The PROCYON survey revealed a high proportion of untreated patients and a lack of patient perceived improvement in LDL-C levels in 41% of patients on drug therapy. This is in line with US registry data, in which 63.9% of the primary prevention patients were untreated or treated on a lower intensity than recommended .
In the conjoint analysis, physicians’ assessment of risk factor relevance was in accordance with the ESC/EAS guidelines with elevated LDL-C levels as one of the main factors . However, the survey indicates inadequate guideline implementation into clinical practice. Most physicians reported initiating pharmacotherapy for primary prevention only at LDL-C levels >150 mg/dL. This complies with the 2017 DEGAM (Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin) guideline on counseling on CV prevention in family medicine, which recommends to consider statin therapy at LDL-C levels <195 md/dL only in case of high or very high CV risk . In contrast, the ESC/EAS 2019 guidelines intend a target of <116 mg/dL even for low-risk patients. Barter et al. reported a target level of 129 mg/dL in clinical practice in Germany and suggested that uncertainties related to statin safety and the safety of very low LDL-C levels might add to the reluctance to adopt the low target recommendations . Furthermore, PROCYON indicated that the frequency of LDL-C assessments might be too low. More than one third of the patients with above-recommended LDL-C levels despite drug therapy undergo LDL-C assessments only once per year or less. An assessment once per year is standard in patients on LDL-C lowering therapy , but a higher frequency should be considered until the target level is reached.
In addition, only half of the physicians were fully aware of cumulative LDL-C as a risk correlate of CVD. While pack years are established to quantify the cumulative impact of smoking, cumulative LDL-C exposure and the associated necessity of early screening and treatment is not fully acknowledged in primary care. Screening for hypercholesterolemia has just recently become reimbursable in Germany once between 18 and 34 years of age. From the age of 35 years onwards routine checks can be performed every 3 years . However, earlier screening is supported by data on the high prevalence of elevated LDL-C levels in preschool children .
PROCYON showed that treatment was often not escalated despite inadequate LDL-C reduction. Cardiologists tended to escalate earlier than general practitioners and internists. The reluctance might be attributable to the fact that the 2017 DEGAM guideline recommends a fixed-dose statin treatment instead of a treat-to-target approach and opts against a combination therapy .
General practitioners thought that mainly a lack of lifestyle adaption impaired target attainment. However, even dramatic changes can only reduce LDL-C levels by 10 to 15% . Pharmacological intervention is essential for target attainment.
In contrast to general practitioners, internists and cardiologists considered adherence and tolerability as the most important reasons for missing the target. The high adherence rates reported by patients might reflect a participation bias, with high self-activation in respondents. However, frequent patient-initiated treatment discontinuations rather suggest that patients overestimated their adherence, which is common due to social desirability and memory biases . Improving adherence could constitute a major factor for treatment success with a potential in CHD risk reduction of 52% .
Previous studies revealed that negative media information about statins was a major driver of treatment discontinuation [20, 21]. A trusting patient-physician relationship that addresses the patients’ risk perception, existing side-effects as well as information gaps, allows for correction of misinformation . While the importance of patient information was generally accepted in PROCYON, the lack of knowledge on LDL-C targets and current levels indicate a need for well-composed educational material to support patient-physician communication. The involvement of patient organizations could further add to education and activation. Patients with FH and other severe hereditary lipid disorders in Germany can be referred to the “Cholesterin und Co e.V.” (CholCo.org). For primary prevention patients without hereditary disorders, a patient organization has not been established yet.
The physician survey revealed a wish for interdisciplinary networking. Patient management could benefit from professional networks through facilitated transitory processes (i.e. between medical specialists, general practitioners, and lipid ambulances) and diagnosis of rare lipid disorders through lipid competence centers. Furthermore, networks could promote inter- and intradisciplinary exchange and continued training (e.g. qualification as certified “lipidologist“) .
The present survey has some limitations. First, except for PAM-13, no validated questionnaire was available to support the study objective. Second, LDL-C levels collected in the patient survey were implausible and could not be interpreted, possibly due to confusion of the units. Patients could choose to enter their LDL-C levels in mg/dL or mmol/L, as both units are used in Germany, depending on regional preference. The documented range in mg/dL was 1.3 – 1,485; the documented range in mmol/L was 0 – 180,119. Therefore, assessment of LDL-C changes was based on the patients’ perceived LDL-C development only. Third, web-based medical surveys are prone to a participation bias with higher level of education and better health state among the respondents compared to non-respondents . Survey results might further be biased by social desirability  and participants with higher self-activation might be overrepresented as only responders who answered all questions were included. Survey participation of patients was not encouraged by incentives. Physicians received small expense allowance for participation, however, only a minor response bias is expected.
In summary, PROCYON has shown that adequate and effective interventions for optimization of hypercholesterolemia patient care are urgently needed. PROCYON identified potentials for improvement with respect to guideline awareness and implementation from a physician’s perspective as well as improved risk awareness, disease knowledge, and adherence from a patient’s perspective.