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LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkEN - EnglishSelect a languageLanguagesEN - EnglishFR - FrançiasStudy DesignEfficacySafety ProfileDosingSupporting Resources Supporting ResourcesNICE RecommendationAvailability in Scotland2021 ESC Heart Failure GuidelinesRisk Minimisation MaterialContact usVideosMaterials

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

VYNDAQEL efficacy resultsOnce-daily oral VYNDAQEL demonstrated efficacy in ATTR-CM1,2

Efficacy was demonstrated in ATTR-ACT, a phase 3 multicentre, international, parallel design double-blind, placebo-controlled, randomised, 3-arm study in 441 patients with wild-type or hereditary ATTR-CM.1,2

The analysis compared the results of a pooled tafamidis (20 mg and 80 mg as meglumine) treatment group (n=264) with the placebo group (n=177).2 

The licensed dose for VYNDAQEL in ATTR-CM is 61 mg once daily.1 VYNDAQEL 61 mg (tafamidis) corresponds to 80 mg tafamidis meglumine. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. 20 mg dose is not licensed for ATTR-CM.1

Primary and secondary endpoints were met at 30 months.1,2

VYNDAQEL was superior to placebo in reducing the combination of all-cause mortality* and CV-related hospitalisations over 30 months (Win Ratio 1.70 [95% CI:1.26-2.29];p<0.001)2 

 Primary endpoint: VYNDAQEL was superior to placebo in reducing the combination of all-cause mortality* and CV-related hospitalisations over 30 months; p<0.0012The primary endpoint hierarchically† assessed all-cause mortality followed by frequency of CV-related hospitalisation over 30 months.2

The win ratio method (number of pairs of the treated patient wins divided by number of pairs of placebo patient wins) may be helpful in interpreting the Finkelstein-Schoenfeld result.2‡    *Heart transplantation, combined heart and liver transplantation and cardiac mechanical assist device implantation were treated as equivalent to death in this analysis.2
†Primary analysis determined by the Finkelstein-Schoenfeld method. A statistical method used to compare each patient to every other patient within each stratum in a pair-wise manner that proceeds in a hierarchical fashion using all-cause mortality first. The test statistic is based on the sum of scores and stratified by TTR genotype (wild-type and hereditary) and NYHA baseline classification (class I or II vs class III) resulting in a total of 4 strata.2
‡A win ratio of 1.7 (95% CI: 1.26-2.29) indicates that a tafamidis-treated patient had a 70% higher chance of having a better outcome based on a hierarchical combination of all-cause mortality and CV-related hospitalisation relative to a placebo patient.2 Primary endpoint components: VYNDAQEL reduced all-cause mortality* and annual CV-related hospitalisation frequency in ATTR-CM over 30 months vs. placebo (NNT=7.5)1–3Kaplan–Meier survival curves showed that pooled tafamidis resulted in a reduction in all-cause mortality, with the curves diverging after approximately 18 months of treatment.2
8 patients need to be treated to prevent 1 death over a 30-month study period (NNT=7.5)3

VYNDAQEL reduced annual CV-related hospitalisation frequency by 32% vs. placebo in patients with ATTR-CM1,2

Exploratory analyses indicated that pooled tafamidis patients in NYHA I/II had reduced CV-related hospitalisations vs placebo whilst patients in NYHA III had increased CV-related vs placebo.2 *Heart transplantation, combined heart and liver transplantation and cardiac mechanical assist device implantation were treated as equivalent to death in this analysis.2
§All cause mortality analysed with the use of a Cox proportional hazards model, with treatment and stratification factors treated as co-variates.2
¶This analysis was based on a Poisson regression model with treatment, TTR genotype (variant and wild-type), New York Heart Association (NYHA) Baseline classification (NYHA Classes I and II combined and NYHA Class III), treatment-by-TTR genotype interaction, and treatment-by-NYHA Baseline classification interaction terms as factors.2Key secondary endpoint: VYNDAQEL significantly delayed patients functional decline vs. placebo as early as Month 6 (p=0.0067), as measured by 6-minute walk test1,2,4Key secondary endpoint: VYNDAQEL helped patients preserve greater QoL vs. placebo, as measured by KCCQ-OS1,2,4A significant treatment effect favouring pooled tafamidis was first observed at Month 6 (p=0.0113) and remained consistent through Month 30 (p<0.0001) on KCCQ-OS score.2,4

6MWT=6-minute walk test; ARR=absolute risk reduction; ATTR-CM=transthyretin amyloid cardiomyopathy; CI=confidence interval; CV=cardiovascular; HR=hazard ratio; KCCQ-OS=Kansas City Cardiomyopathy Questionnaire Overall Summary; LS=least squares; NNT=number needed to treat; NYHA=New York Heart Association; RRR=relative risk reduction; SE=standard error; TTR=transthyretin. 

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References:

VYNDAQEL 61 mg (tafamidis) Summary of Product Characteristics.Maurer MS, Schwartz JH, Gundapaneni B, et al. N Eng J Med. 2018;379:1007–1016.Maurer MS, Mann DL. J Am Coll Cardiol Basic Trans Sci. 2018;3(6):871–873.Rapezzi C. Oral Presentation. European Society of Cardiology Congress 25-29 August, 2018.
PP-VYN-GBR-1126. November 2023
Section links

Explore the study of VYNDAQEL in ATTR-CM

 ATTR-ACT study design Loading

See the safety profile of VYNDAQEL

 Safety profileLoading

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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