Cholesterol-Lowering Treatments for High Cholesterol

Overseen By Benjamin Scirica, M.D., MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: No PCP, dialysis, hospice, dementia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Best-Practice Alert for lowering cholesterol?

Research shows that treatments aimed at lowering LDL cholesterol (the 'bad' cholesterol) can reduce the risk of heart-related problems and improve survival in people with heart disease and other related conditions. Statins, a common type of cholesterol-lowering drug, are effective in reducing LDL cholesterol and have been shown to improve patient outcomes when used consistently. ^{1 2 3 4 5}

Is the cholesterol-lowering treatment safe for humans?

The cholesterol-lowering treatments, including statins and PCSK9 inhibitors, are generally safe for humans. Statins have been well-tolerated in numerous studies, though they may cause muscle, liver, or kidney issues in some cases. PCSK9 inhibitors are also well-tolerated, with common side effects like injection-site reactions and flu-like symptoms, which usually resolve over time. ^{6 7 8 9 10}

How does this drug differ from other cholesterol-lowering drugs?

This treatment may involve newer cholesterol-lowering drugs like PCSK9 inhibitors, which are different from traditional statins because they work by blocking a protein that affects how the liver processes cholesterol, potentially offering an option for patients who cannot tolerate statins or need additional help to reach cholesterol targets. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this project is to study different approaches to improve the utilization of guideline directed medicines to lower cholesterol in patients with or at high risk of atherosclerosis (cholesterol buildup in the arteries).

Research Team

Benjamin Scirica, M.D., MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for individuals with high cholesterol or at high risk of atherosclerosis, which means they have plaque buildup in their arteries that could lead to cardiovascular disease. Specific eligibility criteria are not provided, but typically participants should meet certain health conditions.

Inclusion Criteria

I have diabetes.

High-Risk Primary Prevention

I might have Familial Hypercholesterolemia.

Exclusion Criteria

No primary care physician (PCP), cardiologist, endocrinologist, or nephrologist at MGB

Enrolled in a hospice program

I have advanced dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EHR-Based Provider Notification or Remote Pharmacist-Driven Medication Management for lipid optimization

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Extension

Continued monitoring and assessment of lipid levels and therapy intensification

6 months

Treatment Details

Interventions

• Best-Practice Alert

Trial Overview The study explores various strategies to enhance the use of medications recommended by guidelines for lowering cholesterol. It includes drugs like statins, ezetimibe, bempedoic acid, evolocumab, alirocumab and inclisiran as well as a Best-Practice Alert system.

Participant Groups

Group I: EHR-Based Provider Notification for Lipid Optimization Active Control 1 Intervention

Group II: Remote Pharmacist-Driven Medication Management Program Active Control 1 Intervention

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

In a multicenter, placebo-controlled trial involving 196 patients with primary type II hypercholesterolemia, pravastatin significantly reduced total cholesterol by 23-27% and LDL cholesterol by 30-34% after 8 weeks, demonstrating its efficacy as a treatment.

Pravastatin was well tolerated with a low incidence of adverse events, indicating a favorable safety profile, as no patients withdrew from the study due to side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of pravastatin in patients with primary hypercholesterolemia. II. Once-daily versus twice-daily dosing. Hunninghake, DB., Mellies, MJ., Goldberg, AC., et al.[2019]

In a real-world analysis of 164 patients, 41.5% reported adverse events (AEs) after using PCSK9 inhibitors, with the most common being injection-site reactions (33.8%) and influenza-like illness (27.9%).

The overall safety profile of PCSK9 inhibitors in clinical practice is comparable to that observed in randomized clinical trials, indicating they are well tolerated, with AEs resolving in 71.1% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Associated With PCSK9 Inhibitors: A Real-World Experience. Gürgöze, MT., Muller-Hansma, AHG., Schreuder, MM., et al.[2021]

Statins have been proven effective in improving lipid levels and significantly reducing the risk of atherosclerotic coronary artery disease (CAD), which leads to lower morbidity and mortality rates associated with CAD.

While statins are generally well tolerated, there are safety concerns regarding potential adverse effects on muscles, liver, kidneys, and the nervous system, with some risks being well-documented and others remaining speculative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statin safety: an overview and assessment of the data--2005. Bays, H.[2022]

PCSK9 inhibitors, used for lipid-lowering therapy, have a low incidence of injection-site reactions leading to discontinuation, with 15 events per 1000 persons over 5 years, indicating they are generally safe.

These inhibitors do not increase the risk of serious side effects such as new-onset diabetes, neurocognitive issues, cataracts, or gastrointestinal bleeding, suggesting they are a safe option for patients needing lipid management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of proprotein convertase subtilisin/kexin 9 inhibitors: a systematic review and meta-analysis. Li, J., Du, H., Wang, Y., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

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Impact of guidelines on health care use for the management of dyslipidemia in two Canadian provinces, Alberta and Nova Scotia, from 1990 to 2001. [2015]

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Low-cost intervention produces dramatic results in managing LDL cholesterol. [2006]

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Changing perspectives in the prevention of coronary artery disease. [2019]

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Efficacy and safety of pravastatin in patients with primary hypercholesterolemia. II. Once-daily versus twice-daily dosing. [2019]

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Adverse Events Associated With PCSK9 Inhibitors: A Real-World Experience. [2021]

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Exploring the Management of Statin Intolerant Patients: 2016 and Beyond. [2019]

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Statin safety: an overview and assessment of the data--2005. [2022]

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Safety of proprotein convertase subtilisin/kexin 9 inhibitors: a systematic review and meta-analysis. [2022]

11. Spain pubmed.ncbi.nlm.nih.gov

Therapeutic targets in the treatment of dyslipidaemias: From statins to PCSK9 inhibitors. Unmet needs. [2021]

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Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. The Expert Panel. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Prescription cholesterol-lowering medication use in adults aged 40 and over: United States, 2003-2012. [2022]