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Myocardial Infarction Stabilization

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361. Reproducibility in Serial C-Reactive Protein and Interleukin-6 Measurements in Post-Myocardial Infarction Patients: Results from the AIRGENE Study. Full Text available with Trip Pro

Reproducibility in Serial C-Reactive Protein and Interleukin-6 Measurements in Post-Myocardial Infarction Patients: Results from the AIRGENE Study. Among the numerous emerging biomarkers, high-sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6) have received widespread interest, and a large database has been accumulated on their potential role as predictors of cardiovascular risk. The concentrations of inflammatory biomarkers, however, are influenced, among other things (...) , by physiological variation, which is the natural within-individual variation occurring over time. Implementation of hsCRP and IL-6 measurement into clinical practice requires data on the reliability of such measurements.We serially measured hsCRP and IL-6 concentrations in up to 6 blood samples taken at monthly intervals from 200 post-myocardial infarction patients who participated in the AIRGENE study.The mean (SD) of the ln-transformed plasma concentrations (in milligrams per liter for hsCRP and nanograms

2010 Clinical Chemistry

362. Impact of statin pretreatment on the incidence of plaque rupture in ST-elevation acute myocardial infarction. (Abstract)

Impact of statin pretreatment on the incidence of plaque rupture in ST-elevation acute myocardial infarction. Several studies in experimental animals have shown that statins stabilize atheromatous plaques by increasing fibrous-cap thickness. However, direct evidence linking the use of statins to the incidence of plaque rupture in humans is lacking. We investigated whether statin treatment before the onset of ST-elevation myocardial infarction (STEMI) influences the incidence of plaque rupture

2010 Atherosclerosis

363. A Gene Expression Test to Assess the Likelihood of Obstructive Coronary Artery Disease

Personalized Gene Expression; CT = computed tomography; D-F = Diamond and Forrester Chest Pain Prediction Rule; IMPACT-CARD = Investigation of a Molecular Personalized Coronary Gene Expression Test on Cardiology Practice Pattern; IMPACT-PCP = Primary Care Providers Use of a Gene Expression Test in Coronary Artery Disease; MACE = major adverse cardiac event; MI = myocardial infarction; MPI = myocardial perfusion imaging; NA = not applicable; NPV = negative predictive value; OR = odds ratio; PPV = positive (...) walk on a treadmill as the speed and incline gradually increase. 7 Stress Echocardiography — Using ultrasound to create images of the heart, before and after walking on a treadmill, to evaluate the presence of heart-wall motion abnormalities that indicate inadequate coronary blood flow. 8 Myocardial perfusion imaging — Using a combination of exercise stress testing and imaging to see the blood supply to the heart. Patients are injected with radioactive tracers that circulate through the blood

2018 CADTH - Issues in Emerging Health Technologies

364. Male Sexual Dysfunction

-onset hypogonadism in males: ISA, ISSAM, EAU, EAA, and ASA recommendations. Eur Urol, 2009. 55: 121. 147. Khera, M., et al. A new era of testosterone and prostate cancer: from physiology to clinical implications. Eur Urol, 2014. 65: 115. 148. Corona, G., et al. Cardiovascular risk associated with testosterone-boosting medications: a systematic review and meta-analysis. Expert Opin Drug Saf, 2014. 13: 1327. 149. Baillargeon, J., et al. Risk of Myocardial Infarction in Older Men Receiving Testosterone (...) and meta-analysis. J Clin Endocrinol Metab, 2010. 95: 2560. 153. Haddad, R.M., et al. Testosterone and cardiovascular risk in men: a systematic review and meta-analysis of randomized placebo-controlled trials. Mayo Clin Proc, 2007. 82: 29. 154. Vigen, R., et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA, 2013. 310: 1829. 155. Sohn, M., et al. Standard operating procedures for vascular surgery in erectile dysfunction

