Blood pressure resistance: a new drug proven to be effective in phase II trials

Blood pressure resistance: a new drug proven to be effective in phase II trials

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Scientists are developing new drugs to treat resistant hypertension. Veejay Villafranca/Bloomberg via Getty Images
  • Uncontrolled high blood pressure – or high blood pressure – affects millions of people around the world, putting them at increased risk of developing serious health conditions.
  • Research into a new drug called Baxdrostat shows that it can significantly reduce blood pressure in people with treatment-resistant hypertension.
  • The results of the phase II trial support the idea that some cases of treatment-resistant hypertension may be caused by the hormone aldosterone.

Blood pressure is a simple measure of the pressure of blood on the walls of the arteries. It consists of two numbers – one of them represents systolic The pressure at heartbeats and the other for the diastolic pressure between heartbeats.

A healthy blood pressure is 120 mmHg systolic and 80 mmHg diastolic. Anything consistently above 130 mmHg and 80 mmHg is considered elevated or elevated blood pressure according to the 2017 American Clinical Practice Guidelines.

Not only does the increased pressure affect the blood vessels, but it also puts the heart, brain, kidneys, and eyes under greater pressure. In the long term, persistent high blood pressure is associated with an increased risk of life-threatening health conditions such as stroke and heart disease, two of the leading causes of infection. the death in the United States of America.

New research from Sencor Pharma, Brigham and Women’s Hospital, Harvard Medical School and Queen Mary University of London may offer hope for people with uncontrolled high blood pressure.

The study published in The New England Journal of MedicinePresented at the American Heart Association scientific conference, he demonstrated a new drug called Baxdrostat that could significantly reduce blood pressure for people for whom current treatments haven’t worked.

There are no warning signs or symptoms of high blood pressure, and the only way to know your blood pressure levels is to have them tested regularly. Risk factors associated with high blood pressure include “genetic, age-related, diet and lifestyle factors,” said Dr. Rigvid Tadwalkar, MD, a board-certified cardiologist at Providence Saint John’s Health Center in California.

The Centers for Disease Control and Prevention It is estimated that tens of millions of people in America suffer from high blood pressure. Of these an estimated 12% Treatment-resistant hypertension (tRH), equivalent to about 7.6 million people.

“Hypertension can be a challenging condition to treat,” said Professor Nilesh Samani, medical director at the British Heart Foundation. Medical news today.

On the other hand, resistant hypertension is classified as having high blood pressure that persists despite its use. This can significantly increase the risk of infection of the patient Cardiovascular disease and kidney failure.

Talking to MNT, Dr. Tadwalkar, who was not involved in the study, explained that tRH is common in clinics.

Approximately 10% of people with hypertension have resistant hypertension. As a result, it is frequently seen in the clinical setting, by cardiologists and primary care physicians alike.

Dr. Tadwalkar said evaluation and treatment of tRH is different from standard hypertension because it is considered ‘clinical’. […] to be in a separate category.

Its causes go beyond the usual risk factors associated with standard hypertension. When investigating tRH, clinicians consider “predisposing medical conditions, contributing medications, and secondary causes of hypertension.”

To understand whether the drug lowers blood pressure, the researchers conducted a phase 2 multicenter BrigHTN clinical trial.

Between July 2020 and June 2022, researchers gave a total of 248 people with a tRH with an average blood pressure of 130/80 mmHg, a daily dose of either 2 mg, 1 mg, or 0.5 mg of Baxdrostat or a placebo for 12 weeks.

Participants taking mineralocorticoid receptor antagonists or a potassium-sparing diuretic were asked to discontinue use of these agents for 4 weeks prior to randomization if they could do so safely. All participants who entered into randomization took the new medication along with their current blood pressure medication.

Subjects with kidney disease and uncontrolled diabetes were excluded from the trial.

The researchers checked in with clinic participants at specific time points with a follow-up call a week after the final dose. They took the participants’ blood pressure measurements along with the Baxdrostat levels they were taking, and their measurements aldosterone And the cortisol levels in the blood and urine. The researchers also gave the participants electrocardiograms and physical examinations.

The researchers noted a decrease in blood pressure with the treatment. The highest dose of 2 mg of Baxdrostat showed a decrease of more than 20 points in systolic blood pressure, which is an 11 point decrease compared to the placebo control group.

Interestingly, lowering the dose to 1 mg also reduced blood pressure by more than 8 points compared to placebo.

120 participants reported 232 adverse events during the study. High levels of side effects were reported in the control group (41%), but most of them were mild. No deaths or adrenocortical insufficiency were reported, but a few patients had recurrent high potassium levels which were managed by temporarily discontinuing the drug and providing routine dietary advice.

Baxdrostat stops the body from producing aldosterone, which is linked to tRH. Increased aldosterone increases the amount of salt and water reabsorbed by the kidneys which increases blood volume and blood pressure.

Study author Dr Maurice J. Brown, Professor of Hypertension in Endocrinology, Queen Mary University of London, explained MNT Basic premise:

“The reason patients are resistant to many conventional medications is that in this group of patients, there is a specific cause of high blood pressure, and that is the hormone aldosterone.”

Dr. Brown said he felt this was one of the “most exciting parts of the study especially since conventional drugs don’t target this.”

But could suppressing aldosterone cause long-term health problems? Dr. Brown said there would be no harm.

In most people, physiological levels of aldosterone are already suppressed due to the excessive amount of salt in the diet. In people with resistant hypertension, aldosterone comes from microscopic clusters of cells in the adrenal gland where certain mutations have shifted aldosterone production to ‘aldosterone’ – the hormone being produced constantly, regardless of the body’s needs.”
– Dr. Maurice J. Brown

The researchers demonstrated a dose-related decrease in blood pressure and aldosterone secretion.

They concluded that Baxdrostat inhibits aldosterone synthase, a key enzyme in aldosterone production that lowers blood pressure in participants with treatment-resistant hypertension.

Dr. Tadwalkar believes that a drug like Baxdrostat offers a potential new treatment option for people with resistant hypertension.

“[A] A drug such as Baxdrostat has a potentially high value in preventing the appearance of these [cardiovascular disease, stroke, heart attack, and heart failure] He said.

We finally have a drug that targets hormone synthesis [aldosterone] which we feel are primarily involved in causing resistant hypertension, and this is a huge step forward.”
– Dr. Rigvid Tadwalkar

The research was also welcomed by Professor Samani, who was not involved in the current study, saying:

“This new type of drug that appears to be safe and effective in lowering blood pressure in some patients who have high blood pressure despite taking other anti-hypertensive medications is welcome.”

However, he cautioned that “[m]Studies of ore are needed to show its long-term benefits.”

It is important to note that the experiment population was predominantly White (70%), therefore, results may not translate to a larger population.

The limitations of this trial are primarily related to it being a phase II study. […]The registered population is usually smaller, and the length of time individuals are followed can be shorter,” Dr. Tadwalker said, also highlighting that phase II trials do not test the drug against existing treatments which would be an important next step.

“At some point after that, it would also be useful to see how well this drug has affected other patient groups, including those with standard hypertension,” he said.

The immediate next step for the research are the results of a phase two experiment called HALO, which will study “[p]Dr. Brown said: Patients whose high blood pressure was not controlled by one or two medications, but did not meet the definition of resistance (HALO patients were not diuretics, while 100% of Brighten patients were).

“We need the third stage [trials]. This will start next year. Realistically, we might look at 2025 as the earliest date for the clinic. However, an intriguing question is whether regulators would accept a much smaller program for a separate indication, ie, patients with primary aldosteronism.

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