New results of phase III analysis of Veltassa (patiromer) for hyperkalaemia- Relypsa

Relypsa has announced results of a pre-specified sub-group analysis from the Phase III OPAL-HK trial of Veltassa (patiromer) oral suspension in patients age 65 and older with chronic kidney disease (CKD) and hyperkalaemia. Data showed patiromer significantly reduced and maintained control of blood potassium levels in hyperkalaemic CKD patients aged 65 and older who were also receiving renin-angiotensin-aldosterone system (RAAS) inhibitor therapy. Patiromer also significantly reduced the percentage of patients with recurrent hyperkalaemia compared with placebo over eight weeks. A separate post-hoc analysis also from the OPAL-HK trial showed patiromer's efficacy in treating hyperkalaemia was not diminished by concomitant use of diuretics. Patiromer was well tolerated in both sub-groups, with mild-to-moderate constipation as the most common adverse event. Data were presented at the American Society of Nephrology’s Kidney Week 2015.

Comment: Veltassa was recently approved by the FDA as the first new medicine for the treatment of hyperkalaemia in more than 50 years. Patients with chronic kidney disease or heart failure are at particular risk for developing hyperkalaemia, especially those treated with renin-angiotensin-aldosterone system (RAAS) inhibitors such as ARBs (angiotensin receptor blockers), AAs (aldosterone antagonists), and ACE (angiotensin-converting enzyme) inhibitors. Although RAAS inhibition has been shown to protect kidney and cardiac function, many patients who could benefit from RAAS inhibitors are untreated or undertreated due to the undesirable side effect of hyperkalaemia.