Valvular & structural heart diseaseRandomised controlled trial
Effect of Evogliptin on the Progression of Aortic Valvular Calcification
- Randomised controlled trial
- multicentre
- double-blind
- placebo-controlled
- stratified-randomized
- parallel
- exploratory
Authors' conclusion
This exploratory study did not demonstrate the protective effect of evogliptin on AV calcification.
Study context
- Population
- Patients with aortic stenosis (AS) (age 67 ± 11 years; 33% women)
- Participants
- 228 patients
- Comparison
- Evogliptin 5 mg or 10 mg vs placebo
- Placebon = 75reference
- Evogliptin 5 mgn = 77
- Evogliptin 10 mgn = 76
- Primary endpoint
- Change in aortic valve calcium volume (AVCV) on CT
- Follow-up
- 96 weeks
Primary result
As reported in the abstract
96-week change in AVCV
Each group vs placeboDifference (95% CI)P value
Evogliptin 5 mg
−5.27(−55.36 to 44.82)
P = 0.84Evogliptin 10 mg
−18.83(−32.43 to 70.10)
P = 0.47Secondary outcomes
| Outcome | Estimate | P value |
|---|---|---|
| Active calcification volume on 18F-NaF PET · 48 weeks — Evogliptin 5 mg vs Placebo | difference −1,325.6 (95% CI −2,285.9 to −365.4) | P = 0.008 |
| Active calcification volume on 18F-NaF PET · 48 weeks — Evogliptin 10 mg vs Placebo | difference −1,582.2 (95% CI −2,610.8 to −553.5) | P = 0.0038 |
| AVCV increase in Placebo: 48–96 weeks vs baseline–48 weeks · 136 mm3 (95% CI: 108-163) vs 102 mm3 (95% CI: 75-129) | AVCV increase 136 vs 102 mm3 | P = 0.0485 |
Aortic valve calcium volume (AVCV) increase in Placebo: 48–96 weeks vs baseline–48 weeks
- This increasing trend in the second half was suppressed in both evogliptin groups
Original publication
Effect of Evogliptin on the Progression of Aortic Valvular Calcification. J Am Coll Cardiol. Published 17 September 2024. doi:10.1016/j.jacc.2024.06.037
Summarised from the published abstract; every number is checked against it