Real-life Patients Research Articles

Changes in the treatment strategy following intracoronary pressure wire in a contemporaneous real-life cohort of patients with intermediate coronary stenosis. Results from a nationwide registry

Abstract Background Intracoronary pressure wire is useful to guide revascularization in patients with coronary artery disease. Aims To evaluate changes in diagnosis (coronary artery disease extent), treatment strategy and clinical results after intracoronary pressure wire study in real-life patients with intermediate coronary artery stenosis. Methods Observational, prospective and multicenter registry of patients in whom pressure wire was performed. The extent of coronary artery disease and the treatment strategy based on clinical and angiographic criteria were recorded before and after intracoronary pressure wire guidance. 12-month incidence of MACE (cardiovascular death, non-fatal myocardial infarction or new revascularization of the target lesion) was assessed. Results 1414 patients with 1781 lesions were included. Complications related to the procedure were reported in 42 patients (3.0%). The extent of coronary artery disease changed in 771 patients (54.5%). Figure 1 shows extent of coronary artery disease based on coronary angiographic analysis and following intracoronary pressure wire study. Figure 2A shows the extent of coronary artery disease based on coronary angiographic analysis and its reclassification following intracoronary pressure wire study. Figure 2B shows the extent of coronary artery disease following pressure wire study and its classification when only considering the coronary angiographic analysis. Figure 2 shows change in treatment strategy following intracoronary pressure wire study. There was a change in treatment strategy in 779 patients (55.1%) (18.0% if medical treatment; 68.8% if PCI; 58.9% if surgery (p<0.001 for PCI vs medical treatment; p=0.041 for PCI vs CABG; p<0.001 for medical treatment vs CABG). In patients with PCI as the initial strategy, the change in strategy was associated with a lower rate of MACE (4.6% vs 8.2%, p=0.034). Conclusions The use of intracoronary pressure wire was safe and led to the reclassification of the extent of coronary disease and change in the treatment strategy in more than half of the cases, especially in patients with PCI as initial treatment. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): The registry was endorsed by the Intracoronary Diagnostic Techniques Working Group of the Interventional Cardiology Association of the Spanish Society of Cardiology. The study was supported by an unconditional grant from Philips-Volcano, Abbott Vascular, and Boston Scientific. The sponsors did not have access to the database or the final results until the preparation of this abstract. None of them participated in the preparation or review of this abstract.

Prevalence of diabetic nephropathy and subsequent cardiovascular outcomes: a nationwide study of 74,014 patients with type 2 diabetes

Abstract Background Nonsteroidal, selective mineralocorticoid receptor antagonists (MRAs) have been shown to reduce cardiovascular events among patients with diabetic nephropathy, a clinical syndrome characterized by persistent albuminuria. However, prior reports have suggested a substantial underuse of MRAs among eligible patients. In real-life, it is unknown how many have urinary excretion of albumin measured, and the cardiovascular outcomes among type 2 diabetes (T2D) patients with versus without albuminuria is relatively unknown. Purpose To identify candidates eligible for treatment with MRAs and compare the risk of cardiovascular events in real-life T2D patients with albuminuria versus without albuminuria. Methods Using the Danish nationwide registers, we identified all patients ≥18 years old with prevalent T2D at index date 1st January 2015 with an albumin-creatinine ratio (ACR) and a creatinine level measured within 365 days prior to the index date. For each patient, the last ACR and estimated glomerular filtration rate (eGFR) registered prior to the index date were used. eGFR was calculated using the CKD-EPI formula. The patients were separated into two groups consisting of patients with T2D with ACR ≥30 mg/g (albuminuria) or ACR<30 mg/g (no albuminuria), respectively. Outcomes for both groups were analyzed as time-to-event as a composite cardiovascular outcome of heart failure (HF), myocardial infarction (MI), stroke, and all-cause death and each component of the composite endpoint was analyzed individually. In both groups, we estimated the 4-year absolute risk of the cardiovascular outcome and the risk of experiencing HF, MI, and stroke. Results A total of 158,904 patients with T2D were identified and of those 74,014 patients (47%) had urinary ACR analyzed within the last year. Of those who had ACR analyzed 29,581 (40%) patients had albuminuria. The absolute 4-year risk of the composite cardiovascular outcome in patients with albuminuria and no albuminuria was 28.6% (95% confidence interval (CI): 28.1–29.1) versus 18.7% (95% CI: 18.4–19.1), respectively. The absolute 4-year risk for the individual components were HF 7.0% (95% CI: 6.7–7.3), MI 4.4% (95% CI: 4.2–4.6), and stroke 7.6% (95% CI: 7.3–7.9) for patients with albuminuria, versus HF 4.0% (95% CI: 3.8–4.2), MI 3.2% (95% CI: 3.1–3.4), and stroke 5.5% (95% CI: 5.3–5.7) for patients with no albuminuria. Conclusion In Denmark, only 47% of patients with T2D had ACR analyzed within a year indicating lack of adherence to the national T2D guidelines. A total of 40% of those who had albuminuria analyzed were eligible for treatment with MRAs based on trial inclusion criteria, and the absolute 4-year risk of experiencing a cardiovascular event was significant. However, patients with no albuminuria still displayed a substantial risk of experiencing a composite event of HF, MI, stroke, and all-cause death. Our analyses may have implications for implementation of new MRAs in patients with T2D. Funding Acknowledgement Type of funding sources: None.

