P1681Clinical profile of patients initiating evolocumab in Spanish Cardiology Units: A RETrospective, Observational Study of Real-World Clinical Practice (RETOSS-Cardio)

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
V Barrios ◽  
M I Antorrena Miranda ◽  
C Bonanad Lozano ◽  
J Cosin Sales ◽  
O Diaz De Castro ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Practice ◽  
Secondary Prevention ◽  
Real World ◽  
Developed Countries ◽  
Atherosclerotic Cardiovascular Disease ◽  
Voluntary Withdrawal ◽  
Spanish Hospital ◽  
Cv Disease ◽  
Almost All

Abstract Background/Introduction Cardiovascular (CV) disease represents the leading cause of death and disability in developed countries with elevated LDL-C among the main risk factors for CV events. Purpose We conducted a study to describe the clinical profile of patients initiating evolocumab in real-world clinical practice, specifically hospital cardiology units in Spain. Methods Retrospective, observational, serial chart review of consecutive hyperlipidemic patients (≥18 years) who initiated evolocumab in 31 Spanish hospital cardiology units from February-2016 to May-2017. Relevant patients characteristics and clinical data were collected from medical records at 12 weeks pre- and 12±4 weeks post-evolocumab initiation. Baseline values correspond to data collected up to 12 weeks prior to initiation of evolocumab. Results 186 patients were enrolled: 72.0% men, mean (SD) age 60.3 (9.8) years, mean (SD) body mass index 28.5 (4.3) kg/m2. CV history and CV risk factors at evolocumab initiation are summarised below (Figure). Half of all patients were statin intolerant and almost all (94.1%) were secondary prevention. At baseline, half (51.1%) of all patients were receiving ezetimibe and 44.1% were receiving high-intensity statins. At baseline, mean (SD) LDL-C was 144.0 (49.0) mg/dL; 38.7% of patients had LDL-C 100-<130 mg/dL, 28.0% had LDL-C 130-<160 mg/dl, 12.4% had LDL-C ≥160 mg/dL, 12.9% had LDL-C ≥190 mg/dL. Mean (SD) baseline HDL-C was 47.7 (13.0) mg/dL. After 12 weeks of evolocumab treatment, mean (SD) LDL-C was reduced by 57.6% (21.6) to 62.2% (44.1) mg/dL (p<0.0001; LDL-C reductions of 57.5% [23.2]/57.6% [21.6] in patients with/without FH and 46.0% [21.5]/58.5% [22.1] in primary/secondary prevention patients, respectively). At week 12, 64.9% patients reached LDL-C levels <70 mg/dL, and 49.1% <50 mg/dL, while statin use remained stable (data not shown). Only 3.2% (n=6) patients discontinued evolocumab (voluntary withdrawal, mostly). Baseline CV history and CV risk factors Conclusions In Spanish Cardiology Units, evolocumab was typically prescribed in patients with FH and/or atherosclerotic cardiovascular disease, aligned with 2016 ESC/EAS guidelines recommendation on PCSK9i usage. Patients tended to have LDL-C levels above the recommended thresholds with LDL- levels markedly reduced after 12 (± 4) weeks of evolocumab treatment. Acknowledgement/Funding This work was supported by Amgen.

scholarly journals Migraine Patients With Cardiovascular Disease and Contraindications: An Analysis of Real-World Claims Data

2020 ◽  
Vol 11 ◽  
pp. 215013272096368
Author(s):  
David W. Dodick ◽  
Anand S. Shewale ◽  
Richard B. Lipton ◽  
Seth J. Baum ◽  
Steven C. Marcus ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cardiovascular Disease ◽  
Real World ◽  
Claims Data ◽  
Cross Sectional ◽  
Data Mart ◽  
Claims Database ◽  
Diagnostic Codes ◽  
Cv Disease ◽  
Sectional Analysis

