schliessen

Filtern

 

Bibliotheken

A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia

The purpose of this study was to evaluate the efficacy and safety profile of ezetimibe/simvastatin(EZE/SIMVA) combination tablet, relative to ezetimibe (EZE) and simvastatin (SIMVA) monotherapy, in patients with primary hypercholesterolemia. This was a randomized, multicenter, double-blind, placebo-... Full description

Journal Title: Clinical therapeutics 2004, Vol.26 (11), p.1758-1773
Main Author: Bays, Harold E
Other Authors: Ose, Leiv , Fraser, Neil , Tribble, Diane L , Quinto, Katherine , Reyes, Robert , Johnson-Levonas, Amy O , Sapre, Aditi , Donahue, Steven R
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: Belle Mead, NJ: EM Inc USA
ID: ISSN: 0149-2918
Zum Text:
SendSend as email Add to Book BagAdd to Book Bag
Staff View
recordid: cdi_proquest_journals_1032781808
title: A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia
format: Article
creator:
  • Bays, Harold E
  • Ose, Leiv
  • Fraser, Neil
  • Tribble, Diane L
  • Quinto, Katherine
  • Reyes, Robert
  • Johnson-Levonas, Amy O
  • Sapre, Aditi
  • Donahue, Steven R
subjects:
  • Administration, Oral
  • Alanine Transaminase - blood
  • Anticholesteremic Agents - administration & dosage
  • Anticholesteremic Agents - adverse effects
  • Anticholesteremic Agents - therapeutic use
  • Aspartate Aminotransferases - blood
  • Atherosclerosis
  • Azetidines - administration & dosage
  • Azetidines - adverse effects
  • Azetidines - therapeutic use
  • Biological and medical sciences
  • Care and treatment
  • Cholesterol, LDL - blood
  • Data Interpretation, Statistical
  • Double-Blind Method
  • Drug Combinations
  • Ezetimibe
  • ezetimibe simvastatin hypercholesterolemia combination tablet low-density lipoprotein cholesterol lipid
  • Female
  • Humans
  • Hypercholesterolemia
  • Hypercholesterolemia - drug therapy
  • Male
  • Medical sciences
  • Middle Aged
  • Pharmacology. Drug treatments
  • Simvastatin
  • Simvastatin - administration & dosage
  • Simvastatin - adverse effects
  • Simvastatin - therapeutic use
  • Tablets
  • Triglycerides - blood
ispartof: Clinical therapeutics, 2004, Vol.26 (11), p.1758-1773
description: The purpose of this study was to evaluate the efficacy and safety profile of ezetimibe/simvastatin(EZE/SIMVA) combination tablet, relative to ezetimibe (EZE) and simvastatin (SIMVA) monotherapy, in patients with primary hypercholesterolemia. This was a randomized, multicenter, double-blind, placebo-controlled, factorial design study Aftera 6- to 8-week washout period and 4-week, single-blind, placebo run in, hypercholesterolemic patients (low-density lipoprotein cholesterol [LDL-C], 145–250 mg/dL; triglycerides [TG], ≤350 mg/dL) were randomized equally to 1 of 10 daily treatments for 12 weeks: EZE/SIMVA 10/10, 10/20, 10/40, or 10/80 mg; SIMVA 10, 20, 40, or 80 mg; EZE 10 mg; or placebo. The primary efficacy analysis was mean percent change from baseline in LDL-C to study end point Secondary end points included percent changes in other lipid variables and C-reactive protein [CRP]. There were 1528 patients randomized to treatment (792 women, 736 men); mean (SD) age ranged from 54.9 (112) years to 56.4 (10.6) years across pooled treatment groups. The treatment groups were well balanced for baseline demographics. Pooled EZE/SIMVA was associated with greater reductions in LDL-C than pooled SIMVA or EZE alone ( P < 0.001). Depending on dose, EZE/SIMVA was associated with reductions in LDL-C of −44.8% to −602%, non-high-density lipoprotein cholesterol of −40.5% to −55.7%, and TG of −22.5% to −30.7%; high-density lipoprotein cholesterol increased by 5.5% to 9.8%. EZE/SIMVA was associated with greater reductions in CRP and remnant-like particle-cholesterol than SIMVA alone ( P < 0.001). More patients receiving EZE/SIMVA versus SIMVA achieved LDL-C concentrations
