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Low dose of ROSuvastatin in combination with EZEtimibe effectively and permanently reduce low density lipoprotein cholesterol concentration independently of timing of administration (ROSEZE): A randomized, crossover study — preliminary results

Karolina Obońska, Michał Kasprzak, Kamila Tymosiak, Tomasz Fabiszak, Magdalena Krintus, Jacek Kubica
DOI: 10.5603/CJ.a2020.0166
·
Pubmed: 33200812

open access

Ahead of print
Original articles
Published online: 2020-11-09

Abstract

Background: In an attempt to improve low density lipoprotein-cholesterol (LDL-C) level control in patients ineffectively treated with statins, we evaluated the effectiveness of a fixed-dose combination (FDC) of 10 mg rosuvastatin and ezetimibe and its relation to the timing of drug administration.

Methods: A randomized, open label, single center, crossover study involving 83 patients with coronary artery disease and hypercholesterolemia with baseline LDL-C ≥ 70 mg/dL. In arm I the FDC drug was administered in the morning for 6 weeks, then in the evening for the following 6 weeks and vice versa in arm II. The primary endpoint was the change in LDL-C after 6 and 12 weeks.

Results: The median LDL-C concentration at baseline, after 6 and 12 weeks respectively was: 98.10 mg/dL (Q1;Q3: 85.10;116.80), 63.14 mg/dL (50.70;77.10) and 59.40 mg/dL (49.00;73.30); p < 0.001. LDL-C levels were similar regardless of the timing of drug administration (morning 62.50 mg/dL [50.70;76.00] vs. evening 59.70 mg/dL [48.20;73.80]; p = 0.259], in both time points: 6 week: 63.15 mg/dL (50.75;80.65) vs. 63.40 mg/dL (50.60;74.00), p = 0.775; and 12 week: 62.00 mg/dL (50.20;74.40) vs. 59.05 mg/dL (47.65;66.05), p = 0.362. The absolute change in LDL-C concentration for the morning vs. evening drug administration was — 6 week: –34.6 mg/dL (–56.55; –19.85) (–34.87%) vs. –31.10 mg/dL (–44.20; –16.00) (–35.87%) (p not significant); 12. week: –34.20 mg/dL (–47.8; –19.0) (–37.12%) vs. –37.20 mg/dL (–65.55; –23.85) (–40.06%) (p not significant). The therapy was safe and well tolerated.

Conclusions: Fixed-dose combination of rosuvastatin and ezetimibe significantly and permanently decreases LDL-C regardless of the timing of drug administration.

Abstract

Background: In an attempt to improve low density lipoprotein-cholesterol (LDL-C) level control in patients ineffectively treated with statins, we evaluated the effectiveness of a fixed-dose combination (FDC) of 10 mg rosuvastatin and ezetimibe and its relation to the timing of drug administration.

Methods: A randomized, open label, single center, crossover study involving 83 patients with coronary artery disease and hypercholesterolemia with baseline LDL-C ≥ 70 mg/dL. In arm I the FDC drug was administered in the morning for 6 weeks, then in the evening for the following 6 weeks and vice versa in arm II. The primary endpoint was the change in LDL-C after 6 and 12 weeks.

Results: The median LDL-C concentration at baseline, after 6 and 12 weeks respectively was: 98.10 mg/dL (Q1;Q3: 85.10;116.80), 63.14 mg/dL (50.70;77.10) and 59.40 mg/dL (49.00;73.30); p < 0.001. LDL-C levels were similar regardless of the timing of drug administration (morning 62.50 mg/dL [50.70;76.00] vs. evening 59.70 mg/dL [48.20;73.80]; p = 0.259], in both time points: 6 week: 63.15 mg/dL (50.75;80.65) vs. 63.40 mg/dL (50.60;74.00), p = 0.775; and 12 week: 62.00 mg/dL (50.20;74.40) vs. 59.05 mg/dL (47.65;66.05), p = 0.362. The absolute change in LDL-C concentration for the morning vs. evening drug administration was — 6 week: –34.6 mg/dL (–56.55; –19.85) (–34.87%) vs. –31.10 mg/dL (–44.20; –16.00) (–35.87%) (p not significant); 12. week: –34.20 mg/dL (–47.8; –19.0) (–37.12%) vs. –37.20 mg/dL (–65.55; –23.85) (–40.06%) (p not significant). The therapy was safe and well tolerated.

Conclusions: Fixed-dose combination of rosuvastatin and ezetimibe significantly and permanently decreases LDL-C regardless of the timing of drug administration.

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Keywords

hypercholesterolemia, fixed-dose, secondary prevention, timing of administration, adherence, apolipoprotein B, lipoprotein(a)

About this article
Title

Low dose of ROSuvastatin in combination with EZEtimibe effectively and permanently reduce low density lipoprotein cholesterol concentration independently of timing of administration (ROSEZE): A randomized, crossover study — preliminary results

Journal

Cardiology Journal

Issue

Ahead of print

Article type

Original Article

Published online

2020-11-09

DOI

10.5603/CJ.a2020.0166

Pubmed

33200812

Keywords

hypercholesterolemia
fixed-dose
secondary prevention
timing of administration
adherence
apolipoprotein B
lipoprotein(a)

Authors

Karolina Obońska
Michał Kasprzak
Kamila Tymosiak
Tomasz Fabiszak
Magdalena Krintus
Jacek Kubica

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