US EditionEfficacy and Safety of a Four-Drug, Quarter-Dose Treatment for Hypertension: the QUARTET USA Randomized Trial
- On June 9, 2025, the US FDA approved WIDAPLIK, a single-pill triple combination therapy, to treat hypertension in adults in the US.
- This approval followed two pivotal Phase 3 trials published in 2024 showing WIDAPLIK's superior blood pressure reduction compared to dual therapy and placebo.
- WIDAPLIK combines telmisartan, amlodipine, and indapamide in three doses, demonstrating good tolerability without increased discontinuation and no serious new safety signals.
- Clinical data showed 65% of patients on ultra-low dose WIDAPLIK achieved blood pressure below 140/90 mm Hg versus 30% on placebo, indicating significant efficacy.
- George Medicines plans to launch WIDAPLIK commercially in the US in Q4 2025 and anticipates regulatory submissions in other markets, aiming to address key challenges in hypertension control.
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Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial
New approaches are needed to lower blood pressure (BP) given persistently low control rates. QUARTET USA sought to evaluate the effect of four-drug, quarter-dose BP lowering combination in patients with hypertension. QUARTET USA was a randomized (1:1), double-blinded trial conducted in federally qualified health centers among adults with hypertension. Participants received either a quadpill of candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.6…
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Anti-Aging, Acupuncture and Health NewsPolypill Approved for Hypertension, Including as Initial Therapy
FDA approves first polypill for initial treatment of hypertension
George Medicines announced the FDA approval of its triple therapy polypill for initial treatment of adults with hypertension.The polypill (Widaplik) — formerly known as GMRx2 — contains three separate drugs for treatment of high BP: telmisartan, an angiotensin receptor blocker; amlodipine, a calcium channel blocker; and indapamide, a thiazide-like diuretic.
Hypertension consists of an increase in chronic and sustained blood pressure. It is estimated that in Spain this health problem suffers from 33 to 43% of the adult population, which amounts to 60% in those over 65 years of age.The Spanish Society of Hypertension-Spanish League for the Fight against Arterial Hypertension (SEH-LELHA) estimates that in our country there are about 14 million hypertensive patients.High blood pressure can cause seriou…
George Medicines announces FDA approval of WIDAPLIK™ (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment
Novel, single pill, triple combination with a standard dose and two lower doses that can deliver the efficacy benefits of combination therapy, with an...
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