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61. Heart Failure - Systolic Dysfunction

initiating ivabradine. Minor drugs. Other frequently relevant drugs include calcium channel blockers, inotropes, anti-arrhythmic drugs, and lipid-lowering agents. Calcium channel blockers. Currently, no evidence supports the use of CCBs for treatment of systolic heart failure (HF). However, if CCB’s are needed for management of hypertension, second generation agents appear to be safe. First generation agents (verapamil, diltiazem) were shown to have adverse outcomes in post-MI patients with systolic (...) Heart Failure - Systolic Dysfunction 1 Quality Department Guidelines for Clinical Care Ambulatory Heart Failure Guideline Team Team Leader William E Chavey, MD Family Medicine Team Members Barry E Bleske, PharmD Pharmacy R Van Harrison, PhD Medical Education Robert V Hogikyan, MD, MPH Geriatric Medicine Yeong Kwok, MD General Medicine John M Nicklas, MD Cardiology Consultant Todd M Koelling, MD Cardiology Initial Release August, 1999 Most Recent Major Update August, 2013 Interim/Minor Revision

2020 University of Michigan Health System

62. Management of Type 2 Diabetes Mellitus

of atherosclerotic disease. However, only very limited trial data evaluate the effectiveness of lowering triglycerides on cardiovascular outcomes. The first-line of treatment for hypertriglyceridemia is optimization of glucose and thyroid (if hypothyroid) control. Use of fibrates is generally discouraged as there is no evidence of benefit in trials using fibrates alone or in combination with statins. If triglycerides are markedly elevated (e.g., over 1000 mg/dL), then treatment may be warranted to avoid (...) Management of Type 2 Diabetes Mellitus Quality Department Guidelines for Clinical Care Ambulatory Diabetes Mellitus Guideline Team Team Leaders Connie J Standiford, MD General Internal Medicine Sandeep Vijan, MD General Internal Medicine Team Members Hae Mi Choe, PharmD College of Pharmacy R Van Harrison, PhD Medical Education Caroline R Richardson, MD Family Medicine Jennifer A Wyckoff, MD Metabolism, Endocrinology & Diabetes Consultants Martha M Funnell, MS, RN, CDE Diabetes Research

2020 University of Michigan Health System

63. Oral Semaglutide for Type 2 Diabetes: Effectiveness and Value

adequate blood glucose control. In addition to lifestyle changes, many individuals with T2DM will require antihyperglycemic medications to achieve and sustain glycemic control. 2,5 Metformin is generally the preferred first-line medication option and has a favorable safety profile in that it does not increase weight or the risk of hypoglycemia (low blood glucose) when used as a single agent. 2,5 If lifestyle changes and metformin do not achieve a desired glycemic target, another glucose-lowering drug (...) General Hospital, University of California, San Francisco No relevant conflicts of interest to disclose, defined as more than $10,000 in health care company stock or more than $5,000 in honoraria or consultancies during the previous year from health care manufacturers or insurers. ©Institute for Clinical and Economic Review, 2019 Page vi Final Evidence Report – Oral Semaglutide for Type 2 Diabetes Return to Table of Contents Table of Contents Executive Summary ES1 Background ES1 Insights Gained from

2020 California Technology Assessment Forum

64. Acute Kidney Injury (AKI)

be complementary rather than contradictory, bridging the gap between the predominantly practical approach of Think Kidneys and the evidence-driven methodology of NICE and seeking to harmonise available guidance. The final scope for the present guidelines was confirmed after posting of a preliminary draft on the Renal Association website between 20 th December 2016 and 28 th February 2017. Literature search terms were then defined, as detailed in appendix 1, but, briefly: The generic, AKI literature was first (...) broader, AKI care processes (e.g. documentation of differential diagnoses of newly detected AKI episodes). The first draft of the guideline was posted on the Renal Association website on January 2019. The draft guideline was also circulated amongst key stakeholder organisations, comprising: ? Kidney Care UK ? The National Kidney Federation ? The Think Kidneys programme ? The Intensive Care Society ? The Association of Clinical Biochemists ? The Society of Acute Medicine ? The British Association