2018 European Association of Urology

366. Stable Coronary Artery Disease (2nd Edition)

Density Lipoprotein Cholesterol LV Left Ventricle LVEF Left Ventricular Ejection Fraction LVH Left Ventricular Hypertrophy MET Metabolic Equivalent MI Myocardial Infarction MPI Myocardial Perfusion Imaging MRI Magnetic Resonance Imaging MUFA Monounsaturated Fatty Acid NCVD National Cardiovascular Disease Registry NOAC Newer Oral Anticoagulant NSTEMI Non-st Elevation Myocardial Infarction OMT Optimal Medical Therapy OSA Obstructive Sleep Apnea PA Physical Activity PCI Percutaneous Coronary Intervention (...) PDE5 Phosphodiesterase Type 5 Inhibitor PET Positron Emission Tomography PTP Pre-test Probability PUFA Polyunsaturated Fatty Acid SCAD Stable Coronary Artery Disease SCD Sudden Cardiac Death SFA Saturated Fatty Acid SLE Systemic Lupus Erythematosus SPECT Single-Photon Emission Computed Tomography STEMI ST Elevation Myocardial Infarction TIA Transient Ischemic Attack TFA Trans Fatty Acid TMR Transmyocardial Revascularization UA Unstable Angina Rationale: Coronary Artery Disease (CAD) covers a wide

2018 Ministry of Health, Malaysia

367. Treatment for Bipolar Disorder in Adults: A Systematic Review

12 Strength of Evidence for Major Comparisons and Outcomes 14 Applicability 15 Peer Review and Public Commentary 15 Chapter 3. Search Results 16 Chapter 4. Drug Treatments for Acute Mania 21 Antipsychotic Drugs for Acute Mania 21 Key Points 21 Eligible Studies for Antipsychotics 22 Aripiprazole 24 Asenapine 27 Cariprazine 29 Olanzapine 30 Quetiapine 35 Risperidone 37 Ziprasidone 39 Haloperidol 41 Mood Stabilizers for Acute Mania 42 Key Points 42 Eligible Studies for Mood Stabilizers 43 (...) of findings with at least low-strength evidence for antipsychotic drug treatments for acute mania 22 Table 7. Population and inclusion criteria for studies of aripiprazole alone for acute mania 24 Table 8. Population and inclusion criteria for aripiprazole plus mood stabilizers studies for acute mania 26 Table 9. Population and inclusion criteria for studies of asenapine alone for acute mania 28 Table 10. Population and inclusion criteria for asenapine plus mood stabilizer studies for acute mania 29 Table

2018 Effective Health Care Program (AHRQ)

369. The British Society for Rheumatology biologic DMARD safety guidelines in inflammatory arthritis Full Text available with Trip Pro

failure Heart failure Cardiac failure Ischaemic heart disease Ischaemic heart disease Ischemic heart disease Myocardial infarct* Coronary artery bypass graft NSTEMI STEMI Acute coronary syndrome Respiratory disease Interstitial lung disease Fibrosis Pulmonary fibrosis Uveitis Uveitis Drug induced uveitis Demyelinating disease Demyelinat* Neuro* Optic neuritis Multiple sclerosis Diverticular disease Diverticul* Vaccinations Vaccin* Vaccine Pneumococcal vacc* Influenza vacc* Singles vacc* Hepattiis vac (...) Ischaemic heart disease Ischemic heart disease Myocardial infarct* Coronary artery bypass graft NSTEMI STEMI Acute coronary syndrome Respiratory disease Interstitial lung disease Fibrosis Pulmonary fibrosis Uveitis Uveitis Drug induced uveitis Demyelinating disease Demyelinat* Neuro* Optic neuritis Multiple sclerosis Diverticular disease Diverticul* Vaccinations Vaccin* Vaccine Pneumococcal vacc* Influenza vacc* Singles vacc* Hepattiis vac* Monitoring Monitor* Test* Connective tissue disease Drug

2018 British Society for Rheumatology

371. Evaluation and Management of Right-Sided Heart Failure

of nutrients, as well as a systemic proinflammatory state. It is the principal cause of death in patients with pulmonary arterial hypertension. Similarly, acute RHF is associated with hemodynamic instability and is the primary cause of death in patients presenting with massive pulmonary embolism, RV myocardial infarction, and postcardiotomy shock associated with cardiac surgery. Functional assessment of the right side of the heart can be hindered by its complex geometry. Multiple hemodynamic (...) , is associated with poor clinical outcomes independently of the underlying mechanism of disease: across the spectrum of left ventricular (LV) ejection fraction (EF) in patients with acute and chronic heart failure (HF), after cardiac surgery, acute myocardial infarction (MI), congenital heart disease (CHD), and PH. To distinguish right-sided HF (RHF) from structural RVD, we define RHF as a clinical syndrome with signs and symptoms of HF resulting from RVD. RHF is caused by the inability of the RV to support

