Latest & greatest articles for liraglutide

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Top results for liraglutide

101. Insulin degludec/liraglutide (Addendum to Commission A15-15)

Insulin degludec/liraglutide (Addendum to Commission A15-15) 1 Translation of addendum A15-36 Insulin degludec/Liraglutid (Addendum zum Auftrag A15-15) (Version 1.0; Status: 24 September 2015). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 24 September 2015 1.0 Commission: A15-36 Version: Status: IQWiG Reports – Commission No. A15-36 Insulin degludec (...) /liraglutide (Addendum to Commission A15-15) 1 Addendum A15-36 Version 1.0 Insulin degludec/liraglutide (Addendum to Commission A15-15) 24 September 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Insulin degludec/liraglutide (Addendum to Commission A15-15) Commissioning agency: Federal Joint Committee Commission awarded on: 8 September 2015 Internal Commission No.: A15-36 Address of publisher

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

102. Insulin degludec/liraglutide (new therapeutic indication): benefit assessment according to §35a Social Code Book V (dossier assessment)

Insulin degludec/liraglutide (new therapeutic indication): benefit assessment according to §35a Social Code Book V (dossier assessment) Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Insulin degludec/Liraglutid (neues Anwendungsgebiet) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 11. November 2015). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative (...) and legally binding. IQWiG Reports – Commission No. A15-30 Insulin degludec/liraglutide (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A15-30 Version 1.0 Insulin degludec/liraglutide (new TI) – Benefit assessment acc. to §35a SGB V 11 Nov 2015 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Insulin degludec/liraglutide (new

2015 Institute for Quality and Efficiency in Healthcare (IQWiG)

103. Type 2 diabetes: insulin degludec/liraglutide (Xultophy)

Type 2 diabetes: insulin degludec/liraglutide (Xultophy) T T ype 2 diabetes: insulin degludec/lir ype 2 diabetes: insulin degludec/liraglutide aglutide (Xultoph (Xultophy) y) Evidence summary Published: 3 July 2015 nice.org.uk/guidance/esnm60 pathways K Ke ey points from the e y points from the evidence vidence The content of this evidence summary was up-to-date in July 2015. See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up (...) - to-date information. Summary In people who are insulin-naïve, insulin degludec/liraglutide (Xultophy) was non-inferior to insulin degludec alone and superior to liraglutide alone for reductions in HbA1c (with a difference of 0.64% compared with liraglutide). In people previously treated with basal insulin, insulin degludec/ liraglutide was superior to insulin degludec alone for reducing HbA1c with a difference of 1.1%. The safety profile and long-term safety concerns of insulin degludec/liraglutide

2015 National Institute for Health and Clinical Excellence - Advice

104. Liraglutide (Saxenda) for weight loss in non-diabetic obese adults

Liraglutide (Saxenda) for weight loss in non-diabetic obese adults Liraglutide (Saxenda) for weight loss in non-diabetic obese adults Liraglutide (Saxenda) for weight loss in non-diabetic obese adults HAYES, Inc. Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc.. Liraglutide (Saxenda) for weight loss in non-diabetic obese adults. Lansdale: HAYES, Inc (...) .. Healthcare Technology Brief Publication. 2015 Final publication URL The report may be purchased from: Indexing Status Subject indexing assigned by CRD MeSH Adult; Anti-Obesity Agents; Humans; Liraglutide; Obesity; Weight Loss Language Published English Country of organisation United States English summary An English language summary is available. Address for correspondence HAYES, Inc., 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218 Email: hayesinfo

2015 Health Technology Assessment (HTA) Database.

105. Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials. (Full text)

Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials. To report the incidence of pancreatitis in type 2 diabetes trials of liraglutide and details of all pancreatitis cases.Data from Novo Nordisk-sponsored trials with liraglutide (phase 2 and 3; NN2211 identifiers) completed by 19 April 2013 were pooled. All pancreatitis cases were reviewed.Total exposure to liraglutide and active (...) comparators was 5,021 and 1,354 patient-years, respectively (n = 6,345 and 1,846, respectively). Eight cases of acute pancreatitis (AP) with liraglutide and one with any comparator (glimepiride) were found. The incidence of AP was 1.6 cases/1,000 patient-years exposure (PYE) for liraglutide vs. 0.7 cases/1,000 PYE for total active comparators. One of the eight AP cases reported with liraglutide did not meet diagnostic criteria for AP. In six of these eight cases, recognized risk factors for AP were

2014 Diabetes Care PubMed abstract

106. Liraglutide for the treatment of type 2 diabetes mellitus: a meta-analysis of randomized placebo-controlled trials. (Abstract)

Liraglutide for the treatment of type 2 diabetes mellitus: a meta-analysis of randomized placebo-controlled trials. Liraglutide has been widely used in the treatment of type 2 diabetes mellitus (T2DM), however, the results of a number of randomized placebo-controlled trials on the effects of liraglutide for the treatment of T2DM have varied. The purpose of this study was to assess the effects of liraglutide versus placebo for the treatment of T2DM.We searched randomized controlled trials (...) comparing liraglutide and placebo for the treatment of T2DM in the following databases: MEDLINE; EMBASE; Cochrane Library Central Register of Controlled Trials; and Clinical Trials Gov (through August 2014). The standard mean difference (SMD) was calculated for the continuous data and a χ (2) test was used to evaluate heterogeneity.Initially, 103 articles were retrieved through the literature search and 11 studies met the requirements for the meta-analysis. The effects of liraglutide on lowering

2014 Advances in therapy

107. Liraglutide and the Preservation of Pancreatic beta-Cell Function in Early Type 2 Diabetes: The LIBRA Trial (Full text)

Liraglutide and the Preservation of Pancreatic beta-Cell Function in Early Type 2 Diabetes: The LIBRA Trial Clinical studies evaluating the effects of medications on β-cell function in type 2 diabetes (T2DM) are compromised by an inability to determine the actual baseline degree of β-cell dysfunction independent of the reversible dysfunction induced by hyperglycemia (glucotoxicity). Short-term intensive insulin therapy (IIT) is a strategy for eliminating glucotoxicity before randomization (...) . This study determined whether liraglutide can preserve β-cell function over 48 weeks in early T2DM following initial elimination of glucotoxicity with IIT.In this double-blind, randomized, placebo-controlled trial, 51 patients with T2DM of 2.6 ± 1.9 years' duration and an A1C of 6.8 ± 0.8% (51 ± 8.7 mmol/mol) completed 4 weeks of IIT before randomization to daily subcutaneous liraglutide or placebo injection, with serial assessment of β-cell function by Insulin Secretion-Sensitivity Index-2 (ISSI-2

2014 EvidenceUpdates Controlled trial quality: predicted high PubMed abstract

108. Cost effectiveness of liraglutide in type II diabetes: a systematic review. (Abstract)

Cost effectiveness of liraglutide in type II diabetes: a systematic review. As novel treatments for type II diabetes enter the market, there is a need to assess their long-term clinical and economic outcomes against currently available treatment alternatives. Objective compilation and evaluation of current pharmacoeconomic evidence can assist payers and decision makers in determining the appropriate place in therapy of a new medication.Our objective was to review the existing pharmacoeconomic (...) literature evaluating the cost effectiveness and overall costs of treatment associated with liraglutide in type II diabetes.Medical literature indexed in MEDLINE, EMBASE, PsycINFO, CINAHL, and EconLit through 1 June 2014 was searched.Full-text, English-language cost-effectiveness, cost-utility, and other cost analyses in type II diabetes that compared liraglutide to one or more anti-diabetic agents were included. Initial screening was based on relevance of titles and abstracts followed by examination

2014 PharmacoEconomics

109. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: Insights from a patient-level pooled analysis of six randomized clinical trials. (Full text)

Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: Insights from a patient-level pooled analysis of six randomized clinical trials. To quantify the effect of liraglutide on systolic blood pressure (SBP) and pulse in patients with type 2 diabetes (T2D), and assess the influence of covariates on observed SBP reductions.A patient-level pooled analysis of six phase 3, randomized trials was conducted.The analysis included 2792 randomized patients (...) . In the intention-to-treat population (n=2783), mean [±SE] SBP reductions from baseline with liraglutide 1.2 mg (2.7 [0.8] mmHg) and 1.8 mg (2.9 [0.7] mmHg) once daily were significantly greater than with placebo (0.5 [0.9] mmHg; P=0.0029 and P=0.0004, respectively) after 26 weeks, and were evident after 2 weeks. Liraglutide was also associated with significantly greater SBP reductions than glimepiride and, at a dose of 1.8 mg, insulin glargine and rosiglitazone. SBP reductions with liraglutide weakly

2014 Journal of diabetes and its complications PubMed abstract

110. A prospective, claims-based assessment of the risk of pancreatitis and pancreatic cancer with liraglutide compared to other antidiabetic drugs (Full text)

A prospective, claims-based assessment of the risk of pancreatitis and pancreatic cancer with liraglutide compared to other antidiabetic drugs We evaluated the relationship between liraglutide and acute pancreatitis or pancreatic cancer in an ongoing post-marketing safety assessment programme.Initiators of liraglutide, exenatide, metformin, pioglitazone or groups containing initiators of dipeptidyl peptidase-4 inhibitors or sulfonylureas were identified in a US commercial health insurance (...) claims database (1 February 2010 to 31 March 2013) and followed for a median of 15 months. We estimated incidence rates (IR/100 000 person-years), rate ratio (RR) and 95% confidence intervals (CI) of new insurance claims with diagnoses of primary inpatient acute pancreatitis or pancreatic cancer from Poisson regression models.The IR for acute pancreatitis for liraglutide was 187.5 compared with 154.4 for all non-glucagon-like peptide-1 (GLP-1)-based therapies (adjusted RR 1.10; CI 0.81-1.49). The IR

2014 EvidenceUpdates PubMed abstract

111. Xultophy - insulin degludec / liraglutide

Xultophy - insulin degludec / liraglutide 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. 24 July 2014 EMA/CHMP/369341/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Xultophy International non (...) -proprietary name: insulin degludec / liraglutide Procedure No. EMEA/H/C/002647/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. 2 Table of contents 1. Background information on the procedure 4 1.1. Submission of the dossier 4 1.2. Manufacturers 5 1.3. Steps taken for the assessment of the product 5 2. Scientific discussion 6 2.1. Introduction 6 2.2. Quality aspects 8 2.3. Non-clinical aspects 14 2.4. Clinical aspects 18 2.5. Clinical

2014 European Medicines Agency - EPARs

112. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. (Abstract)

Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Dulaglutide and liraglutide, both glucagon-like peptide-1 (GLP-1) receptor agonists, improve glycaemic control and reduce weight in patients with type 2 diabetes. In a head-to-head trial, we compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liraglutide in metformin-treated patients (...) with uncontrolled type 2 diabetes.We did a phase 3, randomised, open-label, parallel-group study at 62 sites in nine countries between June 20, 2012, and Nov 25, 2013. Patients with inadequately controlled type 2 diabetes receiving metformin (≥1500 mg/day), aged 18 years or older, with glycated haemoglobin (HbA1c) 7·0% or greater (≥53 mmol/mol) and 10·0% or lower (≤86 mmol/mol), and body-mass index 45 kg/m(2) or lower were randomly assigned to receive once-weekly dulaglutide (1·5 mg) or once-daily liraglutide

2014 Lancet Controlled trial quality: predicted high

113. Liraglutide for obesity or overweight in patients with associated co-morbidities

Liraglutide for obesity or overweight in patients with associated co-morbidities Liraglutide for obesity or overweight in patients with associated co-morbidities Liraglutide for obesity or overweight in patients with associated co-morbidities NIHR HSC Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation NIHR HSC. Liraglutide for obesity

2013 Health Technology Assessment (HTA) Database.

114. Blood pressure-lowering effects of GLP-1 receptor agonists exenatide and liraglutide: a meta-analysis of clinical trials. (Abstract)

Blood pressure-lowering effects of GLP-1 receptor agonists exenatide and liraglutide: a meta-analysis of clinical trials. Aside from lowering blood glucose, glucagon-like peptide-1 receptor agonists (GLP-1 RAs) attract much attention because of their cardioprotective effects. The aim of this study was to assess the blood pressure-lowering effects of the GLP-1 RAs exenatide and liraglutide compared with other common drugs used to treat type 2 diabetes (T2DM) based on randomized controlled trials (...) (RCTs) including data describing complete blood pressure (BP) changes from baseline.We searched the major databases for published or unpublished RCTs that had been performed in patients with T2DM and compared the effects of exenatide and liraglutide to those of other common drugs used to treat T2DM. The RCTs that included data describing BP changes between the baseline and the end of the study were selected for further analysis.A total of 16 RCTs that enrolled 3443 patients in the GLP-1 RA treatment

2013 obesity & metabolism

115. A network meta-analysis to compare glycaemic control in patients with type 2 diabetes treated with exenatide once weekly or liraglutide once daily in comparison with insulin glargine, exenatide twice daily or placebo (Full text)

A network meta-analysis to compare glycaemic control in patients with type 2 diabetes treated with exenatide once weekly or liraglutide once daily in comparison with insulin glargine, exenatide twice daily or placebo The glucagon-like peptide-1 receptor agonists (GLP-1 RAs) exenatide once weekly (ExQW) and liraglutide once daily (QD) are indicated to improve glycaemic control in patients with type 2 diabetes. Although glycaemic control with ExQW versus liraglutide QD 1.8 mg has been directly (...) compared, no studies have compared ExQW with liraglutide QD 1.2 mg or determined the probable relative efficacies of various injectable therapies for glycaemic control; therefore, a network meta-analysis was performed to address these questions.A systematic review identified randomized controlled trials of ≥24 weeks that compared ExQW, liraglutide QD (1.2 mg, 1.8 mg), insulin glargine, exenatide twice daily (ExBID), or placebo. Twenty-two studies evaluating 11 049 patients were included in the network

2013 EvidenceUpdates PubMed abstract

116. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. (Abstract)

Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Glucagon-like peptide-1 receptor agonists exenatide and liraglutide have been shown to improve glycaemic control and reduce bodyweight in patients with type 2 diabetes. We compared the efficacy and safety of exenatide once weekly with liraglutide once daily in patients with type 2 diabetes.We did a 26 week, open-label, randomised, parallel-group study at 105 sites (...) in 19 countries between Jan 11, 2010, and Jan 17, 2011. Patients aged 18 years or older with type 2 diabetes treated with lifestyle modification and oral antihyperglycaemic drugs were randomly assigned (1:1), via a computer-generated randomisation sequence with a voice response system, to receive injections of once-daily liraglutide (1·8 mg) or once-weekly exenatide (2 mg). Participants and investigators were not masked to treatment assignment. The primary endpoint was change in glycated haemoglobin

2013 Lancet Controlled trial quality: predicted high

117. Safety and efficacy of liraglutide in patients with type 2 diabetes and elevated liver enzymes: individual patient data meta-analysis of the LEAD program. (Abstract)

Safety and efficacy of liraglutide in patients with type 2 diabetes and elevated liver enzymes: individual patient data meta-analysis of the LEAD program. Non-alcoholic fatty liver disease has reached epidemic proportions in type 2 diabetes (T2D). Glucagon-like peptide-1 analogues are licensed in T2D, yet little data exist on efficacy and safety in liver injury.To assess the safety and efficacy of 26-week liraglutide on liver parameters in comparison with active-placebo.Individual patient data (...) meta-analysis was performed using patient-level data combined from six 26-week, phase-III, randomised controlled T2D trials, which comprise the 'Liraglutide Effect and Action in Diabetes' (LEAD) program. The LEAD-2 sub-study was analysed to assess the effect on CT-measured hepatic steatosis.Of 4442 patients analysed, 2241 (50.8%) patients had an abnormal ALT at baseline [mean ALT 33.8(14.9) IU/L in females; 47.3(18.3) IU/L in males]. Liraglutide 1.8 mg reduced ALT in these patients vs. placebo

