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® (dulaglutid): REWIND Säkerhetsvideo

Dulaglutide ökade inte signifikant någon av de förutbestämda biverkningar av särskilt intresse, inklusive första läkemedelsutsättning, allvarliga gastrointestinala händelser, svår hypoglykemi, cancer, immunreaktioner, eller pankreatit.

Detailed Information

The REWIND study was an event-driven, randomized, double-blind, phase 3 CV outcomes study of dulaglutide.1

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 CV disease and/or risk factors.1

Dulaglutide 1.5 mg significantly reduced MACE-3 when compared to placebo (HR=0.88 [95% CI 0.79, 0.99]; p=.026), demonstrating a decrease in CV events and showing safety in a population that included a majority of participants without established CV disease.2

The median follow-up time in REWIND was 5.4 years. The safety profile of dulaglutide in REWIND was generally consistent with the GLP-1 receptor agonist class. Dulaglutide did not significantly increase any of the prespecified adverse events of special interest including first study drug discontinuation, serious gastrointestinal events, severe hypoglycemia, cancers, immune reactions, or pancreatitis.2

More detailed information on the REWIND safety events can be found in the REWIND Safety video.

References

1. 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

2. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The Lancet. 2019;394(10193):121-130. https://doi.org/10.1016/S0140-6736(19)31149-3

Glossary

CV = cardiovascular

GLP-1 = glucagon-like peptide-1

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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