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Study of Heart and Renal Protection (SHARP): Randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9,438 patients with chronic kidney disease

Background Lowering low-density lipoprotein (LDL) cholesterol with statin therapy has been shown to reduce the incidence of atherosclerotic events in many types of patient, but it remains uncertain whether it is of net benefit among people with chronic kidney disease (CKD). Methods Patients with adv... Full description

Journal Title: The American heart journal 2010, Vol.160 (5), p.785-794.e10
Main Author: Group, Sharp Collaborative
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: New York, NY: Mosby, Inc
ID: ISSN: 0002-8703
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title: Study of Heart and Renal Protection (SHARP): Randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9,438 patients with chronic kidney disease
format: Article
creator:
  • Group, Sharp Collaborative
subjects:
  • Adult
  • Aged
  • Analysis
  • Anticholesteremic Agents - administration & dosage
  • Anticholesteremic Agents - therapeutic use
  • Atherosclerosis - blood
  • Atherosclerosis - etiology
  • Atherosclerosis - prevention & control
  • Azetidines - administration & dosage
  • Azetidines - therapeutic use
  • Biological and medical sciences
  • Cardiology. Vascular system
  • Cardiovascular
  • CARDIOVASCULAR OUTCOMES
  • Cholesterol
  • Cholesterol, LDL - blood
  • Cholesterol, LDL - drug effects
  • Chronic kidney failure
  • Clinical Medicine
  • CLINICAL-TRIALS
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Therapy, Combination
  • EFFICACY
  • EZETIMIBE
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Kidney Failure, Chronic - blood
  • Kidney Failure, Chronic - complications
  • Kidney Failure, Chronic - therapy
  • Kidneys
  • Klinisk medicin
  • Low density lipoproteins
  • Male
  • Medical and Health Sciences
  • Medical research
  • Medical sciences
  • Medicin och hälsovetenskap
  • Medicine, Experimental
  • METAANALYSIS
  • Middle Aged
  • Nephrology. Urinary tract diseases
  • Nephropathies. Renovascular diseases. Renal failure
  • Renal Dialysis
  • Renal failure
  • REQUIRING PROLONGED OBSERVATION
  • Retrospective Studies
  • SAFETY
  • SIMVASTATIN
  • Simvastatin - administration & dosage
  • Simvastatin - therapeutic use
  • STATINS
  • Treatment Outcome
  • UNITED-KINGDOM HEART
  • Urinary system involvement in other diseases. Miscellaneous
  • Urologi och njurmedicin
  • Urology and Nephrology
ispartof: The American heart journal, 2010, Vol.160 (5), p.785-794.e10
description: Background Lowering low-density lipoprotein (LDL) cholesterol with statin therapy has been shown to reduce the incidence of atherosclerotic events in many types of patient, but it remains uncertain whether it is of net benefit among people with chronic kidney disease (CKD). Methods Patients with advanced CKD (blood creatinine ≥1.7 mg/dL [≥ 150 μmol/L] in men or ≥1.5 mg/dL [ ≥ 130 μmol/L] in women) with no known history of myocardial infarction or coronary revascularization were randomized in a ratio of 4:4:1 to ezetimibe 10 mg plus simvastatin 20 mg daily versus matching placebo versus simvastatin 20 mg daily (with the latter arm rerandomized at 1 year to ezetimibe 10 mg plus simvastatin 20 mg daily vs placebo). The key outcome will be major atherosclerotic events , defined as the combination of myocardial infarction, coronary death, ischemic stroke, or any revascularization procedure. Results A total of 9,438 CKD patients were randomized, of whom 3,056 were on dialysis. Mean age was 61 years, two thirds were male, one fifth had diabetes mellitus, and one sixth had vascular disease. Compared with either placebo or simvastatin alone, allocation to ezetimibe plus simvastatin was not associated with any excess of myopathy, hepatic toxicity, or biliary complications during the first year of follow-up. Compared with placebo, allocation to ezetimibe 10 mg plus simvastatin 20 mg daily yielded average LDL cholesterol differences of 43 mg/dL (1.10 mmol/L) at 1 year and 33 mg/dL (0.85 mmol/L) at 2.5 years. Follow-up is scheduled to continue until August 2010, when all patients will have been followed for at least 4 years. Conclusions SHARP should provide evidence about the efficacy and safety of lowering LDL cholesterol with the combination of ezetimibe and simvastatin among a wide range of patients with CKD.