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First Generation Sulfonylurea

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101. Harm of HPV vaccine: Latest information and examination of epidemiological studies

influenced and distorted by the pharmaceutical industry. "The Informed Prescriber" (TIP: founded in 1986) for professionals and "Med Check, Save Lives" (founded in 2001) targetting general public have provided evidence based rational information which meets the needs of professionals and the general public. This is possible, because they are completely independent: i.e. free from advertisement, funding or any other assistance from industry. The Japanese edition of this bulletin "Med Check - The Informed (...) tumours. Renal, hepatic and gastrointestinal adverse reactions MED CHECK - TIP APRIL 2015 / Vol.1 No.1 · Page 5 Translated as synopsis from Med Chec k TIP 05; 5 (Mar; #58); 7-0. Methadone :Limited use: Useful only in opioid rotation with special precautions Synopsis: Methadone hydrochloride (“methadone”, brand name: Methapain)[1] was first synthesized in Germany in 1937. It was approved in the United States in 1947 as an opioid. Vincent Dole et al. reported in 1964 that it was useful as an alternative

2015 Med Check - The Informed Prescriber

102. 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

103. Central Mechanisms of Glucose Sensing and Counterregulation in Defense of Hypoglycemia. (PubMed)

Central Mechanisms of Glucose Sensing and Counterregulation in Defense of Hypoglycemia. Glucose homeostasis requires an organism to rapidly respond to changes in plasma glucose concentrations. Iatrogenic hypoglycemia as a result of treatment with insulin or sulfonylureas is the most common cause of hypoglycemia in humans and is generally only seen in patients with diabetes who take these medications. The first response to a fall in glucose is the detection of impending hypoglycemia

2019 Endocrine Reviews

104. 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

105. 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

106. 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

107. 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

108. 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

109. Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study

August 2014, using data from 18 Mini-Sentinel data partners. We conducted seven sequential assessments comparing saxagliptin separately with sitagliptin, pioglitazone, second-generation sulfonylureas, and long-acting insulin, using disease risk score (DRS) stratification and propensity score (PS) matching to adjust for potential confounders. Sequential testing kept the overall chance of a false-positive signal below 0.05 (one-sided) for each pairwise comparison.We identified 82,264 saxagliptin users (...) and more than 1.5 times as many users of each comparator. At the end of surveillance, the DRS-stratified hazard ratios (HRs) (95% CI) were 1.08 (0.90-1.28) in the comparison with sitagliptin, 1.11 (0.87-1.42) with pioglitazone, 0.79 (0.64-0.98) with sulfonylureas, and 0.57 (0.46-0.70) with long-acting insulin. The corresponding PS-matched HRs were similar. Only one interim analysis of 168 analyses met criteria for a safety signal: the PS-matched saxagliptin-pioglitazone comparison from the fifth

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2017 EvidenceUpdates

110. Therapies for type 2 diabetes: improving outcomes that matter

, tolerability, effectiveness, prince, and simplicity) to . Their analysis confirmed that metformin should be first-line pharmacotherapy for most persons with type 2 diabetes. Other key points from include: Safety - Sulfonylureas, insulins, meglitinides, and pramlintide increase risk of hypoglycemia. Metformin and acarbose require monitoring, dose adjustments, or discontinuation in patients with chronic kidney disease. Tolerability - Side effects across different drug classes range from gastrointestinal (...) - Metformin, acarbose, sulfonylureas, and generic pioglitazone are the most affordable options. Simplicity - Acarbose and meglitinides are taken three times daily before meals, while insulins, GLP-1 receptor agonists, and pramlintide require subcutaneous injections. Posted by kennylin at Search This Blog Blog Archive (11) (2) (4) (5) (50) (3) (4) (5) (4) (4) (5) (3) (4) (5) (4) (4) (5) (49) (3) (4) (5) (4) (3) (5) (4) (5) (4) (4) (4) (4) (51) (3) (4) (5) (4) (5) (4) (4) (5) (4) (4) (5) (4) (50) (4) (5) (4

