Patient Autonomy and Statin Therapy Adherence (PASTA)

The Patient Autonomy and Statin Therapy Adherence (PASTA) Trial: A Randomized Controlled Trial Comparing Adherence to Atorvastatin Therapy in Primary Prevention Patients Who Decline Statin Therapy, When Given a Choice Between Atorvastatin and Red Yeast Rice Extract as Their Initial Therapy

The rationale for the Patient Autonomy and Statin Therapy Adherence (PASTA) trial is based on the fact that statin therapy is a highly effective and evidence-based treatment for reducing the risk of cardiovascular disease. However, despite the proven benefits of statin therapy, a significant proportion of patients decline to take statins due to concerns about side effects, safety, or a preference for alternative treatments.

One potential strategy to improve statin adherence in patients who decline therapy is to give patients more autonomy in selecting their treatment options. By offering patients a choice between a traditional statin medication (atorvastatin) or a "natural" statin alternative (red yeast rice extract) and involving them in the goal-setting process for their LDL-C levels, patients may feel more empowered and engaged in their own care.

The PASTA trial aims to evaluate whether greater patient autonomy leads to improved adherence to statin therapy in patients who decline initial therapy. By measuring the impact of patient autonomy on statin adherence, the study results may provide valuable insights into how to improve patient engagement and health outcomes in a population that may be hesitant to initiate statin therapy.

Study Overview

• Status: Completed
• Conditions: Drug Adherence
• Intervention / Treatment: Other: Red yeast rice extract initial therapy followed later on by statin therapy; Other: Statin therapy

Detailed Description

Statin therapy is an integral tool in the primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD). Higher compliance with their statin therapy is associated with a lower risk of mortality in a step-wise manner . Despite this, rates of statin compliance are abysmally low. Prior studies suggest that less than 40% of primary prevention patients are compliant with their prescribed statin therapy. Individuals who have suffered a prior MI have an incremental improvement in compliance to around 60%. Younger individuals and women appear to have exceptionally low rates of compliance to statin therapy . Low rates of compliance remains a significant barrier to reducing the burden of ASCVD, with some suggesting efforts to increase compliance can have an oversized impact on reducing rates of ASCVD .

On the other hand, patients often prefer "natural" therapies over conventional medicine for a variety of reasons. Monacolin-K is a naturally occurring molecule in red yeast-rice extract, a commonly used health supplement. It is structurally identical to lovastatin and has been shown to reduce LDL-C levels and ASCVD events in randomized placebo controlled trials.

Patient autonomy is a core bioethical principle affirming the right of the patient to determine the trajectory of their health care at times. This bioethical principle has been referred to as "first among equals", implying that it is the most important bioethical principle. The role of autonomy in patient compliance is not entirely clear, but there is evidence that suggests that increased patient autonomy in the decision-making process can result in higher rates of long term compliance.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania, LT-50161
    • Lithuanian University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

1. Moderate atherosclerotic cardiovascular disease risk
2. Decline statin therapy

Exclusion criteria

1. Dementia
2. Severe Mental Illness
3. History of statin intolerance
4. High-risk for atherosclerotic cardiovascular disease
5. Currently on lipid lowering therapy
6. Currently taking red yeast rice extract
7. Pregnant or breast feeding
8. Concomitant use of the following drugs: anti-retroviral therapy, niacin, calcineurin inhibitors, mTOR inhibitors, amiodarone, and fibrates

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient centered care; Patients concern of refusing statin therapy will initially be addressed.	Other: Red yeast rice extract initial therapy followed later on by statin therapy; Patients will be offered red yeast rice extract to achieve a target LDL-cholesterol level of <2.6 mmol/L, as recommended by the 2019 ESC/EAS guidelines. If a patient's LDL-cholesterol level remains above the target during follow-up, they will be informed that the natural alternative was ineffective, and they will be prescribed atorvastatin.
Active Comparator: Guideline-centered care; patients will be prescribed the standard of care regardless of their concerns toward statin therapy.	Other: Statin therapy; Patients will be provided reassurance through a short, semi-structured discussion on the excellent safety profile of statins, similar to a typical interaction between a clinician and patient. They will then be prescribed atorvastatin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of statin compliance	Based on pharmacy refill records. Values per patient can range from 0-6 according to the number of refills.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of perceived side-effects from statin use	including muscle aches, fatigue, mental fog, and gastrointestinal upset.	8 months

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Collaborators: Klaipėda University; Minneapolis Heart Institute; Kreiskrankenhaus Rotenburg an der fluda

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Primary prevention; Statins; Patient-centered care; Patient autonomy; Red yeast rice extract
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Red yeast rice
• Other Study ID Numbers: LUHSKC-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No