes - calcium channel blocker (amlodipine), ACE inhibitor (perindopril), and a thiazide-like diuretic (indapamide). The primary objective is to determine the most effective two-drug combination, initially at starting doses with forced up-titration at 2 months, in reducing 24-h ambulatory systolic blood pressure (ASBP) at 6 months. The trial has 85 % power to detect a difference of 3 mmHg in 24-h ASBP amongst the groups.Participant recruitment took place from August 2022 to February 2024.
The 1981 participants (42.0 % women) enrolled had a mean age of 52.1 (SD 11.3) years and a mean body mass index of 26.5 (SD 4.2) kg/m2. 58.1 % of participants had a previous diagnosis of hypertension and 18.6 % of participants were known to diabetes. The mean ASBP was 135.6 (SD 17.0) mmHg, and the mean ambulatory diastolic BP was 84.5 (SD 10.9) mmHg.
The TOPSPIN trial is the first randomised evaluation of commonly used BP-lowering combination therapies in a South Asian population. The results have potentially significant implications for choosing first-line antihypertensive agents among Indians and the South Asian diaspora.
印度有超过3亿高血压患者，其负担正在稳步增加。目前大多数指南推荐采用初始联合治疗以有效控制血压（BP）。然而，对于占世界人口四分之一以上的南亚人群，尚无随机对照证据来指导应使用哪种联合治疗方案。
这项多中心、单盲、随机、三臂试验招募了年龄在30 - 79岁的高血压男性和女性。该试验比较了三种药物类别（钙通道阻滞剂（氨氯地平）、ACE抑制剂（培哚普利）和噻嗪类利尿剂（吲达帕胺））常用的单片复方制剂（SPCs）的疗效。主要目的是确定最有效的两药联合方案，最初采用起始剂量，并在2个月时强制上调剂量，以在6个月时降低24小时动态收缩压（ASBP）。该试验有85%的把握度检测出各组之间24小时ASBP有3 mmHg的差异。参与者招募时间为2022年8月至2024年2月。
纳入的1981名参与者（42.0%为女性）平均年龄为52.1（标准差11.3）岁，平均体重指数为26.5（标准差4.2）kg/m²。58.1%的参与者既往有高血压诊断，18.6%的参与者已知患有糖尿病。平均ASBP为135.6（标准差17.0）mmHg，平均动态舒张压为84.5（标准差10.9）mmHg。
TOPSPIN试验是对南亚人群常用降压联合治疗方案的首次随机评估。其结果对于印度人和南亚侨民选择一线抗高血压药物可能具有重大意义。