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0002-8703
fulltext: fulltext
issn:
  • 0002-8703
  • 1097-6744
  • 1097-6744
url: Link


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titleStudy of Heart and Renal Protection (SHARP): Randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9,438 patients with chronic kidney disease
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creatorGroup, Sharp Collaborative
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descriptionBackground Lowering low-density lipoprotein (LDL) cholesterol with statin therapy has been shown to reduce the incidence of atherosclerotic events in many types of patient, but it remains uncertain whether it is of net benefit among people with chronic kidney disease (CKD). Methods Patients with advanced CKD (blood creatinine ≥1.7 mg/dL [≥ 150 μmol/L] in men or ≥1.5 mg/dL [ ≥ 130 μmol/L] in women) with no known history of myocardial infarction or coronary revascularization were randomized in a ratio of 4:4:1 to ezetimibe 10 mg plus simvastatin 20 mg daily versus matching placebo versus simvastatin 20 mg daily (with the latter arm rerandomized at 1 year to ezetimibe 10 mg plus simvastatin 20 mg daily vs placebo). The key outcome will be major atherosclerotic events , defined as the combination of myocardial infarction, coronary death, ischemic stroke, or any revascularization procedure. Results A total of 9,438 CKD patients were randomized, of whom 3,056 were on dialysis. Mean age was 61 years, two thirds were male, one fifth had diabetes mellitus, and one sixth had vascular disease. Compared with either placebo or simvastatin alone, allocation to ezetimibe plus simvastatin was not associated with any excess of myopathy, hepatic toxicity, or biliary complications during the first year of follow-up. Compared with placebo, allocation to ezetimibe 10 mg plus simvastatin 20 mg daily yielded average LDL cholesterol differences of 43 mg/dL (1.10 mmol/L) at 1 year and 33 mg/dL (0.85 mmol/L) at 2.5 years. Follow-up is scheduled to continue until August 2010, when all patients will have been followed for at least 4 years. Conclusions SHARP should provide evidence about the efficacy and safety of lowering LDL cholesterol with the combination of ezetimibe and simvastatin among a wide range of patients with CKD.
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subjectAdult ; Aged ; Analysis ; Anticholesteremic Agents - administration & dosage ; Anticholesteremic Agents - therapeutic use ; Atherosclerosis - blood ; Atherosclerosis - etiology ; Atherosclerosis - prevention & control ; Azetidines - administration & dosage ; Azetidines - therapeutic use ; Biological and medical sciences ; Cardiology. Vascular system ; Cardiovascular ; CARDIOVASCULAR OUTCOMES ; Cholesterol ; Cholesterol, LDL - blood ; Cholesterol, LDL - drug effects ; Chronic kidney failure ; Clinical Medicine ; CLINICAL-TRIALS ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Therapy, Combination ; EFFICACY ; EZETIMIBE ; Female ; Follow-Up Studies ; Humans ; Incidence ; Kidney Failure, Chronic - blood ; Kidney Failure, Chronic - complications ; Kidney Failure, Chronic - therapy ; Kidneys ; Klinisk medicin ; Low density lipoproteins ; Male ; Medical and Health Sciences ; Medical research ; Medical sciences ; Medicin och hälsovetenskap ; Medicine, Experimental ; METAANALYSIS ; Middle Aged ; Nephrology. Urinary tract diseases ; Nephropathies. Renovascular diseases. Renal failure ; Renal Dialysis ; Renal failure ; REQUIRING PROLONGED OBSERVATION ; Retrospective Studies ; SAFETY ; SIMVASTATIN ; Simvastatin - administration & dosage ; Simvastatin - therapeutic use ; STATINS ; Treatment Outcome ; UNITED-KINGDOM HEART ; Urinary system involvement in other diseases. Miscellaneous ; Urologi och njurmedicin ; Urology and Nephrology
