Policy & Regulation
First Patient Treated in DIAMOND Study to Evaluate if Veltassa Improves Outcomes by Enabling Long-Term Use of Essential RAASi Therapy
23 May 2019 - - Swiss drugmaker Vifor Pharma has treated the first patient in its global phase-IIIb DIAMOND study, the company said.

The study will evaluate the potential of Veltassa to improve outcomes by enabling heart failure patients, with or without chronic kidney disease, to be treated with renin-angiotensin-aldosterone system inhibitors (RAASi) therapy in accordance with HF treatment guidelines.

Presently, RAASi treatment is frequently discontinued due to the risk of hyperkalaemia (elevated blood potassium levels).

The DIAMOND study is designed to further support the use of Veltassato effectively control high blood potassium levels, thereby enabling optimal RAASi therapy in HF patients.

It is a global, multicentre, double-blind, placebo-controlled trial aiming to study approximately 2,400 patients in over 400 sites. Eligible patients will have HF (with or without CKD) with either current hyperkalaemia at screening or a history of hyperkalaemia in the past year that led to a reduction or discontinuation of RAASi therapy.

The primary endpoint of the study is the time to first occurrence of cardiovascular death or cardiovascular hospitalisation. Top-line results are expected in 2022.

Hyperkalaemia can cause life-threatening abnormal heart rhythms and even sudden death.

There are often no warning signs, meaning a person can unknowingly experience recurring spikes in potassium levels and be at risk of cardiac events. The risk of hyperkalaemia can be a barrier to initiating and maintaining HF and CKD patients on guideline-recommended therapies such as RAASi treatment.

RAASi therapy has been shown to improve cardiovascular and renal outcomes and is proven to prolong survival and reduce hospitalisation.

Its use is strongly recommended in clinical guidelines for the treatment of HF with reduced ejection fraction, and CKD.

Across the Veltassa clinical trial programme, over 99% of participants were also taking RAASi therapy. However, these therapies can increase blood potassium levels, which can lead to hyperkalaemia.

Approximately 73% of advanced CKD and 40% of chronic HF patients may be at risk of elevated blood potassium levels.

Hyperkalaemia can cause abnormal heart rhythms and even sudden death.

There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events.

Some medicines that are often prescribed to people with CKD and heart failure to help delay progression of their underlying disease and reduce mortality can cause hyperkalaemia as a side effect.

These may include RAASi such as angiotensin receptor blockers, aldosterone antagonists and angiotensin-converting-enzyme inhibitors as well as angiotensin II receptor/neprilysin inhibitors.

Veltassa is a sodium-free potassium binder approved for the treatment of hyperkalaemia. Veltassa should not replace emergency treatment for life-threatening hyperkalaemia.

Made in powder form consisting of smooth, spherical beads, Veltassa is mixed with water and taken once a day with food. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon.

The potassium is then excreted from the body through the normal excretion process.
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