Transcript
Dr. Akinboboye:
The barriers include the fact that the level of know-how about this disease amongst our practitioners is kind of limited. What we've learned over time with this disease is the earlier we start the treatment, the better. But a good number of these uh patients uh with ATTR-CM, they are often misdiagnosed as having either uh hypertrophic cardiomyopathy, hypertensive heart disease, and um some might be misdiagnosed as having ischemic uh cardiomyopathy, uh maybe because they had some type of ischemic event in the past, but that does not preclude having, you know, ATTR-CM.
So many of these patients do go for many years undiagnosed, because a good number of them are actually in primary care offices. So they are the big barrier, in my opinion, is really the fact that a lot of uh—we still need to, uh you know, educate more, get more uh practitioners to be able to recognize this disease. And of course, we need to educate our patients as well, uh because the symptoms can be basically similar to what we see in many other conditions. So it's kind of difficult sometimes to know, unless you really understand this disease, to be able to separate them from other causes of heart failure.
Voiceover:
Indication and Important Safety Information.
Indication
Attruby® (acoramidis) is indicated for the treatment of cardiomyopathy of wild type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation.
Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).
Laboratory Tests
Mean increase in serum creatinine of 0.2 and 0.0 mg/dL and a mean decrease in eGFR of 8.2 and 0.7 mL/min/1.73 m2 was observed in the adults with ATTR-CM treated with Attruby versus placebo, respectively, at Day 28 and then stabilized. These changes were reversible after treatment discontinuation.
Use in Specific Populations
Pregnancy & Lactation: There are no data on the use of Attruby in pregnant women. Animal data have not shown developmental risk associated with the use of Attruby in pregnancy. There are no available data on the presence of Attruby in either human or animal milk or the effects of the drug on the breastfed infant or maternal milk production.
Please see Full Prescribing Information for Attruby at Attruby.com/PI