Left Ventricular Dysfunction Post Myocardial Infarction
Conditions
Keywords
patients with MI- on top of treatment add Eplerenone - assess LVEF and BP
Brief summary
On a population of patients followed by an office-based cardiologist and treated with eplerenone, the objectives of the survey are: * To describe the characteristics of the population treated. * To describe the methods of use of eplerenone (posology, duration of treatment, medicinal combinations). * To describe the follow-up methods of the treatment. * To describe the possible interruptions of the treatment
Detailed description
A sample size in the region of N = 400 patients will allow this accuracy of estimation, as for this size, the half-width would be equal to 5% for a frequency of 50% corresponding to a confidence interval of maximum width. In view of the type of survey and the need for 12 months of monitoring in the context of standard practice, it may be anticipated that the drop-off rate will be about 20%. A sample size of N = 500 patients was therefore chosen.
Interventions
OTHERProspective Observational
this is an observational study non interventional
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
The following patients may be selected to participate in the survey: * Those undergoing treatment with eplerenone in accordance with the MA or not, with a known start date. * Those likely to be followed by the same physician for a minimal period of twelve months.
Exclusion criteria
* Severe Kidney Disease * Hyperkamiemia more than 5.5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Worsened Renal Function | Baseline up to Month 12 | — |
| Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population | Baseline | Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction. |
| Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population | Month 3 | Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant. |
| Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population | Month 6 | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. |
| Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population | Month 9 | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. |
| Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population | Month 12 | Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant. |
| Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | Baseline, Month 3 | Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease. |
| Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population | Baseline, Month 6 | Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease. |
| Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population | Baseline, Month 9 | Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease. |
| Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population | Baseline, Month 12 | Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease. |
| Percentage of Participants Who Died in SAS Population | Baseline up to Month 12 | — |
| Percentage of Participants Hospitalized in FAS Population | Baseline up to Month 12 | — |
| Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population | Baseline | Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Concomitant Cardiovascular Treatment in FAS Population | Baseline up to Month 12 | Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study. |
| Number of Participants With Concomitant Cardiovascular Treatment in SAS Population | Baseline up to Month 12 | Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study. |
| Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population | Baseline up to Month 12 | — |
| Number of Participants With Reason for Increased or Decreased Eplerenone Dose | Baseline up to Month 12 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Baseline, Months 3, 6, 9, 12 | New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Percentage of participants in each functional class was reported. |
| Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population | Baseline | Reasons for starting eplerenone treatment included myocardial infarction, heart failure and other conditions including severe hypertension by primary hyperaldosteronism; hypertension/coronaropathy and hypokalaemia; hypertension; left ventricular failure; not tolerated spironolactone; hypertension: gynecomastia with aldactone; pulmonary suboedema; hypertension: adrenal hyperplasia, gynecomastia with aldactone; hypertension not controlled. |
| Percentage of Participants With General Practitioner (GP) Consultation in FAS Population | Baseline up to Month 12 | — |
| Percentage of Participants With Other Notable Events in FAS Population | Baseline up to Month 12 | Other notable events included any clinically significant event other than death or hospitalization (example, ventricular tachycardia treated by defibrillator, imbalanced diabetes, work accident, right foot gout crisis, low back pain-oliguria, chest pain, bronchitis, renal failure, heart failure, hypotension, edema, standardization of gamma glutamyl transpeptidase (GT) after stopping lamisyl (peros) prescribed for a long term for mycosis, pain, nausea, fracture, trauma, gonarthrosis, increased urea, elevation of gamma GT etc.). |
| Number of Measurements Per Month for Kalaemia Levels in FAS Population | Months 3, 6, 9, 12 | The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 millimole per liter (mmol/L). Number of measurements per month for the kalaemia levels was reported. |
| Maximum Kalaemia Levels in Serum in FAS Population | Baseline up to Month 12 | The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. |
| Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population | Baseline up to Month 12 | The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. Change in maximum value kalaemia level was calculated by subtracting the baseline values from the maximum observed value of kalaemia levels during the study. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eplerenone Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level. | 160 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
Baseline characteristics
| Characteristic | Eplerenone |
|---|---|
| Age, Continuous | 67.70 Years STANDARD_DEVIATION 11.72 |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 160 |
| serious Total, serious adverse events | 17 / 160 |
Outcome results
Primary
Number of Participants With Worsened Renal Function
Time frame: Baseline up to Month 12
Population: Data were not analyzed because the assessment of renal function was not included in the planned analysis of this study.
