A post-hoc analysis of the THAOS registry (Transthyretin Amyloidosis Outcomes survey) was conducted with data from 1,441 patients who had ATTR-CM and a predominantly cardiac phenotype. Patients were categorised as Tafamidis-treated if they received Tafamidis while enrolled in THAOS or Tafamidis-untreated if they have never received Tafamidis while enrolled in THAOS.The analysis included all patients in the registry with a predominately cardiac phenotype at enrolment , defined as patients with ATTR-CM without signs and symptoms suggestive of associated ATTR amyloidosis- related neuropathy.

It is important to remember that real-world studies provide information about the effectiveness and tolerability of treatments under real-world conditions. Randomised Clinical Trials measure the efficacy and safety of an intervention in a randomised population.
Real-world studies are designed to evaluate associations among variables and cannot establish causality. They are not intended for direct comparison with clinical trials.

The post-hoc analysis included patients who received any dosage of Tafamidis, not just the licensed Tafamidis meglumine 80 mg daily/Tafamidis 61 mg daily, to provide real-world representation beyond the scope of randomised clinical trials.

Observational retrospective analyses are designed to evaluate associations among variables, cannot establish causality between treatment and outcomes and may introduce bias. Results are not intended to be compared with clinical trials and should be interpreted with caution in the context of the totality of evidence.

Analysis of RWE shows no new safety signals, supporting the long-term safety and tolerability profile of tafamids in a real-world setting.

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