Statin Underdosing Common in Higher-Risk Patients: PALM Registry Analysis

Patrice Wendling

September 08, 2016

ROME, ITALY — Despite a notable shift in focus from lipid goals to statin intensity in the 2013 US treatment guidelines, statins continue to be underdosed in higher-risk patients, according to a Patient and Provider Assessment of Lipid Management (PALM) Registry analysis[1].

After examining data for 5906 adults who met indications for a statin and had routine access to care, the investigators found that 74% of patients were on a statin, but only 45% were on the appropriate-intensity statin.

The largest gap in underuse was seen in those recommended for high-intensity statins, in whom 80% were on a statin but only 29% were on the appropriate high-intensity statin.

In contrast, 67% of patients recommended for moderate-intensity statins were on a statin and 60% were on the appropriate dose, principal investigator Dr Ann M Navar (Duke Clinical Research Institute, Durham NC) said at the European Society of Cardiology (ESC) 2016 Congress.

Dr Ann M Navar

One possible explanation for the undertreatment is "simple clinical inertia. New starts may be more likely to be given high-intensity statins, but those already on a statin are not uptitrated," she told heartwire from Medscape.

The study included 2532 patients on moderate-intensity statins and 3374 on high-intensity statins treated at 140 cardiology, primary-care, and endocrinology outpatient practices in the PALM registry. Statin intensity was based on the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines.

They recommend high-intensity statins for adults aged <75 years with atherosclerotic cardiovascular disease (ASCVD), any adult with an LDL-cholesterol level >190 mg/dL, and high-risk diabetics aged 40 to 75 years with a 10-year ASCVD risk >7.5%. Moderate-intensity statins are recommended for those with primary-prevention indications and an ASCVD risk >7.5%, older adults >75 years with ASCVD, and low-risk diabetics with an ASCVD risk <7.5%.

When the investigators split the analysis by primary- and secondary-prevention indications, undertreatment was much more common in the primary-prevention population regardless of the statin-recommendation stratum.

Among those recommended for a moderate-intensity statin, 42% of the primary-prevention population vs 19% of the secondary-prevention population were not on any statin at all.

Among those recommended for high-intensity statins, only 36% with a secondary-prevention indication were on high-intensity statins, but this "was still vastly higher than the 16% recommended for high-intensity statins for primary prevention," Navar said.

Among those recommended for high-intensity statins, undertreated patients were more likely than those treated per guidelines to be female (42.2% vs 29.6%), African American (15.4% vs 11.0%), or diabetic (60.9% vs 53.7%) and less likely to have been seen by a cardiologist (43.4% vs 63.2%; P<0.001 for all comparisons).

An examination of LDL-C levels suggests that the explanation for statin undertreatment is not that patients already had low enough LDL-C so they didn't need their statins intensified, Navar observed. In fact, nearly one in two undertreated patients recommended for a high-intensity statin had an elevated LDL-C (>100 mg/dL) compared with only 22% treated appropriately.

"This lends credence to the 2013 guidelines emphasis on starting with high-intensity statins in the highest-risk groups, who have the most to gain from LDL lowering," she added.

Navar told heartwire that the guidelines are meant to be a starting point for a broader conversation about CVD risk and prevention between patients and providers. Earlier this month, she and her colleagues published a four-part model[2] to help improve that very dialogue.

"Not all patients may decide to take high-intensity statins, but those who meet guideline recommendations should have the opportunity to engage with their provider to discuss the benefits and risks of more aggressive LDL lowering," she said. "We hope our data from PALM, highlighting the number of adults seen in practice daily who may benefit from higher-intensity statins, encourage more providers to have this type of conversation with their patients."

The study was funded by Sanofi and Regeneron. Navar reports research contracts with and consulting for Sanofi and Regeneron.

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