X hits on this document

525 views

0 shares

0 downloads

0 comments

167 / 170

9

something that there should be more data on, more because it could be that this drug is a

10

safer drug to use under some circumstances. There wasn’t enough data in terms of that or

11

in terms of use in the elderly where there are some sluggish responses to hypoglycemia

12

and so forth that might make them different from middle-aged patients, so I think that

13

should also be monitored in a future study.

1

wouldn’t be fair to apply that rule today, but on the other hand, it isn’t fair to not

2

insist on getting that type of data in the relatively near future, so that we can be sure that

3

our optimism about the data that we’ve looked at is, applies across the whole spectrum of

4

diabetic patients, I’ve been more struck in the last couple of years looking at the results of

5

ACORD and the VA study and the long-term results of the UK PBS that the

6

cardiovascular complications are more complex than many of us had thought and that we

7

just need more data in that area.

17

that everyone wants good post-marketing studies with the criteria that we mentioned

18

earlier and I want to congratulate the committee for really doing a good job of walking

19

the fine line between preserving patient safety and yet trying to move drugs in this

20

transitional period into the market. I would like to ask if the FDA has any other

21

comments or questions that they would like to bring up at the present time, No?

22

Anybody have any other issues?

8

I also think that the issue of avoiding hypoglycemia is important and

166

14

DR. LESAR: I voted no. For many of the reasons that have already been

23

(No response.)

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

15

16

discussed and particular the need to study this drug further in patients with high risk.

DR. BURMAN: Thank you. I think this is an easy one to summarize in

Document info
Document views525
Page views525
Page last viewedFri Dec 09 22:34:57 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments