This protocol covers the structured next step for patients with bilateral primary aldosteronism, unknown lateralization status, or lateralizing disease in individuals who decline surgery or are not surgical candidates — when the initial mineralocorticoid receptor antagonist regimen has not achieved its key clinical goals.
Lifelong medical therapy with a mineralocorticoid receptor antagonist (MRA) is the established approach for bilateral primary aldosteronism, lateralization status unknown, or for those who are not surgical candidates. This protocol applies when that initial regimen has proven insufficient.
The preceding treatment — a mineralocorticoid receptor antagonist started at a low initial dose — is considered insufficient when its primary goal of blood pressure control has not been achieved, and/or its secondary goal of normokalemia remains unmet. When renin remains suppressed and hypertension persists, a dose escalation strategy is indicated.
The next step centres on upward dose adjustment of the existing mineralocorticoid receptor antagonist, timed at defined intervals, with the aim of achieving renin de-suppression alongside blood pressure control. The complete escalation protocol — including agents, specific increments, intervals, and decision pathway — is available in the structured regimen.
The primary indicator of adequate therapy is a demonstrable rise in renin from the pretreatment baseline — evidence of de-suppression — together with control of blood pressure. Specific renin thresholds serve as supporting reference points rather than rigid absolute targets.
Lifelong medical therapy that includes an MRA is usually offered to individuals with bilateral PA or lateralization status unknown (refer to Question 6 for definition of lateralization) and to those who decline the surgical option or who are not surgical candidates.
In individuals with primary aldosteronism (PA) receiving PA-specific medical therapy whose hypertension is not controlled and renin is suppressed, we suggest increasing PA-specific medical therapy to raise renin.
Spironolactone may be increased in 25- to 50-mg increments, and eplerenone in 25- to 100-mg increments.
MRA dose changes to target BP control should occur at 8- to 12-week intervals, and the full drug effect may take up to 3 months in more severe PA forms.
Rather than targeting a specific renin threshold, we suggest that the observation that renin has increased from its pretreatment baseline should provide some reassurance of treatment efficacy.
A recent large international consensus group endorsed targeting a rise in renin when implementing aldosterone-directed medical therapy to a level higher than 1.0 ng/mL/h (plasma renin activity [PRA]) or 10 mU/L (direct renin concentration [DRC]).
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