ispartofThe American heart journal, 2010, Vol.160 (5), p.785-794.e10
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0Study of Heart and Renal Protection (SHARP): Randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9,438 patients with chronic kidney disease
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descriptionBackground Lowering low-density lipoprotein (LDL) cholesterol with statin therapy has been shown to reduce the incidence of atherosclerotic events in many types of patient, but it remains uncertain whether it is of net benefit among people with chronic kidney disease (CKD). Methods Patients with advanced CKD (blood creatinine ≥1.7 mg/dL [≥ 150 μmol/L] in men or ≥1.5 mg/dL [ ≥ 130 μmol/L] in women) with no known history of myocardial infarction or coronary revascularization were randomized in a ratio of 4:4:1 to ezetimibe 10 mg plus simvastatin 20 mg daily versus matching placebo versus simvastatin 20 mg daily (with the latter arm rerandomized at 1 year to ezetimibe 10 mg plus simvastatin 20 mg daily vs placebo). The key outcome will be major atherosclerotic events , defined as the combination of myocardial infarction, coronary death, ischemic stroke, or any revascularization procedure. Results A total of 9,438 CKD patients were randomized, of whom 3,056 were on dialysis. Mean age was 61 years, two thirds were male, one fifth had diabetes mellitus, and one sixth had vascular disease. Compared with either placebo or simvastatin alone, allocation to ezetimibe plus simvastatin was not associated with any excess of myopathy, hepatic toxicity, or biliary complications during the first year of follow-up. Compared with placebo, allocation to ezetimibe 10 mg plus simvastatin 20 mg daily yielded average LDL cholesterol differences of 43 mg/dL (1.10 mmol/L) at 1 year and 33 mg/dL (0.85 mmol/L) at 2.5 years. Follow-up is scheduled to continue until August 2010, when all patients will have been followed for at least 4 years. Conclusions SHARP should provide evidence about the efficacy and safety of lowering LDL cholesterol with the combination of ezetimibe and simvastatin among a wide range of patients with CKD.
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1Aged
2Analysis
3Anticholesteremic Agents - administration & dosage
4Anticholesteremic Agents - therapeutic use
5Atherosclerosis - blood
6Atherosclerosis - etiology
7Atherosclerosis - prevention & control
8Azetidines - administration & dosage
9Azetidines - therapeutic use
10Biological and medical sciences
11Cardiology. Vascular system
12Cardiovascular
13CARDIOVASCULAR OUTCOMES
14Cholesterol
15Cholesterol, LDL - blood
16Cholesterol, LDL - drug effects
17Chronic kidney failure
18Clinical Medicine
19CLINICAL-TRIALS
20Dose-Response Relationship, Drug
21Double-Blind Method
22Drug Therapy, Combination
23EFFICACY
24EZETIMIBE
25Female
26Follow-Up Studies
27Humans
28Incidence
29Kidney Failure, Chronic - blood
30Kidney Failure, Chronic - complications
31Kidney Failure, Chronic - therapy
32Kidneys
33Klinisk medicin
34Low density lipoproteins
35Male
36Medical and Health Sciences
37Medical research
38Medical sciences
39Medicin och hälsovetenskap
40Medicine, Experimental
41METAANALYSIS
42Middle Aged
43Nephrology. Urinary tract diseases
44Nephropathies. Renovascular diseases. Renal failure
45Renal Dialysis
46Renal failure
47REQUIRING PROLONGED OBSERVATION
48Retrospective Studies
49SAFETY
50SIMVASTATIN
51Simvastatin - administration & dosage
