In a real-world setting, patients with diabetes have low-density lipoprotein cholesterol (LDL-C) levels below recommended treatment goals, but high-intensity statin treatment is frequently avoided, according to research results published in the European Journal of Clinical Investigation.
Using data from the EPHESUS registry, researchers compared data from patients with and without diabetes in order to gather insight into real-life management practices of patients with diabetes in terms of LDL-C goal attainment and lipid therapy recommendations.
Additionally, investigators evaluated results of a physician survey for each patient, where attending physicians were asked if the patient achieved the LDL-C target.
EPHESUS (ClinicalTrials.gov identifier NCT02608645) is a nationwide, cross-sectional, observational registry enrolling consecutive patients admitted to cardiology outpatient clinics from 40 centers in Turkey between 2016 and 2018.
Of 1868 consecutively enrolled study, 47% (n=873) had diabetes. The majority of those without diabetes—91.6%—were in the secondary prevention group (n=911), which included patients with atherosclerotic cardiovascular disease, peripheral artery disease, or known CHD.
Patients with diabetes were more likely to be women and to have less education. Although patients with diabetes also appeared to be more adherent to their medication, the proportion of patients on statin therapy was significantly lower in the diabetes group (67.8% vs 55.3%). Both LDL-C and total cholesterol levels were significantly higher in the diabetes group, and the proportion of patients who achieved LDL-C targets was lower in this population (17.8% vs 15%). The proportion of patients being treated with high-intensity statins was also significantly lower in those with vs without diabetes (18.2% vs 24.2%), as was the LDL-C goal attainment rate in patients with diabetes receiving high vs low intensity statins (24.3% vs 20.8%).
Statin adherence was higher in the secondary prevention group compared with the primary prevention group (n=388), which included patients at very high risk: adults with type 2 diabetes undergoing either pharmacologic or nonpharmacologic treatment with a major risk factor like smoking, hypertension, or hypercholesterolemia. Patients who did adhere to statin therapy generally had lower LDL-C levels, and the proportion of those who achieved LDL-C goals was higher vs nonadherent patients.
For patients with diabetes, cardiologists were most likely to initiate statin therapy (51.1%); the next most likely were internists (35.6%), family practitioners (3.9%), and neurologists (1.0%). Overall, though, 28.9% of patients (n=247) reported at least one past discontinuation of statin therapy—mostly commonly due to negative information about statins (32.1%), recommendations of physicians to stop lipid lowering treatment (29.6%), and achievement of target LDL-C levels (15%).
Results of the patient survey showed that nearly half of the patients—either with or without diabetes—were aware that they had a high cholesterol level. Despite this, only one-third of patients knew their cholesterol level; this did not differ between patients with and without diabetes.
Results of the physician survey showed that physicians could accurately identify off-target patients (negative predictive value, 98.4%; positive predictive value, 48.8%). Physicians also reported that patients without diabetes who were prescribed statins discontinued lipid lowering treatment more frequently compared with those with diabetes.
Reasons for not achieving LDL-C goals included a lack of prescribed statins (38%) and inadequate statin doses, due to either too low a dose or nonadherence (28.3%). Only 4.7% of physicians believed that the cause was nonadherence to healthy lifestyle measures.
Study limitations include the use and analysis of only a “snapshot” of patient characteristics, limiting the outcomes reflected including those for hyperlipidemia; the inclusion only of patients from cardiology outpatient clinics, limiting generalizability; and the use of a nonvalidated questionnaire.
“Based on real-life evaluation, diabetic patients in either primary or secondary prevention follow-up in cardiology outpatient clinics are far below the recommended LDL-C treatment goals,” the researchers wrote. “LDL-C targets were attained [by] only 15% of patients with [diabetes], which can be explained by poor adherence to statin therapy.”
“Negative media coverage about statins and physician recommendations were the major reasons for statin discontinuation [as well as] physicians and…cardiologists refrain[ing] from giving optimal doses of statins,” the researchers concluded. “Better educational awareness programs for both patients and physicians are urgently needed to emphasize the goals and importance of [lipid lowering treatment] including lifestyle modifications for this high-risk population.”
Mert KU, Basaran O, Mert GO, et al. Management of LDL-cholesterol levels in patients with diabetes mellitus in cardiology practice: Real-life evidence of under-treatment from the EPHESUS registry. Eur J Clin Invest. Published online March 11, 2021. doi: 10.1111/eci.13528