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CV Safety Outcomes
The Trajenta® CardioVascular Outcome Trial (CVOT) Program.
Two studies examining CV safety outcomes across 13,000 patients with T2DM at high CV risk1,12,13*†
![Visual icon of a double-headed arrow with people inside. Half of the people are in purple to represent the CARMELINA study and the other half are in orange to represent the CAROLINA study.](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/cv_safety_outcomes.graphic_1_latest.png)
Trajenta® is not indicated for cardiovascular or renal outcomes.
- MACE
- =major adverse cardiovascular event;
- UACR
- =urinary albumin:creatinine ratio.
CARMELINA study: Randomized, double-blind, placebo-controlled, parallel-group, time- and event-driven, multicentre study evaluating the effect of Trajenta® on cardiovascular safety and renal microvascular outcomes in patients with type 2 diabetes at high risk of cardiovascular and renal events. Patients (≥18 years) had inadequately controlled T2D (A1C 6.5–10%), and had either albuminuria and previous macrovascular disease (39%) or evidence of impaired renal function (42%) or both (18%). Primary endpoint was time to first occurrence of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (3-point MACE).
CAROLINA study: Randomized, double-blind, active-controlled, parallel-group, time- and event-driven, multicentre study assessing the effect of Trajenta® versus glimepiride on cardiovascular safety outcomes in patients with relatively early type 2 diabetes and high cardiovascular risk. Primary endpoint time to first occurrence of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (3-point MACE).
High CV risk: defined as a history of coronary artery disease, stroke or peripheral vascular disease, and microalbuminuria or macroalbuminuria, defined as UACR >30 mg/g or equivalent.
High renal risk: defined as (1) eGFR of 45–75 mL/min/1.73 m2 and UACR >200 mg/g or equivalent or (2) eGFR of 15–45 mL/min/1.73 m2 regardless of UACR.
High CV risk: defined as previous vascular disease, evidence of vascular-related end-organ damage, ≥70 years of age, and ≥2 multiple CV risk factors (duration of diabetes >10 years, hypertension, current smoker, dyslipidemia).
![](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/cv_heart_icon_orange.png)
Trajenta®, when added to standard of care, did not increase the risk of major adverse CV events (composite endpoint) vs. placebo.1
Time to first occurrence of CV death, nonfatal MI or nonfatal stroke (1° composite endpoint)1
12.4% (n=434) Trajenta® vs. 12.1% (n=240) placebo
![cv_safety_outcomes.graphic_2_title CARMELINA CV events graph showing the demonstrated time to first occurrence of CV death, nonfatal MI or nonfatal stroke (primary composite endpoint) for Trajenta® (n=3,494) and placebo (n=3,485). Described under the heading CARMELINA CV events graph full text.](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/cv_graphic_2_mb.png)
Trajenta® is not indicated for cardiovascular outcomes.
CARMELINA CV events graph full textSuperiority to placebo was not demonstrated for any endpoint in hypothesis testing of 3-point MACE.
- MI
- =myocardial infarction;
- HR
- =hazard ratio;
- CI
- =confidence interval.
![](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/cv_kidney_icon_orange.png)
Trajenta®, when added to standard of care, did not increase the risk of adverse renal outcome events (composite endpoint) vs. placebo.1
Time to first occurrence of renal death, sustained end-stage renal disease, or sustained ≥40% decrease in eGFR (key 2° composite endpoint)1,12
9.4% (n=327) Trajenta® vs. 8.8% (n=306) placebo
![CARMELINA renal outcome events graph showing the demonstrated time to first occurrence of renal death, sustained end-stage renal disease, or sustained ≥40% decrease in eGFR (key secondary composite endpoint) for Trajenta® (n=3,494) and placebo (n=3,485). Described under the heading CARMELINA renal outcome events graph full text. CARMELINA renal outcome events graph showing the demonstrated time to first occurrence of renal death, sustained end-stage renal disease, or sustained ≥40% decrease in eGFR (key secondary composite endpoint) for Trajenta® (n=3,494) and placebo (n=3,485). Described under the heading CARMELINA renal outcome events graph full text.](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/cv_graphic_3_mb.png)
Trajenta® is not indicated for renal outcomes.
CARMELINA renal outcome events graph full textCARMELINA: Study design.
Randomized, double-blind, placebo-controlled, parallel-group trial1,12
![Eligibility criteria included: Age ≥18 years, Inadequately controlled T2D (A1C 6.5 to 10%), Albuminuria and previous macrovascular disease (39%) or evidence of impaired renal function (42%) or both (18%). Randomization (N=6,979) was to Trajenta® 5 mg once daily plus standard of care (n=3,494) or to placebo plus standard of care (n=3,485). Median follow-up was 2.2 years and 98.7% of patients completed the study.](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/cv_safety_outcomes.study_1_graphic_source1.png)
Primary endpoint
- Time to first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE): CV death, nonfatal MI or nonfatal stroke
Key secondary endpoint
- Time to the first occurrence of any of the following adjudication-confirmed components of composite renal endpoint 1: renal death, sustained end-stage renal disease, sustained decrease of ≥40% in eGFR
OD=once daily; SOC=standard of care.
![](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/cv_heart_icon_orange.png)
Trajenta®, when added to standard of care, did not increase the risk of major adverse CV events (composite endpoint) vs. glimepiride.1
Time to first occurrence of CV death, nonfatal MI or nonfatal stroke (1° composite CV endpoint)1,13,14
118% (n=356) Trajenta® vs. 12.0% (n=362) glimepiride
![CAROLINA CV events graph showing the demonstrated time to first occurrence of CV death, nonfatal MI or nonfatal stroke (primary composite CV endpoint) for Trajenta® (n=3,023) and glimepiride (n=3,010). Described under the heading CAROLINA CV events full text. CAROLINA CV events graph showing the demonstrated time to first occurrence of CV death, nonfatal MI or nonfatal stroke (primary composite CV endpoint) for Trajenta® (n=3,023) and glimepiride (n=3,010). Described under the heading CAROLINA CV events full text.](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/cv_graphic_4_mb.png)
Trajenta® is not indicated for cardiovascular outcomes.
CAROLINA CV events full textSuperiority to glimepiride was not demonstrated for any endpoint in hypothesis testing of 3-point MACE.
CAROLINA: Study design.
Randomized, double-blind, active-controlled trial1,13
![Eligibility criteria included: Age ≥18 years, Inadequately controlled T2D (A1C 6.5 to ≤8.5% or 6.5¬–7.5% depending on whether treatment-naïve, on monotherapy or on combination therapy), High CV risk, defined as: Previous vascular disease, Evidence of vascular-related end-organ damage, Age ≥70 years, ≥2 multiple CV risk factors (disease duration >10 years, hypertension, current smoker, dyslipidemia). Randomization (N=6,033) was to Trajenta® 5 mg once daily plus standard of care (n=3,023) or to glimepiride 1 to 4 mg plus standard of care (n=3,010). Median follow-up was 6.3 years and 96% of patients completed the study.](https://pro.boehringer-ingelheim.com/ca/products/trajenta/images/cv_safety_outcomes.study_2_graphic_source1.png)
Primary CV safety endpoint
- Time to first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE): CV death, nonfatal MI or nonfatal stroke
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