Tofogliflozin long-term effects on atherosclerosis progression and major clinical parameters in patients with type 2 diabetes mellitus lacking a history of cardiovascular disease: a 2-year extension study of the UTOPIA trial
Primary result · Change in mean IMT of the common carotid artery (IMT-CCA)Result — go to the resultIntergroup difference in changes 0.013 mm 95% CI - 0.012 to 0.037Authors' conclusion
Tofogliflozin was not associated with improved inhibition of carotid wall thickening but exerted long-term positive effects on various cardiovascular risk factors and baPWV while showing a good safety profile.
Study context
- Population
- Patients with T2D lacking an apparent history of CVD
- Comparison
- Tofogliflozin vs conventional treatment
- Primary endpoint
- Changes in carotid intima-media thickness (IMT)
Methodological details2-year extension, mixed-effects model for repeated measures
- 2-year extension
- Mixed-effects model for repeated measures
Primary result
As reported in the abstract
Change in mean IMT of the common carotid artery (IMT-CCA) · throughout the follow-up period
Intergroup difference in changes
0.013 mm
95% CI - 0.012 to 0.037
P = 0.32
Change by group
Tofogliflozin
- 0.067
mean · SE 0.009 · mm
Conventional treatment
- 0.080
mean · SE 0.009 · mm
Tofogliflozinvs Conventional treatment
intergroup difference in changes 0.013 mm (95% CI - 0.012 to 0.037); P = 0.32
Secondary outcomes
| Outcome | Tofogliflozin | Conventional treatment | Intergroup difference in changes (cm/s) (95% CI) | P value |
|---|---|---|---|---|
| Change in baPWV | - 17.5 ± 221.3 cm/s | 82.7 ± 210.3 cm/s | - 100.2 (- 182.8 to - 17.5) | P = 0.018 |
| p | p = 0.54 | p = 0.008 |
HbA1c, HDL-C, BMI, abdominal circumference and systolic blood pressure
- Tofogliflozin significantly improved HbA1c and HDL-C levels, BMI, abdominal circumference and systolic blood pressure vs conventional treatment
Safety
- Frequencies of total and serious adverse events did not vary significantly between the groups
Original publication
Tofogliflozin long-term effects on atherosclerosis progression and major clinical parameters in patients with type 2 diabetes mellitus lacking a history of cardiovascular disease: a 2-year extension study of the UTOPIA trial. Cardiovasc Diabetol. Published 22 June 2023. doi:10.
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