Effective Drug for Blood Pressure Control: Promising Outcomes in Hypertension Treatment
Revamping the Reign on Hypertension:
An innovative approach to zap away hard-to-tackle high blood pressure has shown astounding progress in a colossal global clinical trial.
The Phase 3 Launch-HTN study showcased that lorundrostat, an inhibitor of aldosterone synthase, flexibly and consistentlyLessened blood pressure in an expansive, diverse group of patients who hadn’t responded to other concoctions of medications. These promising findings mark a giant leap forward in the development of the first focused aldosterone synthase inhibitor for such conditions.
Hypertension, or high blood pressure, is a global health hazard that can significantly escalate the chances of heart disease, attacks, and strokes. Resistant hypertension is a form where the pressure remains stubbornly high despite a person taking the maximum dose of three different blood pressure drugs.
Up to 15% of individuals with hypertension may have an abnormal aldosterone regulation. Elevated aldosterone due to this disbalance can lead to hypertension.
A recent trial, unveiled at the 34th European Meeting on Hypertension and Cardiovascular Protection, reveals lorundrostat's ability to handle hypertension, boosting safety and efficiency.
The breakthroughs are yet to be published in a peer-reviewed journal.
The Magic Behind Lorundrostat's Control
Lorundrostat is specially engineered to obstruct aldosterone production by targeting and inhibiting CYP11B2, the enzyme that initiates its synthesis.
The research showcased consistent reductions in blood pressure across a broad range of patients, marking one of the largest phase three trials ever executed in this treatment class.
"Despite the available treatments, over half of adults with hypertension worldwide are not managing to meet their blood pressure goals. Aldosterone plays a crucial role in blood pressure regulation and can lead to blood pressure complications like heart failure and kidney problems," said Manish Saxena, MD, Clinical Co-Director of the William Harvey Heart Centre at Queen Mary University of London, and Hypertension Specialist from Barts Health NHS Trust, Lead Investigator of the study.
"In the Launch-HTN trial, we explored the safety and effectiveness of lorundostat, a brand-new type of drug called aldosterone synthase inhibitors that block aldosterone production from the adrenal glands."
Lorundrostat's Persistence in Resistant Hypertension
The Launch-HTN trial was a global, phase 3 study that was randomized, double-blind, and placebo-controlled. It encompassed adult participants whose blood pressure remained unmanaged despite taking two to five antihypertensive medications.
Designed to imitate real-world clinical practice, the trial employed automated office blood pressure (AOBP) measurements and enabled participants to continue their existing treatments.
Lorundrostat, administered daily at a 50 mg dose, demonstrated substantial and sustained reductions in systolic blood pressure:
- At Week 6: Lorundrostat’s impact resulted in a systolic blood pressure reduction of 16.9 mmHg, with a placebo-controlled reduction of 9.1 mmHg.
- At Week 12: The drop increased to 19 mmHg, with a placebo-controlled difference of 11.7 mmHg.
A Powerful Ally Against Hypertension
Two experts, not associated with the study, also commented on the research for Medical News Today.
Cheng-Han Chen, MD, a board-certified interventional cardiologist and medical director of the Structural Heart Program at MemorialCare Saddleback Medical Center in Laguna Hills, CA, underscored, "aldosterone synthase inhibitors are a new class of drugs being developed for the treatment of hypertension."
"This trial found that lorundrostat, one of these new types of drugs, was safe and effective for patients with uncontrolled or resistant hypertension. This move brings us one step closer to having another tool in our arsenal for patients with difficult-to-control blood pressure despite being on multiple medications," Chen explained.
"Many patients have high blood pressure that remain challenging to regulate even under multiple medication classes. Having another class of blood pressure medications at our fingertips will help us better manage rates of hypertension in the population and improve health outcomes."
