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Myocardial Infarction Stabilization

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461. Regular exploratory examination of the need for DMP revision - a feasibility study using the example of the DMP "CHD"

Bedeutung KI Konfidenzintervall LoE Level of Evidence MI Myokardinfarkt NICE National Institute of Health and Care Excellence NSTEMI non ST-segment elevation myocardial infarction (Nicht-ST- Hebungsinfarkt) NVL Nationale VersorgungsLeitlinie PCI percutaneous coronary intervention (perkutane Koronarintervention) PPI Protonenpumpeninhibitor PTCA percutaneous transluminal coronary angioplasty (Ballondilatation) RCT randomized controlled trial (randomisierte kontrollierte Studie) RR relatives Risiko RSA (...) -ÄndV Risikostrukturausgleichsänderungsverordnung SIGN Scottish Intercollegiate Guideline Network SR systematic review (systematische Übersicht) SGB Sozialgesetzbuch STEMI ST-elevation myocardial infarction (Myokardinfarkt mit ST- Streckenhebung) VStG Versorgungsstrukturgesetz WHO World Health Organization Arbeitspapier GA14-06 Version 1.0 DMP Überprüfung 07.10.2014 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) - xiv - Kurzfassung Das Institut für Qualität und

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

462. Palbociclib (Ibrance) - locally advanced or metastatic breast cancer

for toxicology and clinical studies through Phase 2. However, its physical properties were deemed unsuitable for commercial development. Therefore, the free base of palbociclib, which was found to have excellent physical and chemical stability, was selected for commercial use. Palbociclib exhibits polymorphism. The crystalline anhydrous Form A of palbociclib free base is the thermodynamically more stable form within the temperature ranges that are relevant to manufacturing and storage conditions (...) was prepared and used for toxicology and clinical studies through Phase 2. However, its physical properties were deemed unsuitable for commercial development. Therefore, the free base of palbociclib, which was found to have adequate physical and chemical stability, was selected for commercial use. The active substance is packaged in two sealed, low density polyethylene (LDPE) antistatic liners. The bagged material is then inserted in a high density polyethylene (HDPE) drum. The LDPE liner is suitable

2016 European Medicines Agency - EPARs

463. Etelcalcetide (Parsabiv) - reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism)

of the product 7 2. Scientific discussion 8 2.1. Introduction 8 2.1.1. Problem statement 8 2.1.2. About the product 9 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active Substance 10 General information 10 Manufacture, characterisation and process controls 10 Specification 11 Stability 12 2.2.3. Finished Medicinal Product 12 Manufacture of the product and process controls 13 Product specification 13 Stability of the product 14 Adventitious agents 15 2.2.4. Discussion on chemical, pharmaceutical (...) used for toxicological, clinical, stability and validation studies. The results are within the specifications at the time of testing and consistent from batch to batch, taking into account the changes in manufacturing process. Assessment report EMA/664198/2016 Page 12/98 Stability Stability data on 7 batches of active substance at >10% of the stated production scale from the proposed manufacturer stored in the intended commercial package (although smaller scale) for up to 24 months (1 batch for 36

2016 European Medicines Agency - EPARs

464. Cabometyx (cabozantinib) - advanced renal cell carcinoma

by the release and stability data from representative batches which were manufactured at the intended commercial scale. The proposed GTI specification limits are below the threshold of toxicological concern (TTC, 1.5 µg/day) considering the highest dose of 60 mg, and are therefore considered to be acceptable. The analytical methods used have been adequately described and the non-compendial methods appropriately validated in accordance with the ICH guidelines. Satisfactory information regarding the reference (...) standards used for identity, assay and impurities testing has been presented. Batch analysis data have been provided on 16 commercial scale batches produced by the proposed manufacturer and process. In addition, batch analysis results from historical batches were presented. The results are within the specifications and demonstrate that the active ingredient can be manufactured reproducibly. Stability Stability data on ten commercial scale batches of active substance manufactured by the commercial

2016 European Medicines Agency - EPARs

465. Uptravi (selexipag) - pulmonary arterial hypertension

, and in 1-octanol/aqueous phosphate buffer, pH 6.9 was found 2.1. Selexipag is achiral. Three crystal forms named Form I, II and III are identified and discussed. All selexipag batches manufactured so far correspond to the polymorphic form I which is sufficiently stable at room temperature. The amounts of Form II and III have been also monitored during stability studies of the clinical batches and registration batches. For all batches, no change in the amount of Form II and Form III can be observed (...) substance because it was never detected in any batch manufactured and during stability studies. Two solvents are routinely tested since these solvents are used in the final step of the manufacturing process. The proposed limit of ACT-333679 is considered acceptable form a toxicological point of view because this is the active metabolite of selexipag. The analytical methods used have been adequately described and non-compendial methods appropriately validated in accordance with the ICH guidelines

