hope for therapy in Germany

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Re : hope for therapy in Germany

Post by angieb » Mon Jun 28, 2010 12:45 am

Thanks Caryn! That does explain a lot.

Re : hope for therapy in Germany

Post by caryn » Sun Jun 27, 2010 11:03 pm

Re: 23-weekers -- I suspect this varies quite a lot by hospital. 23 weekers are right at the stage where the lungs are differentiating from a solid mass of tissue to something with air sacs, so some 23 weekers have nothing to inflate with oxygen yet. Those who do would require specialized equipment (particularly very very small equipment) so to some extent it would come down to whether or not you were at a very high-level NICU and then it would depend on the developmental stage the lungs were at. As I understand it steroids cannot act on the undifferentiated tissue, because it hasn't yet developed the proper receptors.

Re: tests -- Standard of care will take a while -- in particular, they'll need to see if administering the test improves outcomes! It seems to me that it is likely to do so, if it allows time for steroids, but it's always possible that babies will be delivered earlier in response to a positive predictive test and that this will lead to poorer outcomes than not administering the test. So yeah, further study.

Here's the abstract for the journal article I find the most interesting. :) It says 1) The PlGF/sEng ratio and its delta and slope had an excellent predictive performance for the prediction of early-onset preeclampsia, with very high likelihood ratios for a positive test result and very low likelihood ratios for a negative test result; and 2) Although the positive likelihood ratios are high and the positive predictive values low, the number of patients needed to be closely followed is 4:1 for the PlGF/sEng ratio and 3:1 for the slope of PlGF/sEng.

This is of course math talk. For those who don't speak math: "ratio" just means the difference between the two. One part PlGF to two parts sEng might be normal, but one part PlGF to fifteen parts sEng might not be. "Slope" means "rate of change between two points" -- in other words they will compare the levels from your 12 week bloodwork and your 24 week bloodwork and if they are changing faster than some cutoff it will meet diagnostic criteria. So for example -- in completely imaginary numbers -- if sFlt levels doubled, that wouldn't be diagnostic, but if they quadrupled, they would. And "delta" means that if the rate is accelerating, curving upwards on a graph, at some particular rate, that you'll be diagnosed. For that they would need three points, to make a curve, so I'm assuming this means MOAR BLOODWORKS.

It's also possible to use these tests just once, as a "spot test", with an absolute cutoff. Say 99.5% of people with levels above 6 widgets are severely preeclamptic -- so they'd check your bloodwork to see if your levels were above 6, and if they were they'd treat you as if you were a severe preeclamptic. This would be a lot faster than waiting for a 24-hour urine.

So as I understand things, the idea is to use sFlt and sEng to develop a test to predict preeclampsia onset before 34 weeks gestation, also usable as a confirmatory diagnostic test in the hospital. But it won't be usable at 24 weeks to predict PE at 37 weeks. Still, at that gestational age you'd just deliver; what we really want to know is who's going to get sick early, so we can watch them closely and get steroids on board before things go truly pear-shaped.

Also, the reason I keep saying "sFlt" and the abstract says "PlGF" is that soluble Flt binds to Placental Growth Factor, so measuring one just is measuring the other. IIRC it was easier to measure PlGF because they already had an assay for it.

Re : hope for therapy in Germany

Post by jules2 » Sun Jun 27, 2010 04:32 pm

No, its definitely not standard of care in the UK at the moment, the UK preeclampsia sites would report on it if it were.

Does anyone know when the sFlt test can be used? Or link me to the research evidence to see if its any good anyway?

Re : hope for therapy in Germany

Post by angieb » Sun Jun 27, 2010 01:31 pm

How many weeks can a pregnant women recieve steroids to develop babys lungs?

My (current) MFM will only do them at 24 weeks but the NICU she delivers at doesn't even attempt to save 23 weekers even though their survival rates aren't totally hopeless. So I'm not sure if she won't do it earlier because of the hospital policy or because the shot doesn't work before 24 weeks.

Re : hope for therapy in Germany

Post by miamibunnie » Wed Jun 23, 2010 09:48 pm

How many weeks can a pregnant women recieve steroids to develop babys lungs?

Originally posted by Caryn

This is precisely where a lot of the ongoing research is looking for a bench-to-bedside therapy -- right at the soluble factors like sFlt-1. What we want is something safe for the mother that allows pregnancy to be prolonged for at least 48 hours, to get the steroid shots on board.

Probably an English translation will show up in PubMed shortly.

Re : hope for therapy in Germany

Post by caryn » Tue Jun 08, 2010 11:14 pm

Ah, it's Roche who launched in Europe: http://www.roche.com/media/media_releases/med_dia_2009-01-06.htm

Here I believe it's coming out first from Miraculins and Inverness: http://www.miraculins.com/press_releases.aspx?id=101

Re : hope for therapy in Germany

Post by sam10 » Tue Jun 08, 2010 10:45 pm

I dug around in the internet and could not find any more details other than the same article being published everywhere! I have checked the German forums and somebody mentioned that she actually was tested in Koeln.Perhaps she is willing to share her results. Will try to figure out more. This is rather interesting.

Re : hope for therapy in Germany

Post by caryn » Tue Jun 08, 2010 10:18 pm

These tests are in development, and will likely become available in the USA within the year, through labs. Turning the research data into a practical test has taken time, though.

I believe the UK or Europe already has a sFlt test on the market but it is not standard of care yet and does not include the sEng markers.

Re : hope for therapy in Germany

Post by sam10 » Tue Jun 08, 2010 07:52 pm

Thanks for sharing this.

It says in this article that the concentration of sFlt-1 can be used as an indicator for the likelihood of PE in a pregnant woman and of the severity of PE. Is this an medical/statistical assumption or is this already been established? If so, why aren't all pregnant women tested on their levels of sFlt-1? This should become standard.

It would be great if it were that simple to filter out the sFlt-1 as a method to prolong a PE pregnancy.

I will print out this article for future reference.

Nothing else in this article stuck out that we don't know. Just some general information on PE and of how great the cooperation was and so forth and so on. No further details on the method itself unfortunately.

Re : hope for therapy in Germany

Post by caryn » Fri May 28, 2010 09:12 pm

I don't know if you could request it yet. Any human therapy has to go through a sufficiently controlled human trial to show that it doesn't introduce harms before you can introduce it as standard of care -- and there's not supposed to be any adoption of therapies until those trials are completed. If this study meets those criteria then it will make it through hospital IRBs and be adopted as the new standard of care.

That sounds like I'm being a stickler for rules when babies are dying. But. An awful lot of docs recommended and people adopted, in an uncontrolled experimental fashion, antioxidant therapies, on the grounds that they couldn't hurt and might help, based on some small studies. And then the big studies showed that actually, they *could* hurt. Mostly this disease is just so counterintuitive that docs have gotten a lot more cautious. The HYPITAT study one of the only ones where I'd expect printing it out to potentially change an individual practice, and that's because induction at term for maternal indicators is already an accepted practice, if that makes sense.