Retrospective real-world analysis of adherence and persistence to lipid-lowering therapy in Germany.

BACKGROUND: Cardiovascular disease is the leading cause of mortality in Germany. Cardiovascular risk can be mitigated with long-term lipid-lowering therapies (LLTs) that reduce levels of low-density lipoprotein cholesterol. Although effective, risk mitigation is hindered by poor persistence and adherence. OBJECTIVE: To investigate real-world persistence and adherence to LLTs through 36 months post-initiation. METHODS: This retrospective cohort study included patients with dyslipidemia who were newly prescribed LLTs between July and December 2017, using anonymized prescription data from the Insight Health™ Patient Insight Tool, and followed up until March 2021. Persistence and adherence to the therapies were stratified by age and sex. The proportion of days covered (PDC) was used to measure adherence. RESULTS: Patients with dyslipidemia and newly prescribed statins (n = 865,732), ezetimibe (n = 34,490), or anti-proprotein convertase subtilisin/kexin type 9 monoclonal antibodies (anti-PCSK9 mAbs; n = 1940) were included. Persistence to LLTs declined gradually across all treatment subgroups and was lower in women than men. Adherence, calculated as the mean PDC at the end of the analysis period (July 2017‒March 2021) was 0.84, 0.92, and 0.93 for statins, ezetimibe, and anti-PCSK9 mAbs, respectively. Among patients who discontinued treatment, mean treatment duration was 265, 255, and 387 days for statins, ezetimibe, and anti-PCSK9 mAbs, respectively. Only ~ 10% of patients persisted between 201 and 300 days. By Day 300, 71% of patients on statins had discontinued treatment. At 36 months, overall persistence rates were lowest with statins (20.6%), followed by ezetimibe (22.3%) and anti-PCSK9 mAbs (50.9%). CONCLUSIONS: High non-persistence rates were observed across all LLT regimens analyzed, with the lowest persistence rates observed with statins.

[Primary and secondary prevention in hypercholesterolemia: differences relevant to patient care in the PROCYON trial]. / Primär- und Sekundärprävention bei Hypercholesterinämie ­ versorgungsrelevante Unterschiede in der PROCYON-Studie.

BACKGROUND: Cardiovascular disease accounts for one third of deaths in Germany. Elevated levels of low-density lipoprotein cholesterol (LDL-C) are considered a major risk factor. Lowering LDL-C levels is therefore an integral part of the prevention of cardiovascular events. METHODS: The aim of this work is to identify potential differences between primary prevention (PP) and secondary prevention (SP) by means of a post-hoc comparison of cross-sectional data from the PROCYON survey. Medical history, concomitant diseases, adherence, and disease awareness in relation to hypercholesterolemia were queried. RESULTS: 5,494 patients had participated in the survey (PP: 3,798; SP: 1,696). Comparison of the results showed a numerically higher proportion of women (PP 70.7% vs. SP 42.5%) as well as more frequent comorbidities such as hypertension (PP 45.6% vs. SP 61.0%), obesity (PP 20.9% vs. SP 27.4%), and type 2 diabetes mellitus (PP 14.1% vs. SP 23.8%). In primary prevention, hypercholesterolemia was most often diagnosed during screening (PP 74.6%), and in secondary prevention, the diagnosis was most often made during cardiovascular-related hospitalization (SP 58.0%). A cardiologist was consulted by 16.3% (PP) and 54.0% (SP) of patients, respectively. At least semiannual LDL-C checks (PP 46.8% vs. SP 77.9%) and drug intervention (PP 43.0% vs. SP 87.0%) were more frequent in the secondary prevention group. In addition, differences in the implementation of lifestyle changes, improvement of LDL-C levels, adjustment of therapy as well as adherence, treatment satisfaction and patient knowledge were observed. CONCLUSION: The comparison of primary and secondary prevention from the PROCYON survey shows overall better utilization of treatment options and higher intensity of care in the secondary prevention group. However, there is still great potential for improvement in both groups to ensure efficient prevention of cardiovascular events.

Different Perspectives of Patients and Physicians on LDL-C Target Achievement in the Treatment of Hypercholesterolemia: Results on Secondary Prevention from the German PROCYON Survey.

