News
3-in-1 low-dose pill to battle high blood pressure
View(s):- Sri Lankan researchers contribute to global effort to improve blood pressure control;
GMRx2 submitted for USFDA approval
By Kumudini Hettiarachchi and Arrenga Nadaraja
With the primary objective of the study being to make an effective and inexpensive medicine available for the treatment of high BP, this single pill ‘GMRx2’ and related information have been submitted to the Food and Drug Administration (FDA) of the United States of America (USA) to obtain market authorization for the single pill triple combination drug.
GMRx2 combines the three blood pressure lowering drugs telmisartan, amlodipine and indapamide.
The data have also been submitted to the World Health Organization (WHO) to be considered for inclusion of this pill in its Model Essential Medicines List.
Almost half the 1,385 participants(nearly 50%) in this important global study conducted from July 9, 2021 to September 1, 2023 at the height of the COVID-19 pandemic, had been drawn from major hospitals across Sri Lanka. The other countries in the study were Austria, the Czech Republic, New Zealand, Poland, the United Kingdom and the US.
This multi-centre international clinical trial had been led by the Clinical Trials Unit (CTU) at the University of Kelaniya, Sri Lanka, in collaboration with The George Institute for Global Health, Imperial College London and other centres of excellence.
The Sri Lankan hospitals where the study was conducted were the National Hospital of Sri Lanka (NHSL) with the investigators Dr. Mervin Fernando, Dr. Gamini Galappatthi, Prof. Senaka Rajapakse, Prof. Godwin Constantine, Dr. Gotabhaya Ranasinghe & Dr. M.B.F. Rahuman; the Kandy National Hospital with Dr. Gnanamoorthy Mayurathan; the Sri Jayewardenepura General Hospital with Dr. Naomali Amarasena; the Colombo North Teaching Hospital, Ragama, with Prof. Arjuna De Silva; the Colombo South Teaching Hospital, Kalubowila, with Dr. Taniya Pereira; the Negombo District General Hospital with Dr. Sandamali Premarathna; the Kurunegala Teaching Hospital with Dr. Lalith Rasnayaka; the Jaffna Teaching Hospital with Dr. Poopalan Lakshman; and the Karapitiya Teaching Hospital with Dr. Wimalasiri Hewa Uluwattage.
Explaining what the study was all about, a member of the international Trial Steering Committee, Prof. Asita de Silva of the Kelaniya University’s Faculty of Medicine, told the Sunday Times that it had demonstrated that a “novel low-dose combination of three blood pressure lowering drugs in a single pill”is superior to the current standard of treatment to control BP.
The trial which involved numerous cardiologists and physicians serving as investigators in Sri Lanka and the other countries, offers promising new insights into improving the control of blood pressure, he said.
Why the focus on hypertension? It is the leading cause of premature death globally and a major contributor of morbidity (illness) and mortality (death) from cardiovascular disease in South Asia, accounting for a third of age-standardized deaths.
Prof. de Silva pointed out that with over 1.3 billion people worldwide estimated to have high BP and just over one-third on any form of treatment, it has been estimated that around 20% of all deaths are attributable to poor control of BP.
“The problem is far more serious in low- and middle-income countries (LMICs). In Sri Lanka, where around 1 in 3 to 4 people is estimated to have high BP, only about 15% manage to reach optimal BP targets, despite being on treatment,” he said, stressing that improving blood pressure control is a priority for health-care systems all over the world.
According to Prof. de Silva with control rates being “very poor” at present, these patients are at very high risk for heart disease, stroke and premature death. “Our study has unequivocally shown that a combination of three widely available and relatively inexpensive drugs given in low doses in a single pill, GMRx2, is superior to current approaches of treating high BP.
The study which included a diverse group of patients had shown that the pill not only worked better at controlling BP, but also did it more rapidly. It had also, importantly, shown the tolerability of the new treatment to be “good” with no increase in withdrawals due to adverse effects.
Prof. de Silva added: “These findings confirmed the benefits of using lower doses of multiple drugs to improve treatment outcomes while minimizing side-effects.”
Sri Lanka’s Coordinating Principal Investigator, Dr. Gotabhaya Ranasinghe who is a Past-President of the Sri Lanka College of Cardiology, said that these findings have public health implications for all countries, not just for Sri Lanka.
“The importance of improving BP control cannot be over-emphasized as it is an important risk factor to control the growing burden of heart disease that has reached epidemic proportions in the world. The problem is greatest in LMICs. In Sri Lanka, we are seeing a lot of heart disease, stroke and chronic kidney disease in younger age groups,” he said.
He added that the cost to the national economy is enormous. “That is why we believe national and global treatment guidelines must now change to be in line with what this important clinical trial has clearly shown.’’
The GMRx2 study was built on the foundation laid by the TRIUMPH clinical trial conducted in Sri Lanka six years ago and published in the Journal of the American Medical Association in 2018. TRIUMPH, also conducted by the same team at the Kelaniya University, demonstrated for the first time that a low-dose triple drug single pill combination was more effective in controlling blood pressure than standard treatment without difference in side-effects.
| Laurels from Lancet for study The prestigious medical journal, ‘The Lancet’ has published the GMRx2 study results last week on October 19, in a piece titled ‘Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial’. The results had also been presented at the European Society of Cardiology (ESC) Congress in August 2024. The results showed that more than 80% of patients reached optimum target blood pressures within one month and the benefit continued throughout the entire duration of the trial. “These outcomes challenge existing treatment protocols and guidelines that typically rely on mono-therapy resulting in much lower BP control rates of less than 50% even in high-income countries,” said Prof. Asita de Silva. Another unique feature of the GMRx2 study, he said, was taking both home and clinic blood pressure measurements in all patients. Home blood pressure monitoring provided insight into day-to-day blood pressure fluctuations, while clinic measurements offered standardized data for comparison. This dual approach was important in assessing the therapy’s effectiveness across different environments. Acknowledging these challenges including patient compliance and follow-up particularly in the midst of the COVID 19 pandemic, the Editors of the Lancet have commented in an editorial: “……it seems remarkable that the research team accomplished and coordinated a multinational, multicentre study.” Emphasizing the public health significance of the study findings, the editorial states that patients with CVD (cardiovascular disease) are on numerous drugs such as aspirin, statins, anti-hypertensives and very frequently anti-diabetics. “The GMRx2 study offers a new approach to effectively overcoming long-standing challenges in managing high blood pressure as well as providing three BP lowering drugs in a single pill thereby increasing patient compliance to treatment,” it adds. “Meanwhile, the European Society of Cardiology has recently revised its high BP treatment guidelines. The updated recommendations now advocate for the early use of combination therapies like GMRx2 as a preferred approach to improve blood pressure control,” said Prof. de Silva. | |
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