2019 The AFP Community Blog

111. Richard Lehman’s journal reviews—23 July 2018

randomised controlled trials: even sham-controlled randomised trials. Knee arthroscopic procedures were the first to fail the criteria of evidence based medicine. . I say “now” although this Finnish study debunking subacromial decompression is only the latest of a succession. Deadoption is a slow process. To paraphrase Upton Sinclair, it is difficult to get a man to understand something when his new Porsche depends on his not understanding it. Sulfonylureas: dangerous drugs for diabetes “ , all cause (...) pathogens has become conflated with a general we’re-all-doomed narrative in which the culprits are doctors who show inadequate “antibiotic stewardship.” There’s more about this in JAMA Intern Med below. As a GP who fell under this cosh I used to long for the emergence of a reliable method for distinguishing between bacterial and viral infection. And then came procalcitonin. It’s a blood marker that goes up if you are fighting bacterial infection, and down when you are winning. It doesn’t respond

2018 The BMJ Blog

112. Richard Lehman’s journal review—23 April 2018

related to the drug product.” Ambulatory BP is most predictive The GP practice I worked in was one of the first in the world to have an ambulatory blood pressure machine (in the early 1990s) and we kept on producing measurements which in those days we had no means of interpreting. It struck me that it would probably be another 20 years before we knew their prognostic significance. Well, the 20+ years have gone by and this is the conclusion: “ ” This analysis was based on a national cohort (...) level and the outcomes desired.” Maybe. JAMA Int Med Apr 2018 Hypoglycaemia: look at patients not hospital data In primary care, we used to see sulfonylurea-induced hypoglycaemia in type 2 diabetic patients all the time, but very little of it reached hospital. The same is still true in America, : “ Surveillance of severe hypoglycemia in the United States is currently based on hypoglycemic events resulting in ED or hospital utilization recorded in the EMR. Although hypoglycemia-related ED visits

2018 The BMJ Blog

113. Semaglutide (Ozempic) - the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise

Information The starting dose is 0.25mg semaglutide once weekly. After 4 weeks the dose should be increased to 0.5mg once weekly. After at least 4 weeks with a dose of 0.5mg once weekly, the dose can be increased to 1.0mg once weekly to further improve glycaemic control. Semaglutide 0.25mg is not a maintenance dose. Weekly doses higher than 1.0mg are not recommended. When semaglutide is added to existing therapy of sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should (...) be considered to reduce the risk of hypoglycaemia. When initiating treatment with semaglutide in combination with a sulfonylurea or an insulin, blood glucose self-monitoring may become necessary to adjust the dose of the sulfonylurea or the insulin to reduce the risk of hypoglycaemia. Semaglutide is to be administered once weekly at any time of the day, with or without meals. Semaglutide is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed

2019 Scottish Medicines Consortium

114. Empagliflozin - Addendum to Commission A16-12

] of its dossier on empagliflozin, the pharmaceutical company (hereinafter referred to as “the company”) had presented a study of direct comparison and 2 indirect comparisons for research question B (empagliflozin plus another blood-glucose lowering drug except insulin in comparison with metformin plus sulfonylurea). All studies used for this were already known from the first assessment A14-26 [3]. The data presented by the company were incomplete, however. In addition, there were noticeable (...) presented study 1245.28 for the comparison of empagliflozin in combination with another blood-glucose lowering drug except insulin in comparison with metformin in combination with a sulfonylurea (glibenclamide, glimepiride). 2.1.2.1 Study design and study characteristics A detailed description of study 1245.28, its limitations, as well as tables presenting the study characteristics, the interventions, and the study population can be found in the first benefit assessment of empagliflozin [3]. 2.1.2.2

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

115. Saxagliptin - Benefit assessment according to §35a Social Code Book V

identified the SAVOR-TIMI 53 study and, on the other, 2 studies for an indirect comparison: study CV181040 (saxagliptin versus placebo) and study Tovi 1998 (sulfonylurea versus placebo). Together with 4 other studies on the ACT, the company had already presented the 2 studies CV181040 and Tovi 1998 for the first assessment of saxagliptin. Based on this, the company had conducted an indirect comparison, which was irrelevant for the benefit assessment. The indirect comparison now presented on the basis (...) D1680L00006 (saxagliptin plus metformin plus sulfonylurea versus placebo plus metformin plus sulfonylurea). The company had already presented the D1680L00006 study and an indirect comparison based on it for the first assessment of saxagliptin. This was irrelevant for the benefit assessment because the studies on the ACT were unsuitable. The analysis of the SAVOR-TIMI 53 study presented by the company for research question D was unsuitable for the present benefit assessment. From the total population

