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Now, based on the clinical profile of Saxagliptin established to-date we

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are planning a randomized controlled event driven clinical trial. The objective of this

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data to identify and compare patients taking Saxagliptin with other oral antidiabetic

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agents on the market. These studies are planned using existing healthcare databases in

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both United States and the European Union. One of the outcomes under study will be

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major cardiovascular adverse events. Both of these programs are described in greater

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detail in your briefing book. These two complementary approaches, enhanced

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pharmacovigilance and observational studies, will allow for this continued assessment of

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the tolerability and safety of Saxagliptin throughout its life cycle.

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Squibb and AstraZeneca have established a history of characterizing the long-term

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benefits for agents such as Pravastatin, Rosuvastatin and Clopidogrel. We plan to

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continue this legacy of post-approval assessment of benefit risk with Saxagliptin in this

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new area. We are excited about the possibilities that the contribution of Saxagliptin can

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

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program of 3b and 4 clinical settings, which will independently adjudicate cardiovascular

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events. These studies include the use of Saxagliptin with Insulin in several active

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comparator controlled studies.

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trial is to characterize the long-term benefits of Saxagliptin in the management of type 2

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diabetes. This study will further develop the cardiovascular profile of Saxagliptin using

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prospective adjudication and analysis of events in a population at an elevated risk. This

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is yet another mechanism for the continued assessment of the clinical profile of

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Saxagliptin post-approval.

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Lastly, randomized clinical trail data would be generated through our

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In the cardiovascular metabolic disease areas both Sponsors Bristol-Myers

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