- A new study points to the efficacy of a new drug for treatment-resistant high blood pressure (hypertension).
- The researchers found that the new drug Baxdrostat has few side effects and is more effective than previous treatments.
- Experts say the path for the new drug is cause for optimism.
In a new study published this week in The New England Journal of MedicineResearchers studied whether a new drug could help people with high blood pressure (hypertension).
In the phase II trial, the drug called baxdrostat reduced high blood pressure in patients whose condition did not resolve with 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 that the blood exerts against the walls of the arteries as the heart beats.
Diastolic is the pressure exerted by the blood on the walls of the arteries between each heartbeat.
A healthy blood pressure reading is defined as anything less than 120/80 or 120 mm Hg systolic/80 mm Hg diastolic.
High blood pressure starts at 130 or more mm Hg systolic and more than 80 mm Hg diastolic. High blood pressure can put you at risk for a number of strokes, heart attacks, or vision loss,
The trial involved 248 patients who completed treatment. The trial was placebo controlled and had participants from multiple locations.
Study participants took the drug for 12 weeks and received 2 mg, 1 mg, 0.5 mg, or a placebo.
The researchers found that the effects were dose-dependent, meaning that those who received a higher dose, on average, saw a greater drop in systolic blood pressure.
They found that the greatest drop in blood pressure was in people taking 2 mg of the drug. Had a 20.3 mm Hg drop 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 1 mg, 0.5 mg of the drug, and the placebo group, respectively.
The study was stopped after 12 weeks because those who supervised it found that it had reached the required level of effectiveness at that 3-month mark.
Other findings include:
- Only two patients saw adverse reactions that the researchers connected to the drug. Both saw an increase in potassium level 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 linked to other reactions, such as a change in inflammation levels.
Experts who spoke to Healthline for this story are hopeful about the possible effects of the drug. The drug still has multiple rounds of additional testing before it can be considered for approval by the US Food and Drug Administration.
Patients with treatment-resistant hypertension, which the study found affects up to 12 million Americans, have often already seen medications such as 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 have fewer side effects.
“From a clinical practice point of view, the challenge of coming up with fourth- and fifth-line pharmacological agents is: number one, the cost-effectiveness is usually quite low; but number two, these are often drugs with a fairly pronounced side effect profile,” Dr Sameer Mehtainterventional cardiologist and president of Denver Heart, to Healthline.
He points to drugs like spironolactone and an older drug called clonidine as examples of long-standing drugs 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, such as the European-developed renal denervation, begin to be approved for study in the US.
Dr Aseem Desaia cardiac electrophysiologist affiliated with Providence Mission Hospital, said the study is a good reminder that not all patients with hypertension will see results even when they follow their plan of care.
“Many times, we attribute refractory hypertension to noncompliance, where a patient is not consistently taking their prescribed medications, or hasn’t lost the target weight that we think will be helpful in controlling their blood pressure, or hasn’t We’ve done it. got them to reduce sodium intake in their diet. And while that may be true, in many cases, there is a small subset of patients who have truly resistant hypertension. They are doing their best and their numbers are still high,” Desai said.
He pointed to the study’s focus on the hormonal system, of which aldosterone is a part, 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 Ruiza GP and internist who now works primarily with sleep disorders, said concerns about high blood pressure lead him and his colleagues to look for other underlying issues that may lead to this resistance.
“As an internist, I can start to consider, ‘Well, does this patient have an underlying thyroid disorder? Does this patient have an underlying component of snoring and sleep apnea? Does this patient have an underlying adrenal tumor that may be causing increased aldosterone hormone secretion? This is how these patients present themselves,” 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 independently funded research would be preferable, the financial landscape of drug development in the United States simply makes that a very difficult goal to achieve.
“I think it’s the unfortunate reality of health care today, that there are limited dollars,” Desai said.