2019 Renal Association

65. Insulin glargine/lixisenatide (Suliqua) - for the treatment of adults with type 2 diabetes mellitus

glycaemic control followed by a 30-week open-label treatment period and a final 3-day safety follow-up period. Recruited patients could have received concomitant treatment with stable doses of oral antidiabetic medicines including metformin (=1,500mg/day), sulfonylureas, meglitinides, sodium- glucose co-transporter 2 (SGLT-2) inhibitors or dipeptidyl peptide 4 (DPP-4) inhibitors. Fasting plasma glucose was required to be =10 mmol/L for patients receiving basal insulin in combination with two oral (...) comparisons, as described in the clinical effectiveness section. The treatment effect of insulin glargine/lixisenatide on HbA1c was derived from the LixiLan-L study, applied for the first year to align with the duration of the trial, and the comparator mean difference applied from the indirect comparison. HbA1c was then modelled using the UKPD68 risk equation until treatment switch, 7 while progression of total cholesterol, high density lipoprotein (HDL) and low density lipoprotein (LDL) was modelled

2020 Scottish Medicines Consortium

66. Chronic Kidney Disease - Identification, Evaluation and Management of Adult Patients

. Consider comorbidities and prognosis. CVD risk assessment Calculate & record CVD risk. See Manage in accordance with relevant guidelines. Check lipids once to establish baseline and after therapy x 1 Consider use of statins and lipid lowering strategies irrespective of LDL levels After LDL reduction achieved, regular monitoring of lipids may not be necessary. Diabetes ACE or ARB is generally first line therapy in proteinuric kidney disease Long-acting sulfonylureas are associated with hypoglycemia (...) and uACR measurements in specific risk categories Repeat eGFR sooner (within 10 days) after any change in medications (e.g. ACEi, ARB, or diuretics, SGLT2i), medical intervention, or hospitalization Check creatinine and potassium prior to starting ACEi, ARB, SGLT2i, MRA within 7-14 days of starting, and within 7-14 days after a dose increase Creatinine rise >20% after dose increase should be followed by further measurements within 7-14 days Blood pressure ACE or ARB is generally first line therapy

2019 Clinical Practice Guidelines and Protocols in British Columbia

67. Clinical Management of Stable Coronary Artery Disease in Patients With Type 2 Diabetes Mellitus: A Scientific Statement From the American Heart Association

, a number of factors have shifted that have forced the cardiology community to reconsider the role of T2DM in CAD. First, in addition to being associated with increased cardiovascular risk, T2DM has the potential to affect a number of treatment choices for CAD. In this document, we discuss the role that T2DM has in the selection of testing for CAD, in medical management (both secondary prevention strategies and treatment of stable angina), and in the selection of revascularization strategy. Second (...) to the increased burden of obesity, is projected to affect >600 million patients worldwide in the next 2 decades. T2DM has a major impact on survival and quality of life, especially among patients diagnosed at a younger age. Although all complications of T2DM are important, cardiovascular disease in general and coronary artery disease (CAD) specifically continue to be the leading causes of morbidity and mortality in this group. After steady declines in acute myocardial infarction, stroke, and lower limb

2020 American Heart Association

68. Obese, overweight with risk factors: liraglutide (Saxenda)

with obstructive sleep apnoea. However, the clinical significance of this is unclear as there is no established minimum clinically significant difference for this measure. The European Public Assessment Report (EPAR) for liraglutide (Saxenda) reports that the general adverse event profile is in-line with that for liraglutide (Victoza). The EPAR states that there is currently insufficient data to assess if uncommon events (pancreatitis/neoplasms) occur more frequently with liraglutide 3.0 mg daily compared (...) were taking concomitant sulfonylureas (Davies et al. 2015, RCT, n=846, 56 weeks). P Patient factors atient factors Liraglutide is given by subcutaneous injection. Orlistat is an oral treatment, which may be preferable to some patients. Orlistat and liraglutide have different adverse effect profiles, which also need to be considered. More participants in the liraglutide 3.0 mg groups withdrew from the studies due to adverse events compared with the placebo groups (from 9.2% to 13.0% with liraglutide