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0149-2918
fulltext: fulltext
issn:
  • 0149-2918
  • 1879-114X
url: Link


@attributes
NO1
SEARCH_ENGINEprimo_central_multiple_fe
SEARCH_ENGINE_TYPEPrimo Central Search Engine
RANK2.4430904
LOCALfalse
PrimoNMBib
record
control
sourceidgale_proqu
recordidTN_cdi_proquest_journals_1032781808
sourceformatXML
sourcesystemPC
galeidA197890158
sourcerecordidA197890158
originalsourceidFETCH-LOGICAL-c3999-8f924f2b17de4b267782ac7a4fc7635e7c1e3b5f95dce66ac039aed44bf247843
addsrcrecordideNqNUk2P0zAQDQjELoUbZ7CEuG26cZLm47CHasWXtBIXkLhZE3vcunLiYDuLur-eybaigJBAPow8em_mzcxLklc8W_KMV5e7pbRmiFv0sMyzrFxyvqT8w-ScN3Wbcl5-fZScZ7xs07zlzVnyNIRdlmVFu8qfJGd8VRVt1TTnD16sWT_ZaCQOEf0F8zAo15s7VBdMuamzmHbUiX6jBYmdS6UbonfWzggNMjpvwDKFwWwGFuKk9iw6hrdgJ4jISCOzZjQqBUsdzLBhqLWRIPeMerEAGuOejd5pY5E5fc_AO4ymNx1eBtPfQogQzcAikJ7IpOtH8KjYdxO3J-ih3C_w3g3ufkXjntF3pCRNGQ600Zse_J5t9yN6uXUWA8mj0Bt4ljzWYAM-P8ZF8uXd28_XH9KbT-8_Xq9vUlm0bZs2us1LnXe8Vlh2eVXXTQ6yhlLLuipWWEuORbfS7UpJrCqQtH5AVZadzsu6KYtF8vpQl6b_NpEAsXOTH6il4FmR1w1vsuaE2oBFYQbtogfZmyDFmrd102Z8NaOWf0HRUzQR3Qzn9f5OqA8E6V0IHrU4roR6i9lkYid-mkzMJhOcC8oT8-VR9tT1qE68o6sI8OYIgCDBajKVNOGEq4qm4mTGRXL1hwRp5tPNDgNj_0PI-sBHOtKtQS-CpBNLVMajjEI5888aPwBBCRDu
sourcetypeAggregation Database
isCDItrue
recordtypearticle
pqid1032781808
display
typearticle
titleA multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia
sourceAlma/SFX Local Collection
creatorBays, Harold E ; Ose, Leiv ; Fraser, Neil ; Tribble, Diane L ; Quinto, Katherine ; Reyes, Robert ; Johnson-Levonas, Amy O ; Sapre, Aditi ; Donahue, Steven R
creatorcontribBays, Harold E ; Ose, Leiv ; Fraser, Neil ; Tribble, Diane L ; Quinto, Katherine ; Reyes, Robert ; Johnson-Levonas, Amy O ; Sapre, Aditi ; Donahue, Steven R ; Ezetimibe Study Group
descriptionThe purpose of this study was to evaluate the efficacy and safety profile of ezetimibe/simvastatin(EZE/SIMVA) combination tablet, relative to ezetimibe (EZE) and simvastatin (SIMVA) monotherapy, in patients with primary hypercholesterolemia. This was a randomized, multicenter, double-blind, placebo-controlled, factorial design study Aftera 6- to 8-week washout period and 4-week, single-blind, placebo run in, hypercholesterolemic patients (low-density lipoprotein cholesterol [LDL-C], 145–250 mg/dL; triglycerides [TG], ≤350 mg/dL) were randomized equally to 1 of 10 daily treatments for 12 weeks: EZE/SIMVA 10/10, 10/20, 10/40, or 10/80 mg; SIMVA 10, 20, 40, or 80 mg; EZE 10 mg; or placebo. The primary efficacy analysis was mean percent change from baseline in LDL-C to study end point Secondary end points included percent changes in other lipid variables and C-reactive protein [CRP]. There were 1528 patients randomized to treatment (792 women, 736 men); mean (SD) age ranged from 54.9 (112) years to 56.4 (10.6) years across pooled treatment groups. The treatment groups were well balanced for baseline demographics. Pooled EZE/SIMVA was associated with greater reductions in LDL-C than pooled SIMVA or EZE alone ( P < 0.001). Depending on dose, EZE/SIMVA was associated with reductions in LDL-C of −44.8% to −602%, non-high-density lipoprotein cholesterol of −40.5% to −55.7%, and TG of −22.5% to −30.7%; high-density lipoprotein cholesterol