AIMS: Low-density lipoprotein cholesterol (LDL-C) reduction in hypercholesterolemia patients at very high cardiovascular (CV) risk is essential in preventing future CV events. The objective was to assess the perception on hypercholesterolemia management in secondary prevention in Germany. METHODS: PROCYON was a two-part online survey, including a patient questionnaire as well as a physician questionnaire. RESULTS: A total of 109 general practitioners, internists, and cardiologists participated. The current ESC/EAS recommendation for high-risk patients is followed by 19.3% of the physicians. The majority (80.7%) reported an LDL-C target failure rate of at least 30%. More than two thirds (71.6%) have stated treating less than half of their patients with the maximum approved statin dose. The survey included 1696 secondary prevention patients. The majority (86.7%) consult their general practitioner for hypercholesterolemia; 54.0% consult a cardiologist (multiple answers allowed). Most patients (87.0%) were receiving lipid-lowering medication. Among these, 800 (54.2%) reported improved LDL-C levels since diagnosis, 569 (38.6%) reported no improvement, and 106 (7.2%) had no information. Of the treated patients with (N' = 800) and without (N' = 569) improvement, 34.3% vs. 37.3% were on their initial drug and dose, 24.8% vs. 23.7% received multiple drug therapy, 48.9% vs. 48.9% reported a dose change, and 16.1% vs. 14.2% had discontinued at least one drug (multiple answers). Disease knowledge was rated as good or very good by 29.8% of patients. CONCLUSION: PROCYON demonstrated insufficient ESC/EAS guideline implementation regarding target levels and therapeutic escalation strategies. Furthermore, a lack of specialist involvement and patient education was identified.

Patient and Physician Reported Perception on Hypercholesterolemia Management in Primary Prevention in Germany: Results from a Nationwide Online Survey.

INTRODUCTION: Effective hypercholesterolemia management is essential in primary prevention of cardiovascular events. The objective of PROCYON was to assess the perception on hypercholesterolemia management in primary prevention and to identify reasons for insufficient target attainment in clinical practice in Germany. METHODS: PROCYON was a two-part online survey including a patient questionnaire on treatment status and disease knowledge and a physician questionnaire on guideline awareness and patient management. A conjoint analysis on the relative importance of cardiovascular risk factors was incorporated. RESULTS: Of 3798 primary prevention patients included, 1632 (43.0%) received lipid-lowering medication. Of these, 790 (48.4%) reported improved low-density lipoprotein cholesterol (LDL-C) levels, 670 (41.1%) reported no improvement, and 172 (10.5%) had no information. Of the treated patients with (N' = 790) and without (N' = 670) improvement, 52.4% vs. 47.9% were on their initial drug and dose, 8.9% vs. 9.0% received multiple drug therapy, 34.7% vs. 38.8% reported a dose change, and 16.0% vs. 19.4% had discontinued at least one drug (multiple answers). In total, 109 physicians participated. In the conjoint analysis, LDL-C level was attributed the highest relative importance (32.0%), followed by diabetes (24.5%) and systolic blood pressure (15.8%). Lipid-lowering therapy is initiated at an LDL-C level > 150 mg/dl by 63 physicians (57.8%). One third (n = 35; 32.1%) stated that ≥ 60% of their primary prevention patients do not receive lipid-lowering medication. CONCLUSION: PROCYON suggests a need for consequent LDL-C target-based treatment implementation.

Evolution of antithrombotic therapy for patients with atrial fibrillation: The prospective global GLORIA-AF registry program.

OBJECTIVE: To assess baseline characteristics and antithrombotic treatment (ATT) prescription patterns in patients enrolled in the third phase of the GLORIA-AF Registry Program, evaluate predictors of treatment prescription, and compare results with phase II. METHODS: GLORIA-AF is a large, global, prospective registry program, enrolling patients with newly diagnosed nonvalvular atrial fibrillation (AF) at risk of stroke. Patients receiving dabigatran were followed for two years in phase II, and all patients were followed for 3 years in phase III. Phase II started when dabigatran became available; phase III started when the characteristics of patients receiving dabigatran became roughly comparable with those receiving vitamin K antagonists (VKAs). RESULTS: Between 2014 and 2016, 21,241 patients were enrolled in phase III. In total, 82% of patients were prescribed oral anticoagulation ([OAC]; 59.5% novel/nonvitamin K oral anticoagulants [NOACs], 22.7% VKAs). A further 11% of patients were prescribed antiplatelets without OAC and 7% were prescribed no ATT. A high stroke risk was the main driver of OAC prescription. Factors associated with prescription of VKA over NOAC included type of site, region, physician specialty, and impaired kidney function. CONCLUSION: Over the past few years, data from phase III of GLORIA-AF show that OACs have become the standard treatment option, with most newly diagnosed AF patients prescribed a NOAC. However, in some regions a remarkable proportion of patients remain undertreated. In comparison with phase II, more patients received NOACs in phase III while the prescription of VKA decreased. VKAs were preferred over NOACs in patients with impaired kidney function.

Human Acellular Dermal Matrix (Epiflex®) in Immediate Implant-Based Breast Reconstruction after Skin- and Nipple-Sparing Mastectomy and Treatment of Capsular Fibrosis: Results of a Multicenter, Prospective, Observational NOGGO-AWOGyn Study.

BACKGROUND: Over the last decades, the number of acellular dermal matrix (ADM)-assisted implant-based breast reconstructions (IBBR) has substantially increased. However, there is still a lack of prospective data on complication rates. METHODS: We performed a non-interventional, multicenter, prospective cohort study to evaluate complication rates of a human ADM in patients undergoing an IBBR after skin- and nipple-sparing mastectomies. Patients with primary reconstruction (cohort A) and patients undergoing a secondary reconstruction after capsular fibrosis (cohort B) using the human ADM Epiflex® (DIZG gGmbH, Berlin, Germany) were enrolled in this study. Patients were followed-up for 12 months after surgery. RESULTS: Eighty-four eligible patients were included in this study of whom 28 women underwent a bilateral breast reconstruction, leading to 112 human ADM-assisted reconstructions in total (cohort A: 73, cohort B: 39). In 33.0% of the reconstructed breasts at least one of the complications of primary interest occurred, including implant loss 7.1%, seroma 15.2%; infection 5.4%, rash 8.0%, and Baker grade III/IV capsular fibrosis 2.7%, with no statistically significant differences between the cohorts. Previous radiation therapy was significantly associated with occurrence of any postoperative complication (OR 20.41; p value 0.027). CONCLUSION: The rates of most complications were comparable to the rates reported for other ADMs with relatively low rates of capsular fibrosis and infections. The rate of seroma was increased in our study. Prior radiation therapy increased the risk of any postoperative complications. Therefore, the use of ADM in these patients should be considered carefully.

Patient-Reported Outcomes and Aesthetic Results after Immediate Breast Reconstruction Using Human Acellular Dermal Matrices: Results of a Multicenter, Prospective, Observational NOGGO-AWOGyn Study.

BACKGROUND: With the increased use of acellular dermal matrices (ADMs) in implant-based breast reconstructions (IBBRs), the evaluation of patient-reported outcomes becomes more important. METHODS: Patients who underwent an immediate human ADM-assisted, submuscular IBBR were included in this noninterventional, multicenter, prospective cohort study. Patients with primary reconstruction (cohort A) and patients with a revision surgery after capsular fibrosis (cohort B) were followed up for 12 months after surgery. Quality of life (EORTC BR-23) and patient and surgeon satisfaction scores (1 ["very satisfied"] to 6 ["not satisfied"]) with the outcome and the aesthetic result evaluated by 2 independent, external experts were assessed. RESULTS: Eighty-four patients were enrolled in the study. The mean patient satisfaction score was 2.1 ± 0.8, with higher satisfaction in cohort B (p = 0.041). The score did not change significantly during the follow-up (p = 0.479). The mean satisfaction score of the surgeons was 2.0 ± 0.7; it was also higher in cohort B (p = 0.016) and showed no changes over time (p = 0.473). The mean aesthetic result was 2.2 ± 0.7. 92.9% of the patients completed at least 1 quality of life questionnaire. Body image and sexual functioning increased during follow-up. One year after surgery, the mean scores were 77.2 ± 22.5 and 44.7 ± 27.3, respectively. CONCLUSION: The level of satisfaction among patients and surgeons and the score of the aesthetic result were constantly high among patients after ADM-assisted IBBR. Higher satisfaction scores could be observed after revision surgery caused by capsular fibrosis (cohort B) compared to primary reconstruction (cohort A). Quality of life increased during the first year after surgery.