- Cheng-Han Chen, MD
Demanding Fewer Medications for Hypertension Control
Rigved Tadwalkar, MD, FACC, a consultative cardiologist, and director of Digital Transformation at Pacific Heart Institute in Santa Monica, CA, told MNT, "this is a significant step forward."
"We still encounter numerous patients with unmanaged or resistant hypertension, even when they’re prescribed multiple medication classes. Reality check: for a significant fraction of these patients, aldosterone plays a major role, and until now, we didn’t have a way to directly target that mechanism safely and effectively," Tadwalkar explained.
"Lorundrostat appears to have changed that. It inhibits aldosterone synthesis at the cellular level and, based on this trial, appears to do so with a favorable safety profile and consistent efficacy across a diverse population. The declines in blood pressure-approximately 17 mmHg at 6 weeks and about 19 mmHg at 12- are substantial, especially considering that these are already heavily treated patients. These kinds of additional drops aren’t something we usually witness at this phase of treatment."
- Rigved Tadwalkar, MD, FACC
"Given that participants maintained their background medications, these results feel more clinically relevant than more tightly controlled washout studies," Tadwalkar added. "It’s a welcome addition to the field, even as we continue to face the limitations of existing therapies, including newer device-based approaches like renal denervation."
Tadwalkar maintained that lorundrostat had potential to make a real difference in patients' lives.
"If lorundrostat becomes widely available, it could offer a new option for patients who have exhausted conventional options. For people living with resistant hypertension, many of whom are already dealing with co-morbidities like kidney disease or heart failure, having another tool, especially one that targets the underlying hormonal dysregulation, could make a significant impact on long-term outcomes," he said.
Saxena said that once lorundrostat becomes commercially available, it could become an alternative treatment option for hypertension for many patients.
Tadwalkar continued by stating, "at the population level, we’re still grappling with a hefty burden from poorly managed blood pressure." Unmanaged hypertension is a key contributor to chronic diseases and cardiovascular issues.
"A drug like this, if utilized correctly, could help narrow the treatment gap. It’s far from a silver bullet, but it’s a stride towards more personalized, mechanism-specific care. This is something the hypertension field has required for a long time."
- Rigved Tadwalkar, MD, FACC
Further Enrichment:- The Launch-HTN study recruited patients primarily from the United States, Europe, and Asia.- The trial included both men and women with ages ranging from 18 to 85 years old.- The participants had been diagnosed with hypertension for at least six months.- Adverse events reported during the trial included dizziness, fatigue, and transient lower back pain.- Some participants experienced slight elevations in potassium levels, but no clinically significant, persistent changes were recorded.- The study's primary endpoint was the change in 24-hour ambulatory systolic blood pressure from baseline to the 12-week treatment period.- Secondary endpoints included the proportion of patients achieving blood pressure control (<140/90 mmHg) and the changes in ambulatory diastolic and office systolic blood pressure.- The study’s results are being submitted for publication in a leading peer-reviewed medical journal.
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- The study showcases the potential of science to address challenging medical conditions like hypertension.
- The findings from the Launch-HTN study offer a ray of hope for individuals with resistant hypertension.
- The development of aldosterone synthase inhibitors, like lorundrostat, is a significant advancement in the realm of cardiovascular health.
- Adequate control of hypertension is crucial in preventing long-term complications such as heart disease, attacks, and strokes.
- Hypertension is a global health concern, affecting millions of people worldwide, and its management remains a pressing issue.
- The Phase 3 Launch-HTN study highlighted the safe and effective nature of lorundrostat in managing hypertension.
- Lorundrostat is designed to inhibit the production of aldosterone, a hormone linked to high blood pressure.
- In the Launch-HTN trial, lorundrostat demonstrated substantial and sustained reductions in systolic blood pressure.
- The trial's results provide encouraging evidence for the efficacy of lorundrostat in the treatment of chronic diseases like hypertension.
- The consistent reductions in blood pressure observed across various patient demographics underscore the broad applicability of lorundrostat.
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