Clinical therapeutics · 2025
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.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Hong Soon Jun, Kim Ju Hyeon, Cha Kwang Soo, Lee Jin Bae, Moon Jae Youn, Cho Goo-Yeong, Cho Deok-Kyu, Park Jong-Pil, Yi Jeong-Eun, Kim Kye Hun, Jeong Hyeonju, Rhee Moo-Yong, Lee Jung-Hee, Ahn Kye Tack, Yoon Young Won, Lee Sang-Yeub, Sung Ki-Chul, Cha Tae-Joon, Shin Jinho, Cho Yoon Haeng, Son Jang-Won, Ahn Jong-Hwa, Park Sang-Don, Kang Woong Chol, Hahn Joo-Yong, Ha Jong-Won
Аннотация
BACKGROUND: Essential hypertension and primary hypercholesterolemia are common and independent cardiovascular risk factors that frequently coexist and warrant integrated management. This study aimed to evaluate the efficacy and safety of triple combination therapy (FMS + ATO/EZE) with Fimasartan (FMS), atorvastatin (ATV), and ezetimibe (EZE) compared with atorvastatin/ezetimibe (ATO/EZE) dual therapy or Fimasartan (FMS) monotherapy in patients with hypertension and hypercholesterolemia.
METHODS: This multicenter, randomized clinical trial was conducted across 25 clinical trial institutions in the Republic of Korea. A total of 315 participants were screened, of whom 148 eligible participants were randomized to receive FMS + ATO/EZE (n = 49), ATO/EZE (n = 49), or FMS (n = 50). The primary efficacy endpoints were 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 low-density lipoprotein cholesterol (LDL-C) from baseline to week 8 in the FMS + ATO/EZE group compared with that in the FMS group. Safety was assessed based on treatment-emergent adverse events (TEAEs).
RESULTS: In the full analysis set, the FMS + ATO/EZE group demonstrated superior reduction in msSBP compared to the ATO/EZE group (least squares [LS] mean difference: -7.26 ± 2.84 mm Hg; 95% confidence interval [CI]: -12.91, -1.61; P = 0.0124). Similarly, the percentage reduction in LDL-C was significantly greater in the FMS + ATO/EZE group than in the FMS group (LS mean difference: -58.02% ± 4.03%; 95% CI: -66.03, -50.02; P < 0.0001). The incidence of TEAEs was comparable across treatment groups: FMS + ATO/EZE (20.83%), ATO/EZE (22.45%), and FMS (16.00%) (P = 0.7030). Serious adverse events occurred in 1.36% of the total safety population, without significant difference between the groups (P = 0.5480).
CONCLUSIONS: Triple combination therapy with FMS + ATO/EZE was superior to dual therapy or monotherapy in reducing both BP and LDL-C levels in patients with essential hypertension accompanied by primary hypercholesterolemia. The safety profile was comparable with that of the individual components, confirming the tolerability and safety of FMS + ATO/EZE therapy. However, the 8-week follow-up period and enrollment of an exclusively Korean cohort may limit the assessment of long-term effects and generalizability to other ethnic populations.
METHODS: This multicenter, randomized clinical trial was conducted across 25 clinical trial institutions in the Republic of Korea. A total of 315 participants were screened, of whom 148 eligible participants were randomized to receive FMS + ATO/EZE (n = 49), ATO/EZE (n = 49), or FMS (n = 50). The primary efficacy endpoints were 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 low-density lipoprotein cholesterol (LDL-C) from baseline to week 8 in the FMS + ATO/EZE group compared with that in the FMS group. Safety was assessed based on treatment-emergent adverse events (TEAEs).
RESULTS: In the full analysis set, the FMS + ATO/EZE group demonstrated superior reduction in msSBP compared to the ATO/EZE group (least squares [LS] mean difference: -7.26 ± 2.84 mm Hg; 95% confidence interval [CI]: -12.91, -1.61; P = 0.0124). Similarly, the percentage reduction in LDL-C was significantly greater in the FMS + ATO/EZE group than in the FMS group (LS mean difference: -58.02% ± 4.03%; 95% CI: -66.03, -50.02; P < 0.0001). The incidence of TEAEs was comparable across treatment groups: FMS + ATO/EZE (20.83%), ATO/EZE (22.45%), and FMS (16.00%) (P = 0.7030). Serious adverse events occurred in 1.36% of the total safety population, without significant difference between the groups (P = 0.5480).
CONCLUSIONS: Triple combination therapy with FMS + ATO/EZE was superior to dual therapy or monotherapy in reducing both BP and LDL-C levels in patients with essential hypertension accompanied by primary hypercholesterolemia. The safety profile was comparable with that of the individual components, confirming the tolerability and safety of FMS + ATO/EZE therapy. However, the 8-week follow-up period and enrollment of an exclusively Korean cohort may limit the assessment of long-term effects and generalizability to other ethnic populations.