Introduction: Triptans, the most commonly prescribed acute treatments for migraine attacks are, per FDA labeling, contraindicated in cardiovascular (CV) disease patients and have warnings and precautions for those with CV risk factors. Methods: Headache specialists, cardiologists, and health economics and outcomes researchers convened to identify diagnostic codes for: (1) CV diseases contraindicating triptans based on FDA labeling; (2) conditions comprising “other significant underlying CV disease”; and (3) CV risk factors included as warnings and precautions for triptans. A retrospective, cross-sectional analysis of commercially insured adult US migraine patients in the 2017 Optum® Clinformatics® Data Mart (CDM) and the 2017 IBM® Watson Health MarketScan® Commercial Claims database was used to estimate the proportion of migraine patients with CV contraindications and warnings and precautions to triptans. Results: Of the 56,662 migraine patients analyzed from Optum CDM, 13.5% had ≥1 CV disease as specified in triptan labeling and an additional 8.5% had ≥1 “other CV disease” judged by the panel to constitute a “significant underlying CV disease” (total: 22.0% migraine patients). Of 176 724 migraine patients analyzed from MarketScan, 12.2% had ≥1 CV disease as specified in the labeling and an additional 8.0% had ≥1 “other significant underlying CV disease” (total: 20.2% of migraine patients). An additional 25.4% and 25.1% of migraine patients had ≥2 CV risk factors in Optum CDM and MarketScan. In total, 47.4% and 45.3% of migraine patients in both databases had a CV disease specified as a contraindication, an “other CV disease” endorsed as significant, or ≥2 CV risk factors identified as warnings and precautions to triptans. Conclusions: Analyses of more than 230,000 people with migraine showed that ≥20% of commercially insured US migraine patients have a CV condition that specifically contraindicates triptan treatment, and an additional 25% have ≥2 CV risk factors identified as warnings and precautions to triptans.

Pool-data of clinical cases of inhaled loxapine (Adasuve)

2016 ◽  
Vol 33 (S1) ◽  
pp. s238-s238
Author(s):  
E. Gil Luna ◽  
J. Morato Parcerisa ◽  
P. Roset Arisso ◽  
A. Boldeanu
Keyword(s):  
Clinical Practice ◽  
Orthostatic Hypotension ◽  
Real World ◽  
Case Series ◽  
Pool Data ◽  
Mechanical Restraint ◽  
Satisfaction With Treatment ◽  
Competing Interest ◽  
Reported Data ◽  
Almost All

IntroductionAgitation is a psychiatric emergency that requires immediate assistance. Inhaled loxapine is a new option for achieving rapid tranquillisation avoiding coercive measures and over-sedation, which fits with patient's preferences and increases their satisfaction with treatment.ObjectiveReview the experience of use of inhaled loxapine in clinical practice.MethodsWe included data from all reports of case series with 10 or more patients published by European prescribers.ResultsTen posters were included that reported data on 116 patients, mostly diagnosed with psychotic or bipolar diseases. Among the 60 patients that were evaluated using PANSS-EC, baseline agitation intensity was above 20 in 45 of them (75%) and between 15 and 32 in 15 (25%). Regarding patients evaluated with the CGI-S scale, 17 patients had a score between 6 and 7 points and 4 had scores between 4 and 5. All patients were able to properly inhalate the drug. In some patients agitation receded as early as 2 minutes, and almost all of them were controlled within 10 minutes. Only 6 patients required the 2nd dose of loxapine within 24 hours. When patients were asked for, they showed a preference for inhaled administration instead of intramuscular one, manifested high levels of satisfaction with inhaled treatment, and in one report inhaled loxapine was stated to contribute to avoid mechanical restraint. Inhaled loxapine was well tolerated and no over-sedation was reported or any EPS, just a case of mild orthostatic hypotension.ConclusionThis pool-data review of inhaled loxapine in real world clinical practice shows that it is an effective treatment, with a very rapid response, easy to administer and well tolerated, with a good acceptance from patients.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Which Diet for Calcium Stone Patients: A Real-World Approach to Preventive Care

Nutrients ◽  
2019 ◽  
Vol 11 (5) ◽  
pp. 1182 ◽  
Author(s):  
Claudia D’Alessandro ◽  
Pietro Manuel Ferraro ◽  
Caterina Cianchi ◽  
Massimiliano Barsotti ◽  
Giovanni Gambaro ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Practice ◽  
Real World ◽  
Kidney Stone ◽  
Stone Disease ◽  
Lifestyle Changes ◽  
Stone Composition ◽  
Kidney Stone Disease ◽  
Cardiovascular Damage ◽  
Rational Management

Kidney stone disease should be viewed as a systemic disorder, associated with or predictive of hypertension, insulin resistance, chronic kidney disease and cardiovascular damage. Dietary and lifestyle changes represent an important strategy for the prevention of kidney stone recurrences and cardiovascular damage. A full screening of risk factors for kidney stones and for cardiovascular damage should be recommended in all cases of calcium kidney stone disease, yet it is rarely performed outside of stone specialist clinics. Many patients have a history of kidney stone disease while lacking a satisfactory metabolic profile. Nonetheless, in a real-world clinical practice a rational management of kidney stone patients is still possible. Different scenarios, with different types of dietary approaches based on diagnosis accuracy level can be envisaged. The aim of this review is to give patient-tailored dietary suggestions whatever the level of clinical and biochemistry evaluation. This can help to deliver a useful recommendation, while avoiding excessive dietary restrictions especially when they are not based on a specific diagnosis, and therefore potentially useless or even harmful. We focused our attention on calcium stones and the different scenarios we may find in the daily clinical practice, including the case of patients who reported renal colic episodes and/or passed stones with no information on stone composition, urinary risk factors or metabolic cardiovascular risk factors; or the case of patients with partial and incomplete information; or the case of patients with full information on stone composition, urinary risk factors and metabolic cardiovascular profile.

