LONDON: According to findings from a phase II trial conducted by a researcher from Queen Mary University of London and associates at CinCor Pharma, USA, a new medication called Baxdrostat has been demonstrated to significantly lower high blood pressure (hypertension) in patients who may not respond to current treatments for the condition.
The trial results mark the first time this long-needed new class of medications to treat resistant hypertension has been effectively created and evaluated.
They were published in the New England Journal of Medicine and presented at the American Heart Association Scientific Sessions meeting.
Over the course of the 12-week experiment, 248 patients were given either a placebo or a once-daily dose of Baxdrostat in varied dosages. Despite taking three or more medications to treat high blood pressure at the time of trial entrance, none of these participants' blood pressure was under control.
Baxdrostat was administered in addition to the patient's regular medications in doses ranging from 2 mg to 1 mg to 0.5 mg. The group that received the most Baxdrostat at the conclusion of the 12-week period experienced a 20-point decrease in blood pressure.
A rarely observed difference in any single blood pressure-lowering medication was an 11-point difference between this group and the placebo-treated group.
The mechanism of action of Baxdrostat is to stop the body from producing aldosterone, a hormone that controls the body's salt levels. Aldosterone levels in the blood and urine were reduced with Baxdrostat.
According to the study, this type of hypertension is partially brought on by an excess production of the hormone aldosterone and results in a significant drop in blood pressure in patients whose hypertension is resistant to conventional treatment.
The challenge in creating such a medication has been tying the enzyme that produces aldosterone to another enzyme that also produces cortisol, a vital steroid hormone.
Professor Morris Brown, the co-senior author of the study and Professor of Endocrine Hypertension at the Queen Mary University of London, said: "The results of this first-of-its-kind drug are exciting, although more testing is required before we can draw comparisons with any existing medications. But Baxdrostat could potentially offer hope to many people who do not respond to traditional hypertension treatment.
"The effectiveness of older drugs in individual patients can vary substantially, whereas a hallmark of this new class is that it can be predicted to work well in the patients whose aldosterone hormone has made them resistant to older treatments."
The primary risk factor for strokes, heart attacks, and kidney failure is high blood pressure. The majority of those who have the illness require lifelong pharmacological treatment because the aetiology is unclear. A third of adults in the UK have high blood pressure, making it one of the most prevalent disorders among adults.
In recent years, it has been evident that in 5-10 per cent of those who have it, there is a gene mutation in the adrenal glands that causes the overproduction of the steroid hormone aldosterone. In the UK, this might affect more than 500,000 people.
Aldosterone makes the body retain salt, which raises blood pressure. Patients with elevated blood levels of aldosterone are resistant to therapy with the most widely prescribed medications for hypertension.
Professor Brown has directly worked on the medication for more than ten years and provided advice on both the Baxdrostat trial conducted in the US and the medication's earlier development.
He collaborated closely with the pharmaceutical companies that created the medicine as well as the start-ups that obtained the licence.