Dr. Chapa (7:03)
This is Dr. Chapa's obgyn no spin podcast. Sometimes, in the quest to get the news out and be the first on the scene with some new data, things get a little wacky. Look, I don't know what's going on with this article. I'm just gonna read you directly because I don't want to misrepresent what's going on. Because nobody knows, except for the editors and the associate editors, what's going on with this systematic Review and meta analysis. But we saw the same thing during the COVID time, right? So all these papers came out and there was a fair amount of retractions even from very respected and notable journals. They're like, hey, I don't know, this data is kind of whack. I don't know what to do with this. We're gonna, even though we've printed it, it was like, extra, extra, read all about it. And then, you know, two months later, like, I don't know if that was right. Never mind, we're going to, we're just going to cancel it. So sometimes it happens. This isn't unique. I don't know. So let me just tell you what, what this is not, this is not somehow a proponent of canceling these medications or their FDA label. Not at all. It's a systematic review of meta analysis where the editors are saying, we've got, we've got an expression of concern here. I'm going to explain to you what that is. But, but as a reminder, just briefly, as a reminder, personally, I'm all for more medication to take away, you know, moderate, severe hot flashes. Those are terrible. And we've covered both of these medications in the past. This is nothing new. Both of these are related even though they're different medications. One of them actually is a little bit more specific to certain receptors than the other. For example, lunqst, which is elaninosant, is a dual receptor blocker of neurokinin, whereas vioza is a single receptor blocker of a neurokinin. And these work in the chain of command to try to affect the thermoregulatory center. I think this is great. We've covered the mechanism of action of both of these things in the past and they do have independent FDA trial data that say that these things work. I mean, there's, there's nothing new for this. All right. Specifically the OASIS trial, I think we've covered that in the past. That was looking at elaninosant as again, a dual inhibitor of Neurokinin 1 and 3. And it showed, yeah, that that had some efficacy. Fezzolinitant is the antagonist for neurokinin 3. So the thought is if one is good, if you're going to block NK3, well then if Ellen Ninotan can block NK1 and NK3, give you two, block two blockers, maybe Ellen is. That would be quicker on the scene for hot flash relief and, and therefore give you better sleep profile. That at least is a theory. Right. And some of that has you know, bare now borne out in the OASIS trial. So there was yet no meta analysis that was looking at both of these two together to see maybe one was better than the other. So let me just read you from the original publication, just as a reminder. And again, I'm all for these medications. I'm kind of, you know, disappointed that there's something going on with the systematic grievant analysis. But just to be fair, you know, the FDA is still sticking with the label. This is not about label change. I think in the appropriate patient who does not have elevated liver enzymes because both of these can bump liver enzymes. Remember you gotta monitor that, do it at baseline and then again down the road like three months, six months later to make sure that there's no bumps lump. But in the appropriate patient who fears hormonal therapy for moderate or severe hot flashes, I think these have a place. Right? We already talked about that. So these authors, the original authors back in March of 2025 stated, quote, although some meta analyses examined fezzolinitant in menopausal women, no pooled analysis has directly compared both phenylanitant and elenin tint with placebo. End quote. So they had this objective to do the systematic review and meta analysis comparing fezalinitant and eloninasent with placebo in women who are menopausal, experiencing vasomotor symptoms very quickly, they found. The good news is that, yeah, According to this March 2025 Green Journal systematic review and meta analysis, hey, they're both alright. They both had an effect, they both worked. They're both obviously better than placebo surprise. But there was a little bit of benefit towards elenin intent because it had a wider impact on vasomotor symptom relief and it seemed to improve better sleep and seemed to result in better sleep quality compared to fezalinitant. Boy, guys, saying fezilinitant and ella inasant repetitively is very difficult, just FYI. But the short of it is they found while both of them do work, it looked like maybe eleninotent had a larger effect size and maybe improved sleep quality a little bit better compared to fezalinitant. Right? Fine. That was back in March of 2025. Short answer is, hey, both work. But if you're gonna hit two receptors rather than one, maybe might could you would think it would give you a