Trulicity ® (dulaglutid) injektion

För fullständig produktresumé för Trulicity® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Trulicity® (dulaglutide): REWIND Bakgrundsvideo

REWIND utvärderade effekten på MACE-3 och andra allvarliga utfall med dulaglutid 1,5 mg jämfört med placebo vid tillägg till standard för vård hos deltagare 50 år och äldre med T2DM och etablerade kardiovaskulära sjukdomar och/eller riskfaktorer.

Detailed Information

The FDA and the EMA issued guidances for industry in 2008 and 2012, respectively, to help ensure that new medications for the treatment of T2DM do not pose an unacceptable increase in the risk of CV events. 1,2 The FDA guidance provides criteria for evaluating CV safety through a meta-analysis of clinical studies and/or a CV outcome trials.1

The REWIND study was an event-driven, randomized, double-blind, phase 3 CV outcomes study of dulaglutide.3

The study evaluated the effect on MACE-3 and other serious outcomes with once-weekly dulaglutide 1.5 mg treatment compared with placebo when added to standard of care in participants 50 years of age and older with T2DM and established CVD and/or risk factors.3

More details on Trulicity's background and study design can be accessed in the REWIND Background video.

References

1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: diabetes mellitus - evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf. Published December 2008. Accessed June 9, 2019.

2. EMA. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. London: EMA; 2012. Available at: https://www.ema.europa.eu/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-prevention-diabetes-mellitus-revision_en.pdf. Published May 2012. Accessed October 31, 2018

3. Gerstein HC, Colhoun HM, Dagenais GR, et al. REWIND Trial Investigators. Design and baseline characteristics of participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide. Diabetes Obes Metab. 2018;20(1):42-49. https://doi.org/10.1111/dom.13028

Glossary

CV = cardiovascular

CVD = cardiovascular disease

EMA: European Medicines Agency

FDA = Food and Drug Administration

MACE-3 = major adverse cardiovascular events (death due to cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke)

REWIND = Researching cardiovascular Events with a Weekly INcretin in Diabetes

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2020 M03 06


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