2017 National Institute for Health and Clinical Excellence - Advice

69. Ertugliflozin/sitagliptin (type 2 diabetes mellitus) - Benefit assessment according to §35a Social Code Book V

are inadequately controlled with metformin and/or a sulfonylurea and one of the stand-alone substances in ertugliflozin/sitagliptin. Furthermore, ertugliflozin/sitagliptin is approved for patients who are already being treated with the combination of ertugliflozin and sitagliptin in the form of separate tablets. However, this therapeutic indication is not relevant for the benefit assessment, since ertugliflozin is currently not available as a stand-alone product in Germany. The assessment is performed (...) in comparison with the ACT specified by the G-BA. The latter is presented in Table 2. Table 2 2 : Research questions of the benefit assessment of ertugliflozin/sitagliptin Indication ACT a Treatment as an adjunct to diet and exercise in adult patients with type 2 diabetes mellitus who are inadequately controlled under treatment with at least 2 blood glucose lowering drugs (except insulin; here metformin and/or sulfonylurea and ertugliflozin or sitagliptin) b . ? Human insulin + metformin or ? Human insulin

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

70. Glipizide

of antidiabetic drugs, sulfonylureas and metformin, may differentially affect macrovascular (...) complications and mortality in diabetic patients. We compared the long-term effects of glipizide and metformin on the major cardiovascular events in type 2 diabetic patients who had a history of coronary artery disease (CAD). This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 304 type 2 diabetic patients with CAD, mean age = 63.3 years (range, 36-80 years), were (...) enrolled. Participants were randomly assigned to receive either glipizide (30 mg daily 2013 4. TCF7L2 Genetic Variation Augments Incretin Resistance and Influences Response to a Sulfonylurea and Metformin: The Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans (SUGAR-MGH). OBJECTIVE: The rs7903146 T allele in transcription-factor-7-like-2 ( TCF7L2 ) is strongly associated with type 2 diabetes (T2D), but the mechanisms for increased risk remain unclear. We

2018 Trip Latest and Greatest

71. Type 1 diabetes

that clinicians consider adding either a sulfonylurea, a thiazolidinedione, an SGLT-2 inhibitor, or a DPP-4 inhibitor to metformin to improve glycemic control when a second oral therapy is considered. (Grade: weak (...) peptide- 1 (GLP- 1 ) receptor agonists ( ). Guideline Focus and Target Population Since the publication of the 2012 American College of Physicians (ACP) guideline on the comparative effectiveness and safety of oral medications for the treatment of type 2 diabetes , several new studies (...) for prevention of type 2 diabetes in a population with intellectual disabilities: the STOP Diabetes research project Journals Library An error occurred retrieving content to display, please try again 2017 9. ) instrument was used to evaluate the guidelines. Guidance Statement 1 : Clinicians should personalize goals for glycemic control in patients with type 2 diabetes on the basis of a discussion of benefits and harms of pharmacotherapy, patients' preferences, patients' general health and life expectancy

2018 Trip Latest and Greatest

72. Sitagliptin

. National Institutes of Health Example: "Heart attack" AND "Los Angeles" Search for studies: Study Record Detail Study to Compare Sitagliptin Versus Sulfonylurea Treatment During (...) Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262) This study has been completed. Sponsor: Merck Sharp & Dohme Corp. Information provided by (Responsible Party): Merck Sharp & Dohme Corp. ClinicalTrials.gov Identifier: NCT01340768 First received: March 24, 2011 Last updated: February 4, 2016 Last verified (...) International journal of clinical practice Int. J. Clin. Pract. A comparison of glycaemic effects of sitagliptin and sulfonylureas in elderly patients with type 2 diabetes mellitus. 626-31 10.1111/ijcp.12607 In the USA, 45% of patients with type 2 diabetes mellitus (T2DM) are elderly (≥ 65 years old). In general (...) , use of sulfonylurea increases with patient age as does the associated risk for hypoglycaemia, and the consequences of hypoglycaemia can be more pronounced in elderly patients. Sitagliptin

