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Effect of FIXed-dose combination of ARb and statin on adherence and risk factor control: The randomized FIXAR study
, 1
Affiliations- Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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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.
Keywords
hypertension, hypercholesterolemia, drug therapy, renin–angiotensin system, rosuvastatin calcium
About this articleTitle
Effect of FIXed-dose combination of ARb and statin on adherence and risk factor control: The randomized FIXAR study
Journal
Issue
Article type
Original Article
Pages
815-823
Published online
2020-12-01
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4978
Article views/downloads
1517
DOI
10.5603/CJ.a2020.0167
Pubmed
Bibliographic record
Cardiol J 2022;29(5):815-823.
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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