2016 European Medicines Agency - EPARs

466. Iblias - octocog alfa

. Reference materials The strategy for establishing and maintaining reference standards for release testing of the active substance, has been sufficiently described. Reference materials have been adequately characterised and reference standards for potency have been calibrated against relevant International Standards. Stability Real time, real condition stability data of active substance according to ICH guidelines and data generated under accelerated conditions were provided. The stability results (...) of the suitability of the compendial methods used have been provided. Stability of the product The intended shelf-life for the finished product stored at 2-8°C and protected from light is 30 months. Within this period, the finished product may be stored for up to 12 months at a temperature up to 25°C. All of the investigated batches followed a stability program based on ICH guidelines to support the shelf life assignment. The proposed storage conditions have been found acceptably justified and substantiated

2016 European Medicines Agency - EPARs

467. Kovaltry - octocog alfa

of the method is satisfactorily described. Reference materials The strategy for establishing and maintaining reference standards for release testing of the active substance, has been sufficiently described. Reference materials have been adequately characterised and reference standards for potency have been calibrated against relevant International Standards. Stability Real time, real condition stability data of active substance according to ICH guidelines and data generated under accelerated conditions were (...) provided. The stability results indicate that the active substance is sufficiently stable and justify the proposed shelf life in the proposed container. Assessment report EMA/CHMP/40124/2016 rev. 1 Page 11/72 2.2.3. Finished Medicinal Product Description of the product and pharmaceutical development The finished product is supplied as powder and solvent for solution for injection. The powder is white to slightly yellow solid. The reconstituted product is a clear, colourless liquid. The finished product

2016 European Medicines Agency - EPARs

468. Portrazza - necitumumab

) cell line. The description of the gene constructs and transfection of NS0 cells has been adequately detailed. Data is shown in support of correct sequence and integration of the gene construct. A thorough description of the cell bank system has been provided, demonstrating stability of the construct and suitability of the Master Cell Bank (MCB) and Working Cell Bank (WCB) to be used for production. The monitoring and storage of cell banks are well motivated with supporting data for the set limits (...) of cell density and temperature. The stability of the MCB and WCB will be monitored and the stability analysis evaluated and documented. The protocol for the preparation of a replacement WCB is adequately described with justified controls for its capacity to express the active substance. The data from the analysis of cells of in vitro cell age limit are in support of a stable construct and expression of an active substance with a similar oligosaccharide pattern as for substance produced from either

2016 European Medicines Agency - EPARs

469. Eptifibatide Accord

Application Mg Milligrams MI Myocardial infarction Min Minute (s) NMR Nuclear Magnetic Resonance NMT Not more than NQMI Non-Q-wave myocardial infarction PCI Percutaneous coronary intervention Ph. Eur. European Pharmacopoeia RH Relative Humidity SmPC Summary of product characteristics SMs Starting materials STEMI ST-segment elevation myocardial infarction RMP Risk management plan UA Unstable angina UV Ultraviolet Assessment report EMA/21867/2016 Page 4/25 1. Background information on the procedure 1.1 (...) ) of Directive 2001/83/EC and refers to a reference product for which a Marketing Authorisation is or has been granted in the Union on the basis of a complete dossier in accordance with Article 8(3) of Directive 2001/83/EC. The applicant applied for the following indication: Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin. Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave

2016 European Medicines Agency - EPARs

470. Ongentys (opicapone) - Parkinson?s disease

processes that were used during development. Stability Stability data were provided for six production scale batches of active substance from the proposed manufacturer using both proposed manufacturing processes. Batches were stored in a container closure system simulating the packaging intended for market for up to 36 months under long term conditions at 25 ºC / 60% RH and 30 ºC / 65% RH and for up to 6 months under accelerated conditions at 40 ºC / 75% RH according to the ICH guidelines. The samples (...) stored at 25 °C were only analysed if the 30 °C samples showed an out of trend or out of specification result. The parameters tested are the same as for release. The analytical methods used were the same as for release and are stability indicating. Assessment report EMA/343011/2016 Page 11/140 All tested parameters were within the specifications and no significant changes or trends were observed over time. Photostability testing following the ICH guideline Q1B was performed on one batch of non

2016 European Medicines Agency - EPARs

471. Home health monitoring devices compared with usual care for patients with hypertension

of a number of health states. Patients began in the ‘well’ health state (whereby they are stable but have poorly controlled hypertension), then based on transition probabilities, patients could remain in this health state or move to one of four acute health states, that is stroke, myocardial infarction, angina and heart failure. Those patients that survived the acute stage of the model progressed to the chronic phase, whereby they remained until death. The clinical data used to inform the model were drawn (...) section. In addition, this reduction in SBP is considered to be a surrogate marker and therefore serves as a proxy for final patient relevant outcomes, that is stroke or myocardial infarction. Although there are uncertainties surrounding the use of surrogate outcomes, due to the short duration of the trial, this is probably reasonable. Utility values were included in the analysis and quality of life for each health state was estimated via published literature. Patients in the ‘well’ health state were

2016 Evidence Notes from Healthcare Improvement Scotland

472. Lonsurf (trifluridine / tipiracil) - adult patients with metastatic colorectal cancer (CRC)

, characterisation and process controls 13 Specification 14 Stability 14 Tipiracil hydrochloride 15 General information 15 Manufacture, characterisation and process controls 15 Specification 16 Stability 16 2.2.3. Finished medicinal product 16 Description of the product and Pharmaceutical development 16 Manufacture of the product and process controls 18 Product specification 18 Stability of the product 18 Adventitious agents 19 2.2.4. Discussion on chemical, and pharmaceutical aspects 19 2.2.5. Conclusions

2016 European Medicines Agency - EPARs

473. Sex Effects in High-impact Conditions for Women Veterans - Depression, Diabetes, and Chronic Pain

(-0.2%) and 24 months (-0.3%). There were no statistically significant effects on body mass index. Subgroup analyses were not performed. Another review, based on a 2011 AHRQ report, inspected the progression of diabetes-related complications and found significantly decreased risks of peripheral neuropathy, nonfatal myocardial infarction, and death with lifestyle interventions at 13.3 years of follow-up. 79 There were no significant differences in risk for retinopathy or nephropathy between (...) . 127,128,130,131,133,285-291 One additional review compared acupuncture, spinal manipulation, and exercise. 292 Exercise interventions included yoga and Pilates (n=6 studies), 127,128,131,133,290,291 core stability, aerobic or general exercise, 130,286 mixed programs, 285,287-289 and nonspecific programs. 292 The largest review (n=40) found that all types of exercise compared with minimal care improved pain (MD -4.83 [100-point scale], CI -9.36 to -0.30) and disability (MD -6.41, CI -9.76 to -3.05). The number

2016 Veterans Affairs Evidence-based Synthesis Program Reports

474. Chronic Heart Failure - Diagnosis and Management

of HF. These include: hypertension, diabetes, and prior myocardial infarction. A review of new HF cases in BC suggests that 80% of individuals were previously diagnosed with hypertension, 40% with diabetes, and 45% with ischemic heart disease. On average, these co-morbidities were apparent 8, 6 and 4 years before their diagnosis of HF, respectively. To confirm the diagnosis of HF, conduct a thorough medical history, physical examination and initial investigations (see ). Use this information (...) the patient’s quality of life. By contrast, CRT is associated with improved mortality and quality of life (improved symptom status and functional capacity). Table 6. Mortality reductions based on device ICD may be considered in patients with one of the following: History of hemodynamically significant sustained ventricular arrhythmia; Ischemic cardiomyopathy and LVEF ≤ 35% (measured at least 1 month after acute myocardial infarction, or 3 months post coronary artery revascularization); or Non-ischemic

2016 Clinical Practice Guidelines and Protocols in British Columbia

475. Association of Fibroblast Growth Factor 23 With Recurrent Cardiovascular Events in Patients After an Acute Coronary Syndrome: A Secondary Analysis of a Randomized Clinical Trial. Full Text available with Trip Pro

after an acute coronary syndrome (ACS).C-terminal FGF-23 was measured in plasma samples using an established enzyme-linked immunosorbent assay system for 4947 patients within 30 days of ACS (median, 14 days) and with 1 additional CV risk factor in the Stabilization of Plaques Using Darapladib-Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) trial of the lipoprotein-associated phospholipase A2 inhibitor darapladib vs placebo performed from December 1, 2009, to April 24, 2014 (median follow-up (...) [25.8%] female). Patients with higher FGF-23 concentrations were older and more likely female, with a greater proportion of hypertension, diabetes, and previous myocardial infarction. After multivariable adjustment for baseline clinical characteristics and established biomarkers (high-sensitivity troponin I, brain-type natriuretic peptide, and high-sensitivity C-reactive protein), FGF-23 concentration in the top quartile was independently associated with an increased risk of CV death or heart