Preliminary results from REALITY: a nation-wide study of a database with 1.8 million real-life patients to study atherosclerotic cardiovascular disease and familial hypercholesterolemia in Spain

Abstract Introduction Ischemic heart disease and stroke are the leading causes of premature death worldwide. Atherosclerotic cardiovascular disease (ASCVD) is the main determining factor for these and other life-threatening pathologies, such as peripheral artery disease (PAD). LDL-lowering therapies are the gold standard to prevent ASCVD. These treatments are also used for familial hypercholesterolemia (FH), a genetic disorder manifesting with high LDL levels. It is crucial to evaluate the management and level of LDL control in “real-life” patients with ASCVD and FH, but so far very few large-scale studies have focussed on these issues. REALITY is an observational retrospective study of ASCVD and FH in Spain. Purpose The goals of REALITY included the analysis of the demographic and clinical characteristics, comorbidities, and concomitant medication of patients with ASCVD and/or FH by a multidisciplinary group of experts. The lipid-lowering therapies used in Spain were assessed, and patient LDL levels were evaluated according to treatment intensity during the two-year follow-up period. Methods Electronic medical records were retrieved from the BIG-PAC® database that includes anonymized data of patients from seven health areas in Spain. The study population included patients presenting a new or recurrent episode of ASCVD (n=26,976) or a new diagnosis of FH (n=572) during the recruitment period (from 01/01/2017 to 31/12/2018). The index date was defined as the date of the event/diagnosis, and a 2-year follow-up was established. Results The average age was 69.9±11.5 for ASCVD patients and 60.1±12 for FH patients (59.4% and 48.6% males, respectively). The average Charlson index was 2.2±1.6 in ASCVD and 1.2±1.4 in FH. The comorbidities most frequently observed in ASCVD vs. FH were hypercholesterolaemia (55% vs. 100%), arterial hypertension (65% vs. 54%), diabetes mellitus (31% vs. 29%) and obesity (31% vs. 21%). Around 25% and 6% of patients with ASCVD and FH, respectively, presented CV events in the follow-up. During the 24-month period, the highest rate of ischemic heart disease was observed in patients with LDL levels of 55–69 mg/dL, whereas LDL levels below 55 mg/dL were associated with the highest incidence of PAD. The highest lipid biochemical reductions in ASCVD vs. FH were observed in total cholesterol (−52±17.4 vs. −53.5±21.3 mg/dL), triglycerides (−53±7.9 vs. −54.2±8.8 mg/dL) and LDL (−27.4±10.4 vs. −29±12.3 mg/dL). HDL levels showed an average increase of 8.5±2 vs. 9.3±2.5 mg/dL. Treatment intensity correlated with reduction of LDL levels in all ASCVD disease subgroups and FH patients (Table 1). Conclusions The results of REALITY provide an estimated clinical picture of ASCVD and FH in Spain. The impact of therapeutical approaches on LDL levels and the prevention of CV events were evaluated by a multidisciplinary group of experts. The findings of the study will help lower the burden of ASCVD and FH in Spain. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): REALITY study was sponsored by Novartis. Statistical analysis of the BIG-PAC® database was performed by Atrys Health. Medical writing and editing were provided by Medical Science Consulting. All funded by Novartis.

