Treatment with GMRx2, a single pill combination of three low-dose blood pressure medicines, significantly reduced the risk of another stroke in patients with intracerebral haemorrhage and high blood pressure. Results from the TRIDENT randomised controlled trial, led by The George Institute for Global Health, were published today in The New England Journal of Medicine.1
Professor Craig Anderson, Principal Investigator and Senior Professorial Fellow at The George Institute said, "Lowering blood pressure is the only proven method to prevent another stroke, yet achieving good blood pressure control is a real challenge. One big issue is that the number and doses of antihypertensive medications are not increased when needed and doctors and patients struggle with complex pill regimens."
"Our study showed that GMRx2, a once-daily triple combination pill, cut the risk of another stroke by 39%. These findings could translate to important treatment benefits for the millions of people affected by intracerebral haemorrhage worldwide who face a high risk of having another one."
The international study involved 1,670 patients who had experienced intracerebral haemorrhage - a type of stroke characterised by bleeding in the brain - and had systolic blood pressure (SBP) of 130-160mmHg. They received GMRx2, a single pill combination containing telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg, or a placebo, alongside standard care.
During an average period of follow-up of 3 years, stroke occurred in 4.6% of patients receiving GMRx2 compared to 7.4% in the placebo group. This equated to a 39% lower risk of recurrent stroke. Overall, the results showed one stroke was prevented for every 35 patients treated with GMRx2.
The GMRx2 group achieved better blood pressure control, with mean SBP levels 9mmHg lower than the placebo group. Patients treated with GMRx2 also experienced reduced rates of major cardiovascular events (non-fatal stroke, non-fatal heart attack and cardiovascular death) - by 33% versus placebo. Serious adverse events were comparable between the treatment and placebo groups, affecting 23.8% and 26.8% of patients, respectively. Concerns of fatigue, dizziness and falls were infrequent and occurred similarly between the GMRx2 and placebo groups.
Almost 17 million people worldwide have experienced intracerebral haemorrhage, and there are over 3 million new cases each year.2 Among patients who survive this type of stroke, approximately one quarter will later die from recurrent stroke or cardiovascular disease. 3 The condition disproportionately affects people in low- and middle-income countries (LMICs), where there is often poorer control of high blood pressure.4 Intracerebral haemorrhage is one of the most dangerous types of strokes, occurring at almost twice the rate in LMICs compared to high income countries.4
Professor Jeyaraj Pandian, President of the World Stroke Organization, said, "TRIDENT is a major advance in showing the enormous benefits of effective blood pressure control after an intracerebral haemorrhage, and a simple and effective strategy in which this can be achieved, with relevance to patients all over the world."
Professor Anderson added "These study results have the potential to mark a real shift in how we manage blood pressure following a stroke. This single-pill triple combination helped patients reach target blood pressure levels."
"We hope GMRx2 is approved for this indication by regulatory authorities throughout the world, and if so that it is widely used as an effective approach with the potential to improve the outcome for patients affected by intracerebral haemorrhage, and also ischaemic stroke, across the globe."
