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First Generation Sulfonylurea

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161. Treatment of Drug-Susceptible Tuberculosis: Official ATS/CDC/IDSA Clinical Practice Guidelines

? Previous treatment for active or latent tuberculosis Abbreviation: HIV, human immunodeficiency virus. Figure 2. Baseline and follow-up evaluations for patients treated with first-line tuberculosismedications.Shadingaroundboxesindicatesactivitiesthatareoptional or contingent on other information. 1 Obtain sputa for smear and culture at baseline, then monthly until 2 consecutive specimens are negative. Collecting sputa more often early in treatment for assessment of treatment response and at end of treat (...) mass index >25 kg/m 2 , first-degree relative with diabetes, and race/ethnicity of African American, Asian, Hispanic, American Indian/Alaska Native, or Hawaiian Native/Pacific Islander. Abbreviations: ALT, ala- nine aminotransferase; AST, aspartate aminotransferase. ATS/CDC/IDSAClinical Practice Guidelines for Drug-Susceptible TB ? CID 2016:63 (1 October) ? 859 by guest on December 12, 2016 http://cid.oxfordjournals.org/ Downloaded from interruption are also important considerations (see “Interrup

2016 American Thoracic Society

162. Drugs That May Cause or Exacerbate Heart Failure Full Text available with Trip Pro

and other comorbidities, as well as the increasing comorbidity burden in an aging population that may warrant an increasing number of specialist and provider visits. , The HF syndrome is accompanied by a broad spectrum of both cardiovascular and noncardiovascular comorbidities. Five or more cardiovascular and noncardiovascular chronic conditions are present in 40% of Medicare patients with HF. This estimate is much higher compared with the general Medicare population, in which only 7.6% have ≥3 chronic (...) that diabetes mellitus (31%), chronic obstructive pulmonary disease (26%), ocular disorders (24%), osteoarthritis (16%), and thyroid disorders (14%) predominated. As the burden of noncardiovascular comorbidities increases, the number of medications, medication costs, and complexity also may increase. In the general population, patients with ≥5 chronic conditions have an average of 14 physician visits per year compared with only 1.5 for those with no chronic conditions. Medicare beneficiaries with HF see 15

2016 American Heart Association

163. Contributory Risk and Management of Comorbidities of Hypertension, Obesity, Diabetes Mellitus, Hyperlipidemia, and Metabolic Syndrome in Chronic Heart Failure: A Scientific Statement From the American Heart Association Full Text available with Trip Pro

; 95% CI, 0.91–1.08). 140 Some observation studies have sug- gested improved survival with metformin compared with sulfonylurea. 138,141 Prospective, randomized, controlled trials on sulfonylurea use in patients with HF have not been performed. Important adverse effects relevant to patients with HF include the risk of hypoglycemia and weight gain associated with sulfonylurea therapy. The new-generation sulfonylureas (eg, glyburide, gliclazide, glipizide, glimepiride) have largely replaced the first (...) - generation agents (eg, acetohexamide, chlorpropamide, tolazamide, tolbutamide) in routine use because they are more potent, can be administered in lower doses, and can be given on a once-daily basis. A few studies based on older-generation sulfonylureas have led to conflicting results for cardiovascular risk. Some evidence suggests greater risk of mortality with first-generation sulfonyl- ureas 164 compared with more recent ones that have been implicated in marginal cardiovascular benefit. 165

2016 American Heart Association

164. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for Comprehensive Medical Care of Patients with Obesity

pathophysiology of obesity and present an impetus to our health care system to provide effective treatment and prevention. In May of 2014, AACE and the American College of Endocrinology (ACE) sponsored their first Consensus Conference on Obesity (CCO) in Washington, DC, to establish an evidence base that could be used to develop a comprehensive plan to combat obesity (14 [EL 4; NE]). The conference convened a wide array of national stake- holders (the “pillars”) with a vested interest in obesity (...) , intuitive, and pragmatic questions that address key and germane aspects of obesity care: screening, diagnosis, clinical evaluation, treatment options, therapy selection, and treatment goals. In aggregate, these questions evalu- ate obesity as a chronic disease and consequently outline a comprehensive care plan to assist the clinician in caring for patients with obesity. This approach may differ from other CPGs. Specifically, in other CPGs: the scientific evi- dence is first examined and then questions

