Effect of Torcetrapib on Carotid Atherosclerosis in Familial Hypercholesterolemia
Since torcetrapib, an inhibitor of cholesteryl ester transfer protein, markedly increases levels of high-density lipoprotein cholesterol and lowers levels of low-density lipoprotein cholesterol, in principle it might have a beneficial effect on atherosclerosis. However, in this clinical trial, torce...
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| Published in | The New England journal of medicine Vol. 356; no. 16; pp. 1620 - 1630 |
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| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Boston, MA
Massachusetts Medical Society
19.04.2007
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Since torcetrapib, an inhibitor of cholesteryl ester transfer protein, markedly increases levels of high-density lipoprotein cholesterol and lowers levels of low-density lipoprotein cholesterol, in principle it might have a beneficial effect on atherosclerosis. However, in this clinical trial, torcetrapib had no beneficial effect on carotid atherosclerosis, as assessed by ultrasonographic measurement of carotid intima–media thickness. The reasons for this finding are unclear, but the drug did increase blood pressure slightly.
In this clinical trial, torcetrapib had no beneficial effect on carotid atherosclerosis, as assessed by ultrasonographic measurement of carotid intima–media thickness.Published Online March 26, 2007 (DOI:10.1056/NEJMoa071359)
Guidelines for the prevention and management of cardiovascular disease focus on reducing levels of low-density lipoprotein (LDL) cholesterol by means of hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (collectively referred to as statins).
1
,
2
However, recent meta-analyses have shown that even with the most aggressive treatment,
3
,
4
these drugs reduce the risk of a major coronary event by only 30%.
5
This finding, combined with an estimation that mortality from cardiovascular causes will increase worldwide by 90% by the year 2020, as compared with that in 1990,
6
illustrates the need for new efficacious treatments. A review of four large, prospective epidemiologic studies . . . |
|---|---|
| AbstractList | Torcetrapib, an inhibitor of cholesteryl ester transfer protein, may reduce atherosclerotic vascular disease by increasing levels of high-density lipoprotein (HDL) cholesterol.
A total of 850 patients with heterozygous familial hypercholesterolemia underwent B-mode ultrasonography at baseline and at follow-up to measure changes in carotid intima-media thickness. The patients completed an atorvastatin run-in period and were subsequently randomly assigned to receive either atorvastatin monotherapy or atorvastatin combined with 60 mg of torcetrapib for 2 years.
After 24 months, in the atorvastatin-only group, the mean (+/-SD) HDL cholesterol level was 52.4+/-13.5 mg per deciliter and the mean low-density lipoprotein (LDL) cholesterol level was 143.2+/-42.2 mg per deciliter, as compared with 81.5+/-22.6 mg per deciliter and 115.1+/-48.5 mg per deciliter, respectively, in the torcetrapib-atorvastatin group. During the study, average systolic blood pressure increased by 2.8 mm Hg in the torcetrapib-atorvastatin group, as compared with the atorvastatin-only group. The increase in maximum carotid intima-media thickness, the primary measure of efficacy, was 0.0053+/-0.0028 mm per year in the atorvastatin-only group and 0.0047+/-0.0028 mm per year in the torcetrapib-atorvastatin group (P=0.87). The secondary efficacy measure, annualized change in mean carotid intima-media thickness for the common carotid artery, indicated a decrease of 0.0014 mm per year in the atorvastatin-only group, as compared with an increase of 0.0038 mm per year in the torcetrapib-atorvastatin group (P=0.005).