52Simvastatin - therapeutic use
53STATINS
54Treatment Outcome
55UNITED-KINGDOM HEART
56Urinary system involvement in other diseases. Miscellaneous
57Urologi och njurmedicin
58Urology and Nephrology
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titleStudy of Heart and Renal Protection (SHARP): Randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9,438 patients with chronic kidney disease
authorGroup, Sharp Collaborative
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1Aged
2Analysis
3Anticholesteremic Agents - administration & dosage
4Anticholesteremic Agents - therapeutic use
5Atherosclerosis - blood
6Atherosclerosis - etiology
7Atherosclerosis - prevention & control
8Azetidines - administration & dosage
9Azetidines - therapeutic use
10Biological and medical sciences
11Cardiology. Vascular system
12Cardiovascular
13CARDIOVASCULAR OUTCOMES
14Cholesterol
15Cholesterol, LDL - blood
16Cholesterol, LDL - drug effects
17Chronic kidney failure
18Clinical Medicine
19CLINICAL-TRIALS
20Dose-Response Relationship, Drug
21Double-Blind Method
22Drug Therapy, Combination
23EFFICACY
24EZETIMIBE
25Female
26Follow-Up Studies
27Humans
28Incidence
29Kidney Failure, Chronic - blood
30Kidney Failure, Chronic - complications
31Kidney Failure, Chronic - therapy
32Kidneys
33Klinisk medicin
34Low density lipoproteins
35Male
36Medical and Health Sciences
37Medical research
38Medical sciences
39Medicin och hälsovetenskap
40Medicine, Experimental
41METAANALYSIS
42Middle Aged
43Nephrology. Urinary tract diseases
44Nephropathies. Renovascular diseases. Renal failure
45Renal Dialysis
46Renal failure
47REQUIRING PROLONGED OBSERVATION
48Retrospective Studies
49SAFETY
50SIMVASTATIN
51Simvastatin - administration & dosage
52Simvastatin - therapeutic use
53STATINS
54Treatment Outcome
55UNITED-KINGDOM HEART
56Urinary system involvement in other diseases. Miscellaneous
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58Urology and Nephrology
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abstractBackground Lowering low-density lipoprotein (LDL) cholesterol with statin therapy has been shown to reduce the incidence of atherosclerotic events in many types of patient, but it remains uncertain whether it is of net benefit among people with chronic kidney disease (CKD). Methods Patients with advanced CKD (blood creatinine ≥1.7 mg/dL [≥ 150 μmol/L] in men or ≥1.5 mg/dL [ ≥ 130 μmol/L] in women) with no known history of myocardial infarction or coronary revascularization were randomized in a ratio of 4:4:1 to ezetimibe 10 mg plus simvastatin 20 mg daily versus matching placebo versus simvastatin 20 mg daily (with the latter arm rerandomized at 1 year to ezetimibe 10 mg plus simvastatin 20 mg daily vs placebo). The key outcome will be major atherosclerotic events , defined as the combination of myocardial infarction, coronary death, ischemic stroke, or any revascularization procedure. Results A total of 9,438 CKD patients were randomized, of whom 3,056 were on dialysis. Mean age was 61 years, two thirds were male, one fifth had diabetes mellitus, and one sixth had vascular disease. Compared with either placebo or simvastatin alone, allocation to ezetimibe plus simvastatin was not associated with any excess of myopathy, hepatic toxicity, or biliary complications during the first year of follow-up. Compared with placebo, allocation to ezetimibe 10 mg plus simvastatin 20 mg daily yielded average LDL cholesterol differences of 43 mg/dL (1.10 mmol/L) at 1 year and 33 mg/dL (0.85 mmol/L) at 2.5 years. Follow-up is scheduled to continue until August 2010, when all patients will have been followed for at least 4 years. Conclusions SHARP should provide evidence about the efficacy and safety of lowering LDL cholesterol with the combination of ezetimibe and simvastatin among a wide range of patients with CKD.
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