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To evaluate the safety, tolerability, treatment patterns, and effectiveness of calcium polystyrene sulfonate (CPS) and sodium polystyrene sulfonate (SPS) in the management of hyperkalemia (HK) among Chinese patients with renal insufficiency.
Patients with chronic kidney disease (CKD) or acute kidney injury (AKI) with HK in 26 hospitals in China were included in the study. Two full analysis sets (FAS), FAS-P1 (stage 1, followed up for 3 days) and FAS-P2 (stage 2, followed up for 6 months) were defined. Fas-P1 includes all new users taking at least one dose of CPS/SPS 1-3 days after the initial treatment of CPS/SPS, FAS-P2 includes all patients receiving at least one dose of CPS/SPS after enrollment in the user group, and patients receiving at least one dose of CPS/SPS after the initial treatment period in the new user (Fas-P1). The drug use, serum potassium (sK+) level and clinical efficacy of the two data sets were observed, and the safety was evaluated.
A total of 892 patients were selected in the study. 390 patients (CPS 385 cases, SPS 5 cases) and 814 patients (CPS 811 cases, SPS 3 cases) were included in FAS-P1 and FAS-P2, respectively. In FAS-P1 and FAS-P2, the average daily doses of CPS were (7.28±6.24) and (5.13±5.15) g, respectively; and the average daily doses of SPS were (10.75±6.23) and (8.36±7.59) g, respectively. In FAS-P1, the change of sK+ from baseline to day 3 was (-0.72±0.61) mmol·L-1; in FAS-P2, the mean value of sK+ was (5.17±0.68) mmol·L-1 (95% CI: 5.12-5.22). In FAS-P1 and FAS-P2, 56.15% and 55.16% patients had adverse events (AEs), respectively, and the incidence of serious adverse events (SAEs) were 29.23% and 29.24%, respectively. The researchers determined that the incidence of adverse events related to CPS/SPS was low, which was 2.56% in FAS-P1 and 2.09% in FAS-P2. The most common CPS/SPS related AEs were gastrointestinal discomfort (FAS-P1: 2.05%; FAS-P2: 1.70/100 person years) and hypokalemia (FAS-P1: 0.51%; FAS-P2: 2.10/100 person years).
In this study, over 50% of patients with renal insufficiency and hyperkalemia experienced AEs, reflecting the high burden of underlying disease in this population. However, the incidence of AEs related to CPS/SPS was low (approximately 2%), predominantly presenting as gastrointestinal discomfort and hypokalemia.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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