Browsing by Subject "Hypercholesterolemia"

Now showing 1 - 5 of 5
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    A protocol to evaluate the efficacy, perceptions, and cost of a cholesterol packaging approach to improve medication adherence.
    (Contemporary clinical trials, 2014-09) Zullig, Leah L; Pathman, Joshua; Melnyk, S Dee; Brown, Jamie N; Sanders, Linda L; Koropchak, Celine; Howard, Teresa; Danus, Susanne; McCant, Felicia; Bosworth, Hayden B

    Purpose

    Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease (CVD), a leading cause of death in the United States. Despite clinical practice guidelines aimed at facilitating LDL-C control, many Veterans do not achieve guideline-recommended LDL-C levels.

    Methods

    We describe a study focused on VA healthcare system users at risk for CVD (i.e., LDL-C level >130 mg/dl and/or <80% cholesterol pill refill adherence in the last 12 months). We are conducting a two and a half year randomized controlled trial (i.e., intervention administered over 12 months) among Veterans with uncontrolled cholesterol receiving care at select VA-affiliated primary care clinics in North Carolina. We anticipate enrolling 250 diverse patients (10% women; 40% African American). Patients are randomized to an educational control group or intervention group. Intervention group participants' medication is provided in special blister packaging labeled for daily use that includes reminders; MeadWestvaco Corporation's pre-filled DosePak® contains standard doses of statins in accordance with the existing prescriptions.

    Conclusions

    Pre-filled blister packaging may provide an inexpensive solution to improve medication adherence. Our study enrolls a diverse sample and provides information about whether an adherence packaging intervention can: 1) improve medication adherence; 2) improve patients' LDL-C levels; 3) be well received by patients and providers; and 4) provide a cost effective solution to improve medication adherence.
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    Design and rationale of the LAPLACE-TIMI 57 trial: a phase II, double-blind, placebo-controlled study of the efficacy and tolerability of a monoclonal antibody inhibitor of PCSK9 in subjects with hypercholesterolemia on background statin therapy.
    (Clinical cardiology, 2012-01) Kohli, Payal; Desai, Nihar R; Giugliano, Robert P; Kim, Jae B; Somaratne, Ransi; Huang, Fannie; Knusel, Beat; McDonald, Shannon; Abrahamsen, Timothy; Wasserman, Scott M; Scott, Robert; Sabatine, Marc S
    Lowering low-density lipoprotein cholesterol (LDL-C) is a cornerstone for the prevention of atherosclerotic heart disease, improving clinical outcomes and reducing vascular mortality in patients with hypercholesterolemia. The clinical benefits of LDL-C reduction appear to extend even to patients starting with LDL-C as low as 60-80 mg/dL prior to initiating therapy. Statins are the first-line agents for treating hypercholesterolemia and are effective in reducing LDL-C, but many patients are unable to achieve their optimal lipid targets despite intensive statin therapy. Therefore, there has been a strong impetus for the development of novel pharmacologic agents designed to lower LDL-C further in patients already on statin therapy. Genetic mutations resulting in altered cholesterol homeostasis provide valuable information regarding novel approaches for treating hypercholesterolemia. To that end, mutations in proprotein convertase subtilisin/kexin type 9 (PCSK9) were linked to altered levels of LDL-C, illustrating this protein's role in lipid metabolism. PCSK9 promotes degradation of the LDL receptor, preventing its transport back to the cell surface and thereby increasing circulating LDL-C. Conversely, inhibition of PCSK9 can profoundly decrease circulating LDL-C, and thus is an attractive new target for LDL-C-lowering therapy. AMG 145 is a fully human monoclonal immunoglobulin G2 antibody that binds specifically to human PCSK9 and inhibits its interaction with the low-density lipoprotein receptor. In this manuscript, we describe the rationale and design of LDL-C Assessment with PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-Thrombolysis In Myocardial Infarction 57 (LAPLACE-TIMI 57; NCT01380730), a 12-week, randomized, double-blind, dose-ranging, placebo-controlled study designed to assess the safety and efficacy of AMG 145 when added to statin therapy in patients with hypercholesterolemia.
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    Evaluation of a packaging approach to improve cholesterol medication adherence.
    (The American journal of managed care, 2017-09) Bosworth, Hayden B; Brown, Jamie N; Danus, Susanne; Sanders, Linda L; McCant, Felicia; Zullig, Leah L; Olsen, Maren K
    Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease, a leading cause of death in the United States. Our goal was to evaluate a simple, scalable, and affordable medication packaging method for improving cholesterol medication adherence and subsequently lowering LDL-C levels.Mixed-method study.This mixed-method study involved US military veterans with LDL-C levels greater than 130 mg/dL and/or less than 80% refill adherence of cholesterol-lowering medication in the last 12 months; they were randomized to an education-only (control) group or an adherence packaging intervention group. Adherence packaging group participants' statin medication was provided in special blister packaging labeled for daily use that included written reminder prompts. Outcomes included 12-month cholesterol medication possession ratio (MPR) for medication refills; baseline, 6-, and 12-month self-reported cholesterol medication use; LDL-C and high-density lipoprotein cholesterol (HDL-C) levels; and total cholesterol changes over 12 months. Qualitative evaluation of the intervention is presented as well.We enrolled 240 individuals (120 intervention, 120 control). Overall, 54.2% of the adherence packaging intervention group was adherent per MPR over 12 months compared with 46.6% of the education-only group (difference = 7.6%; 95% confidence interval, -5% to 20%; P ≤.24). Both arms reported improvements in self-reported cholesterol adherence at 12 months, and decreases in LDL-C, HDL-C, and total cholesterol were observed, but differences in change between arms were not statistically significant. Qualitatively, patients reported high levels of satisfaction with the blister package.In a sample of US veterans, prefilled calendared blister packaging provided an inexpensive method for improving cholesterol medication adherence.
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    Health beliefs and desire to improve cholesterol levels among patients with hyperlipidemia.
    (Patient education and counseling, 2016-05) Zullig, Leah L; Sanders, Linda L; Thomas, Steven; Brown, Jamie N; Danus, Susanne; McCant, Felicia; Bosworth, Hayden B

