Table 3.
Patient-Related Efficacy (RCTs) | |
Morillo et al., 2015 [20] |
No significant between-group differences were observed in any component of the primary outcome No significant differences between groups with new ECG abnormalities Treatment with BNZ did not reduce cardiac clinical progression |
Torrico et al., 2018 [22] | ECG outcomes were similar across treatment groups, with no clinically significant increases in QTcF during treatment. |
Patient-Related Efficacy (Observational Studies) | |
Antunes et al., 2016 [25] | No cardiac alterations were detected in the study population, regardless of group |
Cardoso et al., 2018 [26] | 14/493 (2.8%) of the treated group died during the 2-year follow-up; 100/1320 (7.6%) of the control group died during the 2-year follow-up (p ≤ 0.001) There was a reduction in well-established markers of CD severity, such as typical ECG abnormalities, high NT-proBNP levels or both. BNZ treatment reduced NT-proBNP levels. |
Colantonio et al., 2016 [27] |
After statistical adjustment treatment with BNZfor 60 days was not associated with less ECG abnormalities as compared to no treatment over a median follow-up of 8.6 years. The prevalence of ECGs with abnormalities was higher among children treated with BNZ compared with those not treated in all assessment periods following the baseline evaluation. |
Fragata-Filho et al., 2016 [29] |
20.92% of the treated patients developed ECG alterations. 3.19% of the untreated patients had worsening of ECG alterations. (p ≤ 0.0001) Death related to CD occurred in five participants with ECG alterations and in one with a normal ECG. (p = 0.001) |
Schmidt et al., 2019 [31] | Those with even minimal wall motion abnormalities have poorer long-term outcomes. LV WMSI>1 was associated with a significantly increased primary outcome event rate and higher all-cause mortality (p ≤ 0.0001). BNZ had no significant effects on echocardiographic progression of CCC over 5.4 years. |
Soverow, et al., 2019 [32] | Treated patients were less likely to have progression of their ECG disease (OR = 0.13, p < 0.001). Untreated patients had a higher likelihood of developing ECG abnormalities compared with their treated counterparts (56.7% vs. 11.9%, p ≤ 0.001). |
ECG = Electrocardiogram, NT-proBNP = N-terminal of the prohormone brain natriuretic peptide, LV WMSI = Left ventricular wall motion score index, QTcF = QT interval/CubeRootRR (seconds).