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Early Eplerenone Treatment in Patients
       with Acute ST-elevation Myocardial
          Infarction without Heart Failure

                                   REMINDER*

           Gilles Montalescot, Bertram Pitt, Esteban Lopez de Sa, Christian W. Hamm,
              Marcus Flather, Freek Verheugt, Harry Shi, Eva Turgonyi, Miguel Orri,
                 John Vincent and Faiez Zannad for the REMINDER Investigators




ClinicalTrials.gov, NCT01176968
*A Double-Blind, Randomized, Placebo-Controlled Trial Evaluating The Safety And Efficacy Of
Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction
Study Design




                                             Eplerenone 25-50 mg qd*
                                25 mg        (+ standard of care)


                                25 mg        Placebo 25-50 mg qd*
                                             (+ standard of care)
                                  1 Day       2nd Day

                                                        Mean Follow-up 10.5 months
                         Randomization




* Dosing based on serum potassium levels and eGFR levels; 88.6% finally received 50 mg in
the eplerenone group
Study Patients

INCLUSION
  – Eligible subjects were identified for inclusion following emergency room
    or ambulance evaluation and diagnosis of acute STEMI in the absence
    of a diagnosis of HF
  – Randomization had to take place as early as possible following
    diagnosis and the first dose of study drug administered as early as
    possible within 24 hours of the onset of symptoms of acute MI and
    preferably within 12 hours.


KEY EXCLUSION CRITERIA
  –   Known ejection fraction < 40%, any previous history of heart failure
  –   Implanted cardioverter defibrillator
  –   Known renal insufficiency or eGFR ≤ 30 ml/min/1.73m2
  –   Uncontrolled hypotension (systolic blood pressure < 90 mmHg)
  –   Any other clinically significant coexisting condition
Baseline Characteristics

Characteristics            Eplerenone (N=506)   Placebo (N=506)
Age (years)                     58.5±10.8          57.8±11.0
Female sex (%)                  86 (17.0)          103 (20.4)
Heart rate (bpm)                  73±13              74±13
Blood pressure (mmHg)         126±19 / 76±13     127±17 / 77±12
Body mass index (kg/m2)          27.9±4.5           28.2±4.2
Serum creatinine (mg/dl)        0.91±0.20          0.91±0.21
eGFR (ml/min/1.73m2)            86.5±28.2          86.4±24.9
Serum potassium (mmol/L)        4.07±0.46          4.05±0.45
Anterior MI (%)                 180 (35.6)         205 (40.5)
Hypertension (%)                241 (47.6)         260 (51.4)
Diabetes (%)                    65 (12.8)           78 (15.4)
Prior MI (%)                     33 (6.5)           23 (4.5)
Primary Endpoint
                            Eplerenone vs Placebo:
                            HR [95% CI] = 0.581 [0.449, 0.753]
                            P = <0.0001




PRIMARY ENDPOINT: Time to first occurrence of CV mortality, re-hospitalization or extended
initial hospital stay due to diagnosis of HF or sustained ventricular tachycardia or ventricular
fibrillation, as well as at 1 month post randomization: LVEF ≤ 40% or elevated BNP / NT-proBNP
Serum Potassium by Treatment Groups



Laboratory values             Eplerenone           Placebo         P-value
                                (N=506)            (N=506)

Potassium Δ from baseline      0.41 ± 0.56        0.32 ± 0.50      <0.0001
to 1 month (mmol/L)

Hyperkalemia (>6.0 mmol/L)    8 / 498 (1.6)      2 / 496 (0.4)      0.11

Hyperkalemia (>5.5 mmol/L)    28 / 498 (5.6)     16 / 496 (3.2)     0.09

Hypokalemia (<4.0 mmol/L)    177 / 498 (35.5)   234 / 496 (47.2)   0.0002

Hypokalemia (<3.5 mmol/L)     7 / 498 (1.4)      28 / 496 (5.6)    0.0002
Conclusions


• This study shows that compared with placebo
  the addition of eplerenone to standard therapy
  within 24 hours of symptom onset improves the
  outcome of patients presenting with acute
  STEMI without evidence of HF or LVEF <40%.
• This is the first large study to demonstrate the
  safety profile of eplerenone during early
  administration (no prior potassium check, titrated
  from 25 to 50 mg on day 2).

