When the transthyretin stabilizer acoramidis received European Union approval in February 2025 for transthyretin amyloid cardiomyopathy, it entered a field where real-world evidence in Europe was essentially nonexistent. A new analysis of German prescription claims, published as an original paper in Clinical Research in Cardiology, now offers the first picture of how the drug is actually being used in routine care. Drawing on the IQVIA Longitudinal Prescription database, which covers approximately 82% of prescriptions reimbursed by Germany’s statutory health insurance, researchers identified 289 adults who received a first acoramidis dispensation between April 1 and September 30, 2025. The findings describe an elderly, predominantly male patient population and a prescribing pattern dominated by first-line use rather than switching from the established stabilizer tafamidis.
The demographic profile of the cohort is striking. Median age at initiation was 82 years, with an interquartile range of 77 to 85, meaning half of all new users fell between those ages. Sex was documented for most patients: 80% were male, 15% were female, and for 5% sex was unknown. The authors note that the proportion of women, while low, was slightly higher than in the pivotal trials of disease-modifying ATTR-CM therapies, though they caution that this difference is modest and should be interpreted cautiously. The elderly skew reflects the epidemiology of the disease itself, which is an increasingly recognized cause of heart failure particularly in older patients, with late diagnosis common and prognosis poor.
Perhaps the most consequential finding concerns pretreatment status. Of the 289 patients, 249 (86%) were classified as treatment-naïve, having no recorded tafamidis 61 mg dispensation from March 2020 until the index date, while only 40 had previously received tafamidis and were counted as switchers. The authors emphasize that treatment-naïve status refers strictly to the absence of observed tafamidis dispensations within the available prescription look-back window, a methodological nuance that matters because the database captures dispensations rather than diagnoses. Still, the conclusion holds: acoramidis was predominantly prescribed as first-line therapy, and switching from tafamidis was comparatively infrequent in these early months of availability.
Where the drug was initiated also stands out. Hospital outpatient departments accounted for 87% of acoramidis starts, underscoring the specialist-driven nature of ATTR-CM care. Initiation in this setting was slightly less common among switchers than among treatment-naïve patients, at 78% versus 88% respectively, a small difference that may reflect that patients already established on tafamidis were somewhat more likely to have the drug started or continued in other care settings. The authors interpret the rapid adoption of acoramidis as an alternative treatment option as a sign of active therapy optimization at specialist centers.
The comedications these patients were taking reveal how medically complex the population is. In the 12 months preceding acoramidis initiation, the most common dispensations were renin–angiotensin system inhibitors at 76%, sodium–glucose cotransporter 2 inhibitors at 74%, beta-blockers at 71%, loop diuretics at 64%, lipid-lowering drugs at 60%, and direct oral anticoagulants at 60%. These figures align closely with contemporary German ATTR-CM care described in other studies. A German IQVIA analysis of tafamidis 61 mg by Attal and colleagues reported a similarly elderly and predominantly male population with frequent cardiovascular comedications, including loop diuretics in 71%, beta-blocking agents in 68%, direct factor Xa inhibitors in 55%, and statins in 56%. A multicenter cohort of 262 patients treated with tafamidis, reported by Nies and colleagues, likewise found frequent use of diuretics (70%), RAS inhibitors (61%), beta-blockers (58%), and oral anticoagulation (64%).
Differences between switchers and treatment-naïve patients add a layer of clinical texture. Switchers were less likely than treatment-naïve patients to be taking RAS inhibitors (60% vs. 79%), mineralocorticoid receptor antagonists (30% vs. 38%), SGLT2 inhibitors (68% vs. 75%), and analgesics (33% vs. 42%), while loop diuretics were more commonly used among switchers (70% vs. 63%). The authors suggest this pattern may be compatible with greater clinical burden or lower tolerance of these agents because of hypotension, a common concern in ATTR-CM. Greater use of direct oral anticoagulants among switchers may be compatible with a higher burden of atrial arrhythmias, which are common in the disease and associated with increased thromboembolic risk. Higher loop diuretic use among switchers may indicate a greater heart failure-related treatment burden, though the authors are careful to note that prescription data cannot determine the reasons for switching or establish disease progression under tafamidis.
