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Clinical Trial
. 2020 Feb;22(2):261-269.
doi: 10.1111/jch.13774. Epub 2020 Jan 31.

A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension

Woohyeun Kim  1 , Kiyuk Chang  2 , Eun Joo Cho  3 , Jeong-Cheon Ahn  4 , Cheol Woong Yu  5 , Kyoung-Im Cho  6 , Yong-Jin Kim  7 , Duk-Hyun Kang  8 , Seok-Yeon Kim  9 , Sang-Hak Lee  10 , Ung Kim  11 , Shin-Jae Kim  12 , Young Keun Ahn  13 , Chang Hoon Lee  14 , Jin Ho Shin  15 , Mikyung Kim  16 , Chang Gyu Park  1
Affiliations
Clinical Trial

A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension

Woohyeun Kim et al. J Clin Hypertens (Greenwich). 2020 Feb.

Abstract

This multicenter, randomized, double-blind, parallel-group phase III clinical trial aimed to investigate the efficacy and safety of a rosuvastatin + amlodipine combination compared with that of rosuvastatin or amlodipine monotherapy in hypertensive patients with dyslipidemia. A total of 106 patients of 15 institutions in Korea were randomly assigned to 1 of 3 treatment groups: rosuvastatin 20 mg + amlodipine 10 mg, amlodipine 10 mg, or rosuvastatin 20 mg. After 8 weeks of treatment, the mean ± SD of change in mean sitting systolic blood pressure (msSBP) was -22.82 ± 12.99 mm Hg in the rosuvastatin + amlodipine group, the most decreased among the treatment groups. The percentage of patients whose msSBP decreased ≥20 mm Hg or msDBP decreased ≥10 mm Hg was also highest in this group (74.29%). The mean ± SD percentage change in low-density lipoprotein cholesterol (LDL-C) level from baseline after 8 weeks was -52.53% ± 11.21% in the rosuvastatin + amlodipine group, the most decreased among the treatment groups. More patients in the rosuvastatin + amlodipine group achieved their target LDL-C goal at 8 weeks, compared with the other treatment groups (97.14%). No serious adverse events or adverse drug reactions were observed in all groups. In hypertensive patients with dyslipidemia, combination treatment with rosuvastatin 20 mg + amlodipine 10 mg effectively reduced blood pressure and LDL-C levels while maintaining safety.

Trial registration: ClinicalTrials.gov NCT03103256.

Keywords: amlodipine; dyslipidemia; hypertension; rosuvastatin; single-pill combination.

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Figures

Figure 1
Figure 1
Study design of the Clinical Trial
Figure 2
Figure 2
Comparison of changes in mean sitting systolic blood pressure after treatment. A, Least‐squares mean change from baseline in mean sitting systolic blood pressure. B, Rate of target goal achievement (left) and blood pressure responder (right). *P‐value < .0001, † P‐value > .05
Figure 3
Figure 3
Comparison of changes in low‐density lipoprotein cholesterol (LDL‐C) after treatment. A, Least‐squares mean percent change from baseline in LDL‐C. B, Rate of target goal achievement. *P‐value < .0001, † P‐value > .05
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References

    1. Wang H, Naghavi M, Allen C, et al. Global, regional, and national life expectancy, all‐cause mortality, and cause‐specific mortality for 249 causes of death, 1980–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388:1459‐1544. - PMC - PubMed
    1. GBD 2015 Disease and Injury Incidence and Prevalence Collaborators . Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet . 2016;388:1545‐1602. - PMC - PubMed
    1. Jeemon P, Gupta R, Onen C, et al. Management of hypertension and dyslipidemia for primary prevention of cardiovascular disease. In: Prabhakaran D, Anand S, Gaziano TA, Mbanya JC, Wu Y, Nugent R, eds. Cardiovascular, Respiratory, and Related Disorders. Washington, DC: The International Bank for Reconstruction and Development/The World Bank (c) 2017 International Bank for Reconstruction and Development/The World Bank; 2017:389‐404. - PubMed
    1. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APHA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13‐e115. - PubMed
    1. Forouzanfar MH, Liu P, Roth GA, et al. Global burden of hypertension and systolic blood pressure of at least 110 to 115 mm hg, 1990–2015. JAMA. 2017;317:165‐182. - PubMed

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