2016 American Association of Clinical Endocrinologists

165. Eperzan - albiglutide

-treated subjects. In general, GLP- 1R agonists have shown increased rates of nausea and vomiting in the first months after initiation. A similar pattern, although non-significant, was seen for albiglutide and most of the GI events occurred within the first 26 weeks (RR 1.03; 95% CI 0.95-1.11). The incidence of nausea and/or vomiting was shown to be related to plasma concentration level of albiglutide in the Phase IIb study (GLP110125) but no evidence of a dose response relationship was found (...) electrocardiography ECLIA electrochemiluminescent immunoassay eGFR estimated glomerular filtration rate ELISA enzyme linked immunosorbent assay EMA European Medicines Agency FcRn neonatal Fc receptor FDA Food and Drug Administration FPG fasting plasma glucose FTIH first-time-in-human GCP Good Clinical Practice GI gastrointestinal GLP-1 glucagon-like peptide-1 GSK GlaxoSmithKline HbA1c hemoglobin A1c (glycosylated hemoglobin) h hour(s) HAS human serum albumin hERG human ether-à-go-go related gene ICH International

2014 European Medicines Agency - EPARs

166. Trulicity - dulaglutide

Standard RVLP Retrovirus-like Particles s.c. Subcutaneous SAE Serious adverse event SAP Statistical analysis plan SBP Systolic blood pressure SC Subcutaneous SDS Sodiumdodecyl Sulfate SEC-HPLC Size exclusion High Performance Liquid Chromatography SEM standard error of the mean SGI Stepped glucose infusion SLS Static light scattering SOC System Organ Class SU Sulfonylurea SV-AUC Sedimentation velocity analytical ultracentrifugation t 1/2 Terminal half-life T2DM Type 2 diabetes mellitus TEAE Treatment (...) October 2013. • The Rapporteur's first Assessment Report was circulated to all CHMP members on 10 January 2014. The Co-Rapporteur's first Assessment Report was circulated to all CHMP members on 13 January 2014. • PRAC RMP Advice and assessment overview, adopted by PRAC on 5 February 2014. • During the meeting on 20 February 2014, the CHMP agreed on the consolidated List of Questions to be sent to the applicant. The final consolidated List of Questions was sent to the applicant on 20 February 2014

2014 European Medicines Agency - EPARs

167. Xultophy - insulin degludec / liraglutide

of the product The Rapporteur and Co-Rapporteur appointed by the CHMP and the evaluation teams were: Rapporteur: Kristina Dunder Co-Rapporteur: Robert James Hemmings • The application was received by the EMA on 31 May 2013. • The procedure started on 26 June 2013. • The Rapporteur's first Assessment Report was circulated to all CHMP members on 13 September 2013. The Co-Rapporteur's first Assessment Report was circulated to all CHMP members on 13 September 2013. • During the meeting on 24 October 2013 (...) and acrylonitrile butadiene styrene, to which a disposable subcutaneous needle is to be attached. Pack sizes of 1, 3, 5 and a multipack containing 10 (2 packs of 5) pre-filled pens have been authorised. 2.2.2. Active Substance Insulin degludec General information Insulin degludec is an analogue of human insulin where threonine in position B30 has been omitted and the e-amino group of lysine B29 has been coupled with hexadecanedioic acid via a ?-glutamic acid spacer. Insulin degludec is produced using

2014 European Medicines Agency - EPARs

168. Xigduo - dapagliflozin / metformin

on 26 December 2012. • The Rapporteur's first Assessment Report was circulated to all CHMP members on 15 March 2013. The Co-Rapporteur's first Assessment Report was circulated to all CHMP members on 25 March 2013. • During the meeting on 25 April 2013, the CHMP agreed on the consolidated List of Questions to be sent to the applicant. The final consolidated List of Questions was sent to the applicant on 25 April 2013. • The applicant submitted the responses to the CHMP consolidated List of Questions (...) increased risk of associated complications. Thus, a new therapeutic combination of dapagliflozin and metformin available as one tablet would provide a treatment option for patients with T2DM, and should improve patient compliance. Dapagliflozin propanediol monohydrate (dapagliflozin) is a first-in-class compound that inhibits the human renal sodium-dependent glucose co-transporter 2 (SGLT2), the major transporter responsible for renal glucose reabsorption. Dapagliflozin’s mechanism of action

