Dataset Information

Profile of evolocumab and its potential in the treatment of hyperlipidemia.

ABSTRACT: Despite the proven efficacy of statins, they often fail to achieve low-density lipoprotein (LDL) cholesterol goals, especially in high-risk patients. Moreover, a large number of subjects cannot tolerate statins or full doses of these drugs, in particular patients with familial hypercholesterolemia. Thus, there is a need for additional effective LDL cholesterol-reducing agents. Evolocumab (AMG145) is a monoclonal antibody inhibiting proprotein convertase subtilisin/kexin type 9 that binds to the liver LDL receptor and prevents it from normal recycling by targeting it for degradation. Phase I, II, and III trials revealed that, on subcutaneous injection, either alone or in combination with statins, evolocumab is able to reduce high LDL cholesterol levels from 54% to 80%, apolipoprotein B100 from 31% to 61%, and lipoprotein(a) from 12% to 36%, in a dose-dependent manner. The incidence of side effects seems to be low and mainly limited to nasopharyngitis, injection site pain, arthralgia, and back pain. Evolocumab is an innovative powerful lipid-lowering drug, additive to statins and/or ezetimibe, with a large therapeutic range associated with a low rate of mild adverse events. If the available data are confirmed in long-term trials with strong outcome measures, evolocumab will become an essential tool in the treatment of a large number of high-risk patients, such as those affected by familial hypercholesterolemia, those who are unable to tolerate an efficacious statin dosage, and those at very high cardiovascular risk and unable to achieve their target LDL cholesterol levels with currently available lipid-lowering therapies.

SUBMITTER: Cicero AF

PROVIDER: S-EPMC4474387 | biostudies-other | 2015

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

Profile of evolocumab and its potential in the treatment of hyperlipidemia.

Cicero Arrigo F G AF Colletti Alessandro A Borghi Claudio C

Drug design, development and therapy 20150615

Despite the proven efficacy of statins, they often fail to achieve low-density lipoprotein (LDL) cholesterol goals, especially in high-risk patients. Moreover, a large number of subjects cannot tolerate statins or full doses of these drugs, in particular patients with familial hypercholesterolemia. Thus, there is a need for additional effective LDL cholesterol-reducing agents. Evolocumab (AMG145) is a monoclonal antibody inhibiting proprotein convertase subtilisin/kexin type 9 that binds to the ...[more]

PMID: 26109850

Similar Datasets

Project description:ObjectiveTo identify the prevalence, treatment, and low-density lipoprotein cholesterol (LDL-C) control of individuals with LDL-C ≥190 mg/dL in contemporary clinical practice.MethodsWe included adults (age ≥18 years) with LDL-C ≥190 mg/dL, at least one LDL-C level drawn from 255 health systems participating in Cerner HealthFacts database (2000-2017, n = 4,623,851), and a detailed examination within Duke University Health System (DUHS, 2015-2017, n = 267,710). Factors associated with LDL-C control were evaluated using multivariable logistic regression modeling.ResultsThe cross-sectional prevalence of LDL-C ≥190 mg/dL was 3.0% in Cerner (n = 139,539/4,623,851) and 2.9% at DUHS (n = 7728/267,710); among these, rates of repeat LDL-C measurement within 13 months were low: 27.9% (n = 38,960) in Cerner, 54.5% (n = 4211) at DUHS. Of patients with follow-up LDL-C levels, 23.6% in Cerner had a 50% of greater reduction in LDL-C, 18.3% achieved an LDL-C <100 mg/dL and 2.7% < 70 mg/dL. At DUHS, 28.4% had a 50% or greater reduction in LDL-C, 28.4% achieved an LDL-C ≤100 mg/dL and 4.4% achieved <70 mg/dL. Within DUHS, 71.6% with LDL-C ≥190 mg/dL were on any statin during follow-up, but only 28.5% were on a high-intensity statin. In multivariable modeling, seeing a cardiologist (Cerner odds ratio [OR] 1.56, confidence interval [CI] 1.33-1.83; DUHS OR 1.89, 95% CI 1.18-3.01) and having diabetes (Cerner OR 1.34 CI 1.23-1.46; DUHS OR 2.07, CI 1.62-2.65) increased odds of LDL-C control, defined as a ≥50% reduction in LDL-C (at Cerner) or initiation of high intensity statin (at DUHS). Prior atherosclerotic cardiovascular disease (OR 1.19, CI 1.07-1.33), hypertension (OR 1.10, CI 1.03-1.18), African American race (OR 0.79, CI 0.71-0.89), and government (vs. private) insurance (OR 0.90, CI 0.83-0.98) were associated with LDL-C control at Cerner. Female sex was associated with lower odds of appropriate therapy (OR 0.69, CI 0.59-0.81) at DUHS.ConclusionsApproximately 3% of United States adults have LDL-C ≥190 mg/dL. Among those with very high LDL-C, rates of repeat measurement within one year were low; of those retested, only about one-fourth met guideline-recommended LDL-C treatment goals.

Dataset Information

Profile of evolocumab and its potential in the treatment of hyperlipidemia.

Publications

Profile of evolocumab and its potential in the treatment of hyperlipidemia.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets