Achieving lipoprotein goals in patients at high risk with severe hypercholesterolemia: Efficacy and safety of ezetimibe co-administered with atorvastatin

Stein, Evan A.; Stender, Steen; Mata, Pedro; Sager, Philip T.; Ponsonnet, Damien; Melani, Lorenzo; Lipka, Leslie J.; Suresh, Ramachandran; Maccubbin, Darbie; Veltri, Enrico P.

doi:10.1016/j.ahj.2004.03.052

Cited by 152 publications

(53 citation statements)

References 23 publications

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“…Since the audit, a new lipid-lowering drug, the cholesterol absorption blocker (ezetimibe), has become available, and has been shown to be effective in lipid lowering in FH patients. 25 Thus a new audit might show greater lipid lowering, with more FH patients reaching target. However, a lower target for LDL-cholesterol of 2 mmol/L for individuals at high risk of CHD is now advocated by the Joint British Societies' guidelines (JBS2).…”

Section: Discussionmentioning

confidence: 99%

Are patients with familial hypercholesterolaemia well managed in lipid clinics? An audit of eleven clinics from the Department of Health Familial Hypercholesterolaemia Cascade Testing project

et al. 2008

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Background: Familial hypercholesterolaemia (FH) is an autosomal co-dominant disorder which is relatively common, leads to high levels of LDL-cholesterol and if untreated to early coronary heart disease. An audit of current practice at National Health Service Trusts in England was undertaken to determine whether FH patients meet the diagnostic criteria for FH; are being offered appropriate advice and treatment; and to what extent their families are contacted and offered testing for the disorder. Methods: Medical records of known FH patients (over 18 years of age and diagnosed before 31 December 2003) were accessed to obtain information on diagnosis, treatment and family tracing. Results: The records of 733 FH patients were examined, 79% met the UK 'Simon Broome' register criteria for the diagnosis of definite or possible FH. Analyses showed that patients were usually offered appropriate advice and treatment, with 89% being on a statin. However, the audit indicated a high variability in family tracing between the sites, with significant differences in the frequency of inclusion of a family pedigree in the notes (range 1-71%, mean 35%); the general practitioner (GP) being advised that first-degree relatives should be tested (range 4-52%, mean 27%); and the proportion of relatives contacted and tested (range 6-50%, mean 32%). Conclusion: FH patients are well cared for in lipid clinics in England, are being given appropriate lifestyle advice and medication, but an increase in recording of LDL-cholesterol levels may lead to improvements in their management. Practice in family tracing appears to vary widely between clinics.

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Section: Discussionmentioning

confidence: 99%

Are patients with familial hypercholesterolaemia well managed in lipid clinics? An audit of eleven clinics from the Department of Health Familial Hypercholesterolaemia Cascade Testing project

et al. 2008

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“…The proportion of subjects reaching their target LDL-C goal of B100 mg/dl was significantly higher in the coadministration group than in the atorvastatin monotherapy group (22 vs. 7%). At 4 weeks, LDL-C levels were reduced significantly more by combination therapy than by doubling the dose of atorvastatin (-22.8 vs. -8.6%) [48]. All dose combinations of ezetimibeatorvastatin were simultaneously assessed in a large prospective randomized double-blind clinical trial.…”

Section: Lipid-lowering Efficacy Of the Ezetimibe/ Atorvastatin Combimentioning

confidence: 99%

“…All dose combinations of ezetimibeatorvastatin were simultaneously assessed in a large prospective randomized double-blind clinical trial. In this study, 628 patients with baseline LDL-C 145-250 mg/dl were randomly assigned to receive one of the following for 12 weeks: ezetimibe 10 mg/day, atorvastatin (10, 20, 40, or Adding EZE to ATO 20 mg resulted in significantly greater reductions in LDL-C and significantly more pts achieving LDL-C \100 mg/dl Stein et al [48] 621 high-risk pts with LDL-C C130 mg/dl despite treatment with ATO 10 mg/day EZE 10 mg/day ? ATO 10 mg/day followed by response-based ATO dose titration up to 40 mg/day vs. monotherapy with ATO 20 mg/day with response-based ATO dose titration up to 80 mg/day Adding EZE to ATO 10 mg/day followed by ATO dose titration was more effective in reducing LDL-C and significantly increased the proportion of pts achieving LDL-C B100 mg/dl Ballantyne et al [49] 628 pts with primary hypercholesterolemia and baseline LDL-C 145-250 mg/dl [49].…”