The REALITY project: analysis of a national database with 1.8 million real-life patients to study atherosclerotic cardiovascular disease and familial hypercholesterolemia in Spain

Abstract Introduction Atherosclerotic cardiovascular disease (ASCVD), hypercholesterolaemia, and familial hypercholesterolaemia (FH) are associated with high mortality, morbidity and direct/indirect economic costs worldwide. However, information about patient characteristics, clinical practice, treatment effectiveness, and economic costs is limited in Spain. To address this issue, a multidisciplinary working group of cardiologists, hospital pharmacists, family physicians, internal medicine specialists, and neurologists took part in the nationwide, observational, retrospective REALITY study. Using information from the Spanish National Health System (SNHS), the group will describe the treatment patterns and clinical profiles of patients with ASCVD and/or FH in Spain. Methods and results REALITY will access 1.8 million electronic medical records in the BIG-PAC® database, which collects anonymised data (in compliance with Organic Law 3/2018 of 5 December) from SNHS primary care centres and hospitals across seven regional health areas in Spain. REALITY was approved by the Hospital of Terrassa Ethics Committee on 17/11/2020. Patients presenting a new/recurrent episode of ASCVD or diagnosed with FH from 01/01/2017 to 31/12/2018 were recruited. The index date was the date of the event/diagnosis, and a two-year follow-up was established. Patients were classified as FH or ASCVD on the basis of their primary diagnosis (five subgroups: stable/unstable angina, acute myocardial infarction, ischemic stroke, transient ischemic attack, and peripheral arterial disease). Primary objectives were to determine demographic and clinical characteristics, comorbidities, and concomitant medication. Secondary objectives were to determine the lipid-lowering therapy applied, persistence of medication and modifications, the rationale for switching therapy, and treatment adherence (including data from non-adherent patients). Endpoints were low-density lipoprotein (LDL) levels, prevalence and incidence of new events, use of healthcare resources (e.g., medical visits or tests, coronary artery bypass surgery, hospitalizations, etc.), and healthcare costs. Using the aforementioned variables, these endpoints were analysed globally according to disease classification. Exploratory objectives included estimation of the percentage of statin-intolerant patients, and a subanalysis of costs according to the intensity of the lipid-lowering treatment and LDL levels. Conclusions The power of the “real-life” data from the BIG-PAC® database and the multidisciplinary approach used in this study will facilitate a wide range of analyses/subanalyses of various clinical issues, including treatment, disease burden, and economic costs. This study will give healthcare practitioners and policy makers valuable data for cardiovascular secondary prevention, control, and strategies to improve management. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): The REALITY study is sponsored by Novartis. Statistical analysis of the BIG-PAC® database was performed by Atrys Health. Medical writing and editing were provided by Medical Science Consulting. All funded by Novartis.

Rural trauma telementoring: a pilot project.

Background:Given Canada’s geographically dispersed population, initial trauma care may occur at rural sites that may not manage patients with trauma frequently; thus, telementoring can play a life-saving role. In this article, we describe a rural trauma telementoring pilot program in British Columbia and report the results of an evaluation of its strengths and weaknesses.Methods:Trauma surgeons from a quaternary trauma centre in Vancouver helped facilitate 3 in situ trauma simulation sessions at a rural BC hospital between fall 2019 and summer 2020. The sessions involved 4 physician participants (a trauma surgeon telementor, a family physician with additional expertise in emergency medicine acting as trauma team leader, a family physician with additional expertise in anesthesia and a family physician with Enhanced Surgical Skills), an emergency department nurse, 2 operating room/trauma team nurses, and laboratory and radiology technicians. The sessions involved simulated damage-control procedures and lasted about 2 hours. The participants completed surveys assessing comfort and confidence regarding aspects of trauma care and use of the telehealth unit before and after each session, and the facilitators assessed team dynamics using the Modified Non-Technical Skills for Trauma (T-NOTECHS) tool. Focus groups were held to gather qualitative data, and costs were tracked.Results:The average presimulation confidence survey score was 19.6/30, and the average postsimulation score was 24.0/30. The mean score improved significantly after both the first and second sessions (p = 0.01 and p = 0.004, respectively). Across the 3 sessions, the average T-NOTECHS score improved significantly, from 18.5/25 to 21.5/25 (p = 0.02). Qualitative analysis identified 3 dominant themes: telementoring increased provider confidence, telementoring increased order to the resuscitation procedure and the technical aspects of telementorship. The telementoring program was well received by all participants.Conclusion:A significant improvement was seen across simulations in physician confidence and trauma team dynamics with telementorship support. Telementoring in trauma may provide a way to lessen the difference between rural and urban patient outcomes within Canada’s geographically dispersed population, although further work investigating the impact of its use in real-life patients, as well as barriers to its implementation, is required.

