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resultados del estudio
EMPA-REG: un punto de inflexión en el tratamiento de la diabetes
Domingo Marzal Martín
Casa del cor...
Empagliflozin is a highly selective inhibitor of the
sodium glucose cotransporter 2 (SGLT2)
in the kidney
• Randomised, double-blind, placebo-controlled CV
outcomes trial
• Objective
To examine the long-term effects of empaglifl...
Randomised
and treated
(n=7020)
Empagliflozin 10 mg
(n=2345)
Empagliflozin 25 mg
(n=2342)
Placebo
(n=2333)
Screening
(n=11...
• Key inclusion criteria
–Adults with type 2 diabetes
–BMI ≤45 kg/m2
–HbA1c 7-10%
–Established cardiovascular disease
• Ke...
• Primary outcome
3-point MACE: Time to first occurrence of CV
death, non-fatal MI or non-fatal stroke
• Further pre-speci...
Baseline characteristics: type 2 diabetes
Glucose-lowering medication
Metformin 1734 (74.3) 1729 (73.7) 1730 (73.9)
Sulpho...
Baseline characteristics: CV complications
Placebo
(n=2333)
Empagliflozin
10 mg
(n=2345)
Empagliflozin
25 mg
(n=2342)
Any ...
6,0
6,5
7,0
7,5
8,0
8,5
9,0
Adjustedmean(SE)HbA1c(%)
Week
Placebo
Empagliflozin 10 mg
Empagliflozin 25 mg
2294
2296
2296
P...
cardiovascular outcomes
HR 0.86
(95.02% CI 0.74-0.99)
p=0.0382
primary outcome: 3-point MACE
Empagliflozin 10 mg
HR 0.85
(95% CI 0.72, 1.01)
p=0.0668
Empagliflozin 25 mg
HR 0.86
(95% CI 0.73, 1.02)
p=0.0865
primary ...
primary outcome: 3-point MACE
Patients with event/analysed
Empagliflozin Placebo HR (95% CI) p-value
3-point MACE 490/4687...
CV death
HR 0.62
(95% CI 0.49, 0.77)
p<0.0001
Empagliflozin 10 mg
HR 0.65
(95% CI 0.50, 0.85)
p=0.0016
Empagliflozin 25 mg
HR 0.59
(95% CI 0.45, 0.77)
p=0.0001
CV death
Empagliflozin Placebo
All patients 4687 2333
Age, years 0.21
<65 2596 1297
≥65 2091 1036
Sex 0.32
Male 3336 1680
Female 13...
heart failure
HR 0.65
(95% CI 0.50, 0.85)
p=0.0017
hospitalization for heart failure
Empagliflozin 10 mg
HR 0.62
(95% CI 0.45, 0.86)
p=0.0044
Empagliflozin 25 mg
HR 0.68
(95% CI 0.50, 0.93)
p=0.0166
hospital...
Heart failure hospitalization
in patients with vs without heart failure at baseline
all-cause mortality
all-cause mortality
HR 0.68
(95% CI 0.57, 0.82)
p<0.0001
HR 0.68
(95% CI 0.57, 0.82)
p<0.0001
Empagliflozin 10 mg
HR 0.70
(95% CI 0.56, 0.87)
p=0.0013
Empagliflozin 25 mg
HR 0.67
...
Patients with event/analysed
Empagliflozin Placebo HR 95% CI p-value
All-cause mortality 269/4687 194/2333 0.68 (0.57, 0.8...
safety and tolerability
confirmed hypoglycaemic
Placebo
(n=2333)
Empagliflozin
10 mg
(n=2345)
Empagliflozin
25 mg
(n=2342)
n (%)
Confirmed hypogly...
genital infection
Rate = per100 patient-years
Placebo
(n=2333)
Empagliflozin
10 mg
(n=2345)
Empagliflozin
25 mg
(n=2342)
n...
conclusions
empagliflozin …
• Reduced HbA1c without increase in hypoglycaemia
• Increased genital infections but was well tolerated
• ...
gracias por vuestra atención
@domingomarzal
domingo.marzal@secardiologia.es
NNT to prevent one death across landmark trials in
patients with high CV risk
1. 4S investigator. Lancet 1994;344:1383-9
2...
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Resultados del estudio EMPA-REG

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EMPA-REG: un punto de inflexión en el tratamiento de la diabetes
18/11/15 20:00h Casa del Corazón (Madrid)
http://empareg.secardiologia.es
#EMPAREG

Resultados del estudio EMPA-REG
Dr. Domingo Marzal Martín, Complejo Hospitalario de Mérida (Badajoz)
@domingomarzal