2018 International Society for Heart and Lung Transplantation

372. Perioperative Management of Obstructive Sleep Apnea and Obesity Hypoventilation Syndrome: A Workshop Report

with OSA (19, 20). One large national database study reported increased rates of shock and cardiac arrest postoperatively in patients with OSA when identifying patients with OSA with International Classi?cation of Diseases data (21). Approximately 9% of patients have asymptomatic elevations of troponin after noncardiac surgery. Even without meeting criteria for myocardial infarction (22), patients with increased postoperative troponinsareat higher riskofcomplications (23) and 30-day mortality (24 (...) complications Arrhythmias (including atrial ?brillation) (9, 10, 19, 21, 37, 79) Heart failure (9–11, 81) Cardiac arrest (9, 21, 37) Myocardial infarction (3, 9–11, 21, 37, 78–80) Biomarkers Troponin (82) Clinical outcomes Mortality (3, 81) Hospital length of stay (3, 19) Medical emergency team responses ICU admission (3, 10, 78) ICU length of stay (3, 78) Health care costs (19) Health care utilization (3, 21, 80) De?nition of abbreviation: ICU=intensive care unit. AMERICAN THORACIC SOCIETY DOCUMENTS 120

2018 American Thoracic Society

374. Brodalumab (Kyntheum) - plaque psoriasis

inflammation of psoriasis may contribute to commonly associated comorbidities, including cardiovascular (CV) disease (including hypertension and increased risk for myocardial infarction, stroke, and CV death), obesity, type 2 diabetes, arthritis, and chronic renal disease. Psoriasis is also associated with serious psychiatric comorbidities, including depression, anxiety, and suicidality, as well as substance abuse. 2.1.5. Management The current therapeutic options for moderate to severe plaque psoriasis (...) performed according to the ICH Q5D guideline. The MCB and WCB are sterile and free of detectable mycoplasma and viruses Any new WCB will be created from a MCB vial following established manufacturing procedures as described and will be qualified to ensure comparability to the existing WCB with respect to safety, genetic stability, cell viability after thaw, cell growth, protein production and product quality. Control of critical steps & intermediates The brodalumab integrated control strategy

2017 European Medicines Agency - EPARs

375. Diagnosis and Treatment of Peripheral Arterial Diseases Full Text available with Trip Pro

extremity artery disease LV Left ventricular MACE Major adverse cardiovascular event MI Myocardial infarction MRA Magnetic resonance angiography MR CLEAN MultiCenter Randomized Clinical Trial of Ischemic Stroke in the Netherlands MRI Magnetic resonance imaging MSAD Multisite artery disease MWD Maximal walking distance NASCET North American Symptomatic Carotid Endarterectomy Trial NNH Number needed to harm NNT Number needed to treat NOAC Non-vitamin K oral anticoagulant OAC Oral anticoagulation ONTARGET (...) Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial OR Odds ratio PADs Peripheral arterial diseases PCI Percutaneous coronary intervention PEGASUS- TIMI 54 Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin–Thrombolysis in Myocardial Infarction 54 PRODIGY PROlonging Dual antiplatelet treatment after Grading stent-induced intimal hYperplasia study PTA Percutaneous transluminal angioplasty

2017 European Society of Cardiology

376. Ribociclib (Kisqali) - breast cancer

for ribociclib succinate. Production of the correct polymorphic form is ensured by an XRPD method in the active substance specification. As described under the stability section, ribociclib succinate form A has been demonstrated to be stable and not to convert into other polymorphic forms under long term and accelerated stability studies when stored in the proposed packaging. Ribociclib is considered to be a new active substance. The applicant demonstrated that neither it, nor its derivatives and salts have (...) -compendial methods appropriately validated in accordance with the ICH guidelines. Satisfactory information regarding the reference standards used for assay and impurities testing has been presented. Batch analysis data from 38 batches of the active substance used in clinical trials, toxicology and stability studies, the last 8 of which used the proposed commercial process and were manufactured on production scale, are provided. The earlier batches used an earlier process which has since undergone only

