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First Generation Sulfonylurea

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101. 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

102. 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

103. 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

104. 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

105. 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

106. 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

107. 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

108. 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

109. 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

110. 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)

111. 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)

112. 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)

113. 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)

114. 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)

115. 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)

116. 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)

117. Saxagliptin/metformin (type 2 diabetes) - Benefit assessment according to §35a Social Code Book V

approved in June 2017: ? saxagliptin/metformin in combination with other medicinal products for the treatment of diabetes (except insulin and sulfonylurea) (as an adjunct to diet and exercise in patients with type 2 diabetes mellitus inadequately controlled with metformin and these medicinal products) The assessment was conducted in comparison with the G-BA’s ACT. This ACT is shown in Table 2. Table 2: Research question of the benefit assessment of saxagliptin/metformin in type 2 diabetes mellitus (...) Subindication ACT a Saxagliptin/metformin plus other drugs for the treatment of diabetes (except insulin and sulfonylurea) ? Human insulin b plus metformin or ? human insulin plus empagliflozin c or ? human insulin if, according to the SPC, metformin and empagliflozin are unsuitable or not sufficiently effective due to intolerance or contraindication a: Presentation of the respective ACT specified by the G-BA. In cases where the company, because of the G-BA’s specification of the ACT, could choose

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

118. Breastfeeding problems

, or detail on the diagnosis and management of mastitis or breast abscess. There are separate CKS topics on , , , and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare. How up-to-date is this topic? How up-to-date is this topic? Changes Changes May 2017 — minor update. Recommendations on use of soft paraffin or purified lanolin cream revised to reflect evidence-base. December 2016 to January 2017 (...) weeks post-partum when the infant removes the milk effectively and frequently. Engorgement Primary engorgement occurs in the first few days after birth when there has been no or insufficient milk removal, for example due to delayed initiation of breastfeeding. This leads to venous or lymphatic stasis before the onset of milk secretion. Secondary engorgement occurs when breastfeeding is less frequent or restricted, or infant demands have decreased, leading to obstruction of the lactiferous ducts

2017 NICE Clinical Knowledge Summaries

119. Candida - female genital

, including on: Avoidance of local irritants (such as soaps and shower gels). General care of the vulval skin (for example moisturising with a simple emollient). Specialist advice should be sought, or referral arranged, if: The diagnosis is unclear. Symptoms do not improve following treatment. Non-albicans Candida species infection is present. Systemic symptoms occur. Have I got the right topic? Have I got the right topic? From age 12 years onwards (Female). This CKS topic covers the primary care (...) management of vulvovaginal candidiasis (genital thrush). This CKS topic does not cover the management of other causes of vaginal discharge and itching. There are separate CKS topics on , , , , , , and . The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare. How up-to-date is this topic? How up-to-date is this topic? Changes Changes May 2017 — minor update. The prescribing information section has been

2017 NICE Clinical Knowledge Summaries

120. Lyxumia (lixisenatide)

Lyxumia (lixisenatide) Report on the Deliberation Results May 31, 2013 Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare [Brand name] Lyxumia Subcutaneous Injection 300 µg [Non-proprietary name] Lixisenatide (JAN*) [Name of applicant] Sanofi K.K. [Date of application] June 11, 2012 [Results of deliberation] In the meeting held on May 24, 2013, the First Committee on New Drugs concluded that the product may be approved (...) and elderly patients (limited numbers of these patients were included in clinical studies), the safety and efficacy of the product in combination with a sulfonylurea and high-dose metformin, and the long-term safety and efficacy of the product in combination with basal insulin, etc. need to be further investigated via post-marketing surveillance. As a result of its regulatory review, the Pharmaceuticals and Medical Devices Agency has concluded that the product may be approved for the following indication

2013 Pharmaceuticals and Medical Devices Agency, Japan

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