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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.

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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

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