Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication INSPRA is an aldosterone antagonist indicated for: • Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. ( 1.1 ) • The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. FDA label
Eplerenone · 4 trials · 2 indications
CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
| Arm | Type | Description |
|---|---|---|
| Eplerenone arm | EXPERIMENTAL | Add on standard heart failure therapy |
| Placebo arm | PLACEBO_COMPARATOR | Add on standard heart failure therapy |
| Name | Type | Description |
|---|---|---|
| Eplerenone | DRUG | Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily |
| Placebo | DRUG | Placebo once daily or every once daily |
Inclusion Criteria: * Japanese chronic systolic heart failure patients with LVEF =\<30% by echocardiography and NYHA II or more * Patients who receive standard therapy (Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blocker or diuretic) Exclusion Criteria: * Patient...
Top 16 of 29 competitors