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New Drug Shows Promise for Treatment-Resistant High Blood Pressure, Study Finds
SAN DIEGO – A groundbreaking clinical trial has revealed a potential new weapon in the fight against uncontrolled hypertension, offering hope to millions of Americans whose high blood pressure remains stubbornly resistant to existing treatments. Researchers at the University of California San Diego School of Medicine have identified lorundrostat,an investigational drug,as a promising candidate for these individuals.
The study, published in the prestigious New England journal of Medicine, demonstrated that participants taking lorundrostat experienced a notable 15-point reduction in systolic blood pressure – the top number in a blood pressure reading – compared to a 7-point reduction observed in those receiving a placebo.
“This study was designed to look at the impact of a novel medication in lowering blood pressure for individuals whose hypertension is inadequately controlled by current standard medications,” said dr. Michael Wilkinson, principal investigator for the study at UC San Diego School of Medicine and cardiologist at UC San Diego Health.
The phase II, multicenter clinical trial involved 285 participants across the nation, including patients at UC San Diego Health, in collaboration with the Cleveland clinic Coordinating Centre for Clinical Research.
The findings arrive at a critical time. According to the U.S. Centers for Disease Control and Prevention (CDC), hypertension plagues approximately 120 million adults in the United States – nearly half of the adult population. high blood pressure is a leading cause of heart disease, stroke, and kidney failure, placing a massive burden on the healthcare system. Direct medical costs attributable to hypertension were estimated at $131 billion between 2017 and 2018, per the CDC.The key to lorundrostat’s potential lies in it’s ability to target aldosterone, a hormone that plays a crucial role in regulating blood pressure. When aldosterone production becomes dysregulated, it can contribute substantially to hypertension, particularly in cases that are resistant to conventional treatments.
“We were specifically studying a new approach to addressing imbalanced aldosterone, which is an often underrecognized cause of treatment-resistant hypertension,” Wilkinson explained.
The 12-week trial involved all participants receiving a standardized antihypertensive medication. In addition to this standard treatment,190 participants received a measured dose of lorundrostat,while 95 received a placebo.The drug works by inhibiting the production of aldosterone.
“All participants used the same standardized medications for their blood pressure for the first three weeks of the trial before beginning the drug or placebo, which allowed us the opportunity for a baseline and to truly understand the effectiveness of the treatment,” said Wilkinson, associate professor of medicine at UC San Diego School of Medicine. “Ultimately,we found that the therapy,compared to placebo,was helpful in lowering a person’s systolic blood pressure.”
Each participant’s blood pressure was closely monitored for 24 hours at the beginning, middle, and end of the trial. Those who received lorundrostat saw their systolic blood pressure levels drop by an average of 15 mmHg (millimeters of mercury).
“While blood pressure readings remained elevated at the end of this Phase II trial in some participants treated with lorundrostat, we find these results promising because almost all participants involved in the study were not able to sufficiently lower their blood pressure with medication before,” Wilkinson added. “As we learn more about the safety and efficacy of this treatment, I’m hopeful we will identify a useful tool in addressing high blood pressure for patients in need.”
Wilkinson also emphasized that the clinical trial benefitted from a more diverse patient population, a factor that could lead to more effective treatments for a wider range of individuals at increased risk of heart disease.
the next step for lorundrostat is a larger, Phase III clinical trial, designed to further evaluate its safety and efficacy before it can be considered for FDA approval.
Counterargument: While the Phase II trial results are encouraging, some experts caution against premature optimism. Prof. Amy Brownstein, a cardiologist at mount Sinai Hospital in New York, not involved in the study, notes that “A 15 mmHg reduction is statistically significant, but it remains to be seen if this translates into a clinically meaningful reduction in cardiovascular events like heart attacks and strokes in the long term. Longer-term studies are crucial.” Brownstein, who was speaking in an unrelated interview with Healio Cardiology just last month, also pointed out the necessity of a cost-benefit analysis, comparing lorundrostat with existing, cheaper, aldosterone antagonists.
FAQ about High Blood Pressure and Lorundrostat
Q: What is treatment-resistant hypertension?
A: Treatment-resistant hypertension is defined as high blood pressure that remains uncontrolled despite the use of three or more diffrent types of blood pressure medications, including a diuretic, at their maximum tolerated doses.
Q: How does lorundrostat work differently from existing hypertension drugs?
A: Lorundrostat works by directly inhibiting the production of aldosterone, a hormone that can contribute to high blood pressure, particularly in treatment-resistant cases. Most existing drugs target other mechanisms, such as blood vessel relaxation or fluid removal.
Q: Is lorundrostat available to the public now?
A: No,lorundrostat is still an investigational drug and is only available through clinical trials. It has not yet been approved by the FDA for widespread use.
Q: What are the potential side effects of lorundrostat?
A: The Phase II trial evaluated the safety and efficacy of the treatment.More detail on the side effects of lorundrostat will be available after the Phase III trial of the medication.
Q: What can I do if I think I have treatment-resistant hypertension?
A: Talk to your doctor. They can evaluate your current treatment plan, assess your aldosterone levels, and determine if you are a candidate for clinical trials involving new medications like lorundrostat.