    Objective

    Because hyperlipidemia is asymptomatic, many veterans affairs (VA) patients may not perceive it seriously. We assessed key Health Belief model concepts to describe patients' cholesterol-related health beliefs and examine associations between patient-level factors and desire to improve cholesterol control.

    Methods

    We used baseline data from an ongoing randomized clinical trial. Eligible patients were receiving care at the Durham VA and had CVD risk-total cholesterol levels >130 mg/dL and/or <80% medication adherence in the previous 12 months. A survey assessed patients' health beliefs about high cholesterol and self-reported medication adherence. Multivariable logistic regression examined whether there was an association between desire to control cholesterol and cholesterol status.

    Results

    Approximately 64% (n=155) of patients perceived high cholesterol as 'very serious'. In multivariable logistic regression analysis, patients who perceived high cholesterol as 'very serious' (OR 2. 26, p=0.032) and/or with high self-efficacy (OR 4.70, p<0.001) had increased odds of desiring cholesterol control.

    Conclusion

    The factors most significantly associated with desire to improve cholesterol control were perceiving hyperlipidemia as 'very serious and self-efficacy for cholesterol control.

    Practice implication

    Educating patients, with the goal of appropriately increasing their perceived risk of disease, is likely necessary to impact cholesterol control.
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    Heart disease and stroke statistics--2011 update: a report from the American Heart Association.
    (Circulation, 2011-02) Roger, Véronique L; Go, Alan S; Lloyd-Jones, Donald M; Adams, Robert J; Berry, Jarett D; Brown, Todd M; Carnethon, Mercedes R; Dai, Shifan; de Simone, Giovanni; Ford, Earl S; Fox, Caroline S; Fullerton, Heather J; Gillespie, Cathleen; Greenlund, Kurt J; Hailpern, Susan M; Heit, John A; Ho, P Michael; Howard, Virginia J; Kissela, Brett M; Kittner, Steven J; Lackland, Daniel T; Lichtman, Judith H; Lisabeth, Lynda D; Makuc, Diane M; Marcus, Gregory M; Marelli, Ariane; Matchar, David B; McDermott, Mary M; Meigs, James B; Moy, Claudia S; Mozaffarian, Dariush; Mussolino, Michael E; Nichol, Graham; Paynter, Nina P; Rosamond, Wayne D; Sorlie, Paul D; Stafford, Randall S; Turan, Tanya N; Turner, Melanie B; Wong, Nathan D; Wylie-Rosett, Judith; American Heart Association Statistics Committee and Stroke Statistics Subcommittee
    Each year, the American Heart Association (AHA), in conjunction with the Centers for Disease Control and Prevention, the National Institutes of Health, and other government agencies, brings together the most up-to-date statistics on heart disease, stroke, other vascular diseases, and their risk factors and presents them in its Heart Disease and Stroke Statistical Update. The Statistical Update is a valuable resource for researchers, clinicians, healthcare policy makers, media professionals, the lay public, and many others who seek the best national data available on disease morbidity and mortality and the risks, quality of care, medical procedures and operations, and costs associated with the management of these diseases in a single document. Indeed, since 1999, the Statistical Update has been cited more than 8700 times in the literature (including citations of all annual versions). In 2009 alone, the various Statistical Updates were cited 1600 times (data from ISI Web of Science). In recent years, the Statistical Update has undergone some major changes with the addition of new chapters and major updates across multiple areas. For this year's edition, the Statistics Committee, which produces the document for the AHA, updated all of the current chapters with the most recent nationally representative data and inclusion of relevant articles from the literature over the past year and added a new chapter detailing how family history and genetics play a role in cardiovascular disease (CVD) risk. Also, the 2011 Statistical Update is a major source for monitoring both cardiovascular health and disease in the population, with a focus on progress toward achievement of the AHA's 2020 Impact Goals. Below are a few highlights from this year's Update. Copyright © 2011 American Heart Association. All rights reserved.