Efficacy and safety of medical treatment of primary aldosteronism: a real-world data study in Spain

Abstract

Objective: This study aims to analyze current medical management of primary aldosteronism (PA) in Spain, including doses, adverse events (AEs), and efficacy.

Methods: SPAIN-ALDO is a national, multicenter, retrospective registry of patients with PA in Spain. For this study, information about medical treatment with mineralocorticoid receptor antagonist (MRA) as first-line or postsurgical therapy and about antihypertensive medications used before PA targeted treatment (MRA or adrenalectomy) was included. We reported surgically and medically treated patients at baseline and at last available follow-up and evaluated clinical and biochemical responses according to Primary Aldosteronism Surgical Outcome (PASO) and Primary Aldosteronism Medical treatment Outcome (PAMO) criteria.

Results: A total of 997 patients with PA were included. Before PA diagnosis, the classes of antihypertensive drugs most used were calcium-channel blockers (66%) and angiotensin II receptor blockers (48.4%). Of the initial cohort, 880 patients had at least 1 visit available after initiation of MRA (N = 511 as first-line therapy, N = 47 postsurgery) or adrenalectomy (N = 322). The median defined daily dose of MRA therapy was 1.33. Spironolactone was more prescribed than eplerenone (58% vs 42%). Eplerenone was better tolerated than spironolactone (AEs in 4% vs 18%), particularly among males. After a median follow-up of 35 and 17 months for medically and surgically managed patients, the latter achieved a complete biochemical (68.1%) or clinical (33.6%) response more frequently than people under MRA as first-line therapy (48.6% and 15.7%; P < .001).

Conclusion: This study underscores the need to optimize PA medical management in Spain to improve patient clinical and biochemical outcomes, since currently the proportion of patients achieving complete clinical and biochemical response with MRA is quite low.

Keywords: aldosterone; eplerenone; primary aldosteronism; renin; spironolactone.