2013 Alimentary pharmacology & therapeutics

118. Effects of exenatide and liraglutide on heart rate, blood pressure and body weight: systematic review and meta-analysis. (Full text)

Effects of exenatide and liraglutide on heart rate, blood pressure and body weight: systematic review and meta-analysis. To synthesise current evidence for the effects of exenatide and liraglutide on heart rate, blood pressure and body weight.Meta-analysis of available data from randomised controlled trials comparing Glucagon-like peptide-1 (GLP-1) analogues with placebo, active antidiabetic drug therapy or lifestyle intervention.Patients with type 2 diabetes.Weighted mean differences between (...) trial arms for changes in heart rate, blood pressure and body weight, after a minimum of 12-week follow-up.32 trials were included. Overall, GLP-1 agonists increased the heart rate by 1.86 beats/min (bpm) (95% CI 0.85 to 2.87) versus placebo and 1.90 bpm (1.30 to 2.50) versus active control. This effect was more evident for liraglutide and exenatide long-acting release than for exenatide twice daily. GLP-1 agonists decreased systolic blood pressure by -1.79 mm Hg (-2.94 to -0.64) and -2.39 mm Hg

2013 BMJ open PubMed abstract

119. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. (Abstract)

A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. The association between GLP-1 agonists, acute pancreatitis (AP), any cancer and thyroid cancer is discussed. This meta-analysis was aimed at evaluating the risk of those serious adverse events associated with GLP-1 agonists in patients with type 2 diabetes.Medline, EMBASE, Cochrane Library and clinicaltrials.gov were searched in order to identify longitudinal studies evaluating (...) exenatide or liraglutide use and reporting data on AP or cancer. Odds ratios (ORs) were pooled using a random-effects model. I(2) statistics assessed heterogeneity.Twenty-five studies were included. Neither exenatide (OR 0.84 [95% CI 0.58-1.22], I(2) = 30%) nor liraglutide (OR 0.97 [95% CI 0.21-4.39], I(2) = 0%) were associated with an increased risk of AP, independent of baseline comparator. The pooled OR for cancer associated with exenatide was 0.86 (95% CI 0.29, 2.60, I(2) = 0%) and for liraglutide

2012 Diabetes research and clinical practice

120. Sequential Intensification of Metformin Treatment in Type 2 Diabetes With Liraglutide Followed by Randomized Addition of Basal Insulin Prompted by A1C Targets (Full text)

Sequential Intensification of Metformin Treatment in Type 2 Diabetes With Liraglutide Followed by Randomized Addition of Basal Insulin Prompted by A1C Targets We evaluated the addition of liraglutide to metformin in type 2 diabetes followed by intensification with basal insulin (detemir) if glycated hemoglobin (A1C) ≥7%.In 988 participants from North America and Europe uncontrolled on metformin ± sulfonylurea, sulfonylurea was discontinued and liraglutide 1.8 mg/day added for 12 weeks (run (...) -in). Subsequently, those with A1C ≥7% were randomized 1:1 to 26 weeks' open-label addition of insulin detemir to metformin + liraglutide (n = 162) or continuation without insulin detemir (n = 161). Patients achieving A1C <7% continued unchanged treatment (observational arm). The primary end point was A1C change between randomized groups.Of 821 participants completing the run-in, 61% (n = 498) achieved A1C <7% (mean change -1.3% from 7.7% at start), whereas 39% (n = 323) did not (-0.6% from 8.3% at start

2012 EvidenceUpdates Controlled trial quality: uncertain PubMed abstract