Boston Heart Diagnostics Makes Statin Adherence Test More Consumer Friendly

Statins, the enzyme-inhibiting medications that have helped millions of Americans keep their cholesterol in check for the past 25 years, often leave patients with a benign but debilitating effect: Muscle aches and fatigue.

As a result, although some 50 million Americans under current medical guidelines could wind up taking statins to preserve their cardiovascular health, many wind up avoiding or abandoning the drug regimen entirely because of how it makes them feel. Boston Heart Diagnostics wants to change that.

The Framingham, Mass.-based laboratory has tweaked its existing genomic test that identifies the presence of SLCO1B1, a gene that directs the processing of statins in the liver and is an indicator of the likelihood of suffering side effects for taking the medication. According to Boston Heart Chief Executive Officer Susan Hertzberg, individuals who carry the SLCO1B1 mutation are 4.5 times more likely to suffer side effects from taking statins and 17 times more likely if that gene has an identical pair.

As opposed to a blood-based test available only through a physician's office, consumers can now order the $99 StatinSmart test online at statinsmart.com and provide a swab from their mouths as a test specimen. The swab is mailed to Boston Heart, and the test is performed and reviewed by a contracting physician. The turnaround time is 48 to 72 hours. Boston Heart officials say making the test more consumer friendly will help with its goal of improving cardiovascular health. "We want to reduce (patients dropping their medications)," Hertzberg said. "What we're currently doing is not successful, and we keep watching the cost of heart disease going up." The company cited studies saying as many as half of patients with cardiovascular disease stop taking their statins due to muscle pains.

"Personalized medicine should be a critical piece of the process for managing cardiovascular disease—one in four people have risk of muscle pain on a statin, and this is the only commercially available genetic test to identify a patient's likelihood of experiencing this side effect," Hertzberg said. "We know that patients are struggling with managing the side effects of statin medications, and StatinSmart can help guide patients and their healthcare providers in selecting a treatment plan to lower cholesterol without suffering through the trial-and-error process of painful side effects."

Hertzberg added that a positive reading for intolerance for a particular class of statins can guide a physician to prescribe another medication, helping to keep the patient healthier if they are more likely to adhere to the regimen. Some new cholesterol- lowering drugs that have recently come onto the market have far fewer side effects than statins, but they are significantly more expensive.

Boston Heart is also working with a hospital and a payer to study whether patients taking the StatinSmart test are more likely to stay on their medications and the related health care outcomes. Hertzberg declined to name those parties, saying it is too early in the study process to release such information.

Takeaway: Boston Heart wants to cut the cost of heart disease by using an assay to improve medication adherence.