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Suspect & Detect About ATTR-CM Study Design Efficacy & Safety Profile Dosing MOD/MOA Important Safety Information Abbreviated Prescribing Information
Study DesignTransthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT) - a clinical study in patients with ATTR-CM1

A phase 3, multicentre, international, randomised, double-blind, placebo-controlled study, which evaluated the pooled tafamidis meglumine doses of 20 mg and 80 mg in 441 patients with wild-type or hereditary ATTR-CM1

Two-thirds of patients in the pooled tafamidis meglumine group were on the 80 mg dose.2

Approval of VYNDAMAX™ was based on ATTR-ACT, which evaluated the pooled tafamidis meglumine doses of 20 mg and 80 mg.3 A single VYNDAMAX™ 61 mg capsule is bioequivalent to tafamidis meglumine 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.4

Inclusion criteria

  • Patients between 18 and 90 years of age2
  • Confirmation of ATTR-CM, wild type or hereditary2
  • Echocardiography with an end-diastolic interventricular septal wall thickness >12 mm2
  • History of heart failure with at least 1 prior hospitalisation for heart failure, or clinical evidence of heart failure (without hospitalisation)2‡
  • NT-proBNP level ≥600 pg/mL2
  • 6MWT >100 m2
Exclusion criteria
  • Heart failure unrelated to ATTR-CM2
  • NYHA class IV heart failure2
  • Light chain amyloidosis2
  • History of liver or heart transplantation2
  • Implanted cardiac mechanical-assist device
  • Pregnancy or breastfeeding5
  • Previous tafamidis meglumine treatment2
  • eGFR <25 mL/min/1.73m4
  • Liver transaminase levels >2X the upper limit of normal2
  • mBMI <6002
  • Concurrent treatment with NSAIDs,‖ tauroursodeoxycholate, doxycycline, calcium-channel blockers or digitalis2
The primary analysis was conducted using the Finkelstein-Schoenfeld method.2
Manifested by signs or symptoms of volume overload or elevated intracardiac pressures requiring treatment with a diuretic for improvement; an NT-proBNP level greater than or equal to 600 pg/mL; and a 6MWT distance exceeding 100 m.2
§Cardiac mechanical-assist device (CMAD) term utilised to cover LVAD. Patients with a permanent pacemaker or implanted cardiac defibrillator were permitted in this study.7
Select NSAIDs were permitted (e.g. aspirin, ibuprofen and naproxen).5

Frequency of CV-related hospitalisations is used to compare patients who cannot be differentiated based on all-cause mortality.
 

ATTR-CM: transthyretin amyloid cardiomyopathy; CV: cardiovascular; eGFR: estimated glomerular filtration rate; LVAD: left ventricular assist device; mBMl: modified body mass index; MOA: mechanism of action; MOD: mechanism of disease; NYHA: New York Heart Association; NSAID: nonsteroidal anti-inflammatory drug; NT-proBNP: N-terminal pro-B-type natriuretic peptide; TTR: transthyretin.

References:VYNDAMAX™ (Tafamidis) Egyptian Drug Authority leaflet approval date 26/7/2021. Revision date: June 2021.Maurer MS, Schwartz JH, Gundapaneni B, et al; ATTR-ACT Study Investigators. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy. N Engl J Med. 2018;379(11):1007-1016.Damy T, Garcia-Pavia P, Hanna M, et al. Efficacy and safety of tafamidis doses in the tafamidis in transthyretin cardiomyopathy clinical trial (ATTR-ACT) and long-term extension study. Eur Heart J. 2021;23(2):277-285.Lockwood PA, Le VH, O'Gorman MT, et al. The bioequivalence of tafamidis 61 mg free acid capsules and tafamidis meglumine 4 × 20-mg capsules in healthy volunteers. Clin Pharmacol Drug Dev. 2020;9(7):849-854.Maurer MS, Schwartz JH, Gundapaneni B, et al; ATTR-ACT Study Investigators. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy [protocol]. N Engl J Med. 2018;379(11):1007-1016.Clinicaltrials.Gov. Accessed June 24, 2022. https://clinicaltrials.gov/ProvidedDocs/89/NCT01994889/SAP_001.pdfMaurer MS, Schwartz JH, Gundapaneni B, et al; ATTR-ACT Study Investigators. Tafamidis treatment for patients with transthyretin amyloid cardiomyopathy [supplemental appendix]. N Engl J Med. 2018;379(11):1007-1016. 

MOH Approval No. : HF0098OA171/082022

Invalidation Date : 11/08/2024

PP-VDM-EGY-0011

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