A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia

Hae Young Lee, Seok Yeon Kim, Kee Joon Choi, Byung Su Yoo, Dong Hun Cha, Hae Ok Jung, Dong Ryeol Ryu, Joon Hyouk Choi, Kwang Je Lee, Tae Ho Park, Ju Hyeon Oh, Sang Min Kim, Ji Yong Choi, Kye Hun Kim, Jaemin Shim, Woo Shik Kim, Si Wan Choi, Dae Gyun Park, Pil Sang Song, Taek Jong HongMoo Yong Rhee, Seung Woon Rha, Seung Woo Park

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Abstract

Purpose The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia. Methods A randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertension and a sitting diastolic blood pressure (SiDBP) of >90 mm Hg and LDL-C levels <250 mg/dL were screened. After a 4-week run-in period with therapeutic lifestyle changes and losartan potassium 100 mg once daily, patients who met both blood pressure criteria (80 mm Hg ≤ SiDBP < 110 mm Hg) and the LDL-C level criteria (defined in the National Cholesterol Education Program Adult Treatment Panel III cardiovascular risk categories) were randomized to 1 of 3 groups and treated once daily for 8 weeks: losartan potassium 100 mg + rosuvastatin 20 mg treatment (L/R 100/20) group, amlodipine camsylate 5 mg + losartan potassium 100 mg treatment (A/L 5/100) group, and amlodipine 5 mg + losartan potassium 100 mg + rosuvastatin 20 mg (A/L/R 5/100/20) group. The primary efficacy variables were the percent change in LDL-C in the A/L/R 5/100/20 and A/L 5/100 groups and the mean change of SiDBP in the A/L/R 5/100/20 and L/R 100/20 groups after 8 weeks of treatment, relative to baseline values. Findings A total of 146 patients were enrolled and the demographic characteristics were similar among the 3 treatment groups. After 8 weeks of treatment, the mean (SD) percent change in LDL-C was significantly greater in the A/L/R group than in the A/L group (–48.40% [2.77%] vs –6.70% [3.00%]; P < 0.0001). Moreover, the mean change in SiDBP was significantly greater in the A/L/R group than in the L/R group (–9.75 [0.92] mm Hg vs –1.73 [1.03] mm Hg; P < 0.0001). SiDBP and LDL-C reductions in the A/L/R group were comparable to reductions in the A/L and L/R groups, respectively. Ten adverse events were reported in 7 patients (4.83%), and 1 patient from the A/L group (0.69%) experienced 2 adverse drug reactions (tachycardia and face edema), which were mild and resolved without specific treatment. There were no clinically significant tolerability issues during the treatment period. Implications Triple combination therapy with amlodipine/losartan/rosuvastatin can be an effective therapeutic strategy in patients with hypertension combined with dyslipidemia. These findings will form the foundation of the future development of a single-pill triple combination. ClinicalTrials.gov identifier: NCT02899455.

Original languageEnglish
Pages (from-to)2366-2379
Number of pages14
JournalClinical Therapeutics
Volume39
Issue number12
DOIs
Publication statusPublished - 2011 Dec 1

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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    Lee, H. Y., Kim, S. Y., Choi, K. J., Yoo, B. S., Cha, D. H., Jung, H. O., Ryu, D. R., Choi, J. H., Lee, K. J., Park, T. H., Oh, J. H., Kim, S. M., Choi, J. Y., Kim, K. H., Shim, J., Kim, W. S., Choi, S. W., Park, D. G., Song, P. S., ... Park, S. W. (2011). A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia. Clinical Therapeutics, 39(12), 2366-2379. https://doi.org/10.1016/j.clinthera.2017.10.013