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Early eplerenone cuts heart risks after STEMI

  • 1. Early Eplerenone Treatment in Patients with Acute ST-elevation Myocardial Infarction without Heart Failure REMINDER* Gilles Montalescot, Bertram Pitt, Esteban Lopez de Sa, Christian W. Hamm, Marcus Flather, Freek Verheugt, Harry Shi, Eva Turgonyi, Miguel Orri, John Vincent and Faiez Zannad for the REMINDER Investigators ClinicalTrials.gov, NCT01176968 *A Double-Blind, Randomized, Placebo-Controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction
  • 2. Study Design Eplerenone 25-50 mg qd* 25 mg (+ standard of care) 25 mg Placebo 25-50 mg qd* (+ standard of care) 1 Day 2nd Day Mean Follow-up 10.5 months Randomization * Dosing based on serum potassium levels and eGFR levels; 88.6% finally received 50 mg in the eplerenone group
  • 3. Study Patients INCLUSION – Eligible subjects were identified for inclusion following emergency room or ambulance evaluation and diagnosis of acute STEMI in the absence of a diagnosis of HF – Randomization had to take place as early as possible following diagnosis and the first dose of study drug administered as early as possible within 24 hours of the onset of symptoms of acute MI and preferably within 12 hours. KEY EXCLUSION CRITERIA – Known ejection fraction < 40%, any previous history of heart failure – Implanted cardioverter defibrillator – Known renal insufficiency or eGFR ≤ 30 ml/min/1.73m2 – Uncontrolled hypotension (systolic blood pressure < 90 mmHg) – Any other clinically significant coexisting condition
  • 4. Baseline Characteristics Characteristics Eplerenone (N=506) Placebo (N=506) Age (years) 58.5±10.8 57.8±11.0 Female sex (%) 86 (17.0) 103 (20.4) Heart rate (bpm) 73±13 74±13 Blood pressure (mmHg) 126±19 / 76±13 127±17 / 77±12 Body mass index (kg/m2) 27.9±4.5 28.2±4.2 Serum creatinine (mg/dl) 0.91±0.20 0.91±0.21 eGFR (ml/min/1.73m2) 86.5±28.2 86.4±24.9 Serum potassium (mmol/L) 4.07±0.46 4.05±0.45 Anterior MI (%) 180 (35.6) 205 (40.5) Hypertension (%) 241 (47.6) 260 (51.4) Diabetes (%) 65 (12.8) 78 (15.4) Prior MI (%) 33 (6.5) 23 (4.5)
  • 5. Primary Endpoint Eplerenone vs Placebo: HR [95% CI] = 0.581 [0.449, 0.753] P = <0.0001 PRIMARY ENDPOINT: Time to first occurrence of CV mortality, re-hospitalization or extended initial hospital stay due to diagnosis of HF or sustained ventricular tachycardia or ventricular fibrillation, as well as at 1 month post randomization: LVEF ≤ 40% or elevated BNP / NT-proBNP
  • 6. Serum Potassium by Treatment Groups Laboratory values Eplerenone Placebo P-value (N=506) (N=506) Potassium Δ from baseline 0.41 ± 0.56 0.32 ± 0.50 <0.0001 to 1 month (mmol/L) Hyperkalemia (>6.0 mmol/L) 8 / 498 (1.6) 2 / 496 (0.4) 0.11 Hyperkalemia (>5.5 mmol/L) 28 / 498 (5.6) 16 / 496 (3.2) 0.09 Hypokalemia (<4.0 mmol/L) 177 / 498 (35.5) 234 / 496 (47.2) 0.0002 Hypokalemia (<3.5 mmol/L) 7 / 498 (1.4) 28 / 496 (5.6) 0.0002
  • 7. Conclusions • This study shows that compared with placebo the addition of eplerenone to standard therapy within 24 hours of symptom onset improves the outcome of patients presenting with acute STEMI without evidence of HF or LVEF <40%. • This is the first large study to demonstrate the safety profile of eplerenone during early administration (no prior potassium check, titrated from 25 to 50 mg on day 2).