Virtual Statin Management for High Cholesterol

(1821534-10 Trial)

Overseen By Catherine G Derington, PharmD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Statins

Disqualifiers: Non-English, Limited life expectancy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether an educational website can encourage individuals who stopped taking statins due to muscle pain to resume their use. The study aims to determine if the website increases the likelihood of participants restarting and continuing statin therapy compared to those receiving regular care. Participants must have previously used a statin from a specific pharmacy, discontinued it due to side effects, and have internet access. Researchers aim to assist patients in making informed treatment decisions and improving cholesterol management through Virtual Statin Management (VSM). As an unphased trial, this study allows participants to contribute to innovative research that could enhance treatment options for others.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It focuses on patients who have already stopped statin therapy due to muscle symptoms.

What prior data suggests that the Virtual Statin Management is safe for patients with high cholesterol?

A previous study showed that statins are generally safe and effective at lowering LDL cholesterol, often called the "bad" cholesterol, in people with high cholesterol. These medications can help reduce the risk of heart disease. However, some people experience muscle pain or discomfort, known as statin-associated muscle symptoms (SAMS), which can lead them to stop taking the medication.

Statins have been well-studied and are widely used, with approval from the FDA. They have a strong safety record for most people. While some individuals experience muscle symptoms, many can manage or overcome these side effects. Trying different statins or adjusting the dose can help reduce symptoms.

The Virtual Statin Management (VSM) tool in this trial is designed to help people understand and manage these muscle symptoms. It provides education to help patients decide if they should try statins again. This tool is an online educational resource and poses no physical risk. It helps users make informed choices with their healthcare providers.

Overall, statins are considered safe for most people, and the VSM tool supports safe and informed decision-making. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Statin Management (VSM) for high cholesterol because it offers a personalized and educational approach to managing cholesterol levels. Unlike traditional treatments that primarily rely on medication, VSM empowers patients with knowledge about heart disease, helps them identify muscle symptoms related to statins, and explores various cholesterol-lowering options. This method aims to foster better communication between patients and healthcare providers, setting more effective and individualized treatment goals. By integrating education with usual care, VSM has the potential to enhance adherence and improve outcomes in cholesterol management.

What evidence suggests that the Virtual Statin Management website is effective for managing high cholesterol?

Research has shown that statins effectively lower cholesterol and reduce the risk of heart attacks and strokes. A study that combined results from many trials found that people taking statins had a 20% to 30% lower chance of dying or experiencing major heart problems compared to those not taking them. Statins lower LDL cholesterol, often called the "bad" cholesterol, in the blood. Another study noted that many heart attacks and strokes could be prevented if people used cholesterol-lowering drugs like statins as recommended. This evidence supports the importance of managing cholesterol with statins, even for those who have stopped due to muscle symptoms. In this trial, participants will receive either usual care or usual care plus Virtual Statin Management (VSM), which aims to enhance understanding and management of statin use and cholesterol levels. ^{6 7 8 9 10}

Who Is on the Research Team?

Jordan B King, PharmD, MS

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for members of KPCO who stopped or delayed statin therapy due to side effects, have an email and internet access, and purchased a statin from a KPCO pharmacy in the last six months but haven't refilled their prescription on time.

Inclusion Criteria

I am a member of KPCO.

I have missed taking my statin medication for more than the prescribed days.

I have an email address registered on kp.org.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants take baseline questionnaires and receive usual care as they would if they were not in the study

1 week

1 visit (in-person)

Intervention

Participants randomized to the website arm engage with the educational website for approximately 30 minutes

1 week

1 visit (virtual)

Follow-up

Participants are monitored for statin re-start and persistence rates, as well as other outcomes such as decision self-efficacy and treatment satisfaction

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Statin Management (VSM)

Trial Overview The study tests if using a Virtual Statin Management (VSM) educational website helps patients with muscle symptoms after stopping statins decide to retry and continue the medication compared to those receiving usual care without the website.

How Is the Trial Designed?

Group I: Usual Care + Virtual Statin Management (VSM) Experimental Treatment 1 Intervention

Participants randomized to usual care + virtual statin management (VSM) will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions, and they will also be given a link to engage with the VSM website. The VSM website is an educational tool which has four principal components: 1) learning how to distinguish if and when muscle symptoms are caused by the statin; 2) learning the essentials about heart disease, focusing on causes, risk factors, and the crucial role of cholesterol management in prevention; exploring various cholesterol lowering options, including when it makes sense to retry a statin and what options exist beyond statins; and 4) learning to engage in productive discussions with healthcare providers and set effective treatment goals together.

Group II: Usual care Active Control 1 Intervention

Participants randomized to usual care will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11503164/

Lifetime effects and cost-effectiveness of statin therapy for ... We assessed the long-term effects and cost-effectiveness of statin therapy for older people in the contemporary UK population using a recent meta-analysis.

2. nature.com nature.com/articles/s41598-025-88693-y

Predicting low density lipoprotein cholesterol target ... This study aimed to develop a machine learning (ML) model to estimate the likelihood of achieving target LDL-C levels in patients hospitalized for coronary ...

3. publichealth.jhu.edu publichealth.jhu.edu/2025/tens-of-thousands-of-heart-attacks-and-strokes-could-be-avoided-each-year-if-cholesterol-lowering-drugs-were-used-according-to-guidelines

Tens of Thousands of Heart Attacks and Strokes Could Be ... Tens of Thousands of Heart Attacks and Strokes Could Be Avoided Each Year if Cholesterol-Lowering Drugs Were Used According to Guidelines. New ...

4. bmjgroup.com bmjgroup.com/new-study-sheds-light-on-long-term-effectiveness-and-safety-of-two-widely-used-statins/

New study sheds light on long term effectiveness and ... The average LDL cholesterol level during the study period was lower in the rosuvastatin group than atorvastatin group (1.8 v 1.9 mmol/L). The rosuvastatin group ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/1105635

Clinical Outcomes in Statin Treatment Trials: A Meta-analysis Patients who received statin treatment demonstrated a 20% to 30% reduction in death and major cardiovascular events compared with patients who received placebo.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11043821/

Statin utilization and cardiovascular outcomes in a real-world ... Lack of statin use was associated with increased cardiovascular events and mortality in high-risk older adults.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10288954/

Comparative efficacy and safety among high-intensity statins ... This review further confirms that high-intensity statins reduce LDL by ≥50%, favoring rosuvastatin over atorvastatin.

8. researchgate.net researchgate.net/publication/361986154_Statin_therapy_for_the_primary_prevention_of_cardiovascular_disease_Pros

Statin therapy for the primary prevention of cardiovascular ... It is well-established that lower serum cholesterol level is associated with better outcome among patients with coronary artery disease (CAD) and is a predictor ...

9. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2024.1415668/full

Efficacy and safety of PCSK9 inhibitors, potent statins ... The combination of PCSK9 inhibitors with robust statins like rosuvastatin and atorvastatin markedly decreases LDL-C levels in patients with hyperlipidemia.

10. ajmc.com ajmc.com/view/epidemiology-and-management-of-hyperlipidemia-article

Epidemiology and Management of Hyperlipidemia Multiple studies have clearly shown that statins can lower LDL-C levels, thereby reducing the risk of developing CVD in patients with elevated LDL-C and ...