Summary

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• Vyndaqel (tafamidis meglumine) is indicated for the treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
• This summary is based on the review of eight systematic review(s)/meta-analysis(es). ^[1-8]
• Tafamidis significantly reduced cardiovascular mortality in the ATTR-ACT trial (OR 0.58; 95% CI: [0.41-0.83], P=0.003) and all-cause mortality (OR 0.45; 95% CI: [0.32-0.64], P≤0.00001).
• Tafamidis treatment was associated with a reduced risk of all-cause death or heart transplantation (pooled RR 0.44; 95% CI: [0.31-0.65], P<0.01) and composite cardiovascular endpoints (RR 0.57; 95% CI: [0.42-0.77], P<0.01).
• Tafamidis showed a decrease in Left Ventricular Ejection Fraction (LVEF) (SMD -0.17; 95% CI: [-0.31 to -0.03]; P=0.02), with no significant LVEF deterioration in wild-type ATTR patients (SMD -0.11; 95% CI: [-0.34 to 0.12]; P=0.34).
• No clear difference between groups in the number of participants who died, dropped out due to adverse events, or experienced at least one severe adverse event compared to placebo.
• Tafamidis might lead to little or no difference in mortality (RR 0.65, 95% CI 0.11 to 3.74; P=0.63; very low-certainty evidence).
• There is no population types or subgroups information available in the reviewed studies.