Following completion of ATTR-ACT, patients were eligible to enrol in an open-label LTE study where they were able to switch from placebo to tafamidis, or continue treatment with tafamidis, for up to 60 months¹

All-cause mortality was assessed in patients taking continuous tafamidis meglumine 80 mg to tafamidis free acid 61 mg vs. those initiated on placebo before transitioning to tafamidis meglumine 80 mg/20 mg and then to tafamidis 61 mg/day in the LTE¹

The licensed dose for VYNDAQEL in ATTR-CM is 61 mg once daily. VYNDAQEL 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. Tafamidis meglumine 20 mg is not licensed in ATTR-CM.² 

Figure adapted from Elliot P, et al. Circ Heart Fail 2022; 15(1):e008193 

There was a significant 41% risk reduction in all-cause mortality in patients receiving continuous tafamidis treatment compared with those first receiving placebo (p<0.001)¹

Tafamadis was generally well tolerated in the LTE.

Frequency of AEs was generally similar or lower, in patients treated with tafamidis meglumine 80 mg/day who transitioned to tafamidis free acid 61 mg/day in the LTE vs. patients from the pooled tafamidis (tafamidis meglumine 80 mg/daily and tafamidis meglumine 20 mg/daily) or placebo arms in ATTR-ACT^3,1

No new safety concerns emerged in patients treated with tafamidis meglumine 80 mg/day or tafamidis free acid 61 mg/day in the LTE¹

• Cumulative clinical data in ATTR-CM participants, as per SmPC:¹
• Common AEs (occurring in ≥1 to <10% of patients) include diarrhoea, rash and pruritus

• Tafamidis reduced the combination of all-cause mortality and cardiovascular-related hospitalisations compared with placebo over 30 months during ATTR-ACT³
• Survival improved in patients who initially received placebo in ATTR-ACT once tafamidis treatment had been initiated during the LTE¹
• Patients receiving continuous tafamidis over 5 years showed a significant reduction in all-cause mortality compared with those who ­first received placebo, highlighting the importance of early diagnosis and treatment initiation in patients with ATTR-CM¹

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