New blood pressure drug helps people with uncontrolled hypertension in trial
In a pivotal Phase 2b clinical trial, patients who took the experimental medication lorundrostat along with two or three currently available hypertension drugs saw a decrease in systolic blood pressure (the upper number) that was 8 points greater than what was seen in patients who got a placebo. The study will be published in The New England Journal of Medicine.
'This new potential therapy for hypertension is exciting,' said the study's lead author, Dr. Luke Laffin, co-director of the Center for Blood Pressure Disorders at the Cleveland Clinic's Heart, Vascular and Thoracic Institute. 'We do a poor job controlling blood pressure in the U.S.'
According to the Centers for Disease Control and Prevention, nearly half of adults in the U.S. have hypertension; among them, less than 1 in 4 have their blood pressure under control.
Hypertension is diagnosed when a person has a blood pressure of 130/80 mm Hg or higher. A systolic measurement between 120 and 129 mm Hg is considered to be elevated. A normal measurement is 120/80 mm Hg or below.
Uncontrolled hypertension — which Laffin defined as a measurement of 130/80 mm Hg or higher even with medication — is linked to a higher risk of heart attacks, strokes, heart failure and kidney failure.
Among patients taking medication for hypertension, the rate of control is 60% to 70%, said Dr. Ajay Kirtane, a cardiologist and professor of medicine at the Columbia University Vagelos College of Physicians and Surgeons in New York City, who wasn't involved with the research. That leaves 30% to 40% of patients who need another option.
Lorundrostat is meant for this group of patients. The drug, part of a class called aldosterone synthase inhibitors, works by blocking the adrenal glands' synthesis of a hormone called aldosterone, which controls the amount of salt retained by the body. When aldosterone is reduced, so are salt levels and therefore blood pressure.
To test the safety and efficacy of lorundrostat, Laffin and his colleagues recruited 285 adults with uncontrolled hypertension whose average age was 60. More than half (53%) of the participants were Black.
Black patients are among those most at risk, Laffin said. About 55% of Black adults have high blood pressure, according to the American Heart Association.
Dr. Oscar Cingolani, director of the hypertension program at Johns Hopkins Medicine, said the inclusion of so many Black patients is 'a big, big thing,' noting that 'African Americans … tend to be more responsive to this pathway.'
All of the patients in the trial were already taking a mix of blood pressure drugs. When the trial began, the researchers standardized those treatments by putting all of the patients on two or three specific medications. Three weeks later, they randomly assigned the participants to get either a placebo or one of two doses of lorundrostat for the next 12 weeks.
At three points, the participants wore a blood pressure cuff for a 24-hour period: at the beginning, four weeks after treatment started and then again at 12 weeks.
Participants taking the lower dose of lorundrostat, 50 milligrams, plus standard medications saw an average systolic blood pressure decrease of 15.4 points, while the group receiving the placebo plus standard drugs saw a decrease of 7.4 points — so the drug-related decrease in blood pressure after accounting for the placebo response was 8 points.
Increasing the dose of the drug didn't improve the results.
While the placebo response may seem high, it's most likely due to people being in a study and having the attention of health professionals, making them more scrupulous about taking their medications, experts said.
With a decrease of 8 points, say from 170 to 162, 'that is the range where you would in a longer-term study see reductions in heart attacks and strokes,' said Dr. Deepak Bhatt, director of the Mount Sinai Fuster Heart Hospital in New York City.
Aldosterone synthase inhibitors are a new class of drugs, some of which are closer to being considered for approval by the Food and Drug Administration than others, Bhatt said. One other, baxdrostat, is currently in Phase 3 trials.
Lorundrostat has shown promise in the three levels of clinical trials needed for approval. The last one, the Phase 3 trial, is completed, though the results haven't been published yet, Laffin said. The researchers are working on the trials with drugmaker Mineralys Therapeutics, which funded the trials.
The drug could potentially be available within 12 to 18 months, Laffin said.
Patients in the trial who got lorundrostat were more likely than those who got the placebo to develop high potassium levels. That's something patients' doctors would need to keep an eye out for, Bhatt said, because it can lead to abnormal heart rhythms.
Cingolani, of Johns Hopkins, said he would like to see long-term studies on the new medication and also ones that could compare lorundrostat to an older medication that works by blocking the receptor for aldosterone.
This article was originally published on NBCNews.com
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