scholarly journals SERUM CORTISOLAS A PROGNOSTIC FACTOR OF EARLY STROKE

2020 ◽  
pp. 1-7
Author(s):  
R. Murugaraj ◽  
V. Padma ◽  
Rameez Raja
Keyword(s):  
Risk Factors ◽  
Developing Countries ◽  
Clinical Practice ◽  
Brain Infarction ◽  
Developed Countries ◽  
Neurological Injury ◽  
Cortisol Response ◽  
Hemorrhage Risk ◽  
Dexamethasone Suppression ◽  
Early Stroke

Stroke is a common neurological disorder in clinical practice causing death in the developing countries as well as developed countries. Stroke is defined as an acute neurological injury occurring due to vascular pathological processes which manifest either as brain infarction or hemorrhage. Risk factors can never explain the timing and activity of the occurrence of stroke. But we can prevent the onset of stroke by reducing the risk factors. A stress response occurs after stroke which causes increased levels of cortisol and catecholamines1 .This has been known since the 1950s. There is also a dysregulation of the hypothalamo-pituitary-adrenal (HPA) system which is shown by a failure of the dexamethasone suppression of cortisol levels in stroke. This cortisol response to stroke has been identified in both cerebral infarction as well as in intracerebral hemorrhage2 of any cause.

scholarly journals Cardiovascular Family History Increases the Risk of Disease Recurrence After a First Myocardial Infarction

2021 ◽  
Author(s):  
Agnes Wahrenberg ◽  
Ralf Kuja‐Halkola ◽  
Patrik K. E. Magnusson ◽  
Henrike Häbel ◽  
Anna Warnqvist ◽  
...  
Keyword(s):  
Risk Factors ◽  
Myocardial Infarction ◽  
Family History ◽  
Secondary Prevention ◽  
Risk Score ◽  
Early Onset ◽  
Disease Onset ◽  
Atherosclerotic Cardiovascular Disease ◽  
Net Reclassification Improvement ◽  
History Of

Background Family history of atherosclerotic cardiovascular disease (ASCVD) is easily accessible and captures genetic cardiovascular risk, but its prognostic value in secondary prevention is unknown. Methods and Results We followed 25 615 patients registered in SWEDEHEART (Swedish Web‐System for Enhancement and Development of Evidence‐Based Care in Heart Disease Evaluated According to Recommended Therapies) from their 1‐year revisit after a first‐time myocardial infarction during 2005 to 2013, until December 31, 2018. Data on relatives, diagnoses and socioeconomics were extracted from national registers. The association between family history and recurrent ASCVD was studied with Cox proportional‐hazard regression, adjusting for risk factors and socioeconomics. A family history of ASCVD was defined as hospitalization due to myocardial infarction, angina with coronary revascularization, stroke, or cardiovascular death in ≥1 parent or full sibling, with early‐onset defined as disease‐onset before 55 years in men and 65 in women. The additional discriminatory value of family history to Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention was assessed with Harrell’s C‐index difference and reclassification was studied with continuous net reclassification improvement. Family history of early‐onset ASCVD in ≥1 first‐degree relative was present in 2.3% and was associated with recurrent ASCVD (hazard ratio [HR] 1.31; 95% CI, 1.17–1.47), fully adjusted for risk factors (HR, 1.22; 95% CI, 1.05–1.42). Early‐onset family history improved the discriminatory ability of the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention, with Harrell’s C improving 0.003 points (95% CI, 0.001–0.005) from initial 0.587 (95% CI, 0.576–0.595) and improved reclassification (continuous net reclassification improvement 2.1%, P <0.001). Conclusions Family history of early‐onset ASCVD is associated with recurrent ASCVD after myocardial infarction, independently of traditional risk factors and improves secondary risk prediction. This may identify patients to target for intensified secondary prevention.

scholarly journals Do nurses have the switch factor?

