Hyperkalemia describes elevated levels of potassium in the blood. Although often asymptomatic, it can, if left untreated, cause cardiovascular problems, resulting in electrocardiogram (ECG) abnormalities (i.e., arrhythmias) and increased mortality. Hyperkalemia can occur for a number of reasons, including renal disease, diabetes, and treatment with medications such as RAAS inhibitors (e.g., ACE inhibitors, ARBs, MRAs). Consequently, certain patient populations are associated with hyperkalemia; they include patients with chronic kidney disease (CKD), heart failure, and diabetes. Effective and tolerable treatment options are lacking for hyperkalemia. Thus, novel hyperkalemia therapies are needed that can safely lower potassium in a rapid and sustained manner in both the acute and chronic settings. Two novel potassium-binding therapies are in development for hyperkalemia: Relypsa’s patiromer (RLY-5016) and ZS Pharma’s ZS-9 (zirconium silicate). Both agents have completed Phase III development in hyperkalemia patients and new drug applications are currently under review by the FDA. This report offers a snapshot into the current and anticipated treatment of hyperkalemia from the perspective of practicing nephrologists and cardiologists.

Questions Answered in This Report:

  • Understand the hyperkalemia patient load among nephrologists and cardiologists. The number of treated patients who have had hyperkalemia in the past year was similar between surveyed nephrologists and cardiologists. How many hyperkalemia patients have physicians seen in the last year, and how many are actively treated with pharmacological therapy? What is the physician-reported percentage of CKD-ND, dialysis, and CHF (chronic heart failure) patients (with and without chronic renal insufficiency) with hyperkalemia? What are some of the comorbidities found in hyperkalemia patients?

  • Understand current physician perspectives regarding the management of hyperkalemia. Surveyed nephrologists perceive a high level of unmet need for improved therapies to treat hyperkalemia. Furthermore, the level of unmet need ascribed to hyperkalemia was significantly higher than that for renal anemia, hyponatremia, hypertension, and gout. What is the level of need for new agents for hyperkalemia and how does it compare with other renal and cardiovascular diseases? What is the level of difficulty that physicians perceive in managing hyperkalemia, and how does it compare with other renal and cardiovascular diseases? What have been the major changes to hyperkalemia management in the past year?

  • Understand the factors that inform treatment decisions by physicians. For example, responses from surveyed physicians suggest that cardiologists may be more vigilant than nephrologists in monitoring ECG changes in their hyperkalemia patients. At what serum K+ levels do physicians initiate pharmacological treatment for hyperkalemia? How do physicians diagnose hyperkalemia? How does the use of RAAS-inhibiting treatment strategies affect hyperkalemia treatment strategies and vice versa?

  • Understand the standard of care in hyperkalemia by disease presentation. For example, a comparison of responses from surveyed physician types suggests that nephrologists recommend patients for ER treatment at higher potassium values compared with cardiologists. What percentage of hyperkalemia patients are treated pharmacologically versus nonpharmacologically? What percentage of patients receive SPS/Kayexalate? What is the prevalence of other hyperkalemia treatment strategies such as dietary modification, IV glucose and insulin, IV calcium, and loop thiazide diuretics, in addition to others?

  • Explore physician receptivity to the two novel hyperkalemia agents in development, Relypsa’s patiromer and ZS Pharma’s ZS-9. For example, nephrologists are divided in their awareness of new hyperkalemia products in development. What is the level of physician awareness and interest in these two products? What percentage of hyperkalemia patients are candidates for these products? How do physicians expect to use patiromer and ZS-9 (K+ level required for initiation, use in specific patient types, anticipated timing of use after launch)? What do physicians perceive as these agents’ greatest advantages and disadvantages? What are their concerns and questions about novel hyperkalemia agents in development?

Scope:

Markets covered: United States.

Primary research: 78 nephrologists and 75 cardiologists via an online survey.

Screening criteria for nephrologists: Have been in practice a minimum of 2 years and a maximum of 30 years. Treat more than 50 hyperkalemia patients in the past year. A minimum of 25 dialysis (HD and PD) and 50 CKD-ND (stage 3, 4, and 5) patients under management. Spend more than 75% of their professional time in clinical practice.

Screening criteria for cardiologists: Have been in practice a minimum of 2 years and a maximum of 30 years. Treat more than 50 hyperkalemia patients in the past year. Treat more than 400 CHF patients in the past year. Initiate treatment with ACE inhibitors, ARBs, and MRAs in their CHF patients. Spend more than 75% of their professional time in clinical practice.

Field Dates: April 13-22, 2015.

Report: PowerPoint format with 125 pages.

Author(s): Joseph Dwyer, Ph.D.
Rob Dubman, M.B.A.