Section: Lipid-lowering Efficacy Of the Ezetimibe/ Atorvastatin Combimentioning

confidence: 99%

“…Despite some isolated reports of myopathy attributable to ezetimibe [73], the adverse event profile in several large trials was similar to that of placebo [74]. Studies assessing specifically the short-term safety of the atorvastatinezetimibe combination showed similar results, with no significant differences in the incidences of laboratory and clinical adverse events, including gastrointestinal, liver, or muscle effects [46][47][48][49][50]. Concerns that ezetimibe could increase the risk of cancer were raised by the SEAS trial.…”

Section: Safety Of the Ezetimibe-atorvastatin Combinationmentioning

confidence: 99%

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Defining the Place of Ezetimibe/Atorvastatin in the Management of Hyperlipidemia

Ferreira

Silva

2016

Am J Cardiovasc Drugs

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Statin-ezetimibe combinations are a potentially advantageous therapeutic option for high-risk patients who need additional lowering of low-density lipoprotein cholesterol (LDL-C). These combinations may overcome some of the limitations of statin monotherapy by blocking both sources of cholesterol. Recently, a fixed-dose combination with atorvastatin, one of the most extensively studied statins, was approved and launched in several countries, including the USA. Depending on atorvastatin dose, this combination provides LDL-C reductions of 50-60%, triglyceride reductions of 30-40%, and highdensity lipoprotein cholesterol (HDL-C) increases of 5-9%. Studies comparing the lipid-lowering efficacy of the atorvastatin-ezetimibe combination with the alternatives of statin dose titration or switching to a more potent statin consistently showed that combination therapy provided greater LDL-C reduction, translating into a greater proportion of patients achieving lipid goals. Simvastatinezetimibe combinations have been shown to reduce the incidence of major atherosclerotic events in several clinical settings to a magnitude that seems similar to that observed with statins for the same degree of absolute LDL-C lowering. The atorvastatin-ezetimibe combination has also been shown to induce the regression of coronary atherosclerosis measured by intravascular ultrasound in a significantly greater proportion of patients than atorvastatin alone. Atorvastatin-ezetimibe combinations are generally well tolerated. Previous concerns of a possible increase in the incidence of cancer with ezetimibe were dismissed in large trials with long follow-up periods. In this paper, we examine the rationale for an atorvastatin-ezetimibe combination, review the evidence supporting it, and discuss its potential role in the management of dyslipidemia. Key PointsStatin-ezetimibe combinations are a realistic treatment option for patients who do not achieve low-density lipoprotein cholesterol (LDL-C) targets while receiving statin monotherapy and for patients prone to dose-dependent statin side effects.The IMPROVE-IT trial was the first to demonstrate a reduction in cardiovascular events with ezetimibe.Recently, combination therapy with atorvastatin plus ezetimibe was also associated with greater coronary plaque regression than atorvastatin alone.

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“…Early data from 12 practices suggest that it achieved similar lowering results to that reported in clinical trials. 20 Where data are difficult Although we can graph the age-sex profile of the practice, ethnicity data important in many disease areas (including CKD) are usually recorded in less than 0.5% of cases. 19 We were also not certain whether undiagnosed CKD in computer records was due to poor computer data quality or true failure to record this diagnosis in GP records.…”

Section: Designmentioning

confidence: 99%

Routinely-collected general practice data are complex, but with systematic processing can be used for quality improvement and research

Lusignan¹,

Hague²,

Vlymen³

et al. 2006

Journal of Innovation in Health Informatics

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Background UK general practice is computerised, and quality targets based on computer data provide a further incentive to improve data quality. A National Programme for Information Technology is standardising the technical infrastructure and removing some of the barriers to data aggregation. Routinely collected data is an underused resource, yet little has been written about the wide range of factors that need to be taken into account if we are to infer meaning from general practice data. Objective To report the complexity of general practice computer data and factors that need to be taken into account in its processing and interpretation. Method We run clinically focused programmes that provide clinically relevant feedback to clinicians, and overview statistics to localities and researchers. However, to take account of the complexity of these data we have carefully devised a system of process stages and process controls to maintain referential integrity, and improve data quality and error reduction. These are integrated into our design and processing stages. Our systems document the query,

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Achieving lipoprotein goals in patients at high risk with severe hypercholesterolemia: Efficacy and safety of ezetimibe co-administered with atorvastatin

Cited by 152 publications

References 23 publications

Are patients with familial hypercholesterolaemia well managed in lipid clinics? An audit of eleven clinics from the Department of Health Familial Hypercholesterolaemia Cascade Testing project

Are patients with familial hypercholesterolaemia well managed in lipid clinics? An audit of eleven clinics from the Department of Health Familial Hypercholesterolaemia Cascade Testing project

Defining the Place of Ezetimibe/Atorvastatin in the Management of Hyperlipidemia

Routinely-collected general practice data are complex, but with systematic processing can be used for quality improvement and research

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