2018 JAMA cardiology Controlled trial quality: predicted high

477. Qtern (saxagliptin / dapagliflozin propanediol monohydrate) - Diabetes Mellitus, Type 2

of Questions LT Long-term MA Marked abnormality MA Marketing Authorisation MAH Marketing Authorisation holder MDRD Modification in Diet and Renal Disease Qtern Assessment report Page 5/91 MEB Medicines and Evaluation Board MI Myocardial infarction MOA Mechanism of action MPA Medical Products Agency MRHD Maximum recommended human dose MTT NF Meal tolerance test USP National Formulary NHANES National Health and Nutrition Examination Survey NYHA New York Heart Association NOAEL no observed-adverse-effect (...) -density polyethylene (LDPE) bags within a HDPE drum with a secure fitting lid. The suitability is supported by stability results. The polyethylene bags comply with the Ph. Eur. requirements and with the relevant EC regulations for plastic materials and articles intended to come into contact with foodstuffs. Specification The active substance release specification includes appropriate tests and limits for: appearance and colour (visual inspection), identity (IR-ATR or Raman, HPLC), assay (HPLC

2016 European Medicines Agency - EPARs

478. Acute and Chronic Heart Failure Full Text available with Trip Pro

always be obtained. HF is unusual in an individual with no relevant medical history (e.g. a potential cause of cardiac damage), whereas certain features, particularly previous myocardial infarction, greatly increase the likelihood of HF in a patient with appropriate symptoms and signs. At each visit, symptoms and signs of HF need to be assessed, with particular attention to evidence of congestion. Symptoms and signs are important in monitoring a patient's response to treatment and stability over time (...) myocardial infarction AMICA Atrial fibrillation Management In Congestive heart failure with Ablation ANP A-type natriuretic peptide ANS autonomic nervous system ARB angiotensin receptor blocker ARNI angiotensin receptor neprilysin inhibitor ARVC arrhythmogenic right ventricular cardiomyopathy AST aspartate aminotransferase ASV assisted servo-ventilation ATLAS Assessment of Treatment with Lisinopril And Survival ATTR transthyretin-mediated amyloidosis AV atrio-ventricular AVP arginine vasopressin b.i.d

2016 European Society of Cardiology

479. Dyslipidaemias Full Text available with Trip Pro

lipase Lp lipoprotein MetS metabolic syndrome MI myocardial infarction MTP microsomal triglyceride transfer protein MUFA monounsaturated fatty acid NICE National Institute for Health and Care Excellence NNRTI non-nucleoside reverse transcriptase inhibitor NNT number needed to treat NPC1L1 Niemann-Pick C1-like protein 1 NSTE-ACS non-ST elevation acute coronary syndrome NYHA New York Heart Association PAD peripheral arterial disease PCI percutaneous coronary intervention PCSK9 proprotein convertase (...) decisions in older people, with a firm commitment to implementing lifestyle measures such as smoking cessation in the first instance. With these considerations one can propose the following levels of total CV risk ( Table ). Table 4 Risk categories ACS = acute coronary syndrome; AMI = acute myocardial infarction; BP = blood pressure; CKD = chronic kidney disease; DM = diabetes mellitus; GFR = glomerular filtration rate; PAD = peripheral artery disease; SCORE = systematic coronary risk estimation; TIA

2016 European Society of Cardiology

480. Cancer treatments & cardiovascular toxicity 2016 (Position Paper) Full Text available with Trip Pro

following anti-HER2 compounds and VEGF inhibitors – BMI = body mass index; CAD = coronary artery disease; HER2 = human epidermal growth factor receptor 2; HF = heart failure; MI = myocardial infarction; VEGF = vascular endothelial growth factor; VHD = valvular heart disease. Table 3 Factors associated with risk of cardiotoxicity following anti-HER2 compounds and VEGF inhibitors – BMI = body mass index; CAD = coronary artery disease; HER2 = human epidermal growth factor receptor 2; HF = heart failure; MI (...) = myocardial infarction; VEGF = vascular endothelial growth factor; VHD = valvular heart disease. 2.1.1.5 Inhibition of BCR-ABL kinase The inhibition of BCR-ABL kinase by small molecules such as imatinib has profoundly improved the prognosis of patients with several forms of chronic leukaemia and some forms of gastrointestinal stromal tumours. Although initial reports suggested a risk for imatinib-induced cardiotoxicity, analysis of large cohorts did not confirm these data. Newer, more potent inhibitors

2016 European Society of Cardiology

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