El Dr. Alfonso Valle Muñoz comenta los resultados del estudio con dapagliflozina en insuficiencia cardiaca, presentado en ESC Congress 2019.

1. Alfonso Valle
McMurray presentation ESC 2019.
Estudio DAPA-HF

2. Alfonso Valle
McMurray presentation ESC 2019.
• Primary endpoint:
Worsening HF event or cardiovascular death (worsening HF event = unplanned HF
hospitalization or an urgent heart failure visit requiring intravenous therapy)
Estudio DAPA-HF

3. Alfonso Valle
McMurray presentation ESC 2019.
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Informed consent
Inclusion/exclusion
Clinical assessment
ECG
NT-proBNP
Laboratory
N=2371
N=2373
Placebo
Dapagliflozin
10 mg once daily
≥844 Primary endpoints
Composite of:
• CV death
• HF hospitalization
• Urgent HF visit
Visit 1
Day −14
Visit 5
Day 120
Visit 4
Day 60
Visit 2
Day 0
Visit 3
Day 14
Visit 6 etc.
Every 120 days
Enrolment
Estudio DAPA-HF

4. Alfonso Valle
McMurray presentation ESC 2019.
Estudio DAPA-HF

5. Alfonso Valle
McMurray presentation ESC 2019.
Characteristic
Mean age (yr)
Male (%)
NYHA class II/III/IV (%)
Mean LVEF (%)
Median NT pro BNP (pg/ml)
Mean systolic BP (mmHg)
Ischaemic aetiology (%)
Mean eGFR (ml/min/1.73m2)
Prior diagnosis T2D (%)
Any baseline T2D (%)*
Dapagliflozin (n=2373)
66
76
68/31/1
31
1428
122
55
66
42
45
Placebo (n=2371)
67
77
67/32/1
31
1446
122
57
66
42
45
Estudio DAPA-HF

6. Alfonso Valle
McMurray presentation ESC 2019.
Estudio DAPA-HF

7. Alfonso Valle
McMurray presentation ESC 2019.
Primary composite outcome
Estudio DAPA-HF

8. Alfonso Valle
McMurray presentation ESC 2019.
Primary composite outcome
Estudio DAPA-HF

9. Alfonso Valle
McMurray presentation ESC 2019.
No diabetes/diabetes subgroup:
Primary endpoint
*Defined as history of type 2 diabetes or HbA1c ≥6.5% at both enrollment and randomization visits.
Estudio DAPA-HF

10. Alfonso Valle
McMurray presentation ESC 2019.
1.Time to the first occurrence of either of the components of the composite: CV death or hospitalization for HF.
2.Total number of (first and recurrent) HF hospitalizations and CV death
3.Change from baseline measured at 8 months in the total symptom score of the Kansas City Cardiomyopathy Questionnaire (KCCQ), a specific HF
patient reported outcome questionnaire.
4.Time to the first occurrence of any of the components of the composite: ≥50% sustained decline in eGFR or reaching End Stage Renal Disease
(ESRD) or renal death. [ Time Frame: From randomization visit (day 0) up to approximately 3 years ]End Stage Renal Disease (ESRD) is defined as
-Sustained eGFR <15 mL/min/1.73m^2 or,
-Chronic dialysis treatment or,
-Receiving a renal transplant
5. Time to death from any cause.
Estudio DAPA-HF

11. Alfonso Valle
McMurray presentation ESC 2019.
CV death or HF hospitalization
Estudio DAPA-HF

12. Alfonso Valle
McMurray presentation ESC 2019.
Total HF hospitalizations and CV death
Including first and repeat hospitalizations
Estudio DAPA-HF

13. Alfonso Valle
McMurray presentation ESC 2019.
Worsening renal function endpoint
Estudio DAPA-HF

14. Alfonso Valle
McMurray presentation ESC 2019.
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Total Symptom Score: Proportion with ≥5 point change from baseline to 8 months*
Estudio DAPA-HF

15. Alfonso Valle
McMurray presentation ESC 2019.
All-cause death
Estudio DAPA-HF

16. Alfonso Valle
McMurray presentation ESC 2019.
Estudio DAPA-HF

17. Alfonso Valle
• Dapagliflozina añadido a TMO en pacientes con ICrFEVI, redujo el compuesto de muerte cardiovascular (CV) o
empeoramiento de la IC en un 26% (p <0,0001) y mostró una reducción en cada uno de los componentes individuales.
• Disminuye un 30% (p <0,0001) en el riesgo de experimentar un primer episodio de IC y reduce el 18% (p = 0,0294) en el riesgo
de muerte CV.
• Resultados en RR y RA del riesgo de muerte u hospitalización por IC en los diferntes subgrupos, incluido en pacientes NO
DIABÉTICOS
• Mejora significativa KCCQ y una reducción nominalmente significativa en lamortalidad por todas las causas en un 17% (7.9
versus 9.5 pacientes con un evento por cada 100 pacientes años)
Estudio DAPA-HF