2018 Trip Latest and Greatest

73. Semaglutide (Ozempic) - Diabetes Mellitus

. However, the study groups and design of these trials were not identical. Therefore, the suggested dose regimen is questionable. As shown in trial 1821, the incidence of GI AEs generally decreased within the first 12 weeks of treatment. Therefore, a 12 week dose escalation regimen might improve the GI tolerability and reduce withdraws. In the answer, the Applicant, based on the data obtained in the phase 3a programme, presented a time course-model for nausea to describe the prevalence of nausea over (...) of exposure PYO patient year of observation RMP risk management plan RR rate ratio SAE serious adverse event SAP statistical analysis plan SBP systolic blood pressure s.c. sub cutaneous sema semaglutide SGLT-2 sodium-dependent glucose transporter two SMQ standardised MedDRA query SOC system organ class SU sulfonylurea SUSTAIN Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes T2D type 2 diabetes mellitus TNF-alpha tumour necrosis factor alpha TZD thiazolidinediones UACR urinary albumin

2018 European Medicines Agency - EPARs

74. Glibenclamide (Amglidia) - Diabetes Mellitus

mellitus. The hypoglycaemic effect of sulfonylureas is due to a stimulation of insulin secretion from pancreatic ß-cells via blockade of the ATP-sensitive K + (K ATP ) channel (Sturgess et al. 1985; Trube et al. 1986; Zünkler et al. 1988a; Panten et al. 1989; review in Panten et al. 1996). The K ATP channel couples cellular metabolism to membrane excitability. The K ATP channel has first been described in guinea pig and rabbit cardiac myocytes (Trube and Hescheler 1984; Noma 1983) and later (...) . INSULINS, Sulfonylureas (A10BB01) Therapeutic indication: Amglidia is indicated for the treatment of neonatal diabetes mellitus, for use in newborns, infants and children. Sulphonylureas like Amglidia have been shown to be effective in patients with mutations in the genes coding for the ß-cell ATP-sensitive potassium channel and chromosome 6q24-related transient neonatal diabetes mellitus. Pharmaceutical form Oral suspension Strengths: 0.6 mg/ml and 6 mg/ml Route of administration: Oral use Packaging

2018 European Medicines Agency - EPARs

75. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

2013 and 23 June 2016. The Scientific Advice pertained to quality, non-clinical and clinical aspects of the dossier. 1.2. Steps taken for the assessment of the product The Rapporteur and Co-Rapporteur appointed by the CHMP were: Rapporteur: Kristina Dunder Co-Rapporteur: Agnes Gyurasics • The application was received by the EMA on 1 February 2017. • The procedure started on 23 February 2017. • The Rapporteur's first Assessment Report was circulated to all CHMP members on 15 May 2017. The Co (...) -Rapporteur's first Assessment Report was circulated to all CHMP members on 22 May 2017. The PRAC Rapporteur's first Assessment Report was circulated to all PRAC members on 29 May 2017. • During the meeting on 22 June 2017, the CHMP agreed on the consolidated List of Questions to be sent to the applicant. • The applicant submitted the responses to the CHMP consolidated List of Questions on 7 September 2017. • The Rapporteurs circulated the Joint Assessment Report on the applicant’s responses to the List

2018 European Medicines Agency - EPARs

76. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

for the assessment of the product The Rapporteur and Co-Rapporteur appointed by the CHMP were: Rapporteur: Kristina Dunder Co-Rapporteur: Agnes Gyurasics • The application was received by the EMA on 1 February 2017. • The procedure started on 23 February 2017. • The Rapporteur's first Assessment Report was circulated to all CHMP members on 15 May 2017. The Co-Rapporteur's first Assessment Report was circulated to all CHMP members on 22 May 2017. The PRAC Rapporteur's first Assessment Report was circulated to all (...) agent or in combination, may provide effective glycaemic control for some patients, many do not achieve their target A1C levels, and glycaemic control deteriorates over time. Current guidelines from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recommend a stepwise and individualized treatment approach to T2DM. These guidelines recommend metformin as the optimal first-line anti-hyperglycaemic agent (AHA), unless the patient has