increased by 5.5% to 9.8%. EZE/SIMVA was associated with greater reductions in CRP and remnant-like particle-cholesterol than SIMVA alone ( P < 0.001). More patients receiving EZE/SIMVA versus SIMVA achieved LDL-C concentrations <100 mg/dL (78.6% vs 45.9%; P < 0.001). EZE/SIMVA was generally well tolerated, with a safety profile similar to SIMVA monotherapy There were no significant differences between EZE/SIMVA and SIMVA in the incidence of consecutive liver transaminase levels ≥3 times the upper limit of normal (ULN) (1 .5% for EZE/SIMVA and 1.1% for SIMVA; P = NS) or creature kinase levels ≥10 times ULN (0.0% for EZE/SIMVA and 02% for SIMVA; P = NS). The EZE/SIMVA tablet was a highlyeffective and well-tolerated LDL-C-lowering therapy in this study of patients with primary hypercholesterolemia.
identifier
0ISSN: 0149-2918
1EISSN: 1879-114X
2DOI: 10.1016/j.clinthera.2004.11.016
3PMID: 15639688
languageeng
publisherBelle Mead, NJ: EM Inc USA
subjectAdministration, Oral ; Alanine Transaminase - blood ; Anticholesteremic Agents - administration & dosage ; Anticholesteremic Agents - adverse effects ; Anticholesteremic Agents - therapeutic use ; Aspartate Aminotransferases - blood ; Atherosclerosis ; Azetidines - administration & dosage ; Azetidines - adverse effects ; Azetidines - therapeutic use ; Biological and medical sciences ; Care and treatment ; Cholesterol, LDL - blood ; Data Interpretation, Statistical ; Double-Blind Method ; Drug Combinations ; Ezetimibe ; ezetimibe simvastatin hypercholesterolemia combination tablet low-density lipoprotein cholesterol lipid ; Female ; Humans ; Hypercholesterolemia ; Hypercholesterolemia - drug therapy ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Simvastatin ; Simvastatin - administration & dosage ; Simvastatin - adverse effects ; Simvastatin - therapeutic use ; Tablets ; Triglycerides - blood
ispartofClinical therapeutics, 2004, Vol.26 (11), p.1758-1773
rights
02004 Excerpta Medica, Inc.
12005 INIST-CNRS
2COPYRIGHT 2004 Elsevier B.V.
lds50peer_reviewed
citedbyFETCH-LOGICAL-c3999-8f924f2b17de4b267782ac7a4fc7635e7c1e3b5f95dce66ac039aed44bf247843
citesFETCH-LOGICAL-c3999-8f924f2b17de4b267782ac7a4fc7635e7c1e3b5f95dce66ac039aed44bf247843
links
openurl$$Topenurl_article
openurlfulltext$$Topenurlfull_article
thumbnail$$Usyndetics_thumb_exl
backlink
0$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16386100$$DView record in Pascal Francis
1$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15639688$$D View this record in MEDLINE/PubMed
search
creatorcontrib
0Bays, Harold E
1Ose, Leiv
2Fraser, Neil
3Tribble, Diane L
4Quinto, Katherine
5Reyes, Robert
6Johnson-Levonas, Amy O
7Sapre, Aditi
8Donahue, Steven R
9Ezetimibe Study Group
title
0A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia
1Clinical therapeutics
addtitleClin Ther
descriptionThe purpose of this study was to evaluate the efficacy and safety profile of ezetimibe/simvastatin(EZE/SIMVA) combination tablet, relative to ezetimibe (EZE) and simvastatin (SIMVA) monotherapy, in patients with primary hypercholesterolemia. This was a randomized, multicenter, double-blind, placebo-controlled, factorial design study Aftera 6- to 8-week washout period and 4-week, single-blind, placebo run in, hypercholesterolemic patients (low-density lipoprotein cholesterol [LDL-C], 145–250 mg/dL; triglycerides [TG], ≤350 mg/dL) were randomized equally to 1 of 10 daily treatments for 12 weeks: EZE/SIMVA 10/10, 10/20, 10/40, or 10/80 mg; SIMVA 10, 20, 40, or 80 mg; EZE 10 mg; or placebo. The primary efficacy analysis was mean