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states that applicants should set up an independent committee to prospectively and

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blindly adjudicate major cardiovascular events. It recommends that the phase 2/phase 3

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development plan be designed to permit a valid pre-specified meta-analysis of major

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cardiovascular events. It recommends that trials include patients at increased risk for

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cardiovascular disease, such as those with longstanding diabetes, renal impairment or

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advanced age. It also notes that trial duration should be longer than the typical six-month

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core Phase 3 trials used in the past for seeking approval for type 2 diabetes products and a

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longer duration would ensure that a sufficient number of cardiovascular events are

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accrued. Also provide long-term data for these chronically used therapies.

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reaffirms hemoglobin A1c as the primary efficacy end-point for glucose reduction but

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also notes vulnerability of patients with diabetes to cardiovascular disease, which is the

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leading cause of mortality in this patient population. It asks Sponsors to demonstrate that

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new therapies for type 2 diabetes do not unacceptably increase cardiovascular risk. FDA

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has also publicly stated that, ‘we would like to see evidence of cardiovascular safety for

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those unapproved therapies that either had already completed their development program

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or were in late stages of the development program at the time the guidance was issued’.

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Note this guidance does not discuss cardiovascular assessment for already approved

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treatments for type 2 diabetes; this will be addressed separately in the near future.

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risk of a new investigational agent. Basically it asks applicants to compare the incidence

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of major cardiovascular events occurring with an investigational drug to the incidence of

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major cardiovascular events occurring with comparator. It recommends that applicants

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Key points from the diabetes cardiovascular guidance are as follows. It

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Key recommendations from the guidance are as follows. The guidance

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The guidance then goes on to explain how to quantify the cardiovascular

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