The new type of drug could help lower blood pressure in people with uncontrolled hypertension, researchers reported at the American Society of Cardiology’s annual meeting in Chicago on Saturday.
A critical phase 2 clinical trial saw a drop in systolic blood pressure (upper number) that was 8 percentage points higher than patients who took the experimental medication and two or three currently available hypertensive medications. This study will be published in the New England Journal of Medicine.
“This new potential treatment for hypertension is exciting,” said Dr. Luke Ruffin, the study’s lead author, who is co-director of the Center for Blood Pressure Disorders at the Cleveland Clinic’s Heart, Vascular and Thoracic Research Institute. “We’re making blood pressure control jobs poor in the US.”
Almost half of US adults have high blood pressure, according to the Centers for Disease Control and Prevention. Less than a quarter of these control blood pressure.
Hypertension is diagnosed when a person’s blood pressure is 130/80 mm Hg or higher. Systolic measurements of 120-129 mm Hg are thought to be elevated. The normal measurement is below 120/80 mm Hg.
Uncontrolled hypertension – Even when taking medications above 130/80 mm Hg, Ruffin is associated with a higher risk of heart attack, stroke, heart failure and kidney failure.
Among patients taking medications for hypertension, control rates range from 60% to 70%, said Dr. Ajay Kirtane, a cardiologist and professor of medicine at Vagelos College of Physicians and Surgeons, Columbia University, New York City, who is not involved in the study. Therefore, 30% to 40% of patients who need another option remain.
LorundRostat is aimed at this patient group. This drug, part of a class called aldosterone synthase inhibitors, works by blocking the adrenal synthesis of the hormone called aldosterone, which controls the amount of salts held in the body. When aldosterone decreases, it also reduces blood pressure, as well as salt levels.
To test the safety and efficacy of Lorundrostat, Ruffin and his colleagues recruited 285 adults with uncontrolled hypertension, with an average age of 60 years. Half of the participants (53%) were black.
Black patients are among the most at-risk people, Ruffin said. According to the American Heart Association, approximately 55% of black adults have high blood pressure.
Dr. Oscar Singorani, director of the Hypertension Program at Johns Hopkins Medicine, said the inclusion of so many black patients was “big, big,” saying “African Americans are more likely to respond to this pathway.”
All patients during the study were already taking a mixture of blood pressure medications. When the trial began, researchers standardized these treatments by administering all patients to two or three specific drugs. Three weeks later, they randomly assigned participants to get a placebo or two LorundRostat over the next 12 weeks.
At 3 points, participants wore a blood pressure cuff for 24 hours. First, again 12 weeks after treatment began.
Low doses of lone drostat, 50 milligrams, and standard medication reduced mean systolic blood pressure by 15.4 percentage points, while the group receiving placebo plus standard medication reduced the number 7.4 percentage points.
Increasing the drug dose did not improve the results.
The placebo response may seem high, but it is likely because people are doing research and are gaining attention from healthcare professionals, and are becoming more rigorous about taking the medication, experts said.
“We are a great place to go,” said Dr. Deepakbat, director of Mount Sinai Faster Heart Hospital in New York City.
Aldosterone synthase inhibitors are a new class of drugs, some of which have been considered for Food and Drug Administration approval more than others, Batt said. Another Baxdrostat is currently undergoing phase 3 exams.
Lorundrostat shows promise in the three levels of clinical trials required for approval. The final one, Phase 3 exam, has been completed, but the results have not yet been published, according to Ruffin. The researchers are working on a trial with drug maker Mineralys Therapeutics and funding the trial.
The drug could be available within 12 to 18 months, Ruffin said.
Patients in the trials who received Lorundrostat were more likely to develop higher potassium levels than those who received a placebo. It should be kept in mind that the patient’s doctor should keep an eye on it, as it can lead to an abnormal heart rhythm, Batt said.
Johns Hopkins’ Chingorani said he wanted to see long-term research on new drugs and what can be compared to older drugs that work by blocking the receptors of aldosterone.
