Efficacy and safety of morning versus evening dose of controlled-release simvastatin tablets in patients with hyperlipidemia: A randomized, double-blind, multicenter phase III trial

Sang Hyun Kim, Min Kyung Kim, Hong Seog Seo, Min Soo Hyun, Kyoo Rok Han, Seong Wook Cho, Young Kwon Kim, Seong Hoon Park

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background: Flexibility in the recommended dosing time for a statin may improve patient compliance. Objective: This study was designed to compare the efficacy and tolerability of morning and evening doses of controlled-release simvastatin in Korean adults with dyslipidemia. It was carried out as a requirement to obtain authorization from the Korean regulatory agency to market the product. Methods: In this prospective, randomized, double-blind, multicenter, placebo-controlled Phase III study, we randomly assigned 132 patients with hypercholesterolemia to a morning-dose group or an evening-dose group. Patients in the morning-dose group received 20 mg controlled-release simvastatin in the morning and a placebo in the evening, and those in the evening-dose group received a placebo in the morning and 20 mg controlled-release simvastatin in the evening. Results: After 8 weeks of the treatment, the difference in the mean change of LDL-C between the morning-dose and evening-dose groups was -2.78% (95% confidence interval, -7.65 to 2.10). The changes in total cholesterol, triglycerides, HDL-C, apolipoprotein A1, apolipoprotein B, and lipoprotein (a) after treatment did not differ between groups. Also, the achievement rates of the target LDL-C goal suggested by the dyslipidemia treatment guideline of the Korean Society of Lipidology and Atherosclerosis were not different. No serious adverse event was observed in either group. Mild and moderate adverse events were observed similarly in both groups. Conclusions: Although controlled-release simvastatin significantly reduces LDL-C levels with good tolerability in Korean adults with dyslipidemia, the time of administration does not affect its efficacy.

Original languageEnglish
JournalClinical Therapeutics
Volume35
Issue number9
DOIs
Publication statusPublished - 2013 Sep 1

Fingerprint

Simvastatin
Hyperlipidemias
Tablets
Dyslipidemias
Safety
Placebos
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lipoprotein(a)
Apolipoprotein A-I
Apolipoproteins B
Patient Compliance
Hypercholesterolemia
HDL Cholesterol
Atherosclerosis
Triglycerides
Therapeutics
Guidelines
Confidence Intervals
oxidized low density lipoprotein

Keywords

  • Controlled-release formulation
  • Dyslipidemia
  • Simvastatin
  • Simvastatin administration and dosage

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Efficacy and safety of morning versus evening dose of controlled-release simvastatin tablets in patients with hyperlipidemia : A randomized, double-blind, multicenter phase III trial. / Kim, Sang Hyun; Kim, Min Kyung; Seo, Hong Seog; Hyun, Min Soo; Han, Kyoo Rok; Cho, Seong Wook; Kim, Young Kwon; Hoon Park, Seong.

In: Clinical Therapeutics, Vol. 35, No. 9, 01.09.2013.

Research output: Contribution to journalArticle

Kim, Sang Hyun ; Kim, Min Kyung ; Seo, Hong Seog ; Hyun, Min Soo ; Han, Kyoo Rok ; Cho, Seong Wook ; Kim, Young Kwon ; Hoon Park, Seong. / Efficacy and safety of morning versus evening dose of controlled-release simvastatin tablets in patients with hyperlipidemia : A randomized, double-blind, multicenter phase III trial. In: Clinical Therapeutics. 2013 ; Vol. 35, No. 9.
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T2 - A randomized, double-blind, multicenter phase III trial

AU - Kim, Sang Hyun

AU - Kim, Min Kyung

AU - Seo, Hong Seog

AU - Hyun, Min Soo

AU - Han, Kyoo Rok

AU - Cho, Seong Wook

AU - Kim, Young Kwon

AU - Hoon Park, Seong

PY - 2013/9/1

Y1 - 2013/9/1

N2 - Background: Flexibility in the recommended dosing time for a statin may improve patient compliance. Objective: This study was designed to compare the efficacy and tolerability of morning and evening doses of controlled-release simvastatin in Korean adults with dyslipidemia. It was carried out as a requirement to obtain authorization from the Korean regulatory agency to market the product. Methods: In this prospective, randomized, double-blind, multicenter, placebo-controlled Phase III study, we randomly assigned 132 patients with hypercholesterolemia to a morning-dose group or an evening-dose group. Patients in the morning-dose group received 20 mg controlled-release simvastatin in the morning and a placebo in the evening, and those in the evening-dose group received a placebo in the morning and 20 mg controlled-release simvastatin in the evening. Results: After 8 weeks of the treatment, the difference in the mean change of LDL-C between the morning-dose and evening-dose groups was -2.78% (95% confidence interval, -7.65 to 2.10). The changes in total cholesterol, triglycerides, HDL-C, apolipoprotein A1, apolipoprotein B, and lipoprotein (a) after treatment did not differ between groups. Also, the achievement rates of the target LDL-C goal suggested by the dyslipidemia treatment guideline of the Korean Society of Lipidology and Atherosclerosis were not different. No serious adverse event was observed in either group. Mild and moderate adverse events were observed similarly in both groups. Conclusions: Although controlled-release simvastatin significantly reduces LDL-C levels with good tolerability in Korean adults with dyslipidemia, the time of administration does not affect its efficacy.

AB - Background: Flexibility in the recommended dosing time for a statin may improve patient compliance. Objective: This study was designed to compare the efficacy and tolerability of morning and evening doses of controlled-release simvastatin in Korean adults with dyslipidemia. It was carried out as a requirement to obtain authorization from the Korean regulatory agency to market the product. Methods: In this prospective, randomized, double-blind, multicenter, placebo-controlled Phase III study, we randomly assigned 132 patients with hypercholesterolemia to a morning-dose group or an evening-dose group. Patients in the morning-dose group received 20 mg controlled-release simvastatin in the morning and a placebo in the evening, and those in the evening-dose group received a placebo in the morning and 20 mg controlled-release simvastatin in the evening. Results: After 8 weeks of the treatment, the difference in the mean change of LDL-C between the morning-dose and evening-dose groups was -2.78% (95% confidence interval, -7.65 to 2.10). The changes in total cholesterol, triglycerides, HDL-C, apolipoprotein A1, apolipoprotein B, and lipoprotein (a) after treatment did not differ between groups. Also, the achievement rates of the target LDL-C goal suggested by the dyslipidemia treatment guideline of the Korean Society of Lipidology and Atherosclerosis were not different. No serious adverse event was observed in either group. Mild and moderate adverse events were observed similarly in both groups. Conclusions: Although controlled-release simvastatin significantly reduces LDL-C levels with good tolerability in Korean adults with dyslipidemia, the time of administration does not affect its efficacy.

KW - Controlled-release formulation

KW - Dyslipidemia

KW - Simvastatin

KW - Simvastatin administration and dosage

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