Tuesday, 02 January 2024 12:17 GMT

Bold New Pill Slashes Stubborn Blood Pressure


(MENAFN- The Arabian Post)

AstraZeneca is poised to reshape hypertension care with a novel oral therapy that has yielded striking reductions in systolic blood pressure among patients whose condition remained uncontrolled despite multiple medications. In the global BaxHTN Phase III trial, daily doses of baxdrostat achieved a placebo-adjusted drop in systolic readings of approximately 9.8 mmHg at 2 mg and 8.7 mmHg at 1 mg over 12 weeks. The 2 mg dose delivered even more impressive results in 24‐hour ambulatory monitoring, with reductions reaching about 16.9 mmHg.

About 40 per cent of participants on baxdrostat achieved controlled blood pressure - defined as systolic pressure under the target threshold - compared with under 20 per cent receiving placebo. Facilitated by trials across 214 clinics in 29 countries, these findings reflect consistency across diverse patient subgroups, including those with uncontrolled and resistant hypertension.

Baxdrostat distinguishes itself from existing therapies by selectively inhibiting aldosterone synthase - thereby reducing aldosterone production directly, rather than merely blocking its receptors. Given aldosterone's role in salt retention and blood pressure elevation, this mechanism addresses a long-identified but elusive driver behind resistant hypertension.

Safety data from the trial are encouraging. Adverse events appeared manageable and were not unexpected. A small proportion of patients experienced elevated potassium levels, with hyperkalaemia leading to discontinuation in 0.8 per cent and 1.5 per cent, while confirmed hyperkalaemia above 6 mmol/l occurred in roughly 1 per cent of each baxdrostat cohort. Serious adverse events registered at 1.9 per cent for 1 mg dose, 3.4 per cent for 2 mg dose, and 2.7 per cent for placebo.

Researchers emphasised the durability of the effect: in a randomised withdrawal phase, patients continuing on baxdrostat at 2 mg experienced further systolic reductions, while those switched to placebo saw an average rise of 1.4 mmHg.

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Principal investigator Professor Bryan Williams of University College London described the findings as a“triumph of science” and a potential game‐changer. He noted that aldosterone overproduction is a central culprit in difficult‐to‐manage hypertension, and baxdrostat's targeted action represents a breakthrough in addressing this key physiological driver.

Analysts have responded to the trial results with optimism over the drug's potential. AstraZeneca plans to file for regulatory approval by the end of 2025, aiming to bring baxdrostat to market in the US and EU by 2026. Forecasts suggest peak global revenue in the region of $5 billion annually. The company's stock also showed positive momentum following the trial announcement, helping offset earlier losses and reinforcing confidence in its commercial potential.

Experts not directly involved in the study highlighted the broader implications. Professor Paul Leeson of Oxford described the drug as a valuable addition that might benefit populations in Asia and lower-income regions, where uncontrolled hypertension is most prevalent. Dr Tomasz Guzik of the University of Edinburgh pointed to the drug's ability not only to lower blood pressure, but also to alter its trajectory - pointing to longer-term physiological resetting beyond transient pharmacological effect.

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