The primary end point was the proportion of patients with serum potassium 3
The primary end point was the proportion of patients with serum potassium 3.8 to 5.0 mEq/L at week 3 or 4 4. not taking RAASi. Results: Demographics and baseline characteristics were related in individuals taking (n = 67) and not taking RAASi (n = 45). Baseline imply (SD) serum potassium was 5.37 (0.37) mEq/L and 5.42 (0.43) mEq/L in individuals taking and not taking RAASi, respectively. Mean (SD) daily patiromer doses were related (10.7 [3.2] Ursodeoxycholic acid and 11.5 [4.0] g, respectively). The primary end point was accomplished in 85% (95% confidence interval [CI]: 74-93) of individuals taking RAASi and in 84% (95% CI: 71-94) of individuals not taking RAASi. From baseline to week 4, the Ursodeoxycholic acid mean (SE) switch in serum potassium was ?0.67 (0.08) mEq/L in individuals taking RAASi and ?0.56 (0.10) mEq/L in individuals not taking RAASi (both .0001 vs baseline, = nonsignificant between groups). Adverse events were reported in 26 (39%) individuals taking RAASi and 25 (54%) not taking RAASi; the most common adverse event was diarrhea (2% and 11%, respectively; no cases were severe). Five individuals (2 taking RAASi) reported 6 severe adverse events; none considered related to patiromer. Conclusions: Patiromer was effective and generally well-tolerated for hyperkalemia treatment, whether or not individuals were taking RAAS inhibitors. .05. Results Disposition and Baseline Characteristics Of 114 individuals randomized, 67 (59%) were taking RAASi at baseline. Number 2 shows disposition for individuals taking and not taking RAASi. Specific RAASi taken by 1 patient included the angiotensin-converting enzyme inhibitors lisinopril (n = 30, including 1 who received lisinopril in combination with hydrochlorothiazide), enalapril (n = 10), ramipril (n = 2), and benazepril (n = 2, including 1 who received benazepril with amlodipine) and the angiotensin II receptor blockers losartan (n = 13) and valsartan (n Ursodeoxycholic acid = 5, including 1 who received valsartan with hydrochlorothiazide). One individual each received candesartan, fosinopril, irbesartan, and olmesartan (olmesartan in combination with amlodipine and hydrochlorothiazide). Four individuals were receiving spironolactone (3 in combination with one of the above RAASi). Open in a separate window Number 2. Disposition of individuals taking and not taking RAAS inhibitors. aExcluded from your efficacy analysis: 1 patient who did not receive patiromer and 1 patient with a protocol violation and no postbaseline serum potassium observations. Excluded from the security analysis: 1 patient who did not receive patiromer. HK shows hyperkalemia; RAASi, reninCangiotensinCaldosterone system inhibitor. Overall, baseline characteristics were similar between organizations (Table 1), except for an imbalance in mean (SD) eGFR: 45.8 (26.4) mL/min/1.73 m2 in those taking RAASi versus 34.7 (23.1) in those not taking RAASi (= .0238). Individuals prior medications were generally related between organizations (Table 2), except there were numerically fewer individuals taking -blockers (= .0842) among individuals taking RAASi. There was no difference in the proportion of individuals taking non-RAASi diuretics. Table 1. Baseline Demographic and Clinical Characteristics. .0001) for individuals taking (?0.67 [0.08]) or not taking RAASi (?0.56 [0.10]) and was not different between organizations (= .27). Using unadjusted means and a combined test, the imply change from baseline (SE) was also statistically significant ( .0001) for individuals taking (?0.60 [0.06]) or not taking RAASi (?0.52 [0.09]) Rabbit polyclonal to RAD17 and was not different between organizations (= .52). The median time to achieving serum potassium in the prospective range was 8 days in both organizations (= .0832 for taking RAASi vs not). Open in a separate window Number 4. Mean (SE) serum potassium over time by baseline RAAS inhibitor use. The shaded area represents the prospective range for serum Ursodeoxycholic acid potassium (3.8-5.0 mEq/L). BL shows baseline; K+, potassium; RAAS, reninCangiotensinCaldosterone system; SE, standard error..