Oral anticoagulants, time in therapeutic range and renal function over time in real-life patients with atrial fibrillation and chronic kidney disease

AimsTo describe the use of warfarin and direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) and chronic kidney disease (CKD), to evaluate changes in renal function over time...

1114P Long-term outcome in Danish real-life patients with advanced non-small cell lung cancer (NSCLC) receiving immune checkpoint inhibitors

1114P Long-term outcome in Danish real-life patients with advanced non-small cell lung cancer (NSCLC) receiving immune checkpoint inhibitors

Escaping delirium: Designing an escape room active learning experience for geriatric resource nurses

Use of a delirium escape room is an effective teaching modality that has demonstrated the application of didactic knowledge into clinical practice. Positive comments were shared by all participating nurses. In addition, this learning method was found to be effective for experienced as well as newly licensed nurses. This team building activity evolved into discussions about real life patients who experienced delirium and each group was able to connect the contributing factors with their patients. Communication, coordination, and collaboration were key components as to what lead to a successful escape for all in the end. Participant's evaluations revealed positive feedback indicating appreciation for this hands-on learning activity and “making it an enjoyable and memorable experience.”

Adherence, persistence and switching rates of apixaban, dabigatran and rivaroxaban in non-valvular atrial fibrillation: a multicentre real-life analysis at 3 years

IntroductionAdherence to and persistence with long-term treatment with oral anticoagulants play a significant role in preventing adverse events and mortality in patients with cardiac conditions. The aim of this study...

Real-life experience of using pegylated liposomal doxorubicin in primary cutaneous T-cell lymphomas.

Mycosis fungoides (MF) is the most prevalent subtype of primary cutaneous T-cell lymphomas (CTCLs). Sézary syndrome (SS) is another entity defined by leukaemic involvement, lymphadenopathy and erythroderma. Pegylated liposomal doxorubicin (PEG-DOXO) is an anthracycline used in the management of advanced primary CTCL, particularly in induction strategies. However, there are limited data on its effectiveness and tolerability in real-life patients. We report 36 patients who received PEG-DOXO for MF or SS in our centre, describing the patients' characteristics, response rates and tolerance to the treatment. The best overall responses were observed for the skin, with lower response rates for nodal involvement and moderate responses for blood disease. The treatment was mainly well tolerated, without severe adverse events, and no cardiotoxicity was observed on cardiac function monitoring.

Clinical Significance of Color Doppler Ultrasound Applied in Patients with Peripherally Inserted Central Venous Catheters before Extubation: A Retrospective Analysis of Real-World Data

Aims and Objectives: By comparing peripherally inserted central venous catheter (PICC)-related complications in real-life patients, we aimed to analyze the significance of color Doppler ultrasound (CDU) applied routinely or once with symptoms of thrombosis before extubation. Methods: For this retrospective study, patient data from January to December 2020 were collected from an intelligent safe platform for infusion, which was embedded in the hospital information system (HIS). After screening by the inclusion and exclusion criteria, venous therapy liaisons were interviewed regarding the PICC procedures and complications of the enrolled patients. Then, the patient medical records were checked to verify the CDU usage and collect the CDU results. Difficulties in extubation and serious complications, including catheter fracture or pulmonary embolism during or after extubation, were also collected. This paper adheres to the RECORD checklist of EQUATOR guidelines. Results: Of the 1455 patients, 489 underwent CDU examination before extubation. Among these, thrombosis was detected in 37 (7.6%) patients and only 1 (0.2%) patient without thrombosis experienced difficulties in extubation. No serious complications were observed in the CDU group. Meanwhile, among the 966 patients in the non-CDU group, three (0.3%) faced difficulties and one patient developed symptoms of pulmonary embolism. Furthermore, among patients with thrombosis in the CDU group, the duration of catheter retention was significantly shorter than that in patients without thrombosis (76.65±42.55 vs. 121.04±45.99 days, P <0.001). Conclusions: After evaluation of their clinical symptoms, patients without symptoms could be directly removed according to conventional procedures, while patients with symptoms should undergo CDU examination before extubation. Relevance to Clinical Practice: When removing the catheter for PICC carriers, it is assessed that the patients have no discomfort symptoms and can be directly extubated without B-ultrasound examination.

