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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

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... Full description

Journal Title: Clinical therapeutics 2013, Vol.35 (9), p.1350-1360.e1
Main Author: Kim, Sang-Hyun, MD, PhD
Other Authors: Kim, Min-Kyung, MD , Seo, Hong-Seok, MD, PhD , Hyun, Min-Soo, MD, PhD , Han, Kyoo-Rok, MD, PhD , Cho, Seong-Wook, MD, PhD , Kim, Young-Kwon, MD, PhD , Hoon Park, Seong, MD, PhD
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: Bridgewater, NJ: EM Inc USA
ID: ISSN: 0149-2918
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title: 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
format: Article
creator:
  • Kim, Sang-Hyun, MD, PhD
  • Kim, Min-Kyung, MD
  • Seo, Hong-Seok, MD, PhD
  • Hyun, Min-Soo, MD, PhD
  • Han, Kyoo-Rok, MD, PhD
  • Cho, Seong-Wook, MD, PhD
  • Kim, Young-Kwon, MD, PhD
  • Hoon Park, Seong, MD, PhD
subjects:
  • Aged
  • Anticholesteremic Agents - administration & dosage
  • Anticholesteremic Agents - adverse effects
  • Anticholesteremic Agents - therapeutic use
  • Antilipemic agents
  • Apolipoproteins
  • Atherosclerosis
  • Biological and medical sciences
  • Blood pressure
  • Cardiology
  • Cardiovascular disease
  • Cholesterol
  • Cholesterol, LDL - blood
  • Clinical trials
  • Compliance
  • Constipation
  • controlled-release formulation
  • Delayed-Action Preparations
  • Disorders of blood lipids. Hyperlipoproteinemia
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Chronotherapy
  • dyslipidemia
  • Female
  • Heart attacks
  • Humans
  • Hypercholesterolemia - drug therapy
  • Hypertension
  • Internal Medicine
  • Lifestyles
  • Male
  • Medical colleges
  • Medical Education
  • Medical sciences
  • Metabolic diseases
  • Middle Aged
  • Patient compliance
  • Patients
  • Pharmacology. Drug treatments
  • Product development
  • Prospective Studies
  • Risk factors
  • Simvastatin
  • Simvastatin - administration & dosage
  • Simvastatin - adverse effects
  • Simvastatin - therapeutic use
  • simvastatin administration and dosage
  • Tablets
  • Triglycerides
  • Triglycerides - blood
ispartof: Clinical therapeutics, 2013, Vol.35 (9), p.1350-1360.e1
description: 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.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0149-2918
fulltext: fulltext
issn:
  • 0149-2918
  • 1879-114X
url: Link


