Adverse events (Figure 5)
Three outcomes were used to evaluate adverse events: the total number of patients who experienced any adverse event, adverse events related to the treatment regimen, and adverse events leading to discontinuation of the trial regimen. All seven studies [5,10,13-17]reported the total number of patients experiencing adverse events, and the pooled analysis revealed that the total number of patients experiencing any adverse event was similar in both groups (RR = 1.00 [0.99, 1.01] p=0.56; I2= 0%). However, 5 out of 7 studies[5,10,14,15,16] reported adverse events related to treatment regimen, and the pooled analysis revealed that treatment with Finerenone was associated with a higher risk of adverse events related to the treatment regimen (RR = 1.40 [1.33, 1.46] p <0.00001; I2= 0%). Similarly, adverse events leading to discontinuation of treatment regimen were reported in six out of seven studies [5,10,13-16], and the pooled analysis revealed that treatment with Finerenone was associated with a higher risk of treatment discontinuation compared to placebo (RR = 1.62 [0.84, 3.10] p=0.15; I2 = 98%), respectively. Due to the high heterogeneity of adverse events leading to treatment discontinuation, a sensitivity analysis was performed, which revealed that excluding Gerasimos 2021 [15] reduced heterogeneity and rendered the results statistically significant (RR = 1.22 [1.11, 1.33] p 0.0001; I2= 0%).