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US-20260124187-A1 - COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION

US20260124187A1US 20260124187 A1US20260124187 A1US 20260124187A1US-20260124187-A1

Abstract

Provided herein are pharmaceutical compositions that are useful for the treatment of hypertension comprising an angiotensin II receptor blocker, a diuretic, and a calcium channel blocker, wherein the dose of each component is below the lowest dose approved for the treatment of hypertension for the component.

Inventors

  • Anthony RODGERS
  • Stephen Macmahon

Assignees

  • The George Institute for Global Health

Dates

Publication Date
20260507
Application Date
20251107

Claims (20)

  1. 1 - 24 . (canceled)
  2. 25 . A method of treating a subject having hypertension, the method comprising administering to the subject a pharmaceutical composition comprising: (a) telmisartan; (b) indapamide; and (c) amlodipine besylate, wherein said pharmaceutical composition is not administered in a subject who is prescribed aliskiren.
  3. 26 . The method of claim 25 , wherein the pharmaceutical composition is formulated for oral administration.
  4. 27 . The method of claim 26 , wherein the pharmaceutical composition is in the form of a pill, tablet, or capsule.
  5. 28 . The method of claim 25 , wherein the treating the subject results in a reduction of systolic blood pressure (SBP) in the subject of about 10 mmHg or greater.
  6. 29 . The method of claim 25 , wherein the treating the subject results in a reduction of diastolic blood pressure (DBP) of about 5 mmHg or greater.
  7. 30 . The method of claim 25 , wherein the treating the subject results in a reduction in SBP or DBP that is greater than the reduction obtained with the full lowest hypertension therapeutic dose of any one of the (a), (b), and (c) in the pharmaceutical composition.
  8. 31 . The method of claim 25 , wherein the treating the subject results in greater long-term tolerability and reduced risk of side effects when compared to treatment with the full lowest hypertension therapeutic dose of any one of (a), (b), and (c) in the pharmaceutical composition.
  9. 32 . The method of claim 25 , wherein a dose of the indapamide is about 0.625 mg.
  10. 33 . The method of claim 25 , wherein a dose of the amlodipine besylate is about EQ 1.25 mg base.
  11. 34 . The method of claim 25 , wherein a dose of the telmisartan is about 10 mg.
  12. 35 . The method of claim 25 , wherein a dose of the indapamide is about 0.625 mg, a dose of amlodipine besylate is about EQ 1.25 mg base, and a dose of the telmisartan is about 10 mg.
  13. 36 . The method of claim 25 , wherein a dose of the indapamide is about 1.25 mg.
  14. 37 . The method of claim 25 , wherein a dose of the amlodipine besylate is about EQ 2.5 mg base.
  15. 38 . The method of claim 25 , wherein a dose of the telmisartan is about 20 mg.
  16. 39 . The method of claim 25 , wherein a dose of the indapamide is about 1.25 mg, a dose of the amlodipine besylate is about EQ 2.5 mg base, and a dose of the telmisartan is about 20 mg.
  17. 40 . The method of claim 25 , wherein a dose of the indapamide is about 2.5 mg.
  18. 41 . The method of any one of claim 25 , wherein a dose of amlodipine besylate is about EQ 5 mg base.
  19. 42 . The method of claim 25 , wherein a dose of telmisartan is about 40 mg.
  20. 43 . The method of claim 25 , wherein a dose of the indapamide is about 2.5 mg, a dose of the amlodipine besylate is about EQ 5 mg base, and a dose of the telmisartan is about 40 mg.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of International Application No. PCT/US2025/054060, filed Nov. 4, 2025, which claims the benefit and priority of U.S. Provisional Application No. 63/716,555, filed on Nov. 5, 2024, each of which is incorporated by reference herein in its entirety. BACKGROUND OF THE DISCLOSURE High blood pressure, also known as hypertension, is a leading cause of preventable morbidity and mortality and it is well established that treatments that lower blood pressure (BP) are beneficial. However, despite the plethora of blood pressure lowering medicines available, many patients continue to have poor blood pressure control as evidenced by multiple large-scale