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Only 31 percent of REWIND trial participants had established CV disease
 
Trulicity® (dulaglutide) significantly reduced major adverse cardiovascular events (MACE), a composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke, meeting the primary efficacy objective in the precedent-setting REWIND trial. 
 
Once-weekly Trulicity is the first type 2 diabetes medicine to demonstrate superiority in the reduction of MACE events in a clinical trial that included a majority of participants who did not have established CV disease.
 
The study included a majority of patients without established CV disease at baseline, a first for the GLP-1 receptor agonist class.
 
REWIND assessed the risk of MACE in adults with type 2 diabetes with a wide range of CV risk. The study compared the effect of once-weekly Trulicity 1.5 mg to placebo when added to standard of care.
 
REWIND is distinct compared to other CV outcome trials due to the limited number of people with established CV disease who participated in the trial, allowing Trulicity's CV effect to be measured in a broad population of people with type 2 diabetes.  
 
Importantly, REWIND had a median follow-up period of more than 5 years, the longest for a CV outcome trial in the GLP-1 receptor agonist class. In comparison, other CV outcome trials had more people with a higher baseline A1C and a greater percentage of patients who had established CV disease.
 
Of the 9,901 REWIND participants, the mean baseline A1C was relatively lower at 7.3 percent, and only 31 percent had established CV disease.
 
The safety profile of Trulicity in REWIND was generally consistent with the GLP-1 receptor agonist class. Lilly plans to submit these data to regulatory authorities next year and to share detailed results at the American Diabetes Association Scientific Sessions in 2019.
 
About the REWIND Study
REWIND (Researching cardiovascular Events with a Weekly INcretin in Diabetes) was a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the effect of Trulicity 1.5 mg, a weekly glucagon-like peptide 1 receptor agonist (GLP-1 RA), compared to placebo, both added to standard of care, on cardiovascular (CV) events in adults with type 2 diabetes.
 
The primary CV outcome was the first occurrence of MACE (the composite of CV death or non-fatal myocardial infarction or non-fatal stroke).
 
Secondary outcomes include each component of the primary composite CV outcome, a composite clinical microvascular outcome comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality.
 
The 9,901 participants from 24 countries had a mean duration of diabetes of 10 years and a mean baseline A1C of 7.3 percent. Thirty-one percent of participants had established CV disease at baseline.
 
Prior (or established) cardiovascular disease in REWIND was defined as prior myocardial infarction, prior ischemic stroke, prior unstable angina, prior revascularization (coronary, carotid, or peripheral), prior hospitalization for ischemia-related events (unstable angina or myocardial ischemia on imaging, or need for percutaneous coronary intervention), or prior documented myocardial ischemia.
 
The REWIND trial's international scope, high proportion of women, high proportion of people without established cardiovascular disease and inclusion of participants with a lower mean baseline A1C suggest that the findings will be directly relevant to the typical type 2 diabetes patient seen in general practice throughout the world.
 
Indication and Limitations of Use for Trulicity®
Trulicity is a once-weekly injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. It should be used along with diet and exercise. Trulicity is not recommended as the first medication to treat diabetes. It has not been studied in people who have had inflammation of the pancreas (pancreatitis). Trulicity should not be used by people with type 1 diabetes, people with diabetic ketoacidosis, or people with a history of severe gastrointestinal (GI) disease. It is not a substitute for insulin. It has not been studied in children under 18 years of age.
 
1. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept of Health and Human Services; 2017. 
2. International Diabetes Federation. IDF Diabetes Atlas, 8th edn. Brussels, Belgium: International Diabetes Federation, 2017. http://www.diabetesatlas.org
 
Nyhetsinfo
 
Kommentar
Studien i sin helhet kommer enligt uppgift att redovisas på amerikanska diabetesmötet ADA i juni 2019.
 
GLP1-studies
 
CV disease history
REWIND dulaglutide 31% 
Sustain-6 semaglutide 83%
LEADER liraglutide 81%
EXSCEL exanenatide 73%
HARMONY albiglutide 100%
 
Median follow-up time years
REWIND dulaglutide 5.4
Sustain-6 semaglutide 2.1
LEADER liraglutide 3,8
EXSCEL exanenatide 3.2
HARMONY albiglutide 1,6
 
Mean Baseline HbA1c mmol/mol
REWIND 55
Sustain-6 semaglutide 70
LEADER liraglutide 70
EXSCEL exanenatide 62
HARMONY albiglutide 70
 
www red DiabetologNytt
 
 
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