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

116. Sitagliptin - Benefit assessment according to §35a Social Code Book V

[glibenclamide, glimepiride]) (research question A1) and, additionally, versus glipizide (research question A2) in this assessment in 2 separate research questions. Research question A1: sitagliptin versus sulfonylurea (glibenclamide, glimepiride) As in the first assessment, the company included one study of direct comparison (P251) for research question A1. This study was unsuitable for the assessment of the added benefit because it can be assumed that the majority of the patients enrolled did not fulfil (...) a joint consideration of all studies versus sulfonylurea, the company also derived an added benefit for all-cause mortality. 2.4.3.3 Subgroups and other effect modifiers As in the first assessment, the subgroup analysis on all-cause mortality is presented according to sex in the present benefit assessment because all deaths occurred in the subgroup of men. In its new dossier, the company additionally presented data on possible effect modifications by region. It considered an influence of the effects

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

117. Saxagliptin/metformin - Benefit assessment according to §35a Social Code Book V

the treating physician apparently considered sulfonylureas to be unsuitable or not necessary. From the placebo group, however, only patients were chosen who received sulfonylureas for the first 3 months after randomization. These different selection criteria chosen by the company for both treatment arms were another reason why structural equality of the comparator groups formed by the company was not ensured. 4) The company selected post hoc patients in the placebo arm who received sulfonylureas within 3 (...) /metformin (type 2 diabetes mellitus) 29 September 2016 Institute for Quality and Efficiency in Health Care (IQWiG) - 1 - 2 Benefit assessment 2.1 Executive summary of the benefit assessment Background In accordance with §35a Social Code Book (SGB) V, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to assess the benefit of saxagliptin/metformin. The pharmaceutical company (hereinafter referred to as “the company” submitted a first dossier

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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

. In both cases, this added benefit is limited to patients in whom near-normal blood glucose levels are aimed at. For patients without such a treatment goal, there is no proof of added benefit of sitagliptin/metformin. Research question B: sitagliptin/metformin plus sulfonylurea As in the first assessment, the company identified no study on the combination of sitagliptin/metformin plus sulfonylurea versus the ACT. Hence the added benefit of sitagliptin/metformin plus sulfonylurea is not proven. Research (...) comparisons from the steps of information retrieval mentioned: HARMONY 3, P803 and P024. Two of these studies investigated the comparison of sitagliptin/metformin versus the ACT specified by the G-BA (sulfonylurea [glibenclamide, glimepiride] plus metformin) and one study (P024) investigated the comparison of sitagliptin/metformin versus glipizide plus metformin. The studies P803 and P024 had already been presented for the first benefit assessment of sitagliptin (see Commission A13-02 [8]). The multi-arm

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

119. Empagliflozin/metformin - benefit assessment

specified by the G-BA. These are shown in Table 2. Table 2: Research questions of the benefit assessment of empagliflozin/metformin Research question Subindication a ACT specified by the G-BA A Fixed combination of empagliflozin and metformin in patients inadequately controlled on their maximally tolerated dose of metformin alone as an adjunct to diet and exercise Metformin plus sulfonylurea (glibenclamide, glimepiride) B Combination therapy with other blood-glucose lowering drugs except insulin (...) in the first dossier and in the corresponding commenting procedure on empagliflozin (single agent). Irrespective of the question whether the data presented by the company were at all relevant for the benefit assessment, the company’s assessment was incomplete with regard to content because it did not analyse all relevant outcomes. Moreover, the documents presented by the company were self-contradictory. Direct comparison The company presented study 1245.28 to prove the added benefit of empagliflozin

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

120. Empagliflozin/Metformin

referred to as “the company”) presented a study of direct comparison and 2 indirect comparisons for research question A (empagliflozin/metformin in comparison with metformin plus sulfonylurea). All studies used for this were already known from the first assessment A14-26 [3]. The data presented by the company were incomplete, however. In addition, there were noticeable discrepancies between the company’s analyses in Module 4 A and the corresponding clinical study reports (CSRs). Furthermore (...) in the first benefit assessment of empagliflozin [3]. In its dossier on empagliflozin/metformin [2], the company presented results of study 1245.28 on the subpopulation of patients who received a daily dose of at least 1700 mg metformin. This corresponded to the relevant subpopulation for the assessment of empagliflozin/ metformin. It comprised about 70% of the total study population. In its dossier, the company did not present results on several patient-relevant outcomes, however, although it was already

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

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