Primary
Percentage of Participants Hospitalized in FAS Population
Time frame: Baseline up to Month 12
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Percentage of Participants Hospitalized in FAS Population | 22.6 Percentage of participants |
Primary
Percentage of Participants Who Died in SAS Population
Time frame: Baseline up to Month 12
Population: SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Percentage of Participants Who Died in SAS Population | 6.1 Percentage of participants |
Primary
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Time frame: Baseline, Month 12
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population | Decrease | 6.1 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population | No change | 78.8 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population | Increase | 15.2 Percentage of participants |
Primary
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Time frame: Baseline, Month 3
Population: FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | Baseline: 10.7 mg daily dose (n=148) | 0.7 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | Baseline: 12.5 mg daily dose (n=148) | 3.4 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | Baseline: 25 mg daily dose (n=148) | 84.5 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | Baseline: 50 mg daily dose (n=148) | 11.5 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | Change at Month 3: Decrease (n=89) | 4.5 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | Change at Month 3: No change (n=89) | 76.4 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population | Change at Month 3: Increase (n=89) | 19.1 Percentage of participants |
Primary
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Time frame: Baseline, Month 6
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population | Decrease | 5.9 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population | No change | 70.6 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population | Increase | 23.5 Percentage of participants |
Primary
Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population
Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.
Time frame: Baseline, Month 9
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population | Decrease | 7.3 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population | No change | 60.0 Percentage of participants |
| Eplerenone | Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population | Increase | 32.7 Percentage of participants |
Primary
Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Time frame: Month 12
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population | 94.3 Percentage of participants |
Primary
Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population
Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.
Time frame: Month 3
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population | 98.9 Percentage of participants |
Primary
Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Time frame: Month 6
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population | 95.8 Percentage of participants |
Primary
Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population
Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.
Time frame: Month 9
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population | 94.8 Percentage of participants |
Primary
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population
Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
Time frame: Baseline
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eplerenone | Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population | 41.2 Percentage of EDV | Standard Deviation 13 |
Primary
Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population
Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.
Time frame: Baseline
Population: SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eplerenone | Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population | 41.40 Percentage of EDV | Standard Deviation 12.82 |
Secondary
Number of Participants With Concomitant Cardiovascular Treatment in FAS Population
Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
Time frame: Baseline up to Month 12
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With Concomitant Cardiovascular Treatment in FAS Population | 143 Participants |
Secondary
Number of Participants With Concomitant Cardiovascular Treatment in SAS Population
Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.
Time frame: Baseline up to Month 12
Population: SAS population included all participants who received study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Number of Participants With Concomitant Cardiovascular Treatment in SAS Population | 144 Participants |
Secondary
Number of Participants With Reason for Increased or Decreased Eplerenone Dose
Time frame: Baseline up to Month 12
Population: Data were not statistically summarized and were provided in individual participant listings as per the planned analysis.
Secondary
Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population
Time frame: Baseline up to Month 12
Population: FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population | 13.3 Percentage of participants |
Other Pre-specified
Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population
The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. Change in maximum value kalaemia level was calculated by subtracting the baseline values from the maximum observed value of kalaemia levels during the study.
Time frame: Baseline up to Month 12
Population: FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone | Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population | Baseline (n=140) | 4.2 mmol/L | Standard Deviation 0.38 |
| Eplerenone | Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population | Change in maximum Kalaemia level (n=123) | 0.4 mmol/L | Standard Deviation 0.59 |
Other Pre-specified
Maximum Kalaemia Levels in Serum in FAS Population
The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L.
