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Riccardo Perfetti, VP, Sanofi-Aventis to speak at Diabetes Summit March 8 in PA

Riccardo Perfetti, VP, Sanofi-Aventis to speak at Diabetes Summit March 8 in PA - Molecular Biology Techniques

Riccardo Perfetti, VP, Sanofi-Aventis to speak at Diabetes Summit March 8 in PA - Molecular Biology Forum. Includes forums for common molecular biology techniques.


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Old 01-16-2011, 05:05 PM
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Post Riccardo Perfetti, VP, Sanofi-Aventis to speak at Diabetes Summit March 8 in PA



Riccardo Perfetti, MD, PhD, Vice President, Global Medical Affairs, Diabetes
Division at Sanofi-Aventis will give a keynote presentation on "The
Regulatory Approval of Glucose-Lowering Agents - An Evolving Landscape" at
the Diabetes Summit to be held in Philadelphia, PA on March 7-8, 2011 by
GTCbio. Dr. Perfetti will discuss the significant changes in the medical
management of diabetes. New drugs and new mechanisms of action have been
proposed as means to lower blood glucose. The post-approval experience with
novel glucose lowering agents have seen major successes and unprecedented
failures. The use of HbA1c as a biomarker of efficacy has been put into
question and the regulatory requirements have included more direct and
indirect evidence of safety. Dr. Perfetti will discuss how the requirements
for more definitive proofs of efficacy and safety will continue to evolve
and lead to changes in the regulatory requirements in the years ahead of us.
Dr. Perfettis presentation is meant to review the latest real-life
experience with the approval process of new glucose lowering agents,
critically discuss the current regulatory requirements, and analyze the
possible evolution of the regulatory landscape.

This Diabetes Summit includes two concurrent tracks: The 4th Diabetes Drug
Discovery and Development Conference and the Diabetes Partnering and Deal
Making Conference.
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Old 08-11-2012, 06:25 PM
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Default Re: Riccardo Perfetti, VP, Sanofi-Aventis to speak at Diabetes Summit March 8 in PA

For to calculate absolute risk of cardiovascular diseases (CVD) in adult with type 2 diabetes, equations derived from that proposed by Anderson K.M. (Anderson KM, Odell PM, Wilson PW, Kannel W. [1991] Cardiovascular disease risk profiles. Am. Heart J. 121:293–8) are used. Specifically, better equations are those that includes, among other things, HbA1c that is highly significant for to predictive also the metabolic diseases and CVD risk, even in normal healthy people (Selvin E., Steffes M.W., et. al. [2010] Glycated Hemoglobin, Diabetes, and Cardiovascular Risk in Nondiabetic Adults. N Engl J Med. 62:800-11).
The risk equation, created for estimation of the 5-year risk of CVD, using q and the HRs (Hazard Ratios) for nine predictors, such as resulted by Cox regression analysis, tabulated with Excel 2007 and analyzed by XSTAT 2009, all statistically significant (P < 0.0001, except for BMI P = 0.0016). These HRs with 95% CI are 1.066 (1.057-1.075) for a 1-year increase in onset age, 1.538 (1.381-1.712) for male sex, 1.087 (1.076 -1.097) for a 1-year increase in diabetes duration, 1.117 (1.074 -1.161) for a 1% increase in A1C, 1.017 (1.006 - 1.028) for a 1-unit increase in BMI, 1.278 (1.143-1.428) for antihypertensive drugs, 1.007 (1.004 -1.010) for a 1 mmHg increase in systolic blood pressure, 1.314 (1.146 -1.507) for lipid lowering drugs, and 1.492 (1.314 - 1.694) for smoking. The baseline hazard (q5) was 0.00013 (0.00003- 0.00022). Starting from these data q equation becomes :
q = 0,00013x1,066^(A-D)x1,538^(S)x1,087^(D)x1,117^(A1c)x1,017^(BMI)x1,2 78^(ATD)x1,007^(SBP)x1,314^(LLD)x1,492^(Sk)
A-D = Age at onset of diabetes (age minus duration, in years); S = Sex with attribution 1 for men, 0 for women; D = diabetes duration time in years; A1c = % of HbA1c in HPLC measured; BMI = Body Mass Index in kg/m2; ATD = antihypertensive drug attributing 1 for drug presence, 0 otherwise; SBP = systolic blood pressure in mmHg; LLD = lipid-lowering drugs attributing 1 for drug presence, 0 otherwise; Sk = Smoker with value 1 for current smoker, 0 otherwise.
From q value CDH risk is calculated by means equation showed below :
5-year risk (CVD) =(1-EXP(-(q)))x100
For example : a female type 2 diabetic patient at age 53 years, with diabetes duration of 15 years, A1C of 8.3%, BMI of 39 kg/m2, and systolic blood pressure 150 mmHg, who was being treated with antihypertensives and lipid lowering drugs and was a non smoker, the 5-year risk of CVD is 11.23. The result has a sensitivity of 78% with predicted risk of ≥ 10 % and a specificity of 75% with risk of ≥ 15%.
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