factors of this population. Saxagliptin was well tolerated with monotherapy and in
combination with other oral antihyperglycemic agents. This table provides a summary of
adverse events based on an analysis of the placebo controlled pool population up to week
24 including rescue therapy. The frequency of patients with adverse events treated with
Saxagliptin 5 mgs was similar to placebo. 72.2% compared with 70.6%. There was no
discernible difference in the clinical AE profile between the Saxagliptin 2.5 mgs and 5mg
groups. Deaths and serious adverse events were infrequent and occurred at comparable
frequencies between patients who received Saxagliptin and placebo.
hypoglycemia, dermatologic safety, lymphocytes, and an overall summary of the
general safety profile. Additional details of the Saxagliptin safety profile can be found in
our briefing book. Our safety review will primarily focus on the cardiovascular profile
with Saxagliptin, our initial assessments of CV safety reflected the concern with
cardiovascular disease as the leading cause of morbidity and mortality in patients with
type 2 diabetes. In addition, a comprehensive set of analyses were undertaken in light of
recent final guidance from FDA on evaluating CV risk and will be presented later by Dr.
combination study with Metformin. AEs leading to discontinuation from study therapy
were infrequent in all treatment groups and were reported in 2.2%, 3.3%, 3.9% and 1.8%
of patients in the Saxagliptin 2.5 mg, 5 mg, 10 mg, and placebo groups, respectively. In
contrast, as described in the briefing book, in the initial combination therapy study with
Metformin, AEs leading to discontinuation were similar in each of the treatment groups,
which contain Saxagliptin and in the Metformin monotherapy group.
Dr. Wolf will also further describe the cardiovascular history and risk
We also observed similar findings across treatment groups in our initial
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