Time frame: Baseline up to Month 12
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eplerenone | Maximum Kalaemia Levels in Serum in FAS Population | 4.6 mmol/L | Standard Deviation 0.56 |
Other Pre-specified
Number of Measurements Per Month for Kalaemia Levels in FAS Population
The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 millimole per liter (mmol/L). Number of measurements per month for the kalaemia levels was reported.
Time frame: Months 3, 6, 9, 12
Population: FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone | Number of Measurements Per Month for Kalaemia Levels in FAS Population | Month 3 (n=92) | 0.5 Measurements per month | Standard Deviation 0.33 |
| Eplerenone | Number of Measurements Per Month for Kalaemia Levels in FAS Population | Month 6 (n=71) | 0.4 Measurements per month | Standard Deviation 0.27 |
| Eplerenone | Number of Measurements Per Month for Kalaemia Levels in FAS Population | Month 9 (n=58) | 0.3 Measurements per month | Standard Deviation 0.23 |
| Eplerenone | Number of Measurements Per Month for Kalaemia Levels in FAS Population | Month 12 (n=70) | 0.2 Measurements per month | Standard Deviation 0.17 |
Other Pre-specified
Percentage of Participants With General Practitioner (GP) Consultation in FAS Population
Time frame: Baseline up to Month 12
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Percentage of Participants With General Practitioner (GP) Consultation in FAS Population | 77.7 Percentage of participants |
Other Pre-specified
Percentage of Participants With Other Notable Events in FAS Population
Other notable events included any clinically significant event other than death or hospitalization (example, ventricular tachycardia treated by defibrillator, imbalanced diabetes, work accident, right foot gout crisis, low back pain-oliguria, chest pain, bronchitis, renal failure, heart failure, hypotension, edema, standardization of gamma glutamyl transpeptidase (GT) after stopping lamisyl (peros) prescribed for a long term for mycosis, pain, nausea, fracture, trauma, gonarthrosis, increased urea, elevation of gamma GT etc.).
Time frame: Baseline up to Month 12
Population: FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Eplerenone | Percentage of Participants With Other Notable Events in FAS Population | 18.9 Percentage of participants |
Other Pre-specified
Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population
Reasons for starting eplerenone treatment included myocardial infarction, heart failure and other conditions including severe hypertension by primary hyperaldosteronism; hypertension/coronaropathy and hypokalaemia; hypertension; left ventricular failure; not tolerated spironolactone; hypertension: gynecomastia with aldactone; pulmonary suboedema; hypertension: adrenal hyperplasia, gynecomastia with aldactone; hypertension not controlled.
Time frame: Baseline
Population: FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eplerenone | Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population | Myocardial infarction | 61.9 Percentage of participants |
| Eplerenone | Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population | Heart failure | 29.9 Percentage of participants |
| Eplerenone | Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population | For another condition | 4.8 Percentage of participants |
| Eplerenone | Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population | Myocardial infarction and heart failure | 3.4 Percentage of participants |
Other Pre-specified
Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population
New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Percentage of participants in each functional class was reported.
Time frame: Baseline, Months 3, 6, 9, 12
Population: FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Baseline: Stage I (n=148) | 16.9 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Baseline: Stage II (n=148) | 54.1 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Baseline: Stage III (n=148) | 28.4 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Baseline: Stage IV (n=148) | 0.7 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 3: Stage I (n=91) | 29.7 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 3: Stage II (n=91) | 61.5 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 3: Stage III (n=91) | 6.6 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 3: Stage IV (n=91) | 2.2 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 6: Stage I (n=71) | 23.9 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 6: Stage II (n=71) | 64.8 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 6: Stage III (n=71) | 8.5 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 6: Stage IV (n=71) | 2.8 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 9: Stage I (n=58) | 22.4 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 9: Stage II (n=58) | 65.5 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 9: Stage III (n=58) | 12.1 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 12: Stage I (n=70) | 27.1 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 12: Stage II (n=70) | 64.3 Percentage of participants |
| Eplerenone | Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population | Month 12: Stage III (n=70) | 8.6 Percentage of participants |