population studies. Contributing factors for poor blood pressure control include poor adherence, complex guidelines recommending multiple up-titration steps, and treatment inertia. Furthermore, the majority of treated patients receive only monotherapy, which has limited potency even at high doses where side effects are increased and tolerability reduced. SUMMARY OF THE DISCLOSURE Recognized herein is a need for new treatments for lowering high blood pressure that are efficacious and tolerable. In one aspect, the present disclosure provides a method of treating a subject having hypertension, the method comprising administering a pharmaceutical composition comprising (a) telmisartan; (b) indapamide; and (c) amlodipine besylate, wherein said pharmaceutical composition is not administered in a subject who is prescribed aliskiren. In some embodiments, the pharmaceutical composition is formulated for oral administration. In some embodiments, the pharmaceutical composition is in the form of a pill, tablet, or capsule. In some embodiments, the treatment results in a systolic blood pressure (SBP) of less than about 140 mmHg. In some embodiments, the treatment results in a reduction of systolic blood pressure (SBP) of about 10 mmHg or greater. In some embodiments, the treatment results in a diastolic blood pressure (DBP) of less than about 90 mmHg. In some embodiments, the treatment results in a reduction of diastolic blood pressure (DBP) of about 5 mmHg or greater. In some embodiments, treatment results in a reduction in systolic blood pressure (SBP) that is greater than the reduction obtained with the full lowest hypertension therapeutic dose of any one of the (a), (b), and (c) in the pharmaceutical composition. In some embodiments, treatment results in a reduction in diastolic blood pressure (DBP) that is greater than the reduction obtained with the full lowest hypertension therapeutic dose of any one of (a), (b), and (c) in the pharmaceutical composition. In some embodiments, the treatment results in greater long-term tolerability and reduced risk of side effects when compared to treatment with the full lowest hypertension therapeutic dose of any one of (a), (b), and (c) in the pharmaceutical composition. In some embodiments, the treatment is an initial or first-line treatment of hypertension. In some embodiments, the treatment is not an initial or first-line treatment of hypertension. In some embodiments, the subject is administered with a first therapy comprising (i) telmisartan at a dose of about 10 mg, (ii) indapamide at a dose of about 0.625 mg, and (iii) amlodipine besylate at a dose of about EQ 1.25 mg base; (b) subsequent to the first therapy of (a), the subject is administered with a second therapy comprising (i) telmisartan at a dose of about 20 mg, (ii) indapamide at a dose of about 1.25 mg, and (iii) amlodipine besylate at a dose of about EQ 2.5 mg base; and (c) subsequent to the first therapy of (a) and the second therapy of (b), the subject is administered with a third therapy comprising (i) telmisartan at a dose of about 40 mg, (ii) indapamide at a dose of about 2.5 mg, and (iii) amlodipine besylate at a dose of about EQ 5 mg base. In some embodiments, a dose of indapamide is about 0.625 mg. In some embodiments, a dose of amlodipine besylate is about EQ 1.25 mg base. In some embodiments, a dose of telmisartan is about 10 mg. In some embodiments, a dose of indapamide is about 0.625 mg, a dose of amlodipine besylate is about EQ 1.25 mg base, and a dose of telmisartan is about 10 mg. In some embodiments, a dose of indapamide is about 1.25 mg. In some embodiments, a dose of amlodipine besylate is about EQ 2.5 mg base. In some embodiments, a dose of telmisartan is about 20 mg. In some embodiments, a dose of indapamide is about 1.25 mg, a dose of amlodipine besylate is about EQ 2.5 mg base, and a dose of telmisartan is about 20 mg. In some embodiments, a dose of indapamide is about 2.5 mg. In some embodiments, a dose of amlodipine besylate is about EQ 5 mg base. In some embodiments, a dose of telmisartan is about 40 mg. In some embodiments, a dose of indapamide is about 2.5 mg, a dose of amlodipine besylate is about EQ 5 mg base, and a dose of telmisartan is about 40 mg. Additional aspects and a