Nearly 40% of Diabetic Patients Not Treated With Statins: PINNACLE Registry

Nearly four out of every 10 diabetic patients without cardiovascular disease treated in US cardiology clinics do not receive a statin despite clinical guidelines recommending the lipid-lowering therapy, according to a new analysis.

“Patients with diabetes derive a significant benefit from statin therapy in terms of [reducing] deaths from cardiovascular disease as well as cardiovascular events,” senior investigator Salim Virani, MD (Michael DeBakey Veterans Affairs Medical Center, Houston, TX), told TCTMD. “Based on a recent meta-analysis, we know there is a 9% reduction in all-cause mortality with roughly a 40-mg/dL reduction in LDL cholesterol. Also, there is about 21% reduction in the risk of vascular events, such as heart attacks and strokes.”Among 215,193 patients at 204 cardiology practices participating in the American College of Cardiology’s Practice Innovation and Clinical Excellence (PINNACLE) registry, just 61.6% of those with diabetes were prescribed a statin. In addition, investigators observed wide variation among US practices, suggesting there is a need to identify barriers in low performers to improve statin use in these high-risk patients, say investigators.

Given that background, the researchers wanted to determine how well US cardiology practices performed in terms of prescribing the “lifesaving” statin therapy, said Virani. In the 2013 American College of Cardiology/American Heart Association guidelines for the treatment of cholesterol, moderate- or high-intensity statin therapy (based on the 10-year risk of cardiovascular disease) is recommended for patients with diabetes.

Results of the PINNACLE analysis, published online yesterday as a research letter ahead of the September 20, 2016, issue of the Journal of the American College of Cardiology, are similar to data reported from a Veterans Affairs (VA) analysis of 130 primary care facilities. In that study, for which Virani was also the senior author, statins were prescribed in 61% of diabetic patients without cardiovascular disease. In the VA analysis, however, there was less variation observed than in the PINNACLE registry.

In PINNACLE, the researchers calculated the median rate ratio (MRR) for statin prescription overall and for attaining LDL cholesterol levels less than 100 mg/dL, which has been used previously as a performance measure in the treatment of diabetic patients. The MRR is a measure of variation across clinical practices for treating patients with similar characteristics. For example, an MRR of 1 suggests no variation between practices, while an MRR of 2 means patients with similar characteristics are twice as likely to be treated differently with a statin at two random practices. Virani said an MRR of 1.20 or less is considered an acceptable degree of variation.

“In this analysis, we found that in terms of the use of statin therapy across practices, the median rate ratio was 1.56, which means there was a 56% variation in the likelihood that a patient would receive statin therapy just based on where they received care,” said Virani. The MRR was adjusted for multiple patient characteristics, including age, gender, history of hypertension and/or dyslipidemia, tobacco use, insurance, and nonstatin lipid-lowering therapy, he added. “Even when you adjust for all these variables, the median rate ratio is fairly high, which suggests the variation lies at the level of the practice for the individual provider.”

For patients with available data on cholesterol levels, 57.7% of diabetic patients in PINNACLE achieved an LDL cholesterol level less than 100 mg/dL. The MRR for achieving LDL cholesterol levels less than 100 mg/dL was 1.47.

Regarding the low rate of statin use in PINNACLE, Virani told TCTMD they focused on diabetic patients without established cardiovascular disease. These patients were likely treated at the cardiology clinic for acute cardiac conditions requiring clinical evaluation and as a result, long-term therapy with statins might be overlooked. “We need to focus on the long-term horizon in terms of our discussion with the patient,” said Virani. “And in the long term, preventive therapies are equally important, if not more important, than just taking care of the acute issue.”

In addition, another reason for the low use of statins might be related to inadequate documentation of statin intolerance, noted Virani. However, the data suggest statin intolerance ranges anywhere from 5% to 20%, which wouldn’t fully explain why 38% of patients didn’t receive statins, he added. Additionally, the present analysis excluded patients with documentation for refusing to take a statin because of side effects or personal preference, although this number was very small.