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events for 1000 patient-years is shown in grey. The error bars represent the standard

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error to the mean. The incidence rate for primary MACE in Saxagliptin exposed patients

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is shown in yellow. Based on the incidence rate we do not see evidence for increased risk

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in sub groups, Saxagliptin exposed patients. The frequency of the four major CV

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endpoints in the pool population is summarized on the next slide. The frequency of

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major CV endpoints for Saxagliptin versus control highlighted in light blue do not

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indicate a signal for increased cardiovascular risk among Saxagliptin exposed patients.

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We also did not see evidence for dose response relationship for Saxagliptin doses at 2.5

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mg to 10 mgs.

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patients with clinically evident cardiovascular disease, and patient history had at least

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one or two additional risk factors for CV events, like a prior history of hypertension,

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hypercholesterolemia, smoking, or family history of premature coronary artery disease.

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The two most common of these risk factors, hypertension and hypercholesterolemia were

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analyzed separately as were male gender in age of at least 65 years.

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analyzed. The FDA requested that we analyze subsets of cardiac disorder adverse events

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corresponding to ischemic heart disease, cardiac failure, cardiac arrhythmias and a

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category of other events corresponding primarily to structural disorders like valvular

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heart disease. As can be seen in this slide, the data for these endpoints do not indicate a

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signal for increased CV risk among Saxagliptin exposed patients. We also analyzed the

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secondary MACE endpoint that counted all deaths not just those deaths attributed to

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cardiovascular etiology. Again, we did not see a signal for increased secondary MACE

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among Saxagliptin exposed patients.

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The incidence rate for primary MACE in controlled patients, expressed in

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As described in our briefing document, several other CV endpoints were

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