The collaborative digital study is intended to prospectively monitor participant response to statin medications via an app, and notify clinicians and patients when the patient should stop or start their medication based on presenting symptoms collected via electronic patient-reported outcomes (ePROs). The app seeks to use this methodology to identify statin-intolerant individuals in the study, by assessing the pattern, location and timing of their muscle symptoms.
Statins, such as Lipitor and Crestor are some of the most widely used drugs in the world, due to their effectiveness for reducing cholesterol and resultantly, cardiovascular disease (CVD) mortality and events. Although statins are widely available, cost-effective drugs, data suggests that over three years, patient compliance may be as low as 50%, due to side effects such as muscle pain. Improving statin adherence will thus have a powerful impact on mitigating the burden of preventable CV disease.
The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is a method for assessing the likelihood that a patient’s muscle symptoms (e.g., pain, aching, cramping and weakness) are caused or worsened by statin use. This is important because the diagnosis and treatment of SAMS relies on patient self-reports of symptoms, which can be biased by a number of non-statin-related factors such as medications and health conditions.