Cross-Resistance Among Sequential Cancer Therapeutics: An Emerging Issue.

Over the past two decades, cancer treatment has benefited from having a significant increase in the number of targeted drugs approved by the United States Food and Drug Administration. With the introduction of targeted therapy, a great shift towards a new era has taken place that is characterized by reduced cytotoxicity and improved clinical outcomes compared to traditional chemotherapeutic drugs. At present, targeted therapies and other systemic anti-cancer therapies available (immunotherapy, cytotoxic, endocrine therapies and others) are used alone or in combination in different settings (neoadjuvant, adjuvant, and metastatic). As a result, it is not uncommon for patients affected by an advanced malignancy to receive subsequent anti-cancer therapies. In this challenging complexity of cancer treatment, the clinical pathways of real-life patients are often not as direct as predicted by standard guidelines and clinical trials, and cross-resistance among sequential anti-cancer therapies represents an emerging issue. In this review, we summarize the main cross-resistance events described in the diverse tumor types and provide insight into the molecular mechanisms involved in this process. We also discuss the current challenges and provide perspectives for the research and development of strategies to overcome cross-resistance and proceed towards a personalized approach.

Simplification and Multidimensional Adaptation of the Stratification Tool for Pharmaceutical Care in People Living With HIV.

People living with human immunodeficiency virus (HIV) require specific pharmaceutical care (PC). Although the 2017 Capacity-Motivation-Opportunity (CMO) PC model allows a multidisciplinary approach that focuses on patient needs, it is too complex and presents room for improvement. The aim of this study is to simplify and adapt the previous 2017 PC tool through a multidimensional approach to improve HIV patient care, to prove the validity of the model in real-life patients. The new PC tool was generated by keeping some of the variables of the 2017 document and conducting a literature search. Content validity was determined by a 2-round Delphi methodology with an expert panel of 42 pharmacists. Consensus for the first and second rounds was defined as ≥70% agreement. The tool generated was validated in 407 real-life patients. Thirty-seven experts completed the first round of the Delphi survey and 36 the second. No consensus was reached for 3 variables, any of the frequency options and 4 interventions, while the experts agreed not to include 1 intervention in round 1. Consensus to include them was found for all but 1 variable and 1 intervention in round 2. The final tool obtained to select and stratify HIV-positive patients was composed of 9 dimensions divided into 17 variables. The new tool was validated with real-life patients and 3 priority levels were defined. We created a new pyramid of score thresholds to classify patients into priority levels. The new tool simplifies the 2017 model and improves its utility to help HIV-positive patients, owing to its multidimensional approach.

Biologics in severe asthma: the role of real-world evidence from registries.

Asthma is one of the most common noncommunicable diseases; in the majority of patients it is well controlled with inhaled bronchodilators and inhaled corticosteroids, but the management of severe asthma has been a significant challenge historically. The introduction of novel biologic drugs in the past few decades has revolutionised the field, presenting physicians with a variety of biologic drugs with different mechanisms for the treatment of severe asthma.It is of crucial importance to evaluate the effectiveness of these drugs by following their "real-life" effectiveness rather than relying solely on their efficacy, established in carefully designed clinical trials, which therefore do not necessarily match the profile of the real-life patient. Understanding the actual effectiveness of the specific drugs in real-life patients is a crucial part of tailoring the right drugs to the right patients. Registries serve as an important tool in obtaining real-life evidence, since they are in effect observational studies, following the entire patient population.