The temporal analysis is where the study becomes most revealing. Restricting the trajectory analysis to first-line acoramidis patients with observable data in both the required pre- and postindex periods, the researchers examined dispensations in predefined 3-month intervals from 12 months before to 3 months after initiation; 128 patients met these criteria. Between the 12–10-month and 3–1-month preinitiation intervals, use of RAS inhibitors remained relatively stable (56% vs. 60%), as did beta-blockers (44% vs. 52%) and calcium channel blockers (16% in both periods). By contrast, substantial increases were observed for mineralocorticoid receptor antagonists, rising from 14% to 31%; loop diuretics, from 34% to 56%; direct oral anticoagulants, from 29% to 46%; and SGLT2 inhibitors, from 22% to 65%. A substantial number of patients, 6%, were on antineuropathic drugs. These trends persisted in the first 3 months after acoramidis initiation.
The authors offer a plausible interpretation of this escalation pattern. Because most patients started acoramidis as first-line therapy, initiation likely coincided with their ATTR-CM diagnosis date. The disease is often not recognized, with an average diagnostic delay of 6 to 8 years, during which other conditions may be presumed and treated. The intensification of comedications before and shortly after acoramidis initiation may therefore reflect increasing diagnostic certainty, with specialist centers tailoring heart failure therapy once ATTR-CM is confirmed. Increasing use of MRAs and SGLT2 inhibitors is consistent with evidence-based management of ATTR-CM, while increased anticoagulant use may signal identification of atrial fibrillation during the diagnostic work-up. Higher loop diuretic use likely represents worsening heart failure symptoms in the year prior to initiation. The authors frame this as consistent with active therapeutic optimization in specialist centers rather than as evidence of any direct drug effect.
The study’s limitations are clearly stated and worth internalizing. The LRx database does not contain diagnoses, ATTR subtype, NYHA class, biomarkers, imaging findings, or outcomes, which limits direct clinical comparison with center-based cohorts. Medication dispensation was used as a proxy for drug intake and may overestimate actual use. Other disease-modifying ATTR-CM therapies were not assessed. Given the small sample size and lack of a control group, the relationships shown are explorative and hypothesis-generating. The analyses were exploratory and descriptive, with subgroups defined by pretreatment status and changes in concomitant medication restricted to patients with observation data in both pre- and postindex periods. Because the database study involved no intervention and used anonymized electronic medical records, German law does not require informed consent from patients or Ethics Committee approval.
What the StarTTR analysis ultimately delivers is an early benchmark. As the authors put it, these data provide a starting point for monitoring acoramidis adoption and will inform future comparative effectiveness research. Ongoing analysis of large prescription databases will be crucial for tracking real-world implementation, adherence, effectiveness, and safety of the drug as its use expands beyond the initial months captured here. For a disease where therapeutic advances have raised awareness and emphasized the importance of early diagnosis and treatment, associated with improved outcomes, knowing who is actually receiving a newly approved stabilizer, in what setting, and with what background therapy is a necessary first step toward understanding whether the promise shown in the phase III ATTRibute-CM trial, where acoramidis improved mortality, morbidity, and function compared with placebo with a similar safety profile, translates into routine clinical practice.
Subject of Research: Real-world use of the transthyretin stabilizer acoramidis in German routine care for ATTR-CM
Article Title: Early real-world use of acoramidis for transthyretin amyloid cardiomyopathy in Germany: results from StarTTR
Article References: Morbach, C., Ohlmeier, C., Trenkwalder, T., aus dem Siepen, F., Kruppert, S., Keuken, G., Evers, T., Pfister, R., Herrmann, S., & Störk, S. (2026). Early real-world use of acoramidis for transthyretin amyloid cardiomyopathy in Germany: results from StarTTR. Clinical Research in Cardiology. https://doi.org/10.1007/s00392-026-03023-0
Image Credits: AI Generated
DOI: 10.1007/s00392-026-03023-0
Keywords: acoramidis, ATTR-CM, transthyretin amyloid cardiomyopathy, tafamidis, real-world evidence, prescription database, IQVIA LRx, heart failure, comedication, Germany, drug utilization, StarTTR
News Source: Ophelia Keating. (November 4, 2026). First real-world look at acoramidis in Germany finds mostly first-line use in older patients. Scienmag.
