At the 2025 American Heart Association (AHA) Scientific Sessions held in New Orleans, Louisiana, from 7 to 10 November, an international collaboration presented new real-world evidence on the comparative effectiveness of amiloride and spironolactone in resistant hypertension. Researchers analysed outcomes for 800 adults across multiple sites using the TriNetX database, with careful matching for age, comorbidity and prior treatment.
Resistant hypertension — a condition where blood pressure remains elevated despite three or more antihypertensive medications, including a diuretic — is a challenge for both physicians and patients. It is well-known as a major risk factor for heart attack, stroke and kidney damage, with limited new oral treatment options. Historically, spironolactone has been the add-on of choice, but its risk of hyperkalemia and hormone-related adverse effects means there is increasing clinical interest in alternatives such as amiloride.
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This study found that amiloride and spironolactone provided similar rates of blood pressure control, major adverse cardiovascular events, acute kidney injury and all-cause mortality over 12 months. Amiloride brought quicker blood pressure control at four weeks, but by one year, both agents performed equivalently on all clinically meaningful outcomes. Safety was also comparable with no new signals, supporting confidence in both therapies.
Key opinion leaders (KOLs) interviewed by GlobalData noted: “Resistant hypertension patients urgently need new therapies that address underlying disease mechanisms and offer better, more durable blood pressure control than current options.” KOLs emphasised that the future commercial opportunity in this market will be for companies that can bring forward innovative treatments able to move beyond incremental benefit and truly transform outcomes for this high-risk, hard-to-treat population.
This study challenges the market’s long-held reliance on spironolactone as the “go-to” fourth-line agent and opens the door to broader uptake of amiloride, especially as generic products. For industry stakeholders, the findings set a higher bar for differentiation — future branded entrants will now need to demonstrate not just efficacy, but also a clear advantage in safety, tolerability or patient convenience to win market share in this highly cost-sensitive segment. The results also reinforce that even in heavily genericised spaces, robust head-to-head clinical evidence remains a powerful lever for changing practice and influencing payer decisions.
Looking ahead, care for resistant hypertension is set to become more patient-centered. The clinical focus will likely shift toward maximising long-term blood pressure control, mitigating risk and refining patient selection — especially for those at risk for adverse effects or with specific comorbidities. Pharmaceutical strategy leaders should expect increased pressure to develop differentiated, value-based offerings in hypertension and prioritise high-quality comparative studies to shift prescribing habits.
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By GlobalData
