UC Examines Statin Usage in the UK; Findings Could Benefit US

CINCINNATI—Six million residents in the United Kingdom affected by or at high risk of heart disease would benefit from either beginning or increasing their current statin therapy medication, according to a study from a University of Cincinnati (UC) College of Medicine researcher and physician.

Dylan Steen, MD, assistant professor in the Division of Cardiovascular Health and Disease and UC Health physician, reviewed 2014 health data from 183,565 patients from the Health Improvement Network database in the UK to determine the results of stain and other lipid-lowering therapy usage in in atherosclerotic cardiovascular disease (ASCVD) patients and non-ASCVD patients with diabetes and/or chronic kidney disease. ASCVD patients include those with acute coronary syndrome, stable coronary heart disease, ischaemic stroke/transient ischaemic attack and peripheral arterial disease.

The study is available online in the scholarly journal BMJ. 

Statins are a class of drugs prescribed to help reduce cholesterol levels and lower the chance of heart attack and stroke in individuals. They work by blocking the action of the liver enzyme that produces cholesterol in the body.

Steen says he determined the gap between real-world usage and recommended guidelines for the 2014 National Institute for Health and Care Excellence (NICE) were published in the UK. About 79 percent of ASCVD patients received statins and 31 percent were on high-intensity statins. In the non-ASCVD group, about 62 percent were on statins and 57 percent were on medium-intensity or high-intensity statins. 

From that information, researchers were able to extrapolate its results to the 2014 general UK population and found that of the 3.3 million individuals with ASCVD, 2.4 million would require boosting the dosage of statins and 680,000 would require statin initiation to meet NICE guidelines, according to Steen. For the 3.5 million high-risk non-ASCVD individuals, 1.6 million would require boosting the dosage of statins and 1.4 million would require initiation of statins.

Steen says boosting the number of people on statins could mean tens of thousands of fewer heart attacks in the UK each year. "Let’s say your LDL cholesterol is 160, and I prescribe you a statin that could lower it by 50 percent,” he explains. "Data suggest that your risk of dying should drop 20 percent. Your risk of having another cardiovascular event should drop by 44 percent. There is no other medication that we know that can do that.”

"Statins are a relatively free lunch,” says Steen, who is also is director of clinical trials and population health research at the UC Heart, Lung and Vascular Institute. "Their side effect profile is relatively benign and their safety is unbelievably good. In almost all cases, you get overwhelming benefit with very few adverse side effects.”

"Some patients have complained of muscle aches,” says Steen. "It is important to explain to them that the research consistently demonstrates that true statin-induced muscle problems is a rare event. Also, one must be weigh these consideration against the possibility of suffering a cardiovascular event such as a heart attack, stroke or death if an individual is at high-risk.”

Most physicians are prescribing statins in the UK for heart patients, but only 6 percent were doing so at the levels required by NICE guidelines, says Steen. The study suggests that a significant effort will be needed from physicians and the healthcare system to help close this gap. Healthcare providers will need to invest in reviewing their patients’ treatments and discussing with them why a change should be made, explains Steen.

"The reality is that people are taking more and more medications, and they have difficulty doing this over years,” says Steen. "Also, a patient’s perception of the severity of their condition, especially an asymptomatic condition like high-cholesterol may lead patients and physicians to underestimate the importance of being vigilant about treating to optimal goals. It’s not like taking Tylenol for a headache in which pain serves as the alert to take a pill. With high cholesterol, you typically feel fine until things change suddenly.”

Steen said physicians have to weigh what medications might have the most the impact in cardiovascular patients and those at high risk of developing cardiovascular disease. "One could say that statins are the most important drug for this entire patient population. The reality is better treatment with these medications could substantially improve health outcomes,” he says.

Steen says in the United States heart patients and those at risk of cardiovascular disease should be recommended statin therapy according to guidelines set by the American Heart Association and the American College of Cardiology. He suggested patients raise the issue with their physicians. They can also consider calculating their own risk of heart disease using the American Heart Association’s online cardiovascular risk calculator or they can visit the American College of Cardiology’s heart health website CardioSmart for more information. 

"The UK has a gap between practice and recommended guidelines, but they have a national health system and a well-trained physician workforce,” says Steen. "The UK is amongst the best in the world in this area, but even for them there is much work to do. Metrics across the United States are almost surely worse considering substantial portions of the population have no insurance or inadequate insurance to adequately maintain good health.”

Co-authors on the study include: Irfan Khan, PhD, Global Health & Economics Outcomes Research, Bridgewater, NJ; David Ansell, IMS Health, Liverpool, UK; Robert Sanchez, PhD, Global Health & Economics Outcomes Research, Bridgewater, NJ; and Kausik Ray, MD, Imperial College, London, UK.

The study was funded by Sanofi and Regeneron Pharmaceuticals, Inc.

Steen receives modest consulting fees from Sanofi and Regeneron. Khan is a stockholder and employees of Sanofi. Ansell is an employee of IMS Health. Sanchez is a stockholder and employee of Regeneron Pharmaceuticals, Inc. Ray has received honoraria for advisory boards, lectures or for serving on the steering committee for clinical trials from Amgen, Sanofi, Regeneron, Pfizer, AstraZeneca, Aegerion, Kowa, IONIS Pharma, MedCo, Cerenis and Resverlogix. 

Ray has received research support by grants to his institution from Pfizer, MSD, Amgen, Sanofi and Regeneron Pharmaceuticals, Inc.