Contemporary Oral Medication Use and Frequency in Patients with Transthyretin Amyloid Cardiomyopathy
Abstract
Introduction: Transthyretin amyloid cardiomyopathy (ATTR-CM) is an increasingly recognized cause of heart failure (HF), with a higher prevalence in older patients with comorbidities requiring concomitant medical therapy. Acoramidis is a next-generation transthyretin stabilizer with near-complete protein stabilization (≥ 90%) administered orally twice daily (BID) for treatment of ATTR-CM. We report on oral medication use in patients with ATTR-CM using two complementary sources: the ATTRibute-CM trial and real-world claims data.
Methods: In the ATTRibute-CM study, participants with ATTR-CM were randomly assigned 2:1 to receive 800 mg of acoramidis hydrochloride or matching placebo BID for 30 months. Participants from acoramidis and placebo groups were pooled for this analysis. Baseline oral medication use was collected upon enrollment in the study. Real-world data were obtained from patients with ATTR-CM in Optum's deidentified Clinformatics Data Mart Database (Optum CDM) who met the stability criteria. Patients meeting the stability criteria had: (1) ≥ 2 years of continuous enrollment with ≥ 3-months look-back and a 12-month look-forward from index diagnosis, during the study period of 2018-2021 and (2) ≥ 28 days of continuous treatment for a given dosing frequency within the 12-month look-forward period.
Results: The ATTRibute-CM study randomly assigned 632 participants with ATTR-CM (mean [± SD] age: 77.3 [6.6] years). At entry to the study, 407 (64.4%) participants were…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 12,116 participants or records.
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