COMPOUNDS AND METHODS FOR TREATING OR PREVENTING CARDIOVASCULAR DISEASES AND CONDITIONS
This invention relates to methods of treating and/or preventing cardiovascular diseases and conditions and to methods of reducing the risk of cardiovascular death, reducing the risk of hospitalization for heart failure, reducing the risk of hospitalization for heart failure, reducing the risk of urgent visits for heart failure, and slowing the progression of kidney disease.
1 . A method of reducing the risk of cardiovascular death in a patient at risk of cardiovascular death, which comprises administering to the patient a prophylactically effective amount of sotagliflozin.
2 . A method of reducing the risk of hospitalization for heart failure in a patient at risk of heart failure, which comprises administering to the patient a prophylactically effective amount of sotagliflozin.
3 . A method of reducing the risk of urgent visits for heart failure in a patient at risk of heart failure, which comprises administering to the patient a prophylactically effective amount of sotagliflozin.
4 . A method of managing heart failure (e.g., slowing the progression of or managing one or more symptoms of heart failure) in a patient at risk of heart failure, which comprises administering to the patient a prophylactically effective amount of sotagliflozin.
5 . A method of reducing the risk of stroke in a patient at risk of suffering a stroke, which comprises administering to the patient a prophylactically effective amount of sotagliflozin.
6 . A method of slowing or preventing the progression of kidney disease in a patient with kidney disease or at risk of having kidney disease, which comprises administering to the patient a prophylactically effective amount of sotagliflozin.
7 . A method of any of the preceding claims, wherein the patient has type 2 diabetes.
8 . A method of any of the preceding claims, wherein the patient has worsening heart failure or at least one additional risk factor for heart failure.
9 . The method of claim 8 , wherein the additional risk factor for heart failure is high blood pressure, coronary artery disease, a history of heart attack or stroke, myocarditis, congenital heart defect, or arrhythmia.
10 . A method of any of claims 1 - 8 , wherein the patient has chronic kidney disease (e.g., CKD2, CKD3, or CKD4).
11 . A method of any of claims 1 - 8 , wherein the patient has an ejection fraction of <40%.
12 . A method of any of claims 1 - 8 , wherein the patient has an ejection fraction of 40% to <50%.
13 . A method of any of claims 1 - 8 , wherein the patient has an ejection fraction of ≥50%.
14 . The method of claim 10 , wherein the patient has albuminuria.
15 . The method of claim 10 , wherein the patient has an eGFR of less than 30 ml/min/173 m 2 .
16 . The method of claim 10 , wherein the patient has an eGFR of 30 to <45 ml/min/173 m 2 .
17 . The method of claim 10 , wherein the patient has an eGFR of ≥45 ml/min/173 m 2 .
18 . A method of any of the preceding claims, wherein sotagliflozin is administered orally.
19 . A method of any of the preceding claims, wherein the prophylactically effective amount is at least 200 mg per day (e.g., 200, 250, 300, 350, or 400 mg/day).
20 . A method of any of the preceding claims, wherein the sotagliflozin is administered in combination with a RAAS inhibitor, beta blocker, diuretic (e.g., loop diuretic), or glucose-lowering medication.
21 . The method of claim 20 , wherein the RAAS inhibitor is an ACE inhibitor, an angiotensin-receptor blocker, an angiotensin receptor-neprilysin inhibitor, or a mineralocorticoid-receptor antagonist.
22 . The method of claim 20 , wherein the glucose-lowering medication is metformin, a sulfonylurea, a DPP-4 inhibitor (e.g., sitagliptin), insulin, or a GLP-1 receptor agonist.