2020 ◽  
Vol 7 (1) ◽  
pp. 129-135
Author(s):  
Greta Mulders ◽  
Nanda Uitslager ◽  
Sharon Alavian ◽  
Anne Wareing ◽  
Kathi Stein Oldenburg ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Best Practice ◽  
Cost Effective ◽  
Developed Countries ◽  
Clotting Factor ◽  
Pharmacokinetic Parameters ◽  
World Federation ◽  
Financial Pressure ◽  
Treatment Centre ◽  
Almost All

AbstractIntroductionSwitching between clotting factor products is becoming increasingly common as product choice increases and financial pressure grows to choose the most cost-effective options. Guidance on carrying out the switch recommends a complex and long process that may benefit from being defined in a protocol. Haemophilia nurses may be responsible for managing product switches; anecdotal evidence suggests that clinical practice is variable.AimTo explore the role of specialist nurses in switching between clotting factor products and their use of a protocol.MethodNurses attending the 2018 World Federation of Hemophilia Congress were surveyed about clinical practice at their treatment centre and use of a protocol for switching clotting factor products.ResultsOf 192 nurses attending the conference, 49 nurses returned completed questionnaires, 45 of which were included in the study after exclusions. Responses were exclusively from economically developed countries. Almost all respondents (96%) had direct experience of switching. Half of those who responded to a question about protocol-based switching reported that switches were based on a protocol. When authorship was reported, the protocol was written by haemophilia nurses in about half of cases. Practice about blood testing to determine individual pharmacokinetic parameters prior to the switch was variable, but most nurses (86%) reported screening for inhibitors prior to switching. Respondents agreed to share their protocols among their peers, although only four were received by the research team.ConclusionsClinical practice in switching between clotting factor products is variable. Some nurses are switching treatments for patients without the supported of a written protocol, whereas others are involved in writing and implementing protocols. Sharing protocols is a first step in helping to establish best practice.

P654Effectiveness of evolocumab for patients with familial hypercholesteraemia (FH) in European clinical practice

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
K K Ray ◽  
M Schoonen ◽  
L Annemans ◽  
B A Van Hout ◽  
M Sibartie ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Genetic Disorder ◽  
Chronic Kidney Disease Stage ◽  
Current Smoker ◽  
Response To Therapy ◽  
Diagnostic Methods ◽  
Disease Stage ◽  
Atherosclerotic Cardiovascular Disease ◽  
Increased Risk

Abstract Background FH is a genetic disorder which causes lifelong elevations in LDL-C from birth, resulting in a significantly increased risk of premature atherosclerotic cardiovascular disease (ASCVD). In clinical trials among patients with heterozygous FH (HeFH) and homozygous FH (HoFH), evolocumab significantly reduced LDL-C by approximately 40–60% from baseline. Few data are available on evolocumab use among FH patients treated in a real-world setting. Purpose Describe the characteristics of FH patients receiving evolocumab in routine clinical practice and their response to therapy. Methods This observational study across 10 European countries follows subjects from the date of evolocumab initiation (baseline) for up to 2.5 years, with relevant clinical data abstracted from medical charts (for subjects on apheresis, LDL-C measures included those obtained directly following apheresis). We analysed a cohort of FH subjects from an interim analysis which included subjects initiating evolocumab from Aug 2015 through Jun 2018. FH was diagnosed by the treating physician using standard criteria. Results A total of 502 FH subjects were included, 477 had HeFH (95%) and 25 HoFH (5%). The main diagnostic methods used included: the Dutch Lipid Clinic Network criteria (39% of HeFH, 28% of HoFH), genetic testing (27% of HeFH, 36% of HoFH), LDL-C values alone (23% HeFH, 16% HoFH). Mean (95% Confidence Interval [CI]) age was 58 (57–59) years for HeFH and 56 (50–61) for HoFH; 71% and 84% <65 years, respectively. 60% of HeFH subjects were male (HoFH: 40% male). In the overall FH cohort, additional CV risk factors were common (59% hypertension, 15% diabetes, 6% chronic kidney disease ≥ stage 2, 17% current smoker, 22% BMI≥30), with the majority having experienced a prior CV event (77% of HeFH, 80% of HoFH). Among HeFH subjects, 40% were receiving a high intensity statin at baseline, 11% medium intensity, 2% low intensity and 47% no statins. For HoFH, the corresponding values were 36%, 16%, 0 and 40%, respectively. Baseline ezetimibe use was 53% in HeFH and 48% in HoFH. Among HeFH patients, median (IQR) baseline LDL-C was 4.30 (3.41, 5.50) mmol/L; this dropped to 1.73 (1.03, 2.97) mmol/L within 3 months of evolocumab initiation, median LDL-C reduction 56% (Figure 1). Only 20 HoFH patients had a baseline LDL-C value; median (IQR), 4.07 (2.68, 6.17) mmol/L which dropped to 2.59 (1.63, 3.40) by month 3 [n=16]. No serious and no fatal adverse reactions were observed. Figure 1 Conclusions In this real-world study of evolocumab use in clinical practice, a large proportion of FH patients were not on statins and had LDL-C levels >4 mmol/L. After initiation of evolocumab median LDL-C fell by about one half in HeFH and by about one third in HoFH. Evolocumab was well-tolerated. Acknowledgement/Funding This study was fully funded by Amgen Inc

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