Efficacy and safety of combination therapy with telmisartan, rosuvastatin, and ezetimibe in patients with dyslipidemia and hypertension: A randomized, double-blind, multicenter, therapeutic confirmatory, phase III clinical trial.
Chan Joo LeeWoong Chol KangSang Hyun IhmIl Suk SohnJong Shin WooJin Won KimSoon Jun HongJung Hyun ChoiJung-Won SuhJae-Bin SeoJoon-Hyung DohJung-Woo SonJae-Hyeong ParkJu-Hee LeeYoung Joon HongJung Ho HeoJinho ShinSeok-Min KangPublished in: Journal of clinical hypertension (Greenwich, Conn.) (2024)
This study aimed to compare and evaluate the efficacy of the blood pressure (BP) control and cholesterol-lowering effects and safety of combination therapy with telmisartan, rosuvastatin, and ezetimibe versus rosuvastatin and ezetimibe double therapy or telmisartan single therapy in dyslipidemia patients with hypertension. After a wash-out/therapeutic lifestyle change period of ≥4 weeks, a total of 100 eligible patients were randomized and received one of three treatments for 8 weeks: (1) telmisartan 80 mg/rosuvastatin 20 mg/ezetimibe 10 mg (TRE), (2) rosuvastatin 20 mg/ezetimibe 10 mg (RE), or (3) telmisartan 80 mg (T). The primary endpoint was the efficacy evaluation of TRE by comparing changes in mean sitting systolic blood pressure (msSBP) and mean percentage change in low-density lipoprotein-C (LDL-C) from baseline after 8 weeks of treatment. The least square (LS) mean (SE) changes in msSBP at 8 weeks compared with baseline were -23.02 (3.04) versus -7.18 (3.09) mmHg in the TRE and RE groups, respectively (p < .0001), and -25.80 (2.74) versus -14.92 (2.65) mmHg in the TRE and T groups, respectively (p = .0005). The percentage changes in the mean (SD) LDL-C at 8 weeks compared with baseline were -54.97% (3.49%) versus -0.17% (3.23%) in the TRE and T groups, respectively (p < .0001). No serious adverse events occurred, and no statistically significant differences in the incidence of overall AEs and adverse drug reactions occurred among the three groups. TRE therapy significantly decreased msSBP and LDL-C compared to RE or T therapy with comparable safety and tolerability profiles.
Keyphrases
- blood pressure
- double blind
- combination therapy
- phase iii
- low density lipoprotein
- clinical trial
- placebo controlled
- open label
- phase ii
- adverse drug
- hypertensive patients
- end stage renal disease
- gestational age
- heart rate
- heart failure
- chronic kidney disease
- cardiovascular disease
- metabolic syndrome
- ejection fraction
- randomized controlled trial
- risk factors
- study protocol
- mesenchymal stem cells
- skeletal muscle
- blood glucose
- prognostic factors
- replacement therapy
- patient reported
- glycemic control