Hyperkalemia in Real-World Patients Under Continuous Medical Care in Japan

Abstract

Introduction: An abnormal serum potassium (S-K) level is an important electrolyte disturbance. However, its relation to clinical outcomes in real-world patients, particularly hyperkalemia burden, is not extensively studied. Methods: An observational retrospective cohort study using a Japanese hospital claims database was done (April 2008-September 2017; N ¼ 1,022,087). Associations between index S-K level and 3-year survival were modeled using cubic spline regression. Cox regression model was applied to estimate the time to death according to different S-K levels. Prevalence, patient characteristics, treatment patterns, and management of patients with hyperkalemia from first episode were assessed. Results: Hyperkalemia prevalence was 67.9 (95% confidence interval [CI]: 67.1-68.8) per 1000 and increased in patients with chronic kidney disease (CKD) (227.9; 95% CI: 224.3-231.5), heart failure (134.0; 95% CI: 131.2-136.8), and renin-angiotensin-aldosterone system inhibitor (RAASi) use (142.2; 95% CI: 139.6-144.7). U-shaped associations between S-K level and 3-year survival were observed with nadir 4.0 mEq/l. The risk of death was increased at S-K 5.1-5.4 mEq with hazard ratio of 7.6 (95% CI: 7.2-8.0). The 3year mortality rate in patients with CKD stages 3a, 3b, 4, and 5 with normokalemia were 1.51%, 3.93%, 10.86%, and 12.09%, whereas that in patients with CKD stage 3a at S-K 5.1-5.4, 5.5-5.9, and $6.0 mEq/l increased to 10.31%, 11.43%, and 22.64%, respectively. Despite treatment with loop diuretics (18.5%) and potassium binders (5.8%), >30% of patients had persistently high S-K ($5.1 mEq/l). Conclusion: This study provides real-world insight on hyperkalemia based on a large number of patients with various medical backgrounds.

Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose–response, phase 2/3 study

“…Patients with CKD, HF, and diabetes are prone to hyperkalemia [2,3,6,7]. As such, our study included patients with many concomitant diseases and treatments; proportions of patients at baseline with comorbid CKD, diabetes, or receiving RAASi were high, reflecting their real-world prevalence among Japanese patients with hyperkalemia [1]. This is also consistent with the study groups included in phase 3 studies of SZC in the non-Japanese population [18,20,21].…”

“…Hyperkalemia, a common electrolyte disorder defined by elevated serum potassium (sK + ), is often associated with comorbidities such as chronic kidney disease (CKD), heart failure (HF), and diabetes [ 1 ]. Hyperkalemia is also a common side effect of renin–angiotensin–aldosterone system inhibitors (RAASi), used in the management of CKD and HF [ 2 – 4 ].…”

A phase 3 multicenter open-label maintenance study to investigate the long-term safety of sodium zirconium cyclosilicate in Japanese subjects with hyperkalemia

“…The results demonstrated that after a year of exposure, SZC had a positive safety profile, treatment was well-tolerated by Japanese patients and potassium levels were well controlled. Importantly, the Japanese patient population in this study was considered representative of real-world Japanese patients with hyperkalemia undergoing chronic management [3], supporting the applicability of these results to the wider Japanese population.…”

Prevalences of hyperuricemia and electrolyte abnormalities in patients with chronic kidney disease in Japan: A nationwide, cross-sectional cohort study using data from the Japan Chronic Kidney Disease Database (J-CKD-DB)

“…Although it remains controversial, asymptomatic hyperuricemia has been reported as a risk factor for eGFR decline in patients with CKD [9,10]. Hyperkalemia and hyperphosphatemia are known risk factors for cardiovascular disease and mortality in patients with CKD [11][12][13][14][15][16].…”

“…The prevalences of hyperuricemia and electrolyte abnormalities in patients with CKD have been reported in clinical and epidemiological studies [8][9][10][11][13][14][15][16][17][18]. Recently, analyses of realworld conditions of patients with CKD were performed based on electronic health records [12,[19][20][21][22]; these studies included analyses of electrolyte abnormality prevalences among patients with CKD [12]. However, electronic health record analyses of the prevalences of hyperuricemia and electrolyte abnormalities according to CKD G category have been limited.…”