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Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Resultados de nuevos estudios:
más allá de la ...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
The LEADERTM trial
Liraglutide Effect and Acti...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Ussher JR, Drucker DJ. Circ Res 2014;114:1788–...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
LEADER: Study design
CV: cardiovascular; DPP-4...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Primary and key secondary outcomes
CV: cardiov...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Study patient disposition
FAS: full analysis s...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Baseline characteristics
(mean ± SD unless sta...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Baseline cardiovascular risk profile
Data are ...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Baseline cardiovascular risk profile
Data are ...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
HbA1c
Data are estimated mean values from rand...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Body weight
Data are estimated mean values fro...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Blood pressure
Data are estimated mean values ...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Heart rate
Data are estimated mean values from...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Primary outcome
CV death, non-fatal myocardial...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
CV death
The cumulative incidences were estima...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Time to non-fatal myocardial infarction
The cu...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Time to non-fatal stroke
The cumulative incide...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Expanded MACE
CV death, non-fatal MI, non-fata...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
All-cause death
The cumulative incidences were...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Hospitalization for heart failure
The cumulati...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Prespecified Cox proportional-hazard regressio...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Prespecified Cox proportional-hazard regressio...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Time to first renal event
Macroalbuminuria, do...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Number needed to treat to prevent one…
CV: car...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Selected adverse events of special interest
Se...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
AEs leading to permanent treatment discontinua...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Hypoglycemia
Confirmed hypoglycemia was define...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Neoplasms
Confirmed by adjudication
*EAC-confi...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Pancreatitis (confirmed by adjudication)
Full ...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Empagliflozin and Liraglutide
CI: confidence i...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
Individual components of the primary endpoint
...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
• Population studied
– High risk of cardiovasc...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
• Liraglutide reduced the risk for 3-point MAC...
Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
• No increase in pancreatitis but an increase ...
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Resultados de nuevos estudios: más allá de la no inferioridad

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Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias
23/06/16 18:00h Casa del Corazón, Madrid
http://ecvdm2.secardiologia.es
#ECVDM2

Resultados de nuevos estudios: más allá de la no inferioridad
Dr. Luis Masmiquel Comas, Endocrinólogo. Hospital Son Llàtzer (Palma de Mallorca)

Published in: Health & Medicine
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Resultados de nuevos estudios: más allá de la no inferioridad

