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The 2nd Cardiovascular Outcome Trial (CVOT) Summit of the Diabetes and Cardiovascular Disease (D&CVD) EASD Study Group was held on the 20th–21st October 2016 in Munich. This second Summit was organized in light of recently published CVOTs on diabetes, with the aim of serving as a reference meeting for discussion on this topic. Along with presentations on the results of the most recently published CVOTs, panel discussions on trial implications for reimbursement and the perspective of cardiologists and/or nephrologists, as well as on CVOTs weaknesses and potentials constituted the heart of the program. Future activities of the D&CVD EASD Study Group in 2017 include an annual meeting in Milano and the 3rd CVOT Summit on Diabetes of the D&CVD EASD Study Group, in Munich (http://www.dcvd.org).
Since the 2008 FDA Guidance for industry “Diabetes Mellitus: Evaluating Cardiovascular Risk in New Antidiabetic Therapies in Type 2 Diabetes”  sponsors of all new antihyperglycemic drugs should demonstrate that the therapy will not result in an unacceptable increase in CV risk. Among the evaluated endpoints stand cardiovascular mortality, myocardial infarction and stroke, but also can include hospitalization for acute coronary syndrome, urgent revascularization procedures, and possibly other endpoints. Moreover, the FDA favors the enrollment of high-risk patients, such as those with relatively advanced disease, elderly patients, or under some degree of renal impairment. Along the lines of the FDA, the European Medicines Agency (EMA)  also requires an overall assessment of safety to exclude that a new drug increases the risk of macrovascular complications such as CVD.
Key topics and aims of the 2nd CVOT Summit on Diabetes were:
Other questions debated during the 2nd CVOT Summit on Diabetes were the following:
The 2nd Meeting on CVOTs in Diabetes of the D&CVD EASD Study Group was a successful scientific meeting where results from the most recently completed trials were discussed in a cross-functional international setting. The Summit discussed on the learnings and limitations of current CVOT study design. Their impact on treatment guidelines and reimbursement and viewed CVOTs results needs to be considered under the specialized perspectives of the nephrologist, cardiologist and diabetologist.
Scientific activities of the D&CVD EASD Study Group in 2017 include the annual meeting in Milano and the 3rd CVOT Summit on Diabetes of the D&CVD EASD Study Group, in Munich (http://www.dcvd.org).
All authors contributed to the discussion and content of the report and agreed to its publication. All authors read and approved the final manuscript.
We would like to thank all speakers and participants on the 2nd CVOT Summit for their active involvement in the scientific discussions leading to the present report. Moreover, we would like to acknowledge the industry partners for their support of the meeting.
The authors declare that they have no competing interests
Data is derived from the discussions during the 2nd CVOT Summit.
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