News
Low dose triple pill cuts risk of recurrent stroke by 40%
View(s):- Evidence from global TRIDENT trial with Lanka playing a major role
By Kumudini Hettiarachchi
Heartening news for stroke survivors – irrevocable facts with powerful scientific proof are now on the table.
A low-dose 3-in-1 pill, GMRx2, to keep the silent killer that is hypertension (high blood pressure) under control has been found to cut the risk of a repeat haemorrhagic stroke (brain bleed) by up to 40% in a global clinical trial, with tiny Sri Lanka playing a major role.
Other findings of the trial were that the pill reduced the risk of another brain bleed by 60% among high-risk patients and reduced the rates of major cardiovascular events. These events include non-fatal stroke, non-fatal heart attacks and cardiovascular death.
Prof. Asita de Silva
This pill combining three widely-used pressure medicines had been prescribed to the trial participants along with standard care. It consisted of 20mg telmisartan; 2.5mg amlodipine; and 1.25mg indapamide, but is also available in different strengths, it is learnt.
The significant findings of this global trial named ‘TRIDENT’ have been published in the prestigious New England Journal of Medicine (NEJM) along with an Editorial on April 23, 2026.
This multi-national, double-blind, randomized, placebo controlled trial over nearly seven years studied 1,670 stroke survivors (with a mean age of 58 years). Nearly 73% of the participants were Asian including almost 70% of patients from Sri Lanka. The study led by the George Institute for Global Health based in Australia, had been conducted in 12 countries.
Sri Lanka had contributed more than 70% of the high quality data for this important trial, the Sunday Times learns with 1,105 participants from here, the largest number from a single participating country.
It had been coordinated in Sri Lanka by Senior Professor Asita de Silva of the Faculty of Medicine, University of Kelaniya, who heads the university’sClinical Trials Unit.
The 11 centres which took part in the trial across the country were: the National Hospitals of Colombo (NHSL), Kandy & Galle; the Teaching Hospitals of Colombo North (Ragama) – 2 sites, Colombo South (Kalubowila), Kurunegala, Peradeniya & Jaffna; the Sri Jayewardenepura General Hospital; and the District General Hospital, Gampaha. The Principal Investigators were Consultant Neurologists.
The other countries which took part in the trial were Australia; Brazil; Georgia; Malaysia; the Netherlands; Nigeria; Singapore; Switzerland; Taiwan; United Kingdom; and Vietnam.
With the TRIDENT findings particularly relevant to Sri Lanka and South Asia, Prof. Asita de Silva says that the triple pill is a game changer with clear evidence of sustained and long-term control of blood pressure. This approach can reduce the risk of recurrent stroke dramatically.
“Clinical trials conducted by us with Sri Lankan specialists and international collaborators during the last 10 years have shown that the triple low-dose combination of blood pressure lowering drugs in a single pill is a very strong approach to control blood pressure, compared to routine approaches in clinical practice today,” he says.
Dr. Bimsara Senanayake
GMRx2 has been approved by the US Food and Drug Administration (June 9, 2025) and is included in the Model List of Essential Medicines (2025) of the World Health Organization (WHO).
He added that the strong Sri Lankan contribution to the trial also demonstrated the country’s growing role in global medical research. The Kelaniya University is now a member of the WHO’s Global Clinical Trials Forum (GCTF).
The NHSL’s Lead Investigator and Consultant Neurologist Dr. Bimsara Senanayakesaid the TRIDENT findings provide important evidence for improving treatment after an intracerebral haemorrhage. With very limited treatment options, uncertainty about the effectiveness of more-intensive blood pressure control and how best to do it have remained unresolved for decades, the TRIDENT trial now gives all of that information for us to implement in our clinical practice.
“The findings are especially significant because patients who survive this type of brain bleed face a heightened risk of another catastrophic event in the years that follow. The better blood pressure control we can achieve in intracerebral haemorrhage, the better for the patients,” he said. The President of the Association of Sri Lankan Neurologists and study author, Dr. Ajantha Keshavaraj said: “Our results have the potential to mark a real shift in how we manage blood pressure following a stroke. This novel treatment, along with lifestyle changes such as reduced salt intake, could save thousands of lives by preventing repeat strokes.”
Titled ‘Three Low-Dose Antihypertensive Agents in a Single Pill after Intracerebral Hemorrhage’, the NEJM article states that among patients with intracerebral haemorrhage (a brain bleed caused by a ischaemic haemorrhagic stroke), treatment with a combination of three low-dose antihypertensive agents in a single pill, in addition to standard care, was associated with a lower incidence of recurrent stroke and major cardiovascular events than placebo.
Dr. Ajantha Keshavaraj
The 200-year-old NEJM, recognized as a leading medical journal and website, is based in Waltham, Massachusetts, United States of America (USA).
The trial had been conducted with patients with a history of intracerebral haemorrhage. After a 2-week active run-in phase during which all the patients received a once-daily pill containing the three antihypertensive agents at low doses (telmisartan, amlodipine and indapamide), the patients had been randomly assigned to continue receiving the triple pill (833 participants) or a matching placebo (837 participants).
The primary outcome was the first recurrent stroke. Secondary outcomes included blood-pressure control, major cardiovascular events, death from cardiovascular causes and safety. (See box for results)
The NEJM’s editorial on the same subject had been titled ‘Blood-Pressure Control after Intracerebral Hemorrhage — An Unbroken Glass Ceiling’.
On October 27, 2024, the Sunday Times in an article headlined ‘3-in-1 low-dose pill to battle high blood pressure’ exclusively reported that Sri Lankan researchers had contributed to a global effort to improve blood pressure control. The triple pill was GMRx2.
| TRIDENT results The TRIDENT trial on the low-dose 3-in-1 pill had found: At a follow-up of 2.5 years, recurrent stroke had occurred in 38 patients (4.6%) in the triple-pill group and 62 (7.4%) in the placebo group. The incidence of major cardiovascular events was lower with the triple pill than with the placebo (6.6% vs. 9.8%) Serious adverse events occurred in 23.2% of the patients in the triple-pill group and 26.0% of those in the placebo group. What is a multi-national, double-blind, randomized, placebo-controlled study? Considered the ‘gold standard’ in clinical research, this is a study used when testing new drugs or treatments, to bring about reliable, unbiased evidence whether a treatment works and most importantly whether it is safe. Multi-national – thestudy is conducted across multiple countriessimultaneously to ensure participant diversity. Randomized – the participants are assigned to different groups – treatment group or placebo group – by chance, not by choice. It ensures that the groups are similar, balancing out factors like age, sex and health status and that any differences in results are due to the treatment rather than group differences. Double-blind – neither the participants nor the researchers (doctors/investigators) know who is receiving the active treatment and who is receiving the placebo. Placebo-controlled – one group of participants receives the new treatment, while another group receives an inactive substance (a placebo or “sugar pill”). This acts as a comparison point to determine if the active drug has a real effect beyond the psychological impact of being treated.
| |
The best way to say that you found the home of your dreams is by finding it on Hitad.lk. We have listings for apartments for sale or rent in Sri Lanka, no matter what locale you're looking for! Whether you live in Colombo, Galle, Kandy, Matara, Jaffna and more - we've got them all!