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April 29, 2021

Post hoc study shows Veltassa is well-tolerated in elderly patients with HK

A post hoc analysis of the multicentre AMETHYST-DN study reveals that the use of Vifor Pharma’s Veltassa (patiromer) significantly reduced levels of serum potassium in patients aged 75 years and older with chronic kidney disease (CKD) related hyperkalemia (HK).

By GlobalData Healthcare

A post hoc analysis of the multicentre AMETHYST-DN study reveals that the use of Vifor Pharma’s Veltassa (patiromer) significantly reduced levels of serum potassium in patients aged 75 years and older with chronic kidney disease (CKD) related hyperkalemia (HK).

Veltassa is a cross-linked polymer of calcium, a high-capacity cation potassium binder. It is formulated as a powder for suspension and administered orally. By week 52, it was found that patients’ serum potassium levels were lower than 5.5mEq/L, and no severe adverse events were observed.

Key opinion leaders (KOLs) interviewed by GlobalData emphasised that they are satisfied with Veltassa’s efficacy and tolerability. KOLs also agreed overall that it will be difficult for drug developers to compete against branded HK agents in the CKD-HK market due to their robust positive clinical data, post-marketing data and preferable patient compliance.

The post hoc analysis looked to evaluate the efficacy of Veltassa in elderly patients with CKD, diabetes and hypertension on a renin-angiotensin-aldosterene system inhibitor. Elderly people are much more likely to suffer from reduced kidney function and are at greater risk of HK. Patients with HK received Veltassa 4.2–16.8g two times per day. Data from the post hoc analysis found that at week 52, all patients’ serum potassium levels were below 5.5mEq/L, and 95% of patients’ levels were below 5mEq/L. The most common adverse event was hypomagnesmia. The study showed that discontinuing a long-term potassium binder may lead to a recurrence of HK.

There are currently two well-tolerated potassium binders available, Veltassa and AstraZeneca’s Lokelma, but unmet needs remain. KOLs emphasised the need for a drug that can offer flexibility in adjusting the dosage, because there are concerns that a major reduction in potassium levels could cause hyperkalemia in patients.

Most treatments for CKD are taken for life, leading to a huge financial burden on patients. In the US, the progression from CKD stage 3 to CKD stages 4–5 can be associated with annual health care costs of around $20,000–100,000 for renal services and therapies for each patient, creating problems of access to more expensive therapies. Despite Veltassa’s preferable profile compared with sodium polystyrene sulfonates, several KOLs confirmed that the issues of access, reimbursements and high cost have continued to restrict its use.

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The post hoc subgroup analysis is the first long-term safety analysis of Veltassa in patients aged 75 years and older. The drug was generally well-tolerated, and the long-term safety profile was similar to the original AMETHYST-DN study, specifically in the older patient population. GlobalData believes that this study could be of high clinical value to physicians with elderly patients looking to find an optimal treatment of choice for HK, which may bolster the current use of the drug among older patients with CKD-HK.

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