The Phase 3 clinical trial results for Hanmi Pharmaceutical’s Amoprel—the world’s first ultra-low-dose triple antihypertensive drug—were published on the 11th in JACC, the official journal of the American Heart Association. This marks the first time that Phase 3 clinical data for a hypertension treatment developed by a domestic South Korean pharmaceutical company has been featured in the prestigious publication.
According to Hanmi Pharmaceutical on the 27th, the two Phase 3 studies published in the journal compared the 8-week efficacy of Amoprel against standard doses of amlodipine (5mg) and losartan (50mg) in patients with mild to moderate hypertension. Amoprel is a fixed-dose combination therapy containing three active components: amlodipine, losartan, and chlorthalidone.
Superior Efficacy and Tolerability at Ultra-Low Doses
In a study of 361 patients with essential (idiopathic) hypertension in South Korea, the reduction in systolic blood pressure after eight weeks of Amoprel administration demonstrated non-inferiority to amlodipine 5mg. Crucially, there was no significant difference in terms of tolerability, meaning patients experienced a similar degree of side effects despite the triple-drug composition.
Furthermore, the Amoprel group proved superior to the losartan 50mg group, reducing systolic blood pressure by an additional 3.4 mmHg. Hanmi Pharmaceutical explained that by using ultra-low doses of three different mechanisms, Amoprel achieves efficacy comparable to or better than standard monotherapies while minimizing the risk of dose-dependent adverse reactions.
Gender-Specific Variations in Blood Pressure Reduction
Notably, the research documented distinct differences in effects based on gender. Both the Amoprel and amlodipine groups showed a more pronounced reduction in systolic blood pressure in female patients compared to male patients.
In the comparison against losartan, the Amoprel group demonstrated superior systolic blood pressure reduction specifically in female patients. While the losartan 50mg group showed no significant difference in efficacy between genders, the Amoprel group exhibited a notably stronger blood pressure-lowering effect in women.
Park Jae-hyun, CEO of Hanmi Pharmaceutical, stated, "The publication of Amoprel’s clinical results in JACC, a world-renowned journal representing the cardiovascular field, signifies that our differentiated strategy of ultra-low-dose combination therapy could become a new global standard in the initial treatment of hypertension."
As one of the most cited and prestigious journals in cardiology, JACC is considered a primary source of truth for heart researchers and clinicians worldwide.