Publicado en: Salud y medicina

Resultados del estudio EMPA-REG

  1. 1. resultados del estudio EMPA-REG: un punto de inflexión en el tratamiento de la diabetes Domingo Marzal Martín Casa del corazón. Madrid, noviembre 2015
  2. 2. Empagliflozin is a highly selective inhibitor of the sodium glucose cotransporter 2 (SGLT2) in the kidney
  3. 3. • Randomised, double-blind, placebo-controlled CV outcomes trial • Objective To examine the long-term effects of empagliflozin versus placebo, in addition to standard of care, on CV morbidity and mortality in patients with type 2 diabetes and high risk of CV events
  4. 4. Randomised and treated (n=7020) Empagliflozin 10 mg (n=2345) Empagliflozin 25 mg (n=2342) Placebo (n=2333) Screening (n=11531) Trial design
  5. 5. • Key inclusion criteria –Adults with type 2 diabetes –BMI ≤45 kg/m2 –HbA1c 7-10% –Established cardiovascular disease • Key exclusion criteria –eGFR <30 mL/min/1.73m2 (MDRD)
  6. 6. • Primary outcome 3-point MACE: Time to first occurrence of CV death, non-fatal MI or non-fatal stroke • Further pre-specified outcomes Hospitalization for heart failure All-cause mortality
  7. 7. Baseline characteristics: type 2 diabetes Glucose-lowering medication Metformin 1734 (74.3) 1729 (73.7) 1730 (73.9) Sulphonylurea 992 (42.5) 985 (42.0) 1029 (43.9) Thiazolidinedione 101 (4.3) 96 (4.1) 102 (4.4) Insulin 1135 (48.6) 1132 (48.3) 1120 (47.8) Mean daily dose, U 65 (50.6) 65 (47.9) 66 (48.9) Placebo (n=2333) Empagliflozin 10 mg (n=2345) Empagliflozin 25 mg (n=2342) HbA1c, % 8.08 (0.84) 8.07 (0.86) 8.06 (0.84) Time since diagnosis of type 2 diabetes, years ≤5 423 (18.1) 406 (17.3) 434 (18.6) >5 to 10 571 (24.5) 585 (24.9) 590 (25.2) >10 1339 (57.4) 1354 (57.7) 1318 (56.3)
  8. 8. Baseline characteristics: CV complications Placebo (n=2333) Empagliflozin 10 mg (n=2345) Empagliflozin 25 mg (n=2342) Any CV risk factor 2307 (98.9%) 2333 (99.5%) 2324 (99.2%) Coronary artery disease 1763 (75.6%) 1782 (76.0%) 1763 (75.3%) Multi-vessel coronary artery disease 1100 (47.1%) 1078 (46.0%) 1101 (47.0%) History of MI 1083 (46.4%) 1107 (47.2%) 1083 (46.2%) Coronary artery bypass graft 563 (24.1%) 594 (25.3%) 581 (24.8%) History of stroke 553 (23.7%) 535 (22.8%) 549 (23.4%) Peripheral artery disease 479 (20.5%) 465 (19.8%) 517 (22.1%) Single vessel coronary artery disease 238 (10.2%) 258 (11.0%) 240 (10.2%) Cardiac failure 244 (10.5%) 240 (10.2%) 222 (9.5%)
  9. 9. 6,0 6,5 7,0 7,5 8,0 8,5 9,0 Adjustedmean(SE)HbA1c(%) Week Placebo Empagliflozin 10 mg Empagliflozin 25 mg 2294 2296 2296 Placebo Empagliflozin 10 mg Empagliflozin 25 mg 2272 2272 2280 2188 2218 2212 2133 2150 2152 2113 2155 2150 2063 2108 2115 2008 2072 2080 1967 2058 2044 1741 1805 1842 1456 1520 1540 1241 1297 1327 1109 1164 1190 962 1006 1043 705 749 795 420 488 498 151 170 195 12 28 52 94 10880 12266 1360 150 164 178 192 20640 HbA1c
  10. 10. cardiovascular outcomes
  11. 11. HR 0.86 (95.02% CI 0.74-0.99) p=0.0382 primary outcome: 3-point MACE
  12. 12. Empagliflozin 10 mg HR 0.85 (95% CI 0.72, 1.01) p=0.0668 Empagliflozin 25 mg HR 0.86 (95% CI 0.73, 1.02) p=0.0865 primary outcome: 3-point MACE
  13. 13. primary outcome: 3-point MACE Patients with event/analysed Empagliflozin Placebo HR (95% CI) p-value 3-point MACE 490/4687 282/2333 0.86 (0.74, 0.99)* 0.0382 CV death 172/4687 137/2333 0.62 (0.49, 0.77) <0.0001 Non-fatal MI 213/4687 121/2333 0.87 (0.70, 1.09) 0.2189 Non-fatal stroke 150/4687 60/2333 1.24 (0.92, 1.67) 0.1638 Favours empagliflozin Favours placebo
