More thoughts on ProZinc & H

I called BIV today to ask them for the research on ProZinc. One study is actually on the ProZinc.us web site under "For Vets":
"Field Safety and Efficacy of Protamine Zinc Recombinant Human
Insulin for Treatment of Diabetes Mellitus in Cats"
http://prozinc.us/document_handler.ashx?document_id=13

The other research document they have is the study comparing PZI Vet to ProZinc. Unfortunately, they would not give it to me directly - they had to fax [no e] to my vet first then my vet will have to get it to me. When I review it I'll post any more impressions. Unfortunately too it is copy written material and I will be unable to post it.

Anyway from the Efficacy study something caught my eye:

The time of the blood glucose nadir varied between cats, ranging from 1 to 9 hours throughout the study, and the time interval from PZIR administration to blood glucose nadir was significantly (P < .05) shorter at day 45, compared with days 7, 14, and 30 (Table 1). The lowest blood glucose concentration was at the last blood sampling time (ie, 9 hours) in 32 cats and presumably the blood glucose nadir occurred later than 9 hours after PZIR administration in some of these cats.

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Here's the "Time to blood glucose nadir (h)" data from Table 1:
Time of blood glucose nadir (h)
Day 0 - ND
Day 7 - 5.4 ±2.5e
Day 14 - 5.4 ±2.5e
Day 30 - 5.5 ±2.5e
Day 45 - 4.6 ±2.2b,c,d,e
b P < .05 significantly different from value obtained on day 7.
c P < .05 significantly different from value obtained on day 14.
d P <.05 significantly different from value obtained on day 30.
e n = 133 cats.

So basically the difference in nadir I think I observed might be a totally expected reaction that cats would have to ProZinc if not PZI in general. And especially since we are starting a new insulin I'm going to assume that I need to wait a little bit longer to really see where his nadir settles.

However, above it says the time to nadir was shorter on Day 45 than before - but the Fig 1 seems to show the opposite. [I'm in the process of figuring out what may explain this.]

"Fig 1" in that PDF is interesting. The 7 day average nadir was at +5 and at the end of 45 days it was at +7. They only tested at +1, 3, 5, 7 & 9. I think this is important to keep in mind for advice givers here that initially nadir would be expected to change as time went on for new ProZinc users. I'll bet this might be true to for other PZIs?

Have you seen this study Gator?
http://www.vetlearn.com/ME2/Audiences/d ... DF82758ACA

Nope, I hadn't. Thank you so much for digging that up!!!

I bet that "Preliminary Study of Protamine Zinc Recombinant Insulin for the Treatment of Diabetes Mellitus in Cats" (PDF version) is the study the BIV lady I spoke with was talking about - the one they had to send to FAX to my vet first [so silly].

At least now I know I'm not missing anything.

Yes I'm glad that they point out the following:

Although PZIR may have been more effective than PZI VET in these cats, another possible explanation for this improvement is that increased frequency of diabetic monitoring (e.g., physical examinations, owner observations, serum fructosamine measurements) may have allowed for finer-tuned dosing and therefore better glycemic control.

Click to expand...

Yep, imagine what could have been possible if they were home testing!! 30 days is unfortunately a pretty short period and not much data - just fructosamine tests really. The study seems limited in scope to reach the basic conclusion of if the switch on a 1:1 is safe or not. "PZIR was safe and effective for the treatment of DM in this study of 47 cats and may serve as a viable substitute for PZI VET."

I'm supposed to be hearing more from BIV next week, we'll see how that goes.

I'm going to call and see if I can talk to Cynthia Cole (it will probably be the week of the 18th) to find out how they defined "moderate" and "well" controlled. She's here in North Carolina so I'm hoping I can get to her directly instead of going through the Help line. I'll let you know if I succeed.

OK a couple things.

First I've started a spreadsheet for H's ProZinc numbers here:
https://spreadsheets.google.com/ccc?key ... XYwVFJ4M0E
I also wanted to point out that beyond H's other issues, part of the variables involved in the switch are from and old bottle to a new bottle [concentration differences may have existed]. Also, H has only 1/2 of a liver [the other half was removed] so I tend to play things safe [I suspect that with only 1/2 a liver he would be able to respond to a rebound situation as efficiently as other cats.]

Also I spoke with Dr. Andy Fox - a staff vet for BIV and asked about the Table 1 data in relation to Figure 1 data. He said he was "not sure how to reconcile it necessarily" and that he would contact Dr. Nelson for clarification. I see this taking a while to achieve. I may try to contact Dr. Nelson myself ultimately.

As for the data from the study, Dr. Fox pointed me to the FDA "center for veterinary medicine" which I assume is this site:
http://www.fda.gov/AnimalVeterinary/
He said I should search for "PZIR" or "ProZinc" which would deliver the FOIA docs for the study. And that the FDA may not have these docs in the system yet. Currently, neither search term show results.

More strips are on the way so I should be able to test a little more here.

Just found this post, very interesting info...

:?: Gator, I noticed on your ss that you are able to add little time notes to some cells. So many times I'm at 1/2 hour increments and cant decide which hour to enter into. Help for a newbie please? :?:

Also interesting that neither of our little guys would have qualified for that study due to other medical issues. It does get complex doesn't it?

Anyway, thanks for the posts and any PZIR updates you might come across. cat_pet_icon

Hi Nancy,

To answer the spreadsheet question:
First you need to send people to the non "HTML" version of your spreadsheet. I'm unsure of why the instructions have people send folks to the HTML version. To do this remove the "&output=html" from your link. Then in google docs spreadsheet right click on the cell and then left click on "insert comment." The same basic thing would be true for Excel as well. You are just inserting a comment for that cell. Just make sure that when you publish it in Google docs that you make it read-only [or so that only you can make changes] for anyone but you. Also I modified the colors in my spreadsheet so they are not so crazy glaring and tightened up the columns. I think if anyone wanted they would save mine then blank it and use it for themselves.

Like Cody, H has triaditis too.

It seems I'm one of the few trying to keep notes on my experience with ProZinc. Unfortunately, we have some other underlying issues that complicate the matter and are not really transferable to other "normal" kitties. You are right, it makes things tough. H's appetite has been pretty heavy now for a while so he is getting a more than average dose and we are just barely keeping up with him since I'm being very non-aggressive with his dosing currently. Then yesterday, BAM his appetite fell out. For the last month I've generally avoided making quick dosing changes and I'm really beginning to questions that. H is not like other cats [his appetite fluctuates and he only has 1/2 a liver for instance]. It's like not only do I have to dose on what his BG at the time is but also what I *think* his appetite *might* be like during the next cycle. And I'm frequently behind by at least one cycle on guessing his appetite. So with the additional testing that I've been doing I would expect my dosing strategy here to change up.

For anyone else out there, please share your experience with ProZinc especially in comparison to PZI Vet. It is important for PZI in general since the current mantra about ProZinc is, "We just don't know enough about it."

Just like you I have tried documenting as we go for my own and other's benefit, but again other issues may be clouding the picture for us as well. If you're interested, I post more often in High dose. Apparently, Cody's 12-13 u vetsulin raised some suspicions. :lol:
Thanks for the info and I'll keep posting the ss, check back.

N