Only 31% of patients in REWIND clinical trials confirmed cardiovascular disease
Lilly said that REWIND's mid-term clinical trial, in which GLP-1 analogue TRURITY weekly (product name: dulaglutide) significantly reduced the primary endpoint, the major cardiovascular event (MACE) results were published. This study showed that this study met the primary study goal due to a decline in the composite assessment index consisting of death from cardiovascular disease, non-fatal myocardial infarction, and undeclared brain. Eli Lilly said Trulli City is the first treatment for type 2 diabetes and confirms the superiority of major cardiovascular events in clinical trials involving many patients without confirmed cardiovascular disease.
The REWIND clinical trial included a large number of patients who were not diagnosed with baseline cardiovascular disease and were the first GLP-1 analogue. The REWIND study measured the main risk of cardiovascular disease in patients with type 2 diabetes with various cardiovascular risk factors. This is the result of a comparison of patients treated with placebo with 1.5 mg / day once a week for standard therapy.
Dr. Hertzel Gerstein, Deputy Director of the Hamilton Health Sciences Institute of Health, Professor at McMaster University School of Medicine in Canada, and principal investigator in the REWIND clinical trial, Truriity is a second-line clinical trial of cardiovascular disease in type 2 diabetes patients and the primary endpoint primary prevention in patients without cardiovascular disease. " "Type 2 Diabetes" The major cardiovascular events that Trulli City has shown in a wide range of patients with heart disease are remarkable results and we look forward to full analysis and data presentation. "
The REWIND clinical trial was designed to evaluate the effect of True Religion on cardiovascular disease in a wide range of patients with type 2 diabetes as the number of patients with confirmed cardiovascular disease in clinical subjects was limited. It differs from research. Another important point is that the mean follow-up of REWIND clinical trials is over 5 years. This is the longest period of cardiovascular safety studies of GLP-1 analogues. Compared to the REWIND clinical study, further studies of cardiovascular safety included patients with higher baseline HbA1c levels and higher numbers of patients with confirmed cardiovascular disease. The mean 9901 HbA1c level in REWIND patients was 7.3%, lower than the median HbA1c levels in the other study participants, and only 31% of patients had confirmed cardiovascular disease.
"The fact that we studied a wide range of patients with type 2 diabetes with or without cardiovascular disease is important for the results of our ongoing studies in REWIND clinical trials," said Enrique Conterno, Director General of the Lilly Diabetes Division and the American Diabetes Division. "In the context of millions of people with type 2 diabetes, cardiovascular risk, REWIND supports Trueruity as a proven option for people with type 2 diabetes."
In REWIND clinical trials, the TRUELITY safety profile generally resembled the GLP-1 analogue sequence. Lilly plans to submit REWIND data to the licensing office next year and publish detailed results at the annual meeting of the American Diabetes Association in 2019.
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