SURPASS-CVOT is a phase 3 study enrolled approximately 13,000 patients at least 40 years of age and have a diagnosis of type 2 diabetes, confirmed atherosclerotic cardiovascular disease, HbA1c 7.0% to 10.5% and a body mass index (BMI) 25 kilograms per meter squared (kg/m 2 )
Acronyms CrCl - Creatinine clearance GLP-1 - Glucagon-Like Peptide-1 P - Drugs with pediatric dosing Dulaglutide Trulicity Trulicity Dosage forms Single-dose pen 0.75 mg/0.5 ml 1.5 mg/0.5 ml 3 mg/0.5 ml 4.5 mg/0.5 ml Comes in carton with 4 pens Dosing Type 2 diabetes Starting: 0.75 mg once weekly Maintenance: 0.75 - 4.5 mg once weekly Max: 4.5 mg once weekly Increase to next higher dose if needed at intervals of 4 weeks May administer without regard to food If a dose is missed, administer ASAP if there are at least 3 days until the next scheduled dose If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the next dose on the regularly scheduled day In each case, patients can then resume their regular once weekly dosing schedule The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before Kidney disease No dose adjustment is recommended in patients with renal impairment including end-stage renal disease Gastrointestinal side effects may be worse in patients with kidney disease Liver disease In a study of patients with varying degrees of liver disease, no clinically relevant change in dulaglutide pharmacokinetics was observed
Study outcomes In this large, population-based retrospective cohort study, our primary outcome was to assess the incidence or new-onset of major adverse cardiovascular events categorized as HF, composite cardiovascular events 23,24 , as well as clinically significant portal hypertension events 25
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