Fifteen-Year Differences in Indications for Cardiac Resynchronization Therapy in International Guidelines-Insights from the Heart Failure Registries of the European Society of Cardiology.

Cardiac resynchronization therapy (CRT) applied to selected patients with heart failure (HF) improves their prognosis. In recent years, eligibility criteria for CRT have regularly changed. This study aimed to investigate the changes in eligibility of real-life HF patients for CRT over the past fifteen years. We reviewed European and North American guidelines from this period and applied them to HF patients from the ESC-HF Pilot and ESC-Long-Term Registries. Taking into consideration the criteria assessed in this study (including all classes of recommendations i.e., class I, IIa and IIb, as well as patients with AF and SR), the 2013 (ESC) guidelines would have qualified the most patients for CRT (266, 18.3%), while the 2015 (ESC) guidelines would have qualified the least (115, 7.9%; p-value for differences between all analyzed papers <0.0001). There were only 26 patients (1.8%) who would be eligible for CRT using the class I recommendations across all of the guidelines. These results demonstrate the variability in recommendations for CRT over the years. Moreover, this data indicates underuse of this form of pacing in HF and highlights the need for more studies in order to improve the outcomes of HF patients and further personalize their management.

Real-life data of antiandrogens (AA) use in metastatic androgen receptor positive triple negative breast cancer (AR+ TNBC): The ATOVAT retrospective French cohort.

e13074 Background: AR+ TNBC account for around 25% of all TNBC. Identification of those patients is difficult since AR expression (IHC) testing is not routinely recommended. Published data of 3 trials using different antiandrogens (AA) found clinical benefit rates (CBR) at 6 months ranging from 19 to 29% with excellent toxicity profiles. The aim of this retrospective trial was to assess the clinical benefit of AA in real life. Methods: Patients with metastatic AR+ (IHC staining &gt; 10% assessed by local laboratories) TNBC treated with an antiandrogen in metastatic setting were eligible. Patients should have received at least one dose of the following AA: abiraterone acetate, enzalutamide or bicalutamide. Antiandrogens had to be given after documented progression and must not be carried out as part of a clinical trial. Patients could be chemotherapy naïve for their metastatic disease or have received any number of previous line. 30 oncology centers involved in clinical research in France were screened by questionnaire and data were collected in each patient files. The aim was to describe the 6-months CBR and safety in real-life patients. Assessable patients received at least 4 weeks of AA and present at least one disease assessment. Results: 26 patients from 5 French sites were deemed eligible and 24 patients were assessable. Treatment were conducted between January 2002 and January 2021. Median age at initiation of AA was 70 years (range 50-90). 50 % (N = 13) presented liver and/or lung mets and 27% (N = 7) non progressing and non-symptomatic cerebral mets. Median number of previous line of chemotherapy was 3 (range 0-10). AA used were: abiraterone acetate (62%), enzalutamide (8%) and bicalutamide (30%). Median time from mets diagnosis to AA treatment initiation was 18 months (range 0-168). 6-months CBR were 29% (N = 7) with 5 objective responses (2 CR, 3 PR) and 2 SD. 4-months CBR were 33% (N = 8). PFS and OS were 3.2 months (0.8- 36.1) and 9.5 (1.3-63.8) months, respectively. 2 pts further received second line AA with 1 with SD as a best response. 57% (4/7) of patients presenting 6-months clinical benefit received AA in first line versus 18% (3/17).There were no grade 3 or more side effects reported. Conclusions: Real-life data of antiandrogens use in metastatic AR+ TNBC are in line with data from published clinical trials using the same drugs. There were no new safety signal in this retrospective cohort supporting the use of antiandrogens in AR+ (&gt; 10%) TNBC in the absence of other therapeutic opportunity or available clinical trials.

