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Only 31% of REWIND trial participants have confirmed cardiovascular disease
Lilly said that the company's REWIND mid-term clinical trial, in which TRURITY (name of the ingredient: dulaglutide), a weekly GLP-1 badogue, significantly reduced the criteria for 39, main evaluation, major cardiovascular event (MACE). The results have been published. This study showed that the present study met the main objective of the study because of the decrease in the composite composite badessment score of cardiovascular disease deaths, non-fatal myocardial infarction and nonfatal stroke. Eli Lilly said Trulli City was the first drug to treat type 2 diabetes, confirming the superiority of major cardiovascular events in clinical trials involving many patients without a confirmed history of cardiovascular disease.
The REWIND clinical trial focused on a large number of patients in whom initial cardiovascular disease was not diagnosed. It was the first drug-based badogue of GLP-1. The REWIND trial measured major cardiovascular risk in type 2 diabetic patients with various cardiovascular risk factors. This is the result of comparing patients treated with placebo at 1.5 mg / day once a week for standard treatment.
Dr. Hertzel Gerstein, Deputy Director of the Hamilton Health Sciences Institute of Population Health, Professor at the Faculty of Medicine at McMaster University in Canada and Principal Investigator of the REWIND Clinical Trial "Truriity is a clinical trial of second-line prevention of cardiovascular disease in patients with type 2 diabetes and a primary goal in the evaluation of primary prevention in patients without cardiovascular disease." "Type 2 Diabetes" The major cardiovascular events revealed by Trulli City on a wide range of patients with heart disease are remarkable results and look forward to a comprehensive badysis and presentation of the data. "
The REWIND clinical trial aimed 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 participants was limit. It is different from research. Another important point is that the median follow-up period for REWIND clinical studies is greater than 5 years. This is the longest period of cardiovascular safety studies of GLP-1 badogues. Compared to the REWIND trial, other cardiovascular safety studies were more likely to involve patients with higher initial HbA1c levels and higher rates of patients with cardiovascular disease. confirmed. The median of the 9,901 HbA1c levels in REWIND participants was 7.3%, which is lower than the median HbA1c levels in the other study participants and only 31%. % of subjects have a history of confirmed cardiovascular disease.
"The fact that we have studied a wide range of patients with type 2 diabetes with and without cardiovascular disease is important for the results of our interim studies in REWIND clinical trials," said Enrique Conterno, director general of the division of Lilly Diabetes and the US Division of Diabetes. "In the context of millions of people with type 2 diabetes who are facing cardiovascular risk, the REWIND study supports the truth as a proven option for people with type 2 diabetes."
In REWIND clinical trials, the safety profile of TRUELITY appeared generally similar to that of the GLP-1 badogue sequence. Lilly plans to submit the REWIND data to the licensing authority next year and publish the detailed results at the annual meeting of the American Diabetes Association in 2019.
References
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13 Japan Press Release "Type 2 Diabetes Treatment by Ateos® Injection for Trulicity®" Wins "Good Design Award 2015" and Selected as "Top 100 Best Design 2015"
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