2014 European Medicines Agency - EPARs

169. Dapagliflozin (Farxiga)

, the data provided in this resubmission are generally supportive of previous findings of efficacy across the Phase 2b and Phase 3 clinical program. Additionally, no new or unexpected safety signals have emerged. While taking into consideration the safety concerns that were identified during the first review cycle, the totality of evidence from the updated efficacy and safety databases appears to support approval of this Application. 1.3 Recommendations for Postmarket Risk Evaluation and Mitigation (...) Figure 5: eDISH Step 1 Graph 78 Figure 6: Time Course of Liver Tests for Patient D169000018-201-8 81 Figure 7: Time Course of Liver Tests for Patient D169000018-203-4 82 Figure 8: Time Course of Liver Tests for Patient MB102077-66-70996 83 Figure 9: Clinical Follow-up of Patient D1690C00004-4402-6 85 Figure 10: Cumulative Probability of the Primary CV Composite Endpoint Over Time All Dapagliflozin vs. All Comparator Pools (ST+LT Treatment Period) 92 Figure 11: Time to First Event of Genital Infection

2014 FDA - Drug Approval Package

170. Lariglutide injection for obesity: sleep apnea study (Saxenda)

the hypothalamus. 4.4.2 Pharmacodynamics The sponsor conducted the phase 2 dose-ranging trial 1807 to establish the dose- response relationship of four doses of liraglutide and placebo on weight loss. In the first 20 weeks of this trial (time point of the primary analysis) there was a significantly greater dose-dependent mean weight loss in the groups treated with liraglutide compared with placebo, ranging from 4.8 kg (liraglutide 1.2 mg) to 7.2 kg (liraglutide 3 mg). Figure 1 illustrates the weight change (...) and therefore the elimination of liraglutide is not organ-specific. Reference ID: 3645293Clinical Review Golden, J. NDA 206321 Saxenda (liraglutide) 31 Liraglutide exposure has been shown to increase proportionally with dose. Exposure increases with decreasing body weight and is higher for women than for men. Liraglutide 3 mg generally resulted in higher exposure than liraglutide 1.8 mg in obese and overweight patients and the exposure increased in a dose-proportional manner. An exposure-response analysis

2014 FDA - Drug Approval Package

171. Clinical Practice Guidelines on Falls Prevention among Older Adults living in the Community

oxidase inhibitors) 15-19 • Antihypertensives (specifically diuretics, but may also include ß-adenoceptor blockers, a-adrenoceptor blockers, centrally acting antihypertensives, calcium channel blockers, angiotensin converting enzyme inhibitors and angiotensin receptor blockers) 18-20 • Antiarrhythmics (type 1a) 18, 20 • Digoxin 14, 16 • Analgesics (including opioid and non-steroidal anti-inflammatory analgesics) 15, 18, 19 • Antihistamines (especially first-generation with highly sedating (...) predictable based on analysis of falls worldwide. We need to translate this understanding on falls into an integrated clinical and public health approach to prevent falls among our older Singaporeans. The development of Clinical Practice Guidelines (CPG) is a key strategy introduced to build the capacity of health professionals to guide their practice. This first CPG on Falls Prevention in the community provides a step-by-step approach to health professionals to identify older adults who are at risk

2015 Ministry of Health, Singapore

172. A new blood glucose management algorithm for type 2 diabetes: a position statement of the Australian Diabetes Society Full Text available with Trip Pro

and decrease BGL. Urinary glucose loss is the mechanism for the weight loss associated with these drugs. Side effects include dehydration, dizziness and increased risk of genitourinary infections. The first two can be prevented with adequate fluid intake, and the latter diminished with meticulous hygiene. Use with loop diuretics should be avoided. SGLT2 inhibitors have diminished efficacy in people with renal impairment. PBS reimbursement requires use with metformin or a sulfonylurea but not both. Glucagon (...) A new blood glucose management algorithm for type 2 diabetes: a position statement of the Australian Diabetes Society A new blood glucose management algorithm for type 2 diabetes: a position statement of the Australian Diabetes Society | The Medical Journal of Australia mja-search search Use the for more specific terms. Title contains Body contains Date range from Date range to Article type Author's surname Volume First page doi: 10.5694/mja__.______ Search Reset  close Individual Login