2017 European Medicines Agency - EPARs

377. Adalimumab (Imraldi) - psoriasis, psoriatic arthritis, axial spondyloarthritis, Crohn?s disease, ulcerative colitis

and process controls Description of manufacturing process and process controls The manufacturing facility at Biogen Inc. (North Carolina, USA) is the intended site for commercial production. Imraldi active substance is manufactured, packaged, stability tested, and quality-control tested in accordance with EU good manufacturing practices. The manufacturing process begins with thawing of a vial of the working cell bank (WCB), which is a Chinese Hamster Ovary (CHO) cell line transfected with Imraldi (...) of these materials. Cell banking system The applicant is using a two-tiered cell bank system in overall accordance with ICH Q5A, Q5B, and Q5D guidelines. The host cell line is a Chinese Hamster Ovary cell line. Its safety is well established and it has been used as the host cell line in the production of numerous commercialised recombinant therapeutic antibodies. The generation of the expression is sufficiently detailed. The genetic stability of the Imraldi cell substrate was confirmed by genetic and phenotypic

2017 European Medicines Agency - EPARs

378. 2017 Focused update on Dual Antiplatelet Therapy (DAPT) Full Text available with Trip Pro

therapy for the prevention of stent thrombosis 219 3.2 Dual antiplatelet therapy for the prevention of spontaneous myocardial infarction 219 3.3 Dual antiplatelet therapy and mortality rate 219 3.4 Safety of dual antiplatelet therapy 219 3.5 Risk stratification tools for ischaemia and bleeding risks 219 3.6 Type of P2Y 12 inhibitor and timing of initiation 221 3.7 Measures to minimize bleeding while on dual antiplatelet therapy 223 3.8 Switching between oral P2Y 12 inhibitors 225 4. Dual antiplatelet (...) Myocardial Infarction ACS Acute coronary syndrome ADP Adenosine 5'-diphosphate AF Atrial fibrillation ANTARCTIC Platelet Function Monitoring to Adjust Antiplatelet Therapy in Elderly Patients Stented for an Acute Coronary Syndrome ARCTIC-Interruption Assessment by a Double Randomisation of a Conventional Antiplatelet Strategy Versus a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and, of Treatment Interruption Versus Continuation 1 Year After Stenting-Interruption ART Arterial

2017 European Society of Cardiology

379. Evidence Brief: Use of Performance Measures as Criteria for Selecting Community Cardiac and Orthopedic Surgical Providers for the Veterans Choice Program

for MI, stroke, deep sternal infection, multisystem failure, or atrial fibrillation Abbreviations: STS=Society of Thoracic Surgeons; SCIP=Surgical Care Improvement Project; NQF=National Quality Forum; MI=myocardial infarction; OR=odds ratio; SSI=Surgical Site Infection Evidence Brief: Performance Measure-based Provider Selection Evidence-based Synthesis Program 17 Orthopedic Surgery Adherence to orthopedic surgical standards was consistently not associated with health outcomes in all of 4 included (...) , wait times may present additional barriers to collection. Different wait time standards may be needed for different subgroups, as safe wait times may vary by patient subgroups and surgery types. 69 There is a risk that clinically-justified longer wait times may be penalized if medical records and/or databases lack a mechanism for recording supporting documentation. For example, frailer patients may be more likely to be delayed due to need for stabilization prior to surgery. 60,62 KEY QUESTION 3

2017 Veterans Affairs Evidence-based Synthesis Program Reports

380. Atezolizumab (Tecentriq) - Non-Small-Cell Lung Carcinoma or Transitional Cell Carcinoma

is routinely tested, tested through monitoring, or not tested. To meet the CQA-AC, restrictions have been included in the specifications of the finished product (release) and active substance (release and stability) based on the knowledge acquired on the process and stability for atezolizumab. For CQAs that are critical for bioactivity or pharmacokinetics (PK), CQA-ACs are established to ensure that CQA levels stay within the cumulative impact ranges for bioactivity and PK. Specification The release (...) . The secondary Reference Assessment report EMA/153102/2018 Page 19/205 Standard is used as the working Reference Standard for testing of the active substance and finished product in all assays requiring a Reference Standard. Qualification of the commercial Reference Standards was conducted by release testing and extensive characterisation. Stability A shelf life of 24 months at = -20 0 C is claimed for the active substance based on stability data obtained with four batches manufactured using the commercial

2017 European Medicines Agency - EPARs

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