You're right, it doesn't, but if you look at studies that do look at relapse rates for oral risperidone, Uzedy's numbers look pretty similar, if not better.
Is there any potential tolerance issue? Even for drugs that have a stable effect at a certain dosage level there can be tolerance effects if you increase that dosage and then drop down (indeed don't we know there are some tolerance effects with anti-psychotics eg seizure risk on abrupt quitting?). That's quite a large dose they are recieving during the first month.
Regarding the apparent half size sample (though I got 161 not 154 when I added them) it sounds like they divided the groups by sex when doing the randomization so maybe those are only the results from one sex?
I would call those withdrawal effects -- I usually think of tolerance as something that would require increased dosing due to reduced effectiveness. Sorry to be a bit of a pedant, but, uh, that's part of what I do here.
If you look at the last graph in my essay, you'll see that actually the peak plasma levels aren't really any higher than you would expect from a comparable oral dose, so I don't think there's much to worry about.
Isn't that plot a log plot? The 100 Ng/ml level is basically at twice the point of the 10ng/ml level. The predicted minimun over the first couple weeks does seem substantially larger than the average/minimum of the or dosing. But I do see your point.
Regarding tolerance, what would you call an effect primarily related to the maximum dose taken for some non-trivial period but not largely about the length of exposure? Your pedantic point may be correct but what's the name for that kind of effect?
Oh sure from an AUC point of view, I see. I don't have much more to say about that observation other than this is also the case with every other LAI and it doesn't seem to cause serious problems.
To your second question, I don't know if there's a fancy term for that. I would probably just call it toxicity or a side-effect
Wait how can you say this "seems to be just as efficacious as oral risperidone"?
I don't see how this trial answers that question.
You're right, it doesn't, but if you look at studies that do look at relapse rates for oral risperidone, Uzedy's numbers look pretty similar, if not better.
See e.g.: https://www.nejm.org/doi/full/10.1056/NEJMoa002028
Copy thanks doc, I used your write up to crush department presentation tyvm
Great write up, thank you
Is there any potential tolerance issue? Even for drugs that have a stable effect at a certain dosage level there can be tolerance effects if you increase that dosage and then drop down (indeed don't we know there are some tolerance effects with anti-psychotics eg seizure risk on abrupt quitting?). That's quite a large dose they are recieving during the first month.
Regarding the apparent half size sample (though I got 161 not 154 when I added them) it sounds like they divided the groups by sex when doing the randomization so maybe those are only the results from one sex?
I would call those withdrawal effects -- I usually think of tolerance as something that would require increased dosing due to reduced effectiveness. Sorry to be a bit of a pedant, but, uh, that's part of what I do here.
If you look at the last graph in my essay, you'll see that actually the peak plasma levels aren't really any higher than you would expect from a comparable oral dose, so I don't think there's much to worry about.
Isn't that plot a log plot? The 100 Ng/ml level is basically at twice the point of the 10ng/ml level. The predicted minimun over the first couple weeks does seem substantially larger than the average/minimum of the or dosing. But I do see your point.
Regarding tolerance, what would you call an effect primarily related to the maximum dose taken for some non-trivial period but not largely about the length of exposure? Your pedantic point may be correct but what's the name for that kind of effect?
Oh sure from an AUC point of view, I see. I don't have much more to say about that observation other than this is also the case with every other LAI and it doesn't seem to cause serious problems.
To your second question, I don't know if there's a fancy term for that. I would probably just call it toxicity or a side-effect