2014 MJA Clinical Guidelines

173. Second and Third-line Therapies for Type 2 Diabetes

nutrition, and adequate exercise), medications, such as metformin and sulfonylureas, play an important role in achieving glycemic control in patients with diabetes mellitus: Metformin is a popular first-line oral antidiabetes drug that is used to help control glycemic levels in patients with diabetes when lifestyle modifications alone are insufficient. Because diabetes is a progressive disease, metformin monotherapy may eventually fail to adequately control glycemic levels. At this point, most patients (...) need one or more oral antidiabetes drug, or insulin, added as a second-line therapy to their treatment regimen. If, after time, second-line therapy fails, most patients will need one or more additional drugs added as a third-line therapy to achieve target glycemic levels. In Canada, seven classes of antidiabetes drugs are available that may be used as second- and third-line therapy: sulfonylureas, meglitinides, alpha-glucosidase inhibitors, thiazolidinediones, incretin agents, weight loss agents

2015 CADTH - Optimal Use

174. Update on Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes Mellitus in Light of Recent Evidence Full Text available with Trip Pro

further research. Throughout, we emphasize that this document is not a comprehensive review of the literature but rather a focus on the major new trials that have led to recent guideline changes in the area of primary prevention of CVD in type 2 diabetes mellitus. New Diagnostic Criteria for Diabetes Mellitus and Prediabetes In 2010, the ADA included A 1c for the first time among the tests recommended for the diagnosis of diabetes mellitus. This recommendation has also been adopted by the European (...) , legumes, vegetables, whole grains, and dairy products in place of other carbohydrate sources ( ADA Level of Evidence B ).Mediterranean-style dietary pattern may improve glycemic control and CVD risk factors ( ADA Level of Evidence B ).Limit of sodium to <2300 mg/d, similar to recommendations for the general population ( ADA Level of Evidence B ; note that the AHA differs and recommends sodium <1500 mg/d). Obesity “2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults

2015 American Heart Association

175. Sex Differences in the Cardiovascular Consequences of Diabetes Mellitus Full Text available with Trip Pro

in CVD Risk Factors and Outcomes in DM Sex Differences Risk factor Sex hormones: testosterone High bioavailable or unbound testosterone predicts incident coronary events Low levels of total testosterone predict incident coronary events Generalized obesity Higher prevalence of obesity in women, particularly postmenopausal women, than men HDL-C Women have higher HDL-C compared with men Hypertension Women with DM have more hypertension at >60 y of age (ie, postmenopausal) Men with DM and hypertension (...) in DM? For years, it has been recognized that the incidence of coronary heart disease (CHD) in women lags behind that of men by ≈10 years, thus generating hypotheses that differences in endogenous sex steroid levels contribute to sex differences in CHD. It also has been recognized for years that DM confers greater risk for CHD death in women compared with men. Early Rancho Bernardo Study publications noted that men with DM by history or by fasting plasma glucose had a 2.4-fold excess risk

2015 American Heart Association

176. Clinical Practice Guideline on management of patients with diabetes and chronic kidney disease stage 3b or higher (eGFR <45 mL/min) Full Text available with Trip Pro

dialysis or haemodialysis as a first modality? Statements 1.1.1 We recommend giving priority to the patient's general status and preference in selecting renal replacement therapy as there is an absence of evidence of superiority of one modality over another in patients with diabetes and CKD stage 5 (1C). 1.1.2 We recommend providing patients with unbiased information about the different available treatment options (1A). 1.1.3 In patients opting to start haemodialysis (HD), we suggest prefering high (...) is this guideline for? This guideline intends to support clinical decision making by any health care professional caring for patients with diabetes and CKD stage 3b or higher (eGFR <45 mL/min), i.e. for general practitioners, internists, surgeons and other physicians dealing with this specific patient population in both an outpatient and an in-hospital setting. The guideline also aims to inform about the development of standards of care by policy-makers. 5.3. What is this guideline about? The intended scope