better result and a wider effect size compared to just one receptor. And that's exactly what they found in that original March of 2025 publication. They're like, hey, both work. Knock yourself out. But if you're looking for a larger effect size and a better effect on sleep quality, then hitting two receptors. In other words, using Linkette seemed to be slightly better, although both obviously were better than placebo. No brainer there. And again, let me just say it right off the bat. Once again, I'm totally in favor for this. I think these medications offer a nice option for those who have moderate to severe hot flashes but are afraid of estrogen use and or have a contraindication, as I've already stated. So we're like, okay, fine. Systematic review, meta analysis, both work. Maybe one works better than the other. We'll take it. However, that brings us now to January 16, 2026, where the editors of the Green Journal. I'm going to read this directly because I don't want to misrepresent this release, this expression of concern. It does not happen very often, guys. So let me just read this directly and then we're going to be done. Quote, the editors of Obstetrics and Gynecology are publishing this editorial response of concern because questions that have been raised about the data presented. Okay. They go on to say, quote, as a result of these concerns, the editors requested additional information which revealed that the interpretation of the data may not be accurate, end quote. Now, I don't know what that means. Maybe is it fezolinitin? That's a little bit better. Maybe they're both comparable. Maybe it's the same as placebo. I don't know. I don't know. But all they left us with is this. Quote, the editors are currently considering editorial action which may include correction, retraction, or retraction and replacement. The readers of Obstetrics and Gynecology will be updated when a decision has been made, end quote. Interesting. It's a little drama. It's a little out there. But this is, again, our job here, guys. And I'm not, you know, trying to, you know, poking at anybody. I just want to let you know what's out there so in case somebody comes up to you again and says, oh, you know, this new meta analysis said that this one is better. Well, we don't know yet as of January 16, 2026, because the data is being examined again independently, because of expressions of concern, and we'll leave it at that. So anyway, just found it interesting. We're recording this on January 24, 2026, as Texas and a lot of other states brace for the ice apocalypse or the snowpocalypse. So we actually are trying to knock these out, you know, early, because I've already been told my team's like, we're not going in to record anything until, like, Wednesday. So I'm like, all right, fine, we'll just do this remotely. So just want to let you know what's out there. And, oh, on a side note, here's what's interesting. Now that we've covered menopausal relief, I did receive this message from one of our podcast family members. Super interesting question. So this physician had a new patient come to them already on transdermal estradiol. Fine. For hot flash relief. And the patient was taking natural progesterone to protect the uterus. Fine. Right. Okay. Natural progesterone, transdermal estradiol. The issue is the patient had a previous history of arterial and venous thrombosis. So the question was, wait, do I need to continue that? Isn't that contraindicated? And so we had this wonderful back and forth discussion via text on the pros and cons of this, because we're learning a lot, guys. We are learning a lot about this. The traditional. Just FYI, even though we may do an episode on this in the future, traditionally a previous arterial or venous thrombosis was a contraindication of hormone therapy. I mean, it just is of all types. However, transdermal estradiol doesn't go through the first pass effect and has almost nil effect on pro inflammatory markers and pro thrombotic factors. And there's a lot of good data, I mean, really good data from international sources and even the US that even in those patients, nothing really happened. So it's a great example of traditionally no newer data. Hey, maybe. And so in the middle is shared decision making. I just found that interesting as we're talking about this publication of fezolin tent and elonin isent for menopausal symptom relief. This patient was like, oh, you're not taking this away. We're going to continue my transdermal estradiol, even though I got a history of arterious immunos thrombosis. And is that a good idea? So we may cover that in a subsequent episode. Anyway, podcast family, as always, we're thankful for you. We're glad you're part of our podcast community. Stay warm in this kind of crazy winter weather. And now that we've done all that, I'm gonna go turn on my heater and let's take it home. Foreign. This has been Dr. Chapa Zobi Gyn no Spin Podcast podcast family. Thank you for your support. Thank you for listening, and as always, we'll see you on another episode of the no Spin Podcast.
