- A new study points to the effectiveness of a new medication for treatment-resistant high blood pressure (hypertension).
- Researchers found that the new medication Baxdrostat has low side effects and is more effective than previous treatments.
- Experts say that the path for the new drug is cause for optimism.
In a new study published this week in The New England Journal of Medicine, researchers studied if a new medication could help people with high blood pressure (hypertension).
In the phase II trial, the drug called baxdrostat reduced hypertension in patients whose condition was not fixed by other forms of treatment.
The drug is designed to block the production of aldosterone – a key hormonal contributor to hypertension – by blocking the enzyme that creates it.
The research was funded by CinCor Pharma which makes Baxdrostat.
The systolic measurement is the amount of pressure the blood puts against artery walls as your heart beats.
Diastolic is how much pressure the blood puts on artery walls in between each heartbeat.
A healthy blood pressure reading is defined as anything lower than 120/80 or 120 mm Hg systolic/ 80 mm Hg diastolic.
High blood pressure starts at 130 or higher mm Hg systolic and over 80mm Hg diastolic. High blood pressure can put you at risk for a host of including stroke, heart attack or vision loss,
The trial involved 248 patients who finished the treatment. The process was placebo-controlled and had participants from multiple places.
The study participants took the medication for 12 weeks and were given 2mg, 1mg, 0.5-mg or a placebo.
The researchers found the effects were dose-dependent, meaning that those who received a higher dose, on average, saw a higher drop in systolic blood pressure.
They found the highest drop in blood pressure was in people taking 2mg of the drug. They had a drop of 20.3 mm Hg in their systolic blood pressure readings
This was compared to a drop of 7.5 mm Hg, 12.1 mm Hg, and 9.4 mm Hg in systolic blood pressure readings for the groups taking 1mg, 0.5-mg of the drug, and the placebo group respectively.
The study was stopped after 12 weeks because those overseeing it found that it had reached the required level of effectiveness at that 3-month mark.
Other findings include:
- Only two patients saw any adverse reactions that the researchers connected to the drug. Both saw an increased level of potassium that did not return when treatment was stopped and restarted.
- Baxdrostat, unlike other treatment options, did not increase cortisol levels. An increase in cortisol can have additional adverse effects and is connected to other reactions like a change in inflammation levels
Experts who spoke to Healthline for this story are hopeful about the possible effects of the drug. The medication still has multiple rounds of further tests before it can be considered for approval by the U.S. Food and Drug Administration.
Patients with treatment-resistant hypertension, which the study says affects up to 12 million Americans, have often already seen drugs like beta blockers and diuretics fail to resolve their high blood pressure.
Experts say that one of the main benefits of these results is that it allows for a treatment that is more selective and appears to not come with as many side effects.
“From a clinical practice standpoint, the challenge of when you get to fourth and fifth-line drug agents is: number one, the bang for the buck is often fairly low; but number two, you’re often dealing with drugs with a fairly pronounced side effect profile,” Dr. Sameer Mehta, an interventional cardiologist and president of Denver Heart, told Healthline.
He points to drugs like Spironolactone and an older drug named Clonidine as examples of long-standing medications that can cause a wide range of side effects.
Mehta calls the level of blood pressure reduction in the study “dramatic” even as other courses of treatment, like Europe’s development of renal denervation, begin to be approved for study in the U.S.
Dr. Aseem Desai, a cardiac electrophysiologist affiliated with Providence Mission Hospital, said that the study is a good reminder that not all patients with hypertension will see results even when following their care plan.
“A lot of times, we attribute treatment-resistant hypertension to noncompliance, that a patient is not consistently taking the drugs prescribed, or they have not lost the target weight that we think will be helpful in controlling their blood pressure, or we have not gotten them to reduce their sodium intake in their diet. And while that may be true, in many cases, there is a small subset of patients that have truly treatment-resistant hypertension. They’re doing everything they possibly can, and their numbers are still running high,” Desai said.
He pointed to the study’s focus on the hormonal system, which aldosterone is part of, as a key differentiator.
“The study highlights that what seems as small as a single hormone can have a profound effect on people who have uncontrolled hypertension,” Desai added.
Dr. Camilo Ruiz, a concierge physician, and internist who now works primarily with sleep disorders, said that hypertension concerns lead him and his colleagues to look at other underlying issues that may lead to this resistance.
“As an internist, I may start considering, ‘Well, does this patient have an underlying thyroid disorder? Does this patient have an underlying snoring and sleep apnea component? Does this patient have an underlying adrenal tumor that may be causing increased hormone secretion of aldosterone?’ This is how these patients present,” Ruiz said.
Of the three experts who spoke to Healthline, none shared deep concerns about the funding source for this research. The main takeaway was that while it would be preferable to see independently-funded research, the financial landscape of American medication development simply makes that a very difficult goal to achieve.
“I think it’s the unfortunate reality of today’s healthcare, is that there’s limited dollars,” Desai said.