Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022;29(5):815-823.
doi: 10.5603/CJ.a2020.0167. Epub 2020 Dec 21.

Effect of FIXed-dose combination of ARb and statin on adherence and risk factor control: The randomized FIXAR study

Seyong Chung  1 , Young-Guk Ko  1 , Jung Sun Kim  1 , Byeong-Keuk Kim  1 , Chul-Min Ahn  1 , Sungha Park  1 , Sung-Jin Hong  1 , Sang-Hak Lee  2 , Donghoon Choi  1
Affiliations
Randomized Controlled Trial

Effect of FIXed-dose combination of ARb and statin on adherence and risk factor control: The randomized FIXAR study

Seyong Chung et al. Cardiol J. 2022.

Abstract

Background: The efficacy of fixed-dose combinations (FDCs) in improving adherence and risk factor control for cardiovascular disease has not been reported consistently. Here, we compared adherence and efficacy between an olmesartan/rosuvastatin FDC and the usual regimen.

Methods: In this 6-month, open-label, randomized, active-control study, we screened 154 patients; of these, 150 were randomly assigned to receive either olmesartan/rosuvastatin FDC or the usual regimen with separate angiotensin receptor blockers and statins. In total, 135 patients completed the study (median age: 68 years; male: 68.9%). The primary outcome was patients' adherence; the secondary outcomes were changes in blood pressure (BP) and lipid parameters.

Results: During follow-up, adherence in both groups was high and similar between the groups (98.9% and 98.3% in the FDC and usual regimen groups, respectively, p = 0.328). Changes in systolic (-8 and -5 mmHg, respectively, p = 0.084) and diastolic BP (-5 and -2 mmHg, p = 0.092) did not differ significantly, although they were numerically greater in the FDC group. Changes in low-density lipoprotein cholesterol (LDL-C) were greater in the FDC group (-13 and -4 mg/dL, respectively, p = 0.019), whereas changes in other lipid parameters were similar between the groups. The test drugs were well tolerated, showing no difference in safety between the groups.

Conclusions: Patients' adherence was excellent and similar in the groups, whereas the reduction in the LDL-C level was greater in the FDC group. We provide comprehensive information on the adherence and efficacy of an FDC compared to the usual regimen in Korean patients with high cardiovascular risk.

Keywords: drug therapy; hypercholesterolemia; hypertension; renin–angiotensin system; rosuvastatin calcium.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: None declared

Figures

Figure 1
Figure 1
Study profile showing the numbers of patients who participated or dropped out; BP — blood pressure; FDC — fixed-dose combination.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Kim MC, Ahn Y, Cho JY, et al. Benefit of early statin initiation within 48 hours after admission in statin-naïve patients with acute myocardial infarction undergoing percutaneous coronary intervention. Korean Circ J. 2019;49(5):419–433. doi: 10.4070/kcj.2018.0341. - DOI - PMC - PubMed
    1. Catapano AL, Graham I, De Backer G, et al. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016;37(39):2999–3058. doi: 10.1093/eurheartj/ehw272. - DOI - PubMed
    1. Goff DC, Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25):S49–S73. - PubMed
    1. Kim TJ, Lee JW, Kang HT, et al. Prevalence of Hypertension in Korean Adults Based on the 1998–2014 KNHANES. Yonsei Med J. 2018;59(3):356–365. doi: 10.3349/ymj.2018.59.3.356. - DOI - PMC - PubMed
    1. Fihn SD, Gardin JM, Abrams J, et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: executive summary: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012;126(25):3097–3137. doi: 10.1161/CIR.0b013e3182776f83. - DOI - PubMed

Publication types

MeSH terms

Substances