FMS + ATO/EZE Greater Than its Parts for Hypertension and Dyslipidemia

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Triple combination therapy with fimasartan, atorvastatin, and ezetimibe (FMS + ATO/EZE) was superior to dual therapy or monotherapy in reducing both blood pressure and low-density lipoprotein cholesterol (LDL-C) levels in patients with hypertension and dyslipidemia, according to new findings from the first phase 3 clinical trial evaluating the combination.1

“The management of [hypertension and dyslipidemia] typically requires multiple medications, increasing regimen complexity and potentially reducing patient adherence. In this context, treatment simplification through single-pill fixed-dose combinations (FDCs) has been associated with improved adherence and more effective risk-factor control. Korean hypertension and dyslipidemia guidelines emphasize the importance of aggressive, integrated management in high-risk patients, underscoring the clinical utility of combination therapies that are both efficacious and conducive to simplified dosing regimens2,” study investigator Soon Jun Hong, MD, Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea, and colleagues wrote.1 “Despite these advances, robust randomized data specifically comparing the FMS + ATO + EZE triple regimen against ATO/EZE dual therapy or FMS monotherapy in patients with essential hypertension and primary hypercholesterolemia remain limited; the recently completed Phase 3 study was designed to address this evidence gap.”

Hong and colleagues conducted the multicenter, randomized clinical trial across 25 clinical trial institutions in the Republic of Korea. The trial screened a total of 315 participants, of whom 148 were randomized to receive FMS + ATO/EZE (n = 49), ATO/EZE (n = 49), or FMS (n = 50). The trial primarily evaluated the change in mean sitting systolic blood pressure (msSBP) from baseline to week 8 in the FMS + ATO/EZE group compared with that in the ATO/EZE group and the percentage change in LDL-C from baseline to week 8 in the FMS + ATO/EZE group compared with that in the FMS group. Trial also evaluated safety through treatment-emergent adverse events (TEAEs).

Investigators found that the FMS + ATO/EZE group demonstrated superior reduction in msSBP compared to the ATO/EZE group (least squares mean difference [LSM], –7.26; SD, 2.84 mm Hg; 95% CI, –12.91 to –1.61; P = .0124). Furthermore, the percentage reduction in LDL-C was significantly greater in the FMS + ATO/EZE group than in the FMS group (LSM, –58.02%; SD, 4.03%; 95% CI, –66.03 to –50.02; P <.0001).

In terms of safety, the incidence of TEAEs was comparable across treatment groups, with a rate of 20.83% in the FMS + ATO/EZE group, 22.45% in the ATO/EZE group, and 16.00% in the FMS group (P = .7030). Serious TEAEs occurred in 1.36% of the total safety population, with 1 case of appendicitis (2.08%) in the FMS + ATO/EZE group and 1 case of humerus fracture (2.04%) in the ATO/EZE group. AEs that could not exclude a causal relationship occurred in 14 participants (9.52%), with a total of 20 events. The FMS + ATO/EZE group had 7 events in 5 participants (10.42%), the ATO/EZE group had 6 events in 4 participants (8.16%), and the FMS group had 7 events in 5 participants (10.00%; P = .9410). The most frequently reported AEs possibly related to therapy were dizziness in 5 participants (3.40%) with 5 events and ALT increase and AST increase, each occurring in 3 participants (2.04%) with 3 events.

“In Korean patients with concomitant hypertension and hypercholesterolemia, the triple combination of FMS + ATO/EZE achieved greater BP reduction than ATO/EZE and greater LDL-C reduction than FMS alone, with a lipid-lowering effect similar to ATO/EZE. The regimen was well tolerated, supporting its use for simultaneous BP and lipid control in this population,” Hong and colleagues wrote.1

References
  1. Hong SJ, Kim JH, Cha KS, et al. Efficacy and Safety of Fimasartan, Atorvastatin, and Ezetimibe Combination Therapy in Patients With Hypertension and Dyslipidemia: A Randomized, Double-Blind, Multicenter, Therapeutic Confirmatory, Phase III Clinical Trial. Clin Ther. Published online September 13, 2025. doi:10.1016/j.clinthera.2025.08.012
  2. Song ZY, Kim MH, Lee HC, et al. Efficacy and Safety of Coadministered Ezetimibe-Rosuvastatin plus Telmisartan in South Korean Patients with Dyslipidemia and Hypertension: A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase III Trial. J Clin Med. 2023;12(6):2377. Published 2023 Mar 19. doi:10.3390/jcm12062377

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