percent change from baseline in LDL-C to study end point Secondary end points included percent changes in other lipid variables and C-reactive protein [CRP]. There were 1528 patients randomized to treatment (792 women, 736 men); mean (SD) age ranged from 54.9 (112) years to 56.4 (10.6) years across pooled treatment groups. The treatment groups were well balanced for baseline demographics. Pooled EZE/SIMVA was associated with greater reductions in LDL-C than pooled SIMVA or EZE alone ( P < 0.001). Depending on dose, EZE/SIMVA was associated with reductions in LDL-C of −44.8% to −602%, non-high-density lipoprotein cholesterol of −40.5% to −55.7%, and TG of −22.5% to −30.7%; high-density lipoprotein cholesterol increased by 5.5% to 9.8%. EZE/SIMVA was associated with greater reductions in CRP and remnant-like particle-cholesterol than SIMVA alone ( P < 0.001). More patients receiving EZE/SIMVA versus SIMVA achieved LDL-C concentrations <100 mg/dL (78.6% vs 45.9%; P < 0.001). EZE/SIMVA was generally well tolerated, with a safety profile similar to SIMVA monotherapy There were no significant differences between EZE/SIMVA and SIMVA in the incidence of consecutive liver transaminase levels ≥3 times the upper limit of normal (ULN) (1 .5% for EZE/SIMVA and 1.1% for SIMVA; P = NS) or creature kinase levels ≥10 times ULN (0.0% for EZE/SIMVA and 02% for SIMVA; P = NS). The EZE/SIMVA tablet was a highlyeffective and well-tolerated LDL-C-lowering therapy in this study of patients with primary hypercholesterolemia.
subject
0Administration, Oral
1Alanine Transaminase - blood
2Anticholesteremic Agents - administration & dosage
3Anticholesteremic Agents - adverse effects
4Anticholesteremic Agents - therapeutic use
5Aspartate Aminotransferases - blood
6Atherosclerosis
7Azetidines - administration & dosage
8Azetidines - adverse effects
9Azetidines - therapeutic use
10Biological and medical sciences
11Care and treatment
12Cholesterol, LDL - blood
13Data Interpretation, Statistical
14Double-Blind Method
15Drug Combinations
16Ezetimibe
17ezetimibe simvastatin hypercholesterolemia combination tablet low-density lipoprotein cholesterol lipid
18Female
19Humans
20Hypercholesterolemia
21Hypercholesterolemia - drug therapy
22Male
23Medical sciences
24Middle Aged
25Pharmacology. Drug treatments
26Simvastatin
27Simvastatin - administration & dosage
28Simvastatin - adverse effects
29Simvastatin - therapeutic use
30Tablets
31Triglycerides - blood
issn
00149-2918
11879-114X
fulltexttrue
rsrctypearticle
creationdate2004
recordtypearticle
recordideNqNUk2P0zAQDQjELoUbZ7CEuG26cZLm47CHasWXtBIXkLhZE3vcunLiYDuLur-eybaigJBAPow8em_mzcxLklc8W_KMV5e7pbRmiFv0sMyzrFxyvqT8w-ScN3Wbcl5-fZScZ7xs07zlzVnyNIRdlmVFu8qfJGd8VRVt1TTnD16sWT_ZaCQOEf0F8zAo15s7VBdMuamzmHbUiX6jBYmdS6UbonfWzggNMjpvwDKFwWwGFuKk9iw6hrdgJ4jISCOzZjQqBUsdzLBhqLWRIPeMerEAGuOejd5pY5E5fc_AO4ymNx1eBtPfQogQzcAikJ7IpOtH8KjYdxO3J-ih3C_w3g3ufkXjntF3pCRNGQ600Zse_J5t9yN6uXUWA8mj0Bt4ljzWYAM-P8ZF8uXd28_XH9KbT-8_Xq9vUlm0bZs2us1LnXe8Vlh2eVXXTQ6yhlLLuipWWEuORbfS7UpJrCqQtH5AVZadzsu6KYtF8vpQl6b_NpEAsXOTH6il4FmR1w1vsuaE2oBFYQbtogfZmyDFmrd102Z8NaOWf0HRUzQR3Qzn9f5OqA8E6V0IHrU4roR6i9lkYid-mkzMJhOcC8oT8-VR9tT1qE68o6sI8OYIgCDBajKVNOGEq4qm4mTGRXL1hwRp5tPNDgNj_0PI-sBHOtKtQS-CpBNLVMajjEI5888aPwBBCRDu
startdate2004
enddate2004
creator
0Bays, Harold E
1Ose, Leiv
2Fraser, Neil
3Tribble, Diane L
4Quinto, Katherine
5Reyes, Robert
6Johnson-Levonas, Amy O
7Sapre, Aditi
8Donahue, Steven R
general
0EM Inc USA
1Excerpta Medica
2Elsevier B.V
3Elsevier Limited
scope
0IQODW
1CGR
2CUY
3CVF
4ECM
5EIF
6NPM
7AAYXX
8CITATION
9BSHEE
103V.