  1. 1. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Resultados de nuevos estudios: más allá de la no inferioridad Dr. Luis Masmiquel Servicio de Endocrinología y Nutrición Hospital Universitario Son Llàtzer Palma de Mallorca
  2. 2. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias The LEADERTM trial Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results A Long-term Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events A phase 3b trial
  3. 3. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Ussher JR, Drucker DJ. Circ Res 2014;114:1788–803.
  4. 4. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias LEADER: Study design CV: cardiovascular; DPP-4i, dipeptidyl peptidase-4 inhibitor; GLP-1RA: glucagon-like peptide-1 receptor agonist; HbA1c: glycated hemoglobin; MEN-2: multiple endocrine neoplasia type 2; MTC: medullary thyroid cancer; OAD: oral antidiabetic drug; OD: once daily; T2DM: type 2 diabetes mellitus.
  5. 5. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Primary and key secondary outcomes CV: cardiovascular; MACE: major adverse cardiovascular event; MI: myocardial infarction.
  6. 6. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Study patient disposition FAS: full analysis set.
  7. 7. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Baseline characteristics (mean ± SD unless stated) *Heart failure includes New York Heart Association class I, II and III. BMI: body mass index; HbA1c: glycated hemoglobin.
  8. 8. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Baseline cardiovascular risk profile Data are number of patients (%). CHD: coronary heart disease; CKD: chronic kidney disease; CVD: cardiovascular disease; eGFR: estimated glomerular filtration rate; NYHA: New York Heart Association; TIA: transient ischemic attack.
  9. 9. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Baseline cardiovascular risk profile Data are number of patients (%). CVD: cardiovascular disease.
  10. 10. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias HbA1c Data are estimated mean values from randomization to month 48. CI: confidence interval; ETD: estimated treatment difference; HbA1c: glycated hemoglobin.
  11. 11. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Body weight Data are estimated mean values from randomization to last scheduled visit for body weight measurement (month 48). CI: confidence interval; ETD: estimated treatment difference.
  12. 12. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Blood pressure Data are estimated mean values from randomization to last scheduled visit for blood pressure measurement (month 48). CI: confidence interval; DBP: diastolic blood pressure; ETD: estimated treatment difference; SBP: systolic blood pressure.
  13. 13. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Heart rate Data are estimated mean values from randomization to last scheduled visit for heart rate measurement (month 48). Bpm: beats per minute; CI: confidence interval; ETD: estimated treatment difference.
  14. 14. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Primary outcome CV death, non-fatal myocardial infarction, or non-fatal stroke The primary composite outcome in the time-to-event analysis was the first occurrence of death from cardiovascular causes, non-fatal myocardial infarction, or non-fatal stroke. The cumulative incidences were estimated with the use of the Kaplan–Meier method, and the hazard ratios with the use of the Cox proportional-hazard regression model. The data analyses are truncated at 54 months, because less than 10% of the patients had an observation time beyond 54 months. CI: confidence interval; CV: cardiovascular; HR: hazard ratio.
  15. 15. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias CV death The cumulative incidences were estimated with the use of the Kaplan–Meier method, and the hazard ratios with the use of the Cox proportional-hazard regression model. The data analyses are truncated at 54 months, because less than 10% of the patients had an observation time beyond 54 months. CI: confidence interval; CV: cardiovascular; HR: hazard ratio.
  16. 16. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Time to non-fatal myocardial infarction The cumulative incidences were estimated with the use of the Kaplan–Meier method, and the hazard ratios with the use of the Cox proportional-hazard regression model. The data analyses are truncated at 54 months, because less than 10% of the patients had an observation time beyond 54 months. CI: confidence interval; HR: hazard ratio.
  17. 17. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Time to non-fatal stroke The cumulative incidences were estimated with the use of the Kaplan–Meier method, and the hazard ratios with the use of the Cox proportional-hazard regression model. The data analyses are truncated at 54 months, because less than 10% of the patients had an observation time beyond 54 months. CI: confidence interval; HR: hazard ratio.
  18. 18. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Expanded MACE CV death, non-fatal MI, non-fatal stroke, coronary revascularization, or hospitalization for unstable angina pectoris or heart failure The cumulative incidences were estimated with the use of the Kaplan–Meier method, and the hazard ratios with the use of the Cox proportional-hazard regression model. The data analyses are truncated at 54 months, because less than 10% of the patients had an observation time beyond 54 months. CI: confidence interval; CV: cardiovascular; HR: hazard ratio; MACE: major adverse cardiovascular event; MI: myocardial infarction.
  19. 19. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias All-cause death The cumulative incidences were estimated with the use of the Kaplan–Meier method, and the hazard ratios with the use of the Cox proportional-hazard regression model. The data analyses are truncated at 54 months, because less than 10% of the patients had an observation time beyond 54 months. CI: confidence interval; HR: hazard ratio.
  20. 20. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Hospitalization for heart failure The cumulative incidences were estimated with the use of the Kaplan–Meier method, and the hazard ratios with the use of the Cox proportional-hazard regression model. The data analyses are truncated at 54 months, because less than 10% of the patients had an observation time beyond 54 months. CI: confidence interval; HR: hazard ratio.
