A new medication, lorundrostat, may provide a solution for people struggling with uncontrolled hypertension, according to recent research presented at the American College of Cardiology’s annual meeting in Chicago.
In a key Phase 2b clinical trial, patients who took lorundrostat alongside two or three other common hypertension drugs experienced an 8-point greater reduction in systolic blood pressure compared to those on a placebo. The study is set to be published in The New England Journal of Medicine.
Dr. Luke Laffin, co-director at Cleveland Clinic’s Center for Blood Pressure Disorders, emphasized the potential of lorundrostat as a breakthrough treatment. “We do a poor job controlling blood pressure in the U.S.,” Laffin noted.
Nearly half of U.S. adults have hypertension, with fewer than 1 in 4 managing it effectively, according to the Centers for Disease Control and Prevention.
Hypertension is defined as blood pressure readings of 130/80 mm Hg or higher, while a systolic measurement between 120 and 129 mm Hg is considered elevated. Normal blood pressure is 120/80 mm Hg or below.
Uncontrolled hypertension, even with medication, increases the risk of heart attacks, strokes, heart failure, and kidney failure.
Despite treatment, 30-40% of patients still fail to manage their blood pressure, said Dr. Ajay Kirtane, a cardiologist from Columbia University. Lorundrostat is aimed at this group, offering a new option.
Lorundrostat belongs to a class of drugs known as aldosterone synthase inhibitors. It works by blocking aldosterone, a hormone that regulates salt retention. Lower aldosterone levels can help reduce salt and blood pressure.
The trial recruited 285 adults with uncontrolled hypertension, with an average age of 60. Over half of the participants (53%) were Black, a group particularly at risk for high blood pressure.
Dr. Oscar Cingolani from Johns Hopkins praised the inclusion of a significant number of Black patients in the trial, noting that this group tends to respond better to treatments targeting this pathway.
The trial involved patients already taking a mix of blood pressure medications. After standardizing their treatments, participants were randomly assigned either a placebo or one of two doses of lorundrostat for 12 weeks.
Blood pressure measurements were taken at three points: at the start of the trial, after four weeks, and at the end of 12 weeks.
Those on lorundrostat (50 mg) showed a 15.4-point decrease in systolic blood pressure, compared to a 7.4-point decrease in the placebo group. After adjusting for the placebo effect, the lorundrostat group experienced an 8-point reduction.
Despite the placebo response being higher than expected, experts attribute this to participants being closely monitored and more diligent about taking their medications.
A decrease of 8 points could lead to significant reductions in heart attacks and strokes in longer-term studies, according to Dr. Deepak Bhatt from Mount Sinai.
Lorundrostat is part of a new class of aldosterone synthase inhibitors, with some nearing FDA approval. Another drug in this class, baxdrostat, is in Phase 3 trials.
The Phase 3 trial for lorundrostat has been completed, though results have not yet been published. The researchers, in collaboration with Mineralys Therapeutics, hope lorundrostat will be available in 12 to 18 months.
While the drug shows promise, some patients in the trial developed high potassium levels, which could lead to abnormal heart rhythms. Doctors will need to monitor potassium levels closely.
Dr. Cingolani hopes to see future studies comparing lorundrostat to older medications that block aldosterone receptors.
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