Table 2.
Included studies for analysis.
| Study ID | Type of study | Place of study | Study period | Primary outcome |
|---|---|---|---|---|
| Agarwal R, et al,16 2019 | Phase II, double-blind, placebo-controlled RCT | 62 outpatient centers in 10 countries (Bulgaria, Croatia, Georgia, Hungary, Ukraine, France, Germany, South Africa, United Kingdom, and the United States) | February 13, 2017, and August 20, 2018 | Patients taking spironolactone at week 12: T = 126/147; C = 98/148 |
| Anker DS, et al,17 2015 | Phase III randomized, double-blind, placebo-controlled trial | 44 sites from cardiology, nephrology, and general research sites in United States, Australia, and South Africa | March-August 2014 | 28-day withdrawal phase; mean serum potassium (mmol/L) SZC-5: 4.7 (95% CI, 4.5–4.9), SZC-10: 4.5 (95% CI, 4.3–4.6), SZC –15: 4.4 (95% CI, 4.2–4.5), C: 5.2 (95% CI, 5.0–5.4) |
| Ash RS18 et al. 2015 | Phase II RCT | 9 US sites | November 2011-May 2012 | Mean reductions in serum potassium were seen on day 2 (hour 28 to 48) with 10-g SZC vs placebo |
| Desai NR, et al,14 2020 | Descriptive observational study | Optum's Clinformatics Data Mart (Eden Prairie, MN) | January 1, 2016, to December 31, 2017 | Rate difference of ED visits (postindex-preindex) on ITT: T= –0.12 (–0.29 to 0.07); C = 0.75 (0.71 to 0.79) |
| Fishbane S, et al,8 2018 | Phase IIIb, randomized, double-blind, placebo controlled trial | 54 sites across Japan, Russia, the United States, and the United Kingdom | December 14, 2017-November 7, 2018 | Proportion of responders 41.2% (n = 40 of 97) in SZC group vs 1.0% (n = 1 of 99) |
| Packham DK, et al,19 2014 | Phase III, 2-stage, double-blind, randomized, placebo controlled study | 65 sites in the United States, Australia, and South Africa | November 2012-November 2013 | In maintenance phase, both the 5-g and 10-g daily doses of SZC were superior to placebo in maintaining normokalemia |
| Peacock WF, et al,7 2020 | Phase II, randomized, double-blind, placebo-controlled trial | 33 sites in Denmark, Italy, Russia, and the United States | February 13, 2018-December 21, 2018 | Greater reduction in serum potassium at 4 h in the SZC group than the placebo group: –0.36 (0.57) for SZC versus –0.25 (0.63) mmol/L for placebo |
| Pitt B, et al,9 2011 | Phase II, randomized, double-blind, placebo-controlled trial | Conducted in 38 centers in United States, Germany, the Czech Republic, Poland, the Ukraine, Russia, and Georgia | June 2009-November 2009 | Change in serum potassium from baseline to day 28 (mEq/L) T = 20.34 + 0.08; C = 0.09 + 0.10 |
| Rafique Z, et al, 202020 | Single-center, single-blinded, randomized, open-label, pilot study | Innercity ED, USA | August 2016-August 2017 | Change in serum potassium (mEq/L) from baseline to 6-h posttreatment T = 6.32 (95% CI 6.0–6.63) C = 5.81(95% CI 5.48–6.14) |
| Weir MR, et al,21 2014 | Phase III randomized, single blind, placebo controlled study | Sites in Eastern Europe (n = 24 sites), the European Union (n = 21), and the United States (n = 14) | February 2013-July 2013 | Initial phase; Change in serum potassium (mmol/L) from baseline to week 4: −1.01 (0.03) |
| Zannad F, et al,22 2019 | Phase III, randomized, double-blind, placebo-controlled study | 45 investigational sites in Japan, Russia, South Korea, and Taiwan | March 3, 2017-February 14, 2018 | Geometric LSM (95% CI) (mmol/L) SZC-10: 4.38 95% CI 4.27–4.50); SZC-5: 4.81 (95% CI 4.69–4.94); C: 5.32 (95% CI 5.16–5.49) |
ED = emergency department; C = Control group; ITT = Intention to Treat; LSM = least square mean; RCT = randomized controlled trial; SZC = sodium zirconium cyclosilicate; T = Treatment group.