2015 European Renal Best Practice

177. Obesity Interventions Delivered in Primary Care for Patients with Diabetes

with either metformin, a sulfonylurea (SFU), or both. Patients on other antidiabetic medications were excluded. Interventions and comparators Two studies, 3,7 evaluated pharmacological interventions for weight loss while three others 4,8,12 investigated lifestyle interventions for weight loss. Pharmacological Interventions The BLOOM-DM study 7 randomized 604 participants in a 1:1:1 ratio to placebo, lorcaserin 10 mg once daily (QD) or lorcaserin 10 mg twice daily (BID) for a 1 year (52 week) study. Only (...) metformin or an antidiabetic medication from the sulfonylurea class was allowed as background therapy. Medication use was well balanced across study arms with most participants in each arm (91% to 95%) treated with metformin, nearly 50% receiving sulfonylurea, and between 41% and 47% treated with both metformin and sulfonylurea. In the second pharmacological intervention study, 3 505 patients were randomized to receive a daily dose of 32 mg naltrexone and 360 mg bupropion (NB) in fixed-dose combination

2014 Canadian Agency for Drugs and Technologies in Health - Rapid Review

178. Saxagliptin (new therapeutic indication) - Benefit assessment according to § 35a Social Code Book V

extract 6 Extract of dossier assessment A13-32 Version 1.0 Saxagliptin (new therapeutic indication) – 28 November 2013 Benefit assessment acc. to § 35a Social Code Book V Institute for Quality and Efficiency in Health Care (IQWiG) - iv - List of tables 3 Page Table 2: Overview of the reasons for exclusion of the studies – indirect comparison: saxagliptin vs. sulfonylurea (glimepiride or glibenclamide) 5 3 Table numbers start with “2” as numbering follows that of the full dossier assessment. Extract (...) 18 years and older with type 2 diabetes mellitus for the therapeutic indication of the monotherapy that was newly approved in July 2013: ? as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance The G-BA specified the following ACT: ? sulfonylurea (glibenclamide or glimepiride) In principle, the company concurred with the G-BA's ACT, but additionally included the sulfonylurea glipizide in its

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

179. Vildagliptin/metformin - Benefit assessment according to § 35a Social Code Book V

Extent and probability of added benefit 14 2.5 Research question A3: vildagliptin/metformin plus sulfonylurea 15 2.5.1 Information retrieval and study pool 15 2.5.2 Results on added benefit 16 2.5.3 Extent and probability of added benefit 16 2.6 Extent and probability of added benefit - summary 16 References for English extract 17 Extract of dossier assessment A13-17 Version 1.0 Vildagliptin/metformin – Benefit assessment acc. to § 35a Social Code Book V 27 June 2013 Institute for Quality (...) and Efficiency in Health Care (IQWiG) - iv - List of tables 3 Page Table 2: Subindications and ACT for vildagliptin/metformin 1 Table 3: Vildagliptin/metformin – extent and probability of added benefit 3 Table 4: Subindications and ACT for vildagliptin/metformin 4 Table 5: Characteristics of the studies included by the company – RCT, direct comparison: vildagliptin/metformin vs. sulfonylurea (glimepiride) plus metformin 7 Table 6: Characteristics of the intervention of the studies included by the company

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

180. Sitagliptin/metformin - Benefit assessment according to § 35a Social Code Book V

List of abbreviations v 2 Benefit assessment 1 2.1 Executive summary of the benefit assessment 1 2.2 Research questions 4 2.3 Research question A: sitagliptin/metformin 7 2.3.1 Information retrieval (research question A) 7 2.3.2 Research question A1: sitagliptin/metformin versus sulfonylurea (glibenclamide, glimepiride) plus metformin 7 2.3.2.1 Study pool 7 2.3.2.2 Results on added benefit 8 2.3.2.3 Extent and probability of added benefit 8 2.3.3 Research question A2: sitagliptin/metformin versus (...) glipizide plus metformin 9 2.3.3.1 Study pool 9 2.3.3.2 Results on added benefit 10 2.3.3.3 Extent and probability of added benefit 10 2.4 Research question B: sitagliptin/metformin plus sulfonylurea 10 2.4.1 Information retrieval and study pool 10 2.4.2 Results on added benefit 11 2.4.3 Extent and probability of added benefit 11 2.5 Research question C: sitagliptin/metformin plus insulin 11 2.5.1 Information retrieval and study pool 11 2.5.2 Results on added benefit 14 2.5.3 Extent and probability

2013 Institute for Quality and Efficiency in Healthcare (IQWiG)

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