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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover better methods for helping patients with high cholesterol receive appropriate treatments to prevent or manage atherosclerosis (cholesterol buildup in arteries). Researchers are testing two methods: notifying healthcare providers through electronic health records (Best-Practice Alert) and using a remote pharmacist to assist in medication management. Potential participants include individuals with diabetes, possible familial hypercholesterolemia (a genetic condition causing high cholesterol), or existing heart disease. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in managing high cholesterol.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Remote Pharmacist-Driven Medication Management Program is generally safe. Studies indicate that pharmacist-led care helps patients adhere to treatment plans and manage health conditions more effectively. This program follows expert guidelines to control cholesterol levels, and other trials have shown positive results. It has been linked to better cholesterol management and fewer side effects compared to usual care.

For the EHR-Based Provider Notification for Lipid Optimization approach, specific safety data from past studies is not available. However, this method involves alerting healthcare providers through electronic health records, a common and generally safe practice in healthcare.

Overall, both approaches aim to improve current care methods and appear well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these protocols because they leverage technology and remote expertise to optimize cholesterol management. The EHR-Based Provider Notification for Lipid Optimization integrates directly with electronic health records to alert healthcare providers about cholesterol levels, facilitating timely and proactive care. Meanwhile, the Remote Pharmacist-Driven Medication Management Program involves pharmacists remotely managing and adjusting medications, ensuring personalized care without requiring patients to visit a clinic. These approaches aim to enhance convenience and efficiency compared to traditional in-person consultations and medication adjustments.

What evidence suggests that this trial's treatments could be effective for lowering cholesterol?

Research has shown that programs led by pharmacists can effectively lower cholesterol levels. In this trial, participants may join the Remote Pharmacist-Driven Medication Management Program, which studies have found helps control LDL (often called "bad" cholesterol) and blood pressure. One study showed that a pharmacist-led program successfully reduced LDL cholesterol and blood pressure in 10,000 patients. Another study found that pharmacist telehealth services improved heart health factors like cholesterol and high blood pressure. These findings suggest that pharmacist-managed approaches can play a crucial role in improving cholesterol levels and heart health. ^{1 3 6 7 8}

Who Is on the Research Team?

Benjamin Scirica, M.D., MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/abs/10.1002/jac5.70107

The Impact of a Pharmacist‐Driven, Interprofessional Lipid ... The primary outcome of interest was the increase in the number of successful lipid optimizations with the LOW-TOC model. Secondary outcomes ...

2. tctmd.com tctmd.com/news/pharmacist-led-intervention-slashes-ldl-and-bp-10000-patients

Pharmacist-Led Intervention Slashes LDL and BP in 10000 ... A remote, algorithm-based management program significantly improved control of blood pressure and LDL-cholesterol levels in patients ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06960655

Improving Lipid Optimization Quality and Treatment ... Remote Pharmacist-driven Medication Management Strategy Procedures: Treatment recommendations in this program are based on current professional society ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772487523000399

Association between pharmacist-led telehealth services ... Pharmacist telehealth is associated with improved cardiovascular risk factors like diabetes, hypertension, and dyslipidemia.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9647559/

Results of a Remotely Delivered Hypertension and Lipid ... Results of a remotely delivered hypertension and lipid program in more than 10 000 patients across a diverse health care network.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10198268/

Outcomes of Pharmacist-Led Pharmaceutical Care ... These interventions have been shown to improve adherence and disease control, clinical outcomes in many chronic diseases, pregnant women's health, tobacco and ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.118.004801

Remote Pharmacist Practice Model of Collaboration in ... A randomized trial of a community-based approach to dyslipidemia management: pharmacist prescribing to achieve cholesterol targets (RxACT study) ...

8. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2798467

Results of a Remotely Delivered Hypertension and Lipid ... Remote medication titration management was significantly associated with decreased blood pressure and low-density lipoprotein cholesterol compared with ...