How Criteria from Primary Aldosteronism Guidelines 2016 Impact Compounding Pharmacists

How Criteria from Primary Aldosteronism Guidelines 2016 Impact Compounding Pharmacists

i-timeAldosteronism: excessive secretion of aldosterone that results in high sodium, low potassium and hypertension. This one-liner seems concise enough, however, despite its brevity, it manages to convey the very serious threat posed by this condition. A few more pieces of info are needed to get a more complete picture of what individuals with aldosteronism face.

Primary aldosteronism is underdiagnosed because symptoms are insidious. Then there’s the fact that prevalence is high—so high that the Endocrine Society encourages certain patients to request a screening. Identifying at-risk patients is one role for compounding pharmacists. It’s also imperative to counsel patients on medication adherence and to consider how compounding may improve outcomes.

Overview of Primary Aldosteronism

When the adrenals begin to excrete too much aldosterone, it’s usually due to an adenoma or hyperplasia. When experts are asked to target the cause of cellular overgrowth, they won’t have an exact answer, although ongoing research is producing promising results. Researchers from the University of Michigan found that normal adrenal glands often have mutations in subcapsular aldosterone-producing cell clusters (APCCs), which cause dysregulation of aldosterone production.1 Their findings suggest that most people already have the origins of primary aldosteronism (PA). Identification of these mutated clusters may lead to diagnostic biomarkers—a step forward that could save lives according to these statistics:

  • Primary aldosteronism causes one in 10 cases of high blood pressure.
  • It affects one in every 50 adults.2
  • Patients with PA are at a 12-fold higher risk for atrial fibrillation, have a four-times higher risk for a heart attack and they’re six times more likely to have a stroke, compared to patients with essential hypertension.3
  • Chronic aldosteronism without high blood pressure is still associated with a higher risk for cardiac injury.

Signs and symptoms: Most patients with PA don’t go to the doctor because they’re worried about symptoms—they feel fine. They seldom have symptoms unless severe hypokalemia develops. The main signs of primary aldosteronism include:

  • Moderate to severe high blood pressure.
  • High blood pressure plus low levels of potassium.
  • Spontaneous or unprovoked hypokalemia.
  • Abdominal distension.
  • Fatigue, muscle weakness, cramping, headaches and palpitations due to hypokalemia.
  • Complications of hypertension, such as renal insufficiency, retinal changes and encephalopathy.

New Criteria from Primary Aldosteronism Guidelines 2016

Noting the fact that PA is quite common yet frequently undiagnosed, the Endocrine Society revised their guidelines for the first time since 2008. The new guidelines are notable for two significant changes. First, they recognize PA as a public health issue. “With 70 million patients in the United States living with hypertension, primary aldosteronism may well account for seven million of these cases,” said John. W. Funder, MD, PhD, and chair of the task force that developed the clinical practice guidelines. The second change is a strong recommendation to screen all patients at risk for PA.

The following high-risk patients should be screened:4

  • Patients with hypertension plus hypokalemia.
  • Patients with hypertension and sleep apnea.
  • Patients with sustained blood pressure above 150/100 mm Hg in three separate measurements taken on different days.
  • Patients with resistant hypertension (uncontrolled with three antihypertensive drugs).
  • Patients with hypertension controlled with four or more medications.
  • Patients who develop hypertension before 40 years of age.
  • Patients with a family history of hypertension, stroke or primary aldosteronism.
  • Patients with hypertension and an adrenal mass.

Treatment and Tips for Pharmacist Outreach

Primary aldosteronism requires surgery, but high blood pressure and hypokalemia are treated first to reduce surgical risks. Adrenalectomy usually cures hypertension when PA is caused by an adrenal aldosteronoma, but barely 20 percent of patients with idiopathic adrenal hyperplasia are cured after surgery. Patients who don’t undergo surgery, and those who still have hypertension following surgery, are prescribed medical treatments.

  • Calcium channel blockers – Reduces the production of aldosterone by inhibiting intracellular calcium flux in adrenocortical cells. Nifedipine significantly improves hypertension, but doesn’t affect the pathophysiology of PA.
  • Mineralcorticoid antagonists – Normalizes plasma volume and serum potassium while controlling blood pressure. Combining spironolactone and thiazides improves blood pressure better than spironolactone alone.
  • ACE inhibitors – Captopril, lisinopril and enalapril are well-tolerated options that lower aldosterone secretion.
  • Potassium-sparing diuretics – Second-line treatment for patients who can’t have surgery; they must be used with other antihypertensives.
  • Glucocorticoids – The lowest possible dose of short-acting glucocorticoids, such as prednisone and hydrocortisone, are recommended for patients with glucocorticoid-remediable aldosteronism.

Pharmacist Outreach: Pharmacists are vital resources for members of the community who may not get their blood pressure checked on a regular basis. Whether you offer blood pressure screening at your pharmacy or put up posters alerting patients to the importance of keeping track of blood pressure, remember that you may be the one health professional in a position to encourage preventative care. Take advantage of the tools available:

  • Medication therapy management: Implement scheduled medication review, start connecting via telemedicine, or take advantage of medication synchronization. All of these interventions give you the opportunity to counsel high-risk patients about hypertension and PA.
  • Talk about adherence to medications: Roughly half of all patients stop taking their antihypertensive medication within the first year, but compliance significantly increases when pharmacists intervene.
  • Consider compounded options: As you counsel patients, consider whether they could use compounded options. For example, adults taking multiple meds might be more motivated to adhere to the regimen by combining them into a single dose.
  • Promote patient education: Make sure patients know that hypertension seldom has obvious signs or symptoms and that it increases the risk of heart attacks, strokes and death.

Proactive Pharmacists Promote Quality of Life

When it comes to hypertension and primary aldosteronism, you have two types of patients to target: patients who feel great and don’t check their blood pressure, and those who got a check-up, take antihypertensives, but still have hypertension. Both groups need the type of patient education and encouragement that you can provide. Pharmacists who take the time to reach out and make a connection significantly contribute to the long-term health of both patients with undiagnosed primary aldosteronism.

Pharmaceutica North America provides high-quality calcium channel blockers in the form of cost-effective bulk APIs. We’re available to answer your questions, so contact us today to talk about how we can support the needs of your patients.

Show 4 footnotes

  1. “Aldosterone-Stimulating Somatic Gene Mutations Are Common in Normal Adrenal Glands,” August 2015,
  2. “Primary Aldosteronism,” June 2016,
  3. “Management of Primary Aldosteronism: Guideline Update,” May 2016,
  4. “The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline,” March 2016,

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