  21. 21. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Prespecified Cox proportional-hazard regression analyses were performed for subgroups of patients with respect to the primary outcome (first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). P values signify tests of homogeneity for between-group differences with no adjustment for multiple testing. The percentages of patients with a first primary outcome between the randomization date and the date of last follow-up are shown. Race or ethnic group was self-reported. CI: confidence interval. Primary outcome: Subgroup analyses
  22. 22. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Prespecified Cox proportional-hazard regression analyses were performed for subgroups of patients with respect to the primary outcome (first occurrence of death from CV causes, nonfatal MI, or nonfatal stroke). P values signify tests of homogeneity for between-group differences with no adjustment for multiple testing. The percentages of patients with a first primary outcome between the randomization date and the date of last follow-up are shown. There were missing data for BMI in 5 patients in the liraglutide group and 4 in the placebo group and for the duration of diabetes in 11 patients in the liraglutide group and 8 in the placebo group. Presented at the AmericanDiabetes Association 76th ScientificSessions, Session 3-CT-SY24. June 13 2016, New Orleans, LA, USA. Primary outcome: Subgroup analyses
  23. 23. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Time to first renal event Macroalbuminuria, doubling of serum creatinine, ESRD, renal death The cumulative incidences were estimated with the use of the Kaplan–Meier method, and the hazard ratios with the use of the Cox proportional-hazard regression model. The data analyses are truncated at 54 months, because less than 10% of the patients had an observation time beyond 54 months. CI: confidence interval; ESRD: end-stage renal disease; HR: hazard ratio.
  24. 24. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Number needed to treat to prevent one… CV: cardiovascular; MACE: major adverse cardiovascular event.
  25. 25. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Selected adverse events of special interest Serious adverse events and nonserious medical events of special interest were identified by search in the Medical Dictionary for Regulatory Activities, version 18.0, or by “action to trial product: trial product permanently discontinued due to adverse event.” P-values were calculated by means of Pearson’s chi-square test.
  26. 26. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias AEs leading to permanent treatment discontinuation *Exploratory analysis with no adjustment of p-values for multiplicity. Permanent discontinuation of the treatment regimen was indicated by the investigator in the adverse event form. P-values were calculated by means of Pearson’s chi-square test.
  27. 27. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Hypoglycemia Confirmed hypoglycemia was defined as plasma glucose level of less than 56 mg per deciliter (3.1 mmol per liter) or a severe event. Severe hypoglycemia was defined as hypoglycemia for which the patient required assistance from a third party. Analyzed using a negative binomial regression model. CI: confidence interval; PG: plasma glucose.
  28. 28. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Neoplasms Confirmed by adjudication *EAC-confirmed neoplasms with EAC onset date from randomization date to follow-up; includes malignant, pre-malignant, benign and unspecified neoplasms. Neoplasms were adjudicated by the event adjudication committee. This committee interpreted neoplastic growth as clonal disorders that grow in an autonomous manner. The abnormality of clonal disorder may not always have been identified nor could autonomous growth always be determined, but both were considered to be fundamental aspects of neoplastic growth. Cox proportional hazard regression model adjusted for treatment. %: proportion of patients; CI: confidence interval; EAC: Event Adjudication Committee; N: number of patients.
  29. 29. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Pancreatitis (confirmed by adjudication) Full analysis set. The occurrence of pancreatitis was adjudicated by the event adjudication committee. P-values were calculated by means of Pearson’s chi-square test. %: proportion of patients; N: number of patients.
  30. 30. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Empagliflozin and Liraglutide CI: confidence interval; CV: cardiovascular; HR: hazard ratio; MI: myocardial infarction. Zinman B et al. N Engl J Med 2015;373:2117-2128. EMPA-REG OUTCOME LEADER CV death, non-fatal MI, or non-fatal stroke CV death, non-fatal MI, or non-fatal stroke
  31. 31. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias Individual components of the primary endpoint *95.02% CI. CV: cardiovascular; Empa: empaglifloin; Lira: liraglutide; MACE: major adverse cardiovascular event; MI: myocardial infarction; Pbo: placebo. Zinman B et al. Presented at European Association for the Study of Diabetes 2015, Stockholm, Sweden. EMPA-REG OUTCOME LEADER
  32. 32. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias • Population studied – High risk of cardiovascular events receiving standard of care – 81% with prior CVD or CKD • Potentially greater benefit in established CVD and eGFR <60 mL/min/1.73 m2 subgroups • Follow-up and retention – 96.8% of patients completed the study – Vital status known for 99.7% of patients • Robust event adjudication by external committee LEADER: Summary CKD: chronic kidney disease; CVD: cardiovascular disease; eGFR: estimated glomerular filtration rate.
  33. 33. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias • Liraglutide reduced the risk for 3-point MACE by 13% – All 3 components of MACE contributed to the risk reduction • Liraglutide reduced composite microvascular endpoints – Driven by reduced new and persistent macroalbuminuria • Liraglutide resulted in reductions in HbA1c, body weight, and hypoglycemia • Liraglutide was generally well tolerated. In line with previous trials, liraglutide was associated with gastrointestinal side effects, increases in pancreatic enzymes and heart rate LEADER: Summary (2) HbA1c: glycated hemoglobin; MACE: major adverse cardiovascular event.
  34. 34. Reduciendo eventos cardiovasculares en pacientes con DM2: nuevas evidencias • No increase in pancreatitis but an increase in acute gallstone disease • No increase in hospitalization for heart failure • Liraglutide reduced the risk of all-cause death by 15% • Liraglutide reduced the risk of CV death by 22% LEADER: Summary (3) CV: cardiovascular.

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