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LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkEN - EnglishSelect a languageLanguagesEN - EnglishFR - FrançiasStudy DesignEfficacySafety ProfileDosingReal-world evidenceSupporting Resources Supporting ResourcesGuidelines and ReimbursementLong Term Extension StudyModels of care MaterialsVideosContact us

Click here for VYNDAQEL®▼ (tafamidis) Prescribing Information. 

Vyndaqel Long Term Extension Study (LTE)Continuous treatment with tafamidis for 5 years significantly reduced all-cause mortality compared to starting on placebo in the LTE study, highlighting the need for early diagnosis and treatment in ATTR-CM1LTE Study Design 

 

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 


*In addition to standard of care (e.g. diuretics)
Figure adapted from Elliot P, et al. Circ Heart Fail 2022; 15(1):e008193 and Damy T, et al. Eur J Heart Fail 2021;23(2): 277-85.Study Results 
Baseline characteristics at month 30 of ATTR-ACT
At month 30 of ATTR-ACT, before enrolling in the LTE, patients treated with placebo had more severe disease than those treated with tafamidis meglumine 80 mg1

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

Primary EndpointContinuous tafamidis treatment over 5 years reduced all-cause mortality1


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


A total of 82 placebo-treated patients continued in LTE, 54 of whom were randomised to receive tafamidis meglumine 80 mg/day and 28 of them were randomised to receive tafamidis meglumine 20 mg/day3

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.1 

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

SafetyIn the LTE, 164 patients treated with tafamidis meglumine 80 mg/day transitioned to tafamidis free acid 61 mg/day1

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-ACT3,1

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
Conclusion 
  • 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
Explore more We have a team ready to support you with any queries.Get in touchLoadingAcronyms 
6MWT, 6-minute walk test; AE, adverse event; ATTR-ACT, Tafamidis in Transthyretin Cardiomyopathy Clinical Trial; ATTR-CM, transthyretin amyloid cardiomyopathy; CV, cardiovascular; HR, hazard ratio; KCCQ-OS, Kansas City Cardiomyopathy Questionnaire Overall Summary; LTE, long term extension; NT-proBNP, N-terminal pro-B-type natriuretic peptide; TTR, transthyretin.


References:

Elliott P, et al. Circ Heart Fail 2022;15(1):e008193.VYNDAQEL 61 mg (tafamidis) Summary of Product Characteristics.Maurer MS, et al. N Engl J Med 2018;379(11):1007–16.
PP-VYN-GBR-1940. March 2025
Download a summary of the ATTR-ACT/ LTE data here
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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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