Doctors are hailing a new pill for patients with high blood pressure resistant to existing medication as a “gamechanger” and a “triumph of science”.
Globally, more than 1.3 billion people have hypertension. In half of them, their high blood pressure is uncontrolled or resistant to existing treatments. They face a much higher risk of heart attack, stroke, kidney disease and early death.
Now a blockbuster new drug – baxdrostat – has been shown in trials to significantly lower blood pressure in those people whose levels remain dangerously high despite taking several medicines.
The results of the BaxHTN study, which involved 796 patients from 214 clinics worldwide, showed that after 12 weeks, patients taking baxdrostat saw their blood pressure fall by about 9-10 mmHg (millimetres of mercury, the unit of measurement of blood pressure) more than placebo – a reduction large enough to cut cardiovascular risk.
About four in 10 patients taking the drug – 1mg (39.4%) or 2mg (40%) once daily in tablet form – reached healthy blood pressure levels, compared with fewer than two in 10 (18.7%) on placebo.
Details of the breakthrough against stubbornly high blood pressure were revealed at the European Society of Cardiology congress in Madrid, the world’s largest heart conference. Results from the trial, which was sponsored by AstraZeneca, were simultaneously published in the New England Journal of Medicine.
Principal investigator Prof Bryan Williams, chair of medicine at UCL, said: “I’ve never seen blood pressure reductions of this magnitude with a drug. Achieving a nearly 10 mmHg reduction in systolic blood pressure with baxdrostat in the BaxHTN phase-3 trial is exciting, as this level of reduction is linked to substantially lower risk of heart attack, stroke, heart failure and kidney disease.
“I think this could be a gamechanger in the way we approach difficult to control or hard to control blood pressure. The results suggest that this drug could help up to half a billion people globally.”
The breakthrough has taken decades of research to achieve.
Blood pressure is strongly influenced by a hormone called aldosterone, which helps the kidneys regulate salt and water balance. Some people produce too much aldosterone, causing the body to hold on to salt and water. This aldosterone dysregulation pushes blood pressure up and makes it very difficult to control.
Tackling aldosterone dysregulation has been a key target of research over many years, but until now it has been impossible to achieve. Baxdrostat works by blocking aldosterone production, directly addressing this driver of high blood pressure.
“This drug development is really a triumph of scientific discovery,” Williams told reporters at the conference in Madrid.
“Aldosterone is a well-known driver of hypertension, but for decades, scientists have struggled to block its production in a precise way. Baxdrostat is one of the first therapies to do so selectively, showing meaningful BP [blood pressure] reductions in uncontrolled or resistant hypertension.”
Historically, wealthier western countries were reported to have greatly increased levels of high blood pressure. However, largely due to changing diets, the numbers of people living with hypertension is now far higher in eastern and lower-income countries. More than half of those affected live in Asia, including 226 million people in China and 199 million in India.
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Prof Paul Leeson, a cardiologist and a professor of cardiovascular medicine at the University of Oxford, who was not involved with the trial, said the pill could become a “valuable additional treatment” to tackle high blood pressure.
“For many years, we have had medications that are able to block aldosterone working but they do not actually lower levels of aldosterone, so patients may still experience adverse effects of the substance.
“Baxdrostat … is one version of a new range of medications that work differently, and directly reduce the levels of aldosterone.
“Importantly, the trial was performed across several countries and included men and women, as well as patients with different ethnic backgrounds. This helps ensure the findings are relevant to the range of patients we see with blood pressure problems.”
Separately, doctors in Madrid were told that a cholesterol-busting jab administered twice a year has the potential to transform heart care.
New trial data presented at the conference suggested Leqvio, also known as inclisiran and made by Novartis, helped patients meet their cholesterol goals faster than other therapies. Patients also experienced less muscle pain, a common side-effect of statins, the cholesterol-lowering medication.