117RV
127U7
137X7
147XB
1588C
1688E
178AO
188FI
198FJ
208FK
218G5
22ABUWG
23AZQEC
24BENPR
25C1K
26DWQXO
27FYUFA
28GHDGH
29GNUQQ
30GUQSH
31K9.
32KB0
33M0S
34M0T
35M1P
36M2O
37MBDVC
38NAPCQ
39PADUT
40PQEST
41PQQKQ
42PQUKI
43PRINS
44Q9U
sort
creationdate2004
titleA multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia
authorBays, Harold E ; Ose, Leiv ; Fraser, Neil ; Tribble, Diane L ; Quinto, Katherine ; Reyes, Robert ; Johnson-Levonas, Amy O ; Sapre, Aditi ; Donahue, Steven R
facets
frbrtype5
frbrgroupidcdi_FETCH-LOGICAL-c3999-8f924f2b17de4b267782ac7a4fc7635e7c1e3b5f95dce66ac039aed44bf247843
rsrctypearticles
prefilterarticles
languageeng
creationdate2004
topic
0Administration, Oral
1Alanine Transaminase - blood
2Anticholesteremic Agents - administration & dosage
3Anticholesteremic Agents - adverse effects
4Anticholesteremic Agents - therapeutic use
5Aspartate Aminotransferases - blood
6Atherosclerosis
7Azetidines - administration & dosage
8Azetidines - adverse effects
9Azetidines - therapeutic use
10Biological and medical sciences
11Care and treatment
12Cholesterol, LDL - blood
13Data Interpretation, Statistical
14Double-Blind Method
15Drug Combinations
16Ezetimibe
17ezetimibe simvastatin hypercholesterolemia combination tablet low-density lipoprotein cholesterol lipid
18Female
19Humans
20Hypercholesterolemia
21Hypercholesterolemia - drug therapy
22Male
23Medical sciences
24Middle Aged
25Pharmacology. Drug treatments
26Simvastatin
27Simvastatin - administration & dosage
28Simvastatin - adverse effects
29Simvastatin - therapeutic use
30Tablets
31Triglycerides - blood
toplevel
0peer_reviewed
1online_resources
creatorcontrib
0Bays, Harold E
1Ose, Leiv
2Fraser, Neil
3Tribble, Diane L
4Quinto, Katherine
5Reyes, Robert
6Johnson-Levonas, Amy O
7Sapre, Aditi
8Donahue, Steven R
9Ezetimibe Study Group
collection
0Pascal-Francis
1Medline
2MEDLINE
3MEDLINE (Ovid)
4MEDLINE
5MEDLINE
6PubMed
7CrossRef
8Academic OneFile (A&I only)
9ProQuest Central (Corporate)
10Nursing & Allied Health Database
11Toxicology Abstracts
12Health & Medical Collection
13ProQuest Central (purchase pre-March 2016)
14Healthcare Administration Database (Alumni)
15Medical Database (Alumni Edition)
16ProQuest Pharma Collection
17Hospital Premium Collection
18Hospital Premium Collection (Alumni Edition)
19ProQuest Central (Alumni) (purchase pre-March 2016)
20Research Library (Alumni Edition)
21ProQuest Central (Alumni Edition)
22ProQuest Central Essentials
23ProQuest Central
24Environmental Sciences and Pollution Management
25ProQuest Central Korea
26Health Research Premium Collection
27Health Research Premium Collection (Alumni)
28ProQuest Central Student
29Research Library Prep
30ProQuest Health & Medical Complete (Alumni)
31Nursing & Allied Health Database (Alumni Edition)
32Health & Medical Collection (Alumni Edition)
33Healthcare Administration Database
34Medical Database
35Research Library
36Research Library (Corporate)
37Nursing & Allied Health Premium
38Research Library China