INITIATION OF EMPAGLIFLOZIN THERAPY IS ASSOCIATED WITH A CLINICALLY RELEVANT DECREASE IN BLOOD PRESSURE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND UNCONTROLLED HYPERTENSION

Objective: In published clinical trials, initiation of empagliflozin is associated with modest BP reductions (around 2–3 mmHg vs. placebo, with doubtful clinical relevance). However, the patients who enter andomised clinical trials are receiving standard-of-care therapy with intensive antihypertensive medication when needed, and their baseline BP values are near-normal (typically around 135/75 mmHg). On the other hand, real-life patients who start empagliflozin therapy are often living with uncontrolled hypertension. Empagliflozin has well-known natriuretic and diuretic effects which might conceivably lower BP more powerfully in those subjects with a higher baseline BP. Design and method: Retrospective analysis of the BP data in patients with type 2 diabetes and office BP &gt; 140/90 mmHg. Data were obtained from the patient's clinical records, and consent for their anonymous analysis and reporting was obtained from included subjects. Patients who changed their antihypertensive medication simultaneously with empagliflozin initiation were excluded. Results: We obtained SBP, height and body weight data from 158 patients (59.5% female, age 64 ± 9 years) in the visit in which empagliflozin was started and the following one (3–4 months afterwards typically). Dosages were 5, 10, 12.5 and 25 mg/day in 8, 126, 10 and 14 patients, respectively. Baseline BMI was 31.5 ± 8.4 Kg/m2. Baseline SBP was 164 ± 18 mmHg, with 141–160 mmHg in 52 patients (Grade 1), 161–180 mmHg in 75 (Grade 2), and &gt; 180 mmHg in 31 (Grade 3). The reduction in SBP was 7.1 ± 5.8 mmHg, clinically and statistically significant (p = 0.014, paired t-test). In Grade 1 patients it was 4.9 ± 3.2 mmHg; 7.5 ± 5.1 mmHg in Grade 2, and 9.7 ± 6.8 mmHg in Grade 3. SBP reduction was strongly correlated with baseline SBP (Pearson's r = 0.39, p &lt; 0.001) and weakly with body weight loss (Pearson's r = 0.318, p = 0.032) but not with gender, age, empagliflozin dosage and baseline BMI. Conclusions: In patients with type 2 diabetes and uncontrolled hypertension, empagliflozin initiation is associated with a reduction in SBP pressure which is both statistically and clinically significant, nearing the effect of classic antihypertensive drugs.

The CNIC-Polypill reduces recurrent major cardiovascular events in real-life secondary prevention patients in Spain: The NEPTUNO study

BackgroundTo evaluate the effectiveness of a cardiovascular polypill including aspirin, ramipril and atorvastatin (CNIC-Polypill), on the incidence of recurrent major cardiovascular events (MACE) and risk factor control in patients with established atherosclerotic cardiovascular disease (ASCVD) vs different pharmacological therapeutic strategies. MethodsRetrospective, observational study using data from electronic-health records. Patients were distributed into 4 different cohorts: CNIC-Polypill (case cohort) vs 3 control cohorts: same monocomponents taken separately (Monocomponents), equipotent drugs (Equipotent) and other drugs not included in the previous cohorts (Other therapies). Patients were followed for 2 years or until MACE or death. ResultsAfter propensity score matching, a total of 6456 patients (1614 patients per cohort) were analysed. After 2 years, the risk of recurrent MACE was lower in the CNIC-Polypill cohort compared to the control groups (22%; p = 0.017, 25%; p = 0.002, 27%; p = 0.001, higher in the Monocomponents, Equipotent and Other therapies cohorts, respectively). The incremental proportion of patients who achieved blood pressure (BP) and low-density lipoprotein cholesterol (LDLc) control from baseline was higher in the CNIC-Polypill cohort vs control cohorts (BP controlled patients: +12.5% vs + 6.3%; p < 0.05, +2.2%; p < 0.01, +2.4%; p < 0.01, LDLc controlled patients: +10.3% vs + 4.9%; p < 0.001, +5.7%; p < 0.001, +4.9%; p < 0.001, respectively). Medication persistence was higher in patients treated with the CNIC-Polypill (72.1% vs 62.2%, 60.0% and 54.2%, respectively; p < 0.001) at study end. ConclusionsIn secondary prevention patients, compared with control groups, treatment with the CNIC-Polypill was associated with significant reductions in the accumulated incidence of recurrent MACE, improved BP and LDLc control rates, and increased medication persistence.

Odor Identification by Parkinson's Disease Patients Tested by Using Sniffin' Sticks versus Natural Spices.