  14. 14. CV death HR 0.62 (95% CI 0.49, 0.77) p<0.0001
  15. 15. Empagliflozin 10 mg HR 0.65 (95% CI 0.50, 0.85) p=0.0016 Empagliflozin 25 mg HR 0.59 (95% CI 0.45, 0.77) p=0.0001 CV death
  16. 16. Empagliflozin Placebo All patients 4687 2333 Age, years 0.21 <65 2596 1297 ≥65 2091 1036 Sex 0.32 Male 3336 1680 Female 1351 653 Race 0.43 White 3403 1678 Asian 1006 511 Black/African-American 237 120 HbA1c, % 0.51 <8.5 3212 1607 ≥8.5 1475 726 Body mass index, kg/m2 0.05 <30 2279 1120 ≥30 2408 1213 eGFR, mL/min/1.73m2 0.15 ≥90 1050 488 60 to <90 2425 1238 <60 1212 607 CV death: subgroup analysis HR (95% CI) Favours empagliflozin Favours placebo p-value for interaction
  17. 17. heart failure
  18. 18. HR 0.65 (95% CI 0.50, 0.85) p=0.0017 hospitalization for heart failure
  19. 19. Empagliflozin 10 mg HR 0.62 (95% CI 0.45, 0.86) p=0.0044 Empagliflozin 25 mg HR 0.68 (95% CI 0.50, 0.93) p=0.0166 hospitalization for heart failure
  20. 20. Heart failure hospitalization in patients with vs without heart failure at baseline
  21. 21. all-cause mortality
  22. 22. all-cause mortality HR 0.68 (95% CI 0.57, 0.82) p<0.0001
  23. 23. HR 0.68 (95% CI 0.57, 0.82) p<0.0001 Empagliflozin 10 mg HR 0.70 (95% CI 0.56, 0.87) p=0.0013 Empagliflozin 25 mg HR 0.67 (95% CI 0.54, 0.83) p=0.0003 all-cause mortality
  24. 24. Patients with event/analysed Empagliflozin Placebo HR 95% CI p-value All-cause mortality 269/4687 194/2333 0.68 (0.57, 0.82) <0.0001 CV death 172/4687 137/2333 0.62 (0.49, 0.77) <0.0001 Non-CV death 97/4687 57/2333 0.84 (0.60, 1.16) 0.2852 All-cause mortality: CV death and non-CV death Favours empagliflozin Favours placebo
  25. 25. safety and tolerability
  26. 26. confirmed hypoglycaemic Placebo (n=2333) Empagliflozin 10 mg (n=2345) Empagliflozin 25 mg (n=2342) n (%) Confirmed hypoglycaemic adverse events 650 (27.9%) 656 (28.0%) 647 (27.6%) Events requiring assistance 36 (1.5%) 33 (1.4%) 30 (1.3%) Patients taking insulin at baseline Total 483 (42.6%) 494 (43.6%) 464 (41.4%) Events requiring assistance 28 (2.5%) 27 (2.4%) 25 (2.2%)
  27. 27. genital infection Rate = per100 patient-years Placebo (n=2333) Empagliflozin 10 mg (n=2345) Empagliflozin 25 mg (n=2342) n (%) Rate n (%) Rate n (%) Rate Events consistent with genital infection 42 (1.8%) 0.73 153 (6.5%) 2.66 148 (6.3%) 2.55 Serious events 3 (0.1%) 0.05 5 (0.2%) 0.08 4 (0.2%) 0.07 Events leading to discontinuation 2 (0.1%) 0.03 19 (0.8%) 0.32 14 (0.6%) 0.23 By sex Male 25 (1.5%) 0.60 89 (5.4%) 2.16 77 (4.6%) 1.78 Female 17 (2.6%) 1.09 64 (9.2%) 3.93 71 (10.8%) 4.81
  28. 28. conclusions
  29. 29. empagliflozin … • Reduced HbA1c without increase in hypoglycaemia • Increased genital infections but was well tolerated • Reduced risk for 3-point MACE 14% • Reduced hospitalization for heart failure 35% • Reduced CV death 38% • Improved survival by reducing all-cause mortality 32%
  30. 30. gracias por vuestra atención @domingomarzal domingo.marzal@secardiologia.es
  31. 31. NNT to prevent one death across landmark trials in patients with high CV risk 1. 4S investigator. Lancet 1994;344:1383-9 2. HOPE investigator. N Engl J Med 2000;342:145-53 Simvastatin1 for 5.4 years High CV risk 5% diabetes, 26% hypertension 1994 2000 2015 Pre-statin era High CV risk 38% diabetes, 46% hypertension Ramipril2 for 5 years Pre-ACEi/ARB era <29% statin Empagliflozin for 3 years T2DM with high CV risk 92% hypertension >80% ACEi/ARB >75% statin

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