– The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare is recruiting the help of Medable, a provider of digital trials to implement a cloud-based platform to evaluate statin-related adverse events called SAMS.
– The virtual study helps monitor patient responses 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.
Medable Inc., a Palo Alto, CA-based provider of a digital trials platform that connects patients, sites and clinical trial teams, today announced that the University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare, has selected its cloud-based platform to evaluate statin-related adverse events using electronic patient-reported outcomes in a digital trial.
Virtual Study Details
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.
Importance of Improving Statin Adherence
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.
Understanding SAMS-CI
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.
“The problem with SAMS is that there are no diagnostic tests for this condition and clinicians have to rely on patient-reported perceptions of pain that may have occurred months or even years ago. We wanted to digitize the paper questionnaire into a clinical index onto an app, where patients could take their statin medication at home, and rank their pain levels in real-time. Medable was able to help us conceptualize the initial research idea into a patient-friendly app, and we wouldn’t have been able to do this without their guidance,” said Dr. Beth Taylor, lead study investigator and Associate Professor of Kinesiology at the University of Connecticut.
Larger Implications of The Virtual Study
“Dr. Taylor’s research is critical to understanding the real-world effects of widely prescribed medications. It is important for the healthcare community to better understand which patient populations have adverse reactions to one of the most widely prescribed and important medications, statins. We are excited to partner with UConn on this groundbreaking research as it will benefit patients and highlights the power of digital to remove key barriers to access of clinical research,” said Dr. Michelle Longmire, CEO & co-founder at Medable.