In patients with familial hypercholesterolemia, the use of torcetrapib with atorvastatin, as compared with atorvastatin alone, did not result in further reduction of progression of atherosclerosis, as assessed by a combined measure of carotid arterial-wall thickness, and was associated with progression of disease in the common carotid segment. These effects occurred despite a large increase in HDL cholesterol levels and a substantial decrease in levels of LDL cholesterol and triglycerides. (ClinicalTrials.gov number, NCT00136981 [ClinicalTrials.gov].). Background: Torcetrapib, an inhibitor of cholesteryl ester transfer protein, may reduce atherosclerotic vascular disease by increasing levels of high-density lipoprotein (HDL) cholesterol. Methods: A total of 850 patients with heterozygous familial hypercholesterolemia underwent B-mode ultrasonography at baseline and at follow-up to measure changes in carotid intima-media thickness. The patients completed an atorvastatin run-in period and were subsequently randomly assigned to receive either atorvastatin monotherapy or atorvastatin combined with 60 mg of torcetrapib for 2 years. Results: After 24 months, in the atorvastatin-only group, the mean (+/- SD) HDL cholesterol level was 52.4 +/- 13.5 mg per deciliter and the mean low-density lipoprotein (LDL) cholesterol level was 143.2 +/- 42.2 mg per deciliter, as compared with 81.5 +/- 22.6 mg per deciliter and 115.1 +/- 48.5 mg per deciliter, respectively, in the torcetrapib-atorvastatin group. During the study, average systolic blood pressure increased by 2.8 mm Hg in the torcetrapib-torvastatin group, as compared with the atorvastatin-only group. The increase in maximum carotid intima-media thickness, the primary measure of efficacy, was 0.0053 +/- 0.0028 mm per year in the atorvastatin-only group and 0.0047 +/- 0.0028 mm per year in the torcetrapib-atorvastatin group (P=0.87). The secondary efficacy measure, annualized change in mean carotid intima-media thickness for the common carotid artery, indicated a decrease of 0.0014 mm per year in the atorvastatin-only group, as compared with an increase of 0.0038 mm per year in the torcetrapib-atorvastatin group (P=0.005). Conclusions: In patients with familial hypercholesterolemia, the use of torcetrapib with atorvastatin, as compared with atorvastatin alone, did not result in further reduction of progression of atherosclerosis, as assessed by a combined measure of carotid arterial-wall thickness, and was associated with progression of disease in the common carotid segment. These effects occurred despite a large increase in HDL cholesterol levels and a substantial decrease in levels of LDL cholesterol and triglycerides. [PUBLICATION ABSTRACT] BACKGROUNDTorcetrapib, an inhibitor of cholesteryl ester transfer protein, may reduce atherosclerotic vascular disease by increasing levels of high-density lipoprotein (HDL) cholesterol.METHODSA total of 850 patients with heterozygous familial hypercholesterolemia underwent B-mode ultrasonography at baseline and at follow-up to measure changes in carotid intima-media thickness. The patients completed an atorvastatin run-in period and were subsequently randomly assigned to receive either atorvastatin monotherapy or atorvastatin combined with 60 mg of torcetrapib for 2 years.RESULTSAfter 24 months, in the atorvastatin-only group, the mean (+/-SD) HDL cholesterol level was 52.4+/-13.5 mg per deciliter and the mean low-density lipoprotein (LDL) cholesterol level was 143.2+/-42.2 mg per deciliter, as compared with 81.5+/-22.6 mg per deciliter and 115.1+/-48.5 mg per deciliter, respectively, in the torcetrapib-atorvastatin group. During the study, average systolic blood pressure increased by 2.8 mm Hg in the torcetrapib-atorvastatin group, as compared with the atorvastatin-only group. The increase in maximum carotid intima-media thickness, the primary measure of efficacy, was 0.0053+/-0.0028 mm per year in the atorvastatin-only group and 0.0047+/-0.0028 mm per year in the torcetrapib-atorvastatin group (P=0.87). The secondary efficacy measure, annualized change in mean carotid intima-media thickness for the common carotid artery, indicated a decrease of 0.0014 mm per year in the atorvastatin-only group, as compared with an increase of 0.0038 mm per year in the torcetrapib-atorvastatin group (P=0.005).CONCLUSIONSIn patients with familial hypercholesterolemia, the use of torcetrapib with atorvastatin, as compared with atorvastatin alone, did not result in further reduction of progression of atherosclerosis, as assessed by a combined measure of carotid arterial-wall thickness, and was associated with progression of disease in the common carotid segment. These effects occurred despite a large increase in HDL cholesterol levels and a substantial decrease in levels of LDL cholesterol and triglycerides. (ClinicalTrials.gov number, NCT00136981 [ClinicalTrials.gov].). Since torcetrapib, an inhibitor of cholesteryl ester transfer protein, markedly increases levels of high-density lipoprotein cholesterol and lowers levels of low-density lipoprotein cholesterol, in principle it might have a beneficial effect on atherosclerosis. However, in this clinical trial, torcetrapib had no beneficial effect on carotid atherosclerosis, as assessed by ultrasonographic measurement of carotid intima–media thickness. The reasons for this finding are unclear, but the drug did increase blood pressure slightly. In this clinical trial, torcetrapib had no beneficial effect on carotid atherosclerosis, as assessed by ultrasonographic measurement of carotid intima–media thickness.Published Online March 26, 2007 (DOI:10.1056/NEJMoa071359) Guidelines for the prevention and management of cardiovascular disease focus on reducing levels of low-density lipoprotein (LDL) cholesterol by means of hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (collectively referred to as statins). 1 , 2 However, recent meta-analyses have shown that even with the most aggressive treatment, 3 , 4 these drugs reduce the risk of a major coronary event by only 30%. 5 This finding, combined with an estimation that mortality from cardiovascular causes will increase worldwide by 90% by the year 2020, as compared with that in 1990, 6 illustrates the need for new efficacious treatments. A review of four large, prospective epidemiologic studies . . . |
| Author | van Leuven, Sander I Riley, Ward A Duggan, William T Bots, Michiel L Burgess, Leslie Grobbee, Diederick E Kastelein, John J.P Barter, Philip J Evans, Greg W Kuivenhoven, Jan A Shear, Charles L Revkin, James H |
| Author_xml | – sequence: 1 givenname: John J.P surname: Kastelein fullname: Kastelein, John J.P – sequence: 2 givenname: Sander I surname: van Leuven fullname: van Leuven, Sander I – sequence: 3 givenname: Leslie surname: Burgess fullname: Burgess, Leslie – sequence: 4 givenname: Greg W surname: Evans fullname: Evans, Greg W – sequence: 5 givenname: Jan A surname: Kuivenhoven fullname: Kuivenhoven, Jan A – sequence: 6 givenname: Philip J surname: Barter fullname: Barter, Philip J – sequence: 7 givenname: James H surname: Revkin fullname: Revkin, James H – sequence: 8 givenname: Diederick E surname: Grobbee fullname: Grobbee, Diederick E – sequence: 9 givenname: Ward A surname: Riley fullname: Riley, Ward A – sequence: 10 givenname: Charles L surname: Shear fullname: Shear, Charles L – sequence: 11 givenname: William T surname: Duggan fullname: Duggan, William T – sequence: 12 givenname: Michiel L surname: Bots fullname: Bots, Michiel L |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18694684$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/17387131$$D View this record in MEDLINE/PubMed |
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| CODEN | NEJMAG |
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| Snippet | Since torcetrapib, an inhibitor of cholesteryl ester transfer protein, markedly increases levels of high-density lipoprotein cholesterol and lowers levels of... Torcetrapib, an inhibitor of cholesteryl ester transfer protein, may reduce atherosclerotic vascular disease by increasing levels of high-density lipoprotein... Background: Torcetrapib, an inhibitor of cholesteryl ester transfer protein, may reduce atherosclerotic vascular disease by increasing levels of high-density... BACKGROUNDTorcetrapib, an inhibitor of cholesteryl ester transfer protein, may reduce atherosclerotic vascular disease by increasing levels of high-density... |
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| SubjectTerms | Adult Anticholesteremic Agents - pharmacology Anticholesteremic Agents - therapeutic use Apolipoproteins Atherosclerosis (general aspects, experimental research) Atherosclerosis - drug therapy Atherosclerosis - etiology Atherosclerosis - pathology Atorvastatin Calcium Biological and medical sciences Blood and lymphatic vessels Cardiology. Vascular system Cardiovascular disease Carotid Arteries - drug effects Carotid Arteries - pathology Carotid Artery Diseases - drug therapy Carotid Artery Diseases - etiology Carotid Artery Diseases - pathology Cholesterol Cholesterol Ester Transfer Proteins - antagonists & inhibitors Cholesterol, HDL - blood Cholesterol, LDL - blood Diet Disease Progression Double-Blind Method Drug Therapy, Combination Female General aspects Heptanoic Acids - therapeutic use Heterozygote Humans Hyperlipoproteinemia Type II - blood Hyperlipoproteinemia Type II - complications Hyperlipoproteinemia Type II - drug therapy Male Medical sciences Middle Aged Prospective Studies Pyrroles - therapeutic use Quinolines - pharmacology Quinolines - therapeutic use |
| Title | Effect of Torcetrapib on Carotid Atherosclerosis in Familial Hypercholesterolemia |
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