Top-line and Full Detailed Clinical Trial Results are not the same thing.

Examples of top-line clinical trial results for past major CVOT trials can be found in this previous post. 

Let's use EMPA-REG OUTCOME as an example.

Top-line data release was on August 20th, 2015: Jardiance® demonstrated cardiovascular (CV) risk reduction in people with type 2 diabetes at high risk for CV events

"Ingelheim, Germany and Indianapolis, US, 20 August, 2015 – Boehringer Ingelheim and Eli Lilly and Company today announced positive top-line results from EMPA-REG OUTCOME®. This is a long-term clinical trial investigating cardiovascular (CV) outcomes for Jardiance® (empagliflozin) in more than 7,000 adults with type 2 diabetes (T2D) at high risk for CV events. EMPA-REG OUTCOME® met its primary endpoint and demonstrated superiority of Jardiance®, when added to standard of care, in CV risk reduction. The primary endpoint was defined as time to first occurrence of either CV death, or non-fatal myocardial infarction or non-fatal stroke.

Jardiance® is the only glucose-lowering agent to have demonstrated CV risk reduction in a dedicated cardiovascular outcomes trial.

The cardiovascular risk reduction Jardiance® demonstrated in the EMPA-REG OUTCOME® trial is exciting and we look forward to sharing the full results,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim. “Approximately 50 percent of deaths in people with type 2 diabetes worldwide are caused by cardiovascular disease. Reducing cardiovascular risk is an essential component of diabetes management.”

The safety profile of Jardiance® was consistent with previous studies. Detailed study results will be presented on 17 September at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden."

There was no detailed data in the top-line release. Simply a statement that EMPA-REG OUTCOME met its primary endpoint. The bolded portion of the top-line data news release above references the full, detailed clinical trail results that were to be subsequently presented at EASD 2015 on September 17, 2015. If you follow that link, you'll see that the full, detailed data set reports the whole enchilada.

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