# Development, testing, and implementation of virtual statin associated muscle symptom (SAMS) management

> **NIH NIH R01** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2021 · $672,046

## Abstract

PROJECT SUMMARY/ABSTRACT
Only half of the >60 million US adults for whom statin therapy is indicated receive statins, and adherence and
persistence is low. The most common reason of statin discontinuation is statin-associated muscle symptoms
(SAMS), a spectrum of muscle symptoms the patient perceives as intolerable enough to impair daily activities
and quality of life. A major driver of SAMS includes patient beliefs that statins are unsafe, further propagated
by misconceptions, conspiracy theories, and negative lay media coverage. Over 90% of patients who
experience SAMS can tolerate continued statin therapy after simple regimen modifications such as dose
reductions, switching to a different statin, or alternate-day dosing. The most effective interventions to improve
statin use, dose intensity, and outcomes in patients with SAMS include careful follow-up and management with
team-based care models. However, reimbursement models, patient and provider acceptance, and other factors
are significant barriers to the widespread implementation of team-based care. Even when team-based care is
available, time constraints and the unique psychology associated with SAMS management have resulted in
only 50% of those who experience SAMS ever re-challenging statin therapy. Systems-based practice—which
uses ancillary personnel, mid-level providers, provider-facing health information technology, and patient self-
management—combined with insights from clinical psychology and novel technology can help address these
challenges to effectively managing SAMS. We propose to develop and test virtual SAMS management (VSM):
a self-guided, web-based tool that incorporates (1) collection of self-reported patient beliefs, medication use
behavior, and symptoms; (2) assessment of the likelihood that statin use is causing the self-reported
symptoms; (3) provision of individualized cardiovascular risk, statin benefit, and SAMS treatment options, with
delivery informed by cognitive debiasing literature; and (4) as appropriate, patients’ ability to self-manage their
SAMS by modifying their statin regimen according to set protocols. First, we will use user iterative design and
usability testing to develop the VSM software (Aim 1). Then, we propose a hybrid type II effectiveness-
implementation randomized trial to determine whether VSM can improve the efficiency and effectiveness of
team-based care at managing SAMS (Aim 2), and to identify facilitators and barriers that affect the uptake,
adoption, and impact of the VSM strategy in team-based care settings (Aim 3). Results from our analysis of
this innovative approach will answer important and timely questions concerning strategies for improving how
patients view statins and encouraging statin re-challenge with evidence-based statin regimen modifications
after SAMS occur. This will address an urgent public health need and open new avenues for research by
optimizing SAMS management leading to increased statin adherence and persistence ...

## Key facts

- **NIH application ID:** 10184656
- **Project number:** 1R01HL157439-01
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** Jordan Bradley King
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $672,046
- **Award type:** 1
- **Project period:** 2021-08-20 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10184656

## Citation

> US National Institutes of Health, RePORTER application 10184656, Development, testing, and implementation of virtual statin associated muscle symptom (SAMS) management (1R01HL157439-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10184656. Licensed CC0.

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