Drug updated on 7/25/2024
Dosage Form | Capsule (oral; 61 mg) |
Drug Class | Transthyretin stabilizers |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Latest News
Summary
- Tafamidis (Vyndamax) 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 information was derived from eight systematic reviews/meta-analyses.
- In a study with 2,765 patients, tafamidis showed a reduction in all-cause death or heart transplantation and composite endpoints, but no significant changes in certain cardiac parameters like intraventricular septum thickness. It demonstrated lower risks of mortality and adverse cardiovascular events particularly in both wild-type and hereditary ATTR patients.
- Another analysis involving data from 876 patients found that tafamidis significantly reduced cardiovascular mortality (OR 0.58) and all-cause mortality (OR 0.45), although it did not show statistical significance for those with heart transplants or cardiac assist devices.
- Comparative studies indicate that while tafamidis improves survival rates compared to natural disease progression, other therapies such as patisiran may offer comparable or superior performance on specific metrics including peripheral neuropathy progression.
- Overall findings suggest that tafamidis is generally well-tolerated with adverse events similar to placebo groups; however, newer agents like patisiran might provide broader improvements necessitating further randomized controlled trials (RCTs) to substantiate its comparative effectiveness.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Vyndamax (tafamidis) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Cardiac amyloidosis: evolving diagnosis and management. | 2020 | American Heart Association |
Canadian Cardiovascular Society/Canadian Heart Failure Society joint position statement of the evaluation and management of patients with cardiac amyloidosis. | 2020 | Canadian Cardiovascular Society |
CCS/CHFS heart failure guidelines: clinical trial update on functional mitral regurgitation, SGLT2 inhibitors, ARNI in HFpEF, and tafamidis in amyloidosis. | 2020 | Canadian Journal of Cardiology |
JCS 2020 Guideline on diagnosis and treatment of cardiac amyloidosis. | 2020 | Circulation Journal |