Despite evidence-based guidelines for thyroid hormone replacement therapy, a significant percentage of patients fail to achieve acceptable/optimal symptom control with T4 monotherapy. What is the role for alternative combination approaches, such as DTE?
That's a very important framework we should. We should apply when as a clinician, as clinicians we look at our patients. The if you want, the universe of patients living with hypothyroidism is very large and with very difference among individuals. Uh, most patients do well only with thyroxine, whereby doing well, uh, I mean. Their symptoms uh uh as fatigue, uh, depression, uh, cold intolerance tend to. Be back to normal, just only water oxygen therapy, and as we say all the time, we really cannot improve perfection, so those patients are totally fine and uh uh they're doing well on a on a well defined therapy, easy to administer, easy to follow, and that's great for them. Some patients unfortunately don't. And uh the question uh there is uh is this related to the hypothyroid state or not? And uh uh guidelines and good clinical practice dictate that we need to investigate very thoroughly whether there are additional causes for patients symptoms. Reason being that uh patient, uh, the symptoms associated with hypothyroidism are incredibly variable, uh, not particularly, uh, defined and uh uh very different among individuals. So we really need to do our job as clinician in sorting out is this because uh is the patient fatigued because uh of hypothyroidism, unresolved hypothyroidism versus uh for instance, uh, anemia. Or vitamin B12 deficiencies, those are conditions that are associated with hypothyroidism, and it's important to sort them out. At the same token, it's common experience that some individuals, despite all our efforts of both optimizing all other conditions. Don't do well and uh uh it's uh uh it's important having opportunities to provide uh additional uh the uh therapeutic options. There is also a background of literature that indicates that yes, when we restored the euthyroid state in the pituitary because we measured TSH, which is a pituitary hormone, as a proxy for all body euthyroidism. If we measure TSH, we achieve a normal normal TSH. But uh the uh if you wanna call it price, we pay to have to have a normal TSH on the levothyroxine only is a small abnormality in thyroid hormone levels. So the T4 tend to go a bit up and the T3 tends to be on the lower end of normal. Once again this is a proxy. It simply tells us that maybe we are not doing a full, we are not achieving a full euthyroid state in the whole body. But then the next step is can we do better? And in order to do better, we need uh alternative uh uh therapeutic approaches. And one of them is providing additional T3 and that can go either with uh niotyronine in combination therapy or as it been going on for more than a uh more than a century. Using the cicadia thyroid extracts and that and that's a uh that's a viable option in my opinion, and I'm really happy that uh uh we've been working together with the FDA in order to develop a program that can provide, Safe and well characterized drug that then can be used officially been FDA approved for treatment of hypothyroidism and that's where the North Star program comes in.