2018 European Medicines Agency - EPARs

77. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

analysis plan SGLT1 sodium-glucose co-transporter 1 SGLT2 sodium-glucose co-transporter 2 SmPC summary of product characteristics SMQ Standard MedDRA Query SOC System organ class T2DM type 2 diabetes mellitus TAMC total aerobic microbial count Tmax time to first occurrence of maximum observed concentration TYMC total combined yeasts/moulds count UGE urinary glucose excretion ULN upper limit of normal US United States USPI United States Prescribing Information UTI urinary tract infection UV ultraviolet (...) The applicant received Scientific Advice from the CHMP on 22 September 2011, 19 December 2013 and on 21 May 2015. The Scientific Advice pertained to clinical aspects of the dossier. 1.2. Steps taken for the assessment of the product The Rapporteur and Co-Rapporteur appointed by the CHMP were: Rapporteur: Kristina Dunder Co-Rapporteur: Agnes Gyurasics • The application was received by the EMA on 27 January 2017. • The procedure started on 23 February 2017. • The Rapporteur's first Assessment Report

2018 European Medicines Agency - EPARs

78. Cardiovascular Outcome Trials for Type 2 Diabetes

of sitagliptin (100 mg or 50 mg in patients with eGFR 30mL/min to 50 mL/min) compared with placebo. Enrolled patients had T2DM with established CVD and were at least 50 years of age, with A1C of 6.5% to 9.0% when treated with stable doses of one or two oral antihyperglycemic agents (metformin, pioglitazone, or sulfonylurea) or insulin (with or without metformin). 25 The primary end point was a composite CV outcome defined as the first confirmed event of CV death, non-fatal MI, non-fatal stroke (...) with T2DM and established CVD Population: patients with T2DM with established CVD who were at least 50 years of age, with A1C of 6.5% to 9.0% when treated with stable doses of one or two oral antihyperglycemic agents (metformin, pioglitazone, or sulfonylurea) or insulin (with or without metformin) Intervention: daily doses of sitagliptin (100 mg or 50 mg in patients with eGFR 30 mL/min to 50 mL/min) Comparator: placebo Outcomes: Primary: composite CV outcome defined as the first confirmed event of CV

2019 CADTH - Issues in Emerging Health Technologies

79. Global Vascular Guidelines for patients with chronic limb-threatening ischemia Full Text available with Trip Pro

Surgery, University of California San Francisco, 400 Parnassus Ave, Ste A581, San Francisco, CA 94143-2202 , x Andrew W. Bradbury Affiliations Department of Vascular Surgery, University of Birmingham, Birmingham, United Kingdom , MD (Co-Editor) b , x Philippe Kolh Affiliations Department of Biomedical and Preclinical Sciences, University Hospital of Liège, Wallonia, Belgium , MD (Co-Editor) c , x John V. White Affiliations Department of Surgery, Advocate Lutheran General Hospital, Niles, Ill , MD (...) of Vascular Sciences, Bangalore, India 6, 10 (co-lead), 13 (lead) None John White (Steering Committee) Advocate Lutheran General Hospital, Niles, Ill 6, 9 (co-lead) None Victor Aboyans Department of Cardiology, Dupuytren University Hospital, France 1, 2 (co-lead), 7 Bayer (honoraria, Scientific Advisory Committee) Amgen Novartis (honoraria) Pfizer/BMS Alliance Sanofi Murat Aksoy Department of Vascular Surgery American Hospital, Turkey 1, 3, 5 None Vlad-Adrian Alexandrescu University of Liège CHU Sart

2019 Society for Vascular Surgery

80. Diagnosis and Management of Glycogen Stored Diseases type VI and IX a practice resource of ACMG

pathogenic variants throughout the gene have been reported. If only one pathogenic variant is found in either the PHKG2 or PHKB gene, deletion/duplication testing is recommended becauselarge deletions and duplicationscan be missed by DNA sequencing. ACMG PRACTICE RESOURCE KISHNANI et al 8 Volume 0 | Number 0 | Month | GENETICS in MEDICINELaboratory diagnostic testing recommendations: ? To avoid liver biopsy, consider DNA testing first. Use of next-generation sequencing panels is recommended because (...) as an educational resource. It highlights current practices and therapeutic approaches to the diagnosis and management of the multiple complications of glycogen storage disease (GSD) types VI and IX. GENERAL BACKGROUND Overview Glycogen is the main storage form of carbohydrate in humans. It is most abundant in liver and muscle but is also present in other tissues. Glycogen is a polymer made up of highly branched chains of glucose molecules. In the liver, glycogen acts as a glucose reserve for maintenance

2019 American College of Medical Genetics and Genomics

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