Drug updated on 4/16/2024
| 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.
Summary
- Tafamidis (Vyndamax) is indicated for the treatment of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults, aiming to reduce cardiovascular mortality and hospitalization related to cardiovascular issues.
- Eight systematic reviews/meta-analyses provided information about Vyndamax's safety and effectiveness compared to other therapeutic options.
- The drug has been shown to be safe for patients suffering from ATTR-CM, with adverse event rates not significantly different from placebo groups. This includes no notable difference in the occurrence of severe adverse events and mortality rates when compared with placebo treatments; incidences of fatigue and hypesthesia were also lower than those observed in the placebo group.
- In terms of effectiveness, tafamidis significantly reduced cardiovascular-related deaths and hospitalizations among patients diagnosed with ATTR-CM. It was associated with stable cardiac function markers such as left ventricular ejection fraction (LVEF), a reduction in all-causes mortality rate, along with fewer occurrences of cardiovascular events.
- Studies covered broad age groups, averaging around 75.9 years old, indicating its applicability mainly towards an older demographic, which is typically more affected by ATTR-CM; however, the male population was predominantly studied, leaving implications on gender-specific efficacy not fully explored.
- When comparing tafamidis' performance against other drugs like patisiran or diflunisal used for familial amyloid polyneuropathies (FAP), it showed effective results in reducing disease progression while improving patient quality of life across both genetic subtype differentiation - wild-type vs hereditary ATTR-CM, without significant differences in outcomes, thus signifying its wide applicability within this patient population segment.
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 |