Introduction Hyposmia is a frequent symptom of Parkinson's disease (PD), which greatly impacts patients' flavor perception and their quality of life. However, PD patients recognize some odors better than others. Identifying which food odors are still recognized by PD patients may be useful for flavor enhancement. Our aim was to evaluate the olfactory identification of Sniffin' Sticks and spice odorants in PD patients and healthy controls (HC), to identify the impact of synthetic odorants compared with real-life food and the impact of odor familiarity and pleasantness on odorant identification in PD patients. Methods Sniffin' Sticks odorant identification was evaluated in 80 PD patients and 105 age-matched HC. In a subset, the spice odorant identification was evaluated. Results The mean total score was higher for the Sniffin' Sticks than for the spice odor identification test in all participants (55.4% versus 22.5%). Sniffin' Sticks orange, peppermint, rose, and fish odorants were best correctly identified by PD patients, by 62.5, 53.8, 52.9, and 57.5%, respectively. Of the spice odor identification test, garlic and “no stimulus” were best correctly identified by PD patients, by, respectively, 38.2 and 67.6%. HC identified most Sniffin' Sticks odorants and spices better than PD patients. Odorant familiarity determined real-life food odorant identification. Conclusion This study demonstrates that some food odorants, both the commercial Sniffin' Sticks as natural odorants, are still recognized by PD patients. Sniffin' Sticks were better recognized compared with real-life odorants, by both HC and PD patients. Odorant familiarity determined PD patients' odorant identification; therefore, familiar food odorants may have potential for a future flavor enhancement. Implications. This is the first study, to our knowledge, to evaluate real-life food odor identification in PD patients. Our results provide a first step towards patient-appropriate flavor enhancement strategies in PD.

P024 Real-world experience of Tocilizumab withdrawal in GCA

Abstract Background/Aims Part 2 of the GIACTA trial explored the maintenance of efficacy in giant cell arteritis (GCA) patients. It showed that nearly half the patients treated with weekly tocilizumab (TCZ) maintained remission, though flares did still occur in the remaining half when TCZ was discontinued. Currently, NHS England has approved the use of TCZ in GCA for only 1 year as this duration was agreed upon by clinical experts to be sufficient to sustain remission. However, this remains a point of concern amongst clinicians as to whether data from real-life patients confirms that 1 year of TCZ can achieve sustainable remission. Methods Our objective is to assess the real-world experience of TCZ withdrawal in GCA patients and how different centres are trying to mitigate risk of relapse after its cessation. We are conducting a patient survey across six hospitals in Wessex, United Kingdom. Our aim is to assess the change in clinical features, acute phase reactants and the rate of sustained remission and relapse. Results 53 patients with GCA were included in the survey. Average age of patients was 73.5 years. 36 patients had cranial GCA, five had large vessel vasculitis and no sub-type was mentioned for the 12 remaining patients. Temporal artery biopsy was the most common diagnostic tool used for 21 patients, followed by PET scan for 14 patients. Eight patients had a clinical diagnosis only, while seven were diagnosed with GCA based on findings of Anterior Ischaemic Optic Neuropathy. Only three patients had their diagnosis confirmed via ultrasound temporal arteries. Out of these 53 patients, 45 started Tocilizumab. 15 patients stopped treatment due to side effects. Of the remaining 30 patients, only 17 have completed their 1 year of TCZ so far. Two patients relapsed 6 months after stopping TCZ. One of them was on methotrexate (MTX) and low dose prednisolone, while other was on mycophenolate mofetil only. Of those who are currently stable since completing TCZ, five patients are on MTX with prednisolone, one patient on leflunomide and prednisolone, four patients on prednisolone only and three patients on MTX only. Two patients are on no treatment currently. Conclusion This is an ongoing study. Our figures so far show that most patients are still on treatment with steroids and MTX, either alone or in combination, after completing 1 year of TCZ. This could be due to clinicians trying to mitigate against relapse once TCZ is withdrawn. This study highlights that real-world data on relapse/remission rates following TCZ withdrawal is essential as it will help shape future GCA treatment and guidelines. Disclosure S. Khalid: None. B. Davidson: None. N. Hopkinson: None. A. Mason: None. M. Malik: None. F. Laskou: None. L. Parker: None.