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titleEfficacy and Safety of Morning Versus Evening Dose of Controlled-Release Simvastatin Tablets in Patients With Hyperlipidemia: A Randomized, Double-Blind, Multicenter Phase III Trial
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creatorKim, Sang-Hyun, MD, PhD ; Kim, Min-Kyung, MD ; Seo, Hong-Seok, MD, PhD ; Hyun, Min-Soo, MD, PhD ; Han, Kyoo-Rok, MD, PhD ; Cho, Seong-Wook, MD, PhD ; Kim, Young-Kwon, MD, PhD ; Hoon Park, Seong, MD, PhD
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descriptionAbstract 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.
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1EISSN: 1879-114X
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3PMID: 23998970
languageeng
publisherBridgewater, NJ: EM Inc USA
subjectAged ; Anticholesteremic Agents - administration & dosage ; Anticholesteremic Agents - adverse effects ; Anticholesteremic Agents - therapeutic use ; Antilipemic agents ; Apolipoproteins ; Atherosclerosis ; Biological and medical sciences ; Blood pressure ; Cardiology ; Cardiovascular disease ; Cholesterol ; Cholesterol, LDL - blood ; Clinical trials ; Compliance ; Constipation ; controlled-release formulation ; Delayed-Action Preparations ; Disorders of blood lipids. Hyperlipoproteinemia ; Double-Blind Method ; Drug Administration Schedule ; Drug Chronotherapy ; dyslipidemia ; Female ; Heart attacks ; Humans ; Hypercholesterolemia - drug therapy ; Hypertension ; Internal Medicine ; Lifestyles ; Male ; Medical colleges ; Medical Education ; Medical sciences ; Metabolic diseases ; Middle Aged ; Patient compliance ; Patients ; Pharmacology. Drug treatments ; Product development ; Prospective Studies ; Risk factors ; Simvastatin ; Simvastatin - administration & dosage ; Simvastatin - adverse effects ; Simvastatin - therapeutic use ; simvastatin administration and dosage ; Tablets ; Triglycerides ; Triglycerides - blood
ispartofClinical therapeutics, 2013, Vol.35 (9), p.1350-1360.e1
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1Kim, Min-Kyung, MD
2Seo, Hong-Seok, MD, PhD
3Hyun, Min-Soo, MD, PhD
4Han, Kyoo-Rok, MD, PhD
5Cho, Seong-Wook, MD, PhD
6Kim, Young-Kwon, MD, PhD
7Hoon Park, Seong, MD, PhD
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0Efficacy and Safety of Morning Versus Evening Dose of Controlled-Release Simvastatin Tablets in Patients With Hyperlipidemia: A Randomized, Double-Blind, Multicenter Phase III Trial
1Clinical therapeutics
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descriptionAbstract 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.
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15Constipation
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18Disorders of blood lipids. Hyperlipoproteinemia
19Double-Blind Method
20Drug Administration Schedule
21Drug Chronotherapy
22dyslipidemia
23Female
24Heart attacks
25Humans
26Hypercholesterolemia - drug therapy
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28Internal Medicine
29Lifestyles
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31Medical colleges
32Medical Education
33Medical sciences
34Metabolic diseases
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36Patient compliance
37Patients
38Pharmacology. Drug treatments
39Product development
40Prospective Studies
41Risk factors
42Simvastatin
43Simvastatin - administration & dosage
44Simvastatin - adverse effects
45Simvastatin - therapeutic use
46simvastatin administration and dosage
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48Triglycerides
49Triglycerides - blood
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titleEfficacy and Safety of Morning Versus Evening Dose of Controlled-Release Simvastatin Tablets in Patients With Hyperlipidemia: A Randomized, Double-Blind, Multicenter Phase III Trial
authorKim, Sang-Hyun, MD, PhD ; Kim, Min-Kyung, MD ; Seo, Hong-Seok, MD, PhD ; Hyun, Min-Soo, MD, PhD ; Han, Kyoo-Rok, MD, PhD ; Cho, Seong-Wook, MD, PhD ; Kim, Young-Kwon, MD, PhD ; Hoon Park, Seong, MD, PhD
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1Anticholesteremic Agents - administration & dosage
2Anticholesteremic Agents - adverse effects
3Anticholesteremic Agents - therapeutic use
4Antilipemic agents
5Apolipoproteins
6Atherosclerosis
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8Blood pressure
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11Cholesterol
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14Compliance
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17Delayed-Action Preparations
18Disorders of blood lipids. Hyperlipoproteinemia
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39Product development
40Prospective Studies
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42Simvastatin
43Simvastatin - administration & dosage
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45Simvastatin - therapeutic use
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47Tablets
48Triglycerides
49Triglycerides - blood
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atitleEfficacy and Safety of Morning Versus Evening Dose of Controlled-Release Simvastatin Tablets in Patients With Hyperlipidemia: A Randomized, Double-Blind, Multicenter Phase III Trial
jtitleClinical therapeutics
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date2013
risdate2013
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issn0149-2918
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abstractAbstract 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.
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pmid23998970
doi10.1016/j.clinthera.2013.06.020