39ProQuest One Academic Eastern Edition
40ProQuest One Academic
41ProQuest One Academic UKI Edition
42ProQuest Central China
43ProQuest Central Basic
jtitleClinical therapeutics
delivery
delcategoryRemote Search Resource
fulltextfulltext
addata
au
0Bays, Harold E
1Ose, Leiv
2Fraser, Neil
3Tribble, Diane L
4Quinto, Katherine
5Reyes, Robert
6Johnson-Levonas, Amy O
7Sapre, Aditi
8Donahue, Steven R
aucorpEzetimibe Study Group
formatjournal
genrearticle
ristypeJOUR
atitleA multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia
jtitleClinical therapeutics
addtitleClin Ther
date2004
risdate2004
volume26
issue11
spage1758
epage1773
pages1758-1773
issn0149-2918
eissn1879-114X
abstractThe purpose of this study was to evaluate the efficacy and safety profile of ezetimibe/simvastatin(EZE/SIMVA) combination tablet, relative to ezetimibe (EZE) and simvastatin (SIMVA) monotherapy, in patients with primary hypercholesterolemia. This was a randomized, multicenter, double-blind, placebo-controlled, factorial design study Aftera 6- to 8-week washout period and 4-week, single-blind, placebo run in, hypercholesterolemic patients (low-density lipoprotein cholesterol [LDL-C], 145–250 mg/dL; triglycerides [TG], ≤350 mg/dL) were randomized equally to 1 of 10 daily treatments for 12 weeks: EZE/SIMVA 10/10, 10/20, 10/40, or 10/80 mg; SIMVA 10, 20, 40, or 80 mg; EZE 10 mg; or placebo. The primary efficacy analysis was mean percent change from baseline in LDL-C to study end point Secondary end points included percent changes in other lipid variables and C-reactive protein [CRP]. There were 1528 patients randomized to treatment (792 women, 736 men); mean (SD) age ranged from 54.9 (112) years to 56.4 (10.6) years across pooled treatment groups. The treatment groups were well balanced for baseline demographics. Pooled EZE/SIMVA was associated with greater reductions in LDL-C than pooled SIMVA or EZE alone ( P < 0.001). Depending on dose, EZE/SIMVA was associated with reductions in LDL-C of −44.8% to −602%, non-high-density lipoprotein cholesterol of −40.5% to −55.7%, and TG of −22.5% to −30.7%; high-density lipoprotein cholesterol increased by 5.5% to 9.8%. EZE/SIMVA was associated with greater reductions in CRP and remnant-like particle-cholesterol than SIMVA alone ( P < 0.001). More patients receiving EZE/SIMVA versus SIMVA achieved LDL-C concentrations <100 mg/dL (78.6% vs 45.9%; P < 0.001). EZE/SIMVA was generally well tolerated, with a safety profile similar to SIMVA monotherapy There were no significant differences between EZE/SIMVA and SIMVA in the incidence of consecutive liver transaminase levels ≥3 times the upper limit of normal (ULN) (1 .5% for EZE/SIMVA and 1.1% for SIMVA; P = NS) or creature kinase levels ≥10 times ULN (0.0% for EZE/SIMVA and 02% for SIMVA; P = NS). The EZE/SIMVA tablet was a highlyeffective and well-tolerated LDL-C-lowering therapy in this study of patients with primary hypercholesterolemia.
copBelle Mead, NJ
pubEM Inc USA
pmid15639688
doi10.1016/j.clinthera.2004.11.016