events for 1000 patient-years is shown in grey. The error bars represent the standard
error to the mean. The incidence rate for primary MACE in Saxagliptin exposed patients
is shown in yellow. Based on the incidence rate we do not see evidence for increased risk
in sub groups, Saxagliptin exposed patients. The frequency of the four major CV
endpoints in the pool population is summarized on the next slide. The frequency of
major CV endpoints for Saxagliptin versus control highlighted in light blue do not
indicate a signal for increased cardiovascular risk among Saxagliptin exposed patients.
We also did not see evidence for dose response relationship for Saxagliptin doses at 2.5
mg to 10 mgs.
patients with clinically evident cardiovascular disease, and patient history had at least
one or two additional risk factors for CV events, like a prior history of hypertension,
hypercholesterolemia, smoking, or family history of premature coronary artery disease.
The two most common of these risk factors, hypertension and hypercholesterolemia were
analyzed separately as were male gender in age of at least 65 years.
analyzed. The FDA requested that we analyze subsets of cardiac disorder adverse events
corresponding to ischemic heart disease, cardiac failure, cardiac arrhythmias and a
category of other events corresponding primarily to structural disorders like valvular
heart disease. As can be seen in this slide, the data for these endpoints do not indicate a
signal for increased CV risk among Saxagliptin exposed patients. We also analyzed the
secondary MACE endpoint that counted all deaths not just those deaths attributed to
cardiovascular etiology. Again, we did not see a signal for increased secondary MACE
among Saxagliptin exposed patients.
The incidence rate for primary MACE in controlled patients, expressed in
As described in our briefing document, several other CV endpoints were
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