Lee Bong-Ki, Kim Byeong-Keuk, Park Jae Hyoung, Chung Jong-Won, Park Chang Gyu, Kim Jin Won, Kim Young Dae, Park Woo-Jung, Kim Sang-Hyun, Cha Jae-Kwan, Kim Cheol Ho, Rha Seung-Woon, Hong Young Joon, Shin Mi-Seung, Cho Seong Wook, Sung Young-Hee, Lee Kiheon, Yu Jae-Myung, Ryu Dong-Ryeol, Yu Sungwook, Song Tae-Jin, Ku Bon D, Kim Sin-Gon, Park Hwan-Cheol, Cho Deok-Kyu, Kim Byung-Su, Han Seong-Woo, Park Sung-Ji, Park Gyung-Min, Han Kyoo-Rok
Division of Cardiology, Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon 24289, Republic of Korea.
Department of Internal Medicine, Division of Cardiology, Yonsei University Severance Cardiovascular Hospital, Seoul 03722, Republic of Korea.
J Clin Med. 2025 Jan 7;14(2):308. doi: 10.3390/jcm14020308.
This study assessed the therapeutic effectiveness of a single-pill combination (SPC) of olmesartan/amlodipine plus rosuvastatin for blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) in patients with hypertension and dyslipidemia. Adult patients with hypertension and dyslipidemia who were decided to be treated with the study drug were eligible. The primary endpoint was the proportion of patients who achieved BP, LDL-C and both BP and LDL-C treatment goals at weeks 24-48. Secondary endpoints were assessed at weeks 24-48 and included changes in BP and LDL-C levels from baseline; the proportion of patients who achieved treatment goals who were initially classified as uncontrolled at baseline; changes and percent changes in lipid parameters; changes in both BP and LDL-C levels among patients who reached treatment goals who were followed for more than 24 weeks; and the overall safety profile. A total of 5476 patients were enrolled, and 4411 patients comprised the effectiveness evaluation set. The proportions of patients who reached the treatment goals for BP, LDL-C levels, and both BP and LDL-C levels were 67.93% [95% confidence interval (CI) 66.52-69.32], 80.19% [95% CI 78.85-81.49], and 58.07% [95% CI 56.43-59.7], respectively. Secondary endpoints showed statistically significant changes. Overall, the treatment was well tolerated. The treatment of patients with hypertension and dyslipidemia with the olmesartan/amlodipine plus rosuvastatin SPC was associated with significant decreases in SBP/DBP and LDL-C levels, and a high proportion of patients achieved the BP and LDL-C treatment goals. The finding of this study is worthwhile in that this study evaluated the effectiveness and safety in a broad patient population representative of those seen in everyday clinical practice.
本研究评估了奥美沙坦/氨氯地平联合瑞舒伐他汀单片复方制剂（SPC）对高血压合并血脂异常患者血压（BP）及低密度脂蛋白胆固醇（LDL-C）的治疗效果。入选成年高血压合并血脂异常患者，且决定接受研究药物治疗。主要终点为在第24至48周达到血压、LDL-C以及血压和LDL-C治疗目标的患者比例。次要终点在第24至48周进行评估，包括血压和LDL-C水平相对于基线的变化；初始被分类为基线未控制但达到治疗目标的患者比例；血脂参数的变化及变化百分比；达到治疗目标且随访超过24周的患者血压和LDL-C水平的变化；以及总体安全性。共纳入5476例患者，4411例患者组成有效性评估集。达到血压、LDL-C水平以及血压和LDL-C水平治疗目标的患者比例分别为67.93%[95%置信区间（CI）66.52 - 69.32]、80.19%[95%CI 78.85 - 81.49]和58.07%[95%CI 56.43 - 59.7]。次要终点显示有统计学意义的变化。总体而言，该治疗耐受性良好。奥美沙坦/氨氯地平联合瑞舒伐他汀SPC治疗高血压合并血脂异常患者可使收缩压/舒张压和LDL-C水平显著降低，且很大比例的患者达到血压和LDL-C治疗目标。本研究结果具有价值，因为该研究在广泛的患者群体中评估了有效性和安全性，这些患者代表了日常临床实践中所见的患者。
