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

Seyong Chung, Young-Guk Ko, Jung Sun Kim, Byeong-Keuk Kim, Chul-Min Ahn, Sungha Park, Sung-Jin Hong, Sang-Hak Lee, Donghoon Choi
DOI: 10.5603/CJ.a2020.0167
·
Pubmed: 33346375

open access

Ahead of print
Original articles
Published online: 2020-12-01

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.

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.

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Keywords

hypertension, hypercholesterolemia, drug therapy, renin–angiotensin system, rosuvastatin calcium

About this article
Title

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

Journal

Cardiology Journal

Issue

Ahead of print

Article type

Original Article

Published online

2020-12-01

DOI

10.5603/CJ.a2020.0167

Pubmed

33346375

Keywords

hypertension
hypercholesterolemia
drug therapy
renin–angiotensin system
rosuvastatin calcium

Authors

Seyong Chung
Young-Guk Ko
Jung Sun Kim
Byeong-Keuk Kim
Chul-Min Ahn
Sungha Park
Sung-Jin Hong
Sang-Hak Lee
Donghoon Choi

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