Adlyxin (lixisenatide) News

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|||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Clinical, Journal: Efficacy and Safety of Lixisenatide as Add-On Therapy to Basal Insulin in Older Adults With Type 2 Diabetes in the GetGoal-O Study. (Pubmed Central) - Apr 24, 2020
P3
Add-on therapy with lixisenatide in non-frail patients aged ≥70 years with T2D uncontrolled with BI is effective, safe, and well tolerated and should be considered in this population.

|||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Retrospective data, Journal: Glucagon-like peptide-1 receptor agonists and risk of bone fracture in patients with type 2 diabetes mellitus: a meta-analysis of randomized controlled trials. (Pubmed Central) - Apr 17, 2020
Add-on therapy with lixisenatide in non-frail patients aged ≥70 years with T2D uncontrolled with BI is effective, safe, and well tolerated and should be considered in this population. Compared with placebo and other anti-diabetic drugs, liraglutide and lixisenatide were associated with a significant reduction in the risk of bone fractures, and the beneficial effects were dependent on the duration of treatment.

|||||||||| Lantus (insulin glargine) / Sanofi
Clinical, Journal: Efficacy and Safety of Basal Insulin/GLP-1 Receptor Agonist Used in Combination for Type 2 Diabetes Management. (Pubmed Central) - Apr 16, 2020
Compared with placebo and other anti-diabetic drugs, liraglutide and lixisenatide were associated with a significant reduction in the risk of bone fractures, and the beneficial effects were dependent on the duration of treatment. This article will review 2 basal insulin/GLP-1 agonist combination products, IDegLira and IGlarLixi, which were approved in November 2016.

|||||||||| Soliqua 100/33 (lixisenatide + insulin glargine) / Sanofi, Lantus (insulin glargine) / Sanofi, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Clinical, Journal: Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with type 2 diabetes. (Pubmed Central) - Apr 16, 2020
P3
This article will review 2 basal insulin/GLP-1 agonist combination products, IDegLira and IGlarLixi, which were approved in November 2016. Uncapping the iGlar dose in LixiLan-O and LixiLan-L would not have led to significant improvements in mean A1C reduction in the iGlar arm, supporting the conclusion that iGlarLixi provides additional, clinically-relevant glycemic control versus iGlar alone.

|||||||||| Journal: Managing Diabetes and Preventing Heart Disease: Have We Found a Safe and Effective Agent? (Pubmed Central) - Apr 15, 2020
However, there are differences among agents in terms of HF and peripheral arterial disease outcomes. Future studies should focus on evaluating other clinical CV outcomes in patients without existing CVD and perhaps single drug regimens for diabetes.

|||||||||| Review, Journal: Heart failure and type 2 diabetes: From CVOTs, with hope. (Pubmed Central) - Mar 31, 2020
The three trials with sodium glucose co-transporter-2 inhibitors (SGLT-2i) (EMPA-REG OUTCOME with empagliflozin, CANVAS with canagliflozin and DECLARE with dapagliflozin) all revealed a robust and significant reduction in the hazard ratios of hospitalization for HF, from 27% to 35%, which remained consistent, significant and of similar magnitude regardless of the presence of a history of HF or established atherosclerotic cardiovascular disease...At present, the robust, consistent and reproducible reduction of about 30% risk of HF by SGLT-2i may be considered a class effect. The beneficial effect on MACE outcome observed with the use of some GLP-1RAs and SGLT-2i must be interpreted within the frame of the single trial.

|||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Clinical, Journal: Effects of lixisenatide on postprandial blood pressure, gastric emptying and glycemia in health and type 2 diabetes. (Pubmed Central) - Mar 31, 2020
In health and T2DM, the marked slowing of GE of glucose induced by lixisenatide is associated with attenuation of the increments in glycemia and SMA flow and fall in systolic BP. Accordingly, lixisenatide may be useful in the management of postprandial hypotension.

|||||||||| Lantus (insulin glargine) / Sanofi
Clinical, Journal: Rationale for a titratable fixed-ratio co-formulation of a basal insulin analog and a glucagon-like peptide 1 receptor agonist in patients with type 2 diabetes. (Pubmed Central) - Mar 26, 2020
The efficacy and safety of titratable fixed-ratio co-formulations have been demonstrated for insulin degludec/liraglutide and insulin glargine/lixisenatide in the DUAL and LixiLan trials, respectively, in both insulin-naive and -experienced patients. Titratable fixed-ratio co-formulations represent an attractive treatment option for many patients with T2D.

|||||||||| Soliqua 100/33 (lixisenatide + insulin glargine) / Sanofi, Lantus (insulin glargine) / Sanofi
Comparison of iGlarLixi with a basal bolus regimen in patients with type 2 diabetes using propensity score matching (PSM) (poster area 6) - Mar 22, 2020 - Abstract #DDG2020DDG_367;
iGlarLixi as a once-daily fixed combination of insulin glargine 100 U / ml and the GLP-1-RA lixisenatide could be a simple alternative to escalation to a basal bolus (BB) regime. iGlarLixi is an effective alternative to a BB regime with less hypoglycaemia and weight gain for patients with T2D who are not adequately controlled with a BOT at a moderate basal insulin dose.

|||||||||| Soliqua 100/33 (lixisenatide + insulin glargine) / Sanofi, Lantus (insulin glargine) / Sanofi
Switching to iGlarLixi compared to continued treatment with a GLP-1 receptor agonist for insufficiently controlled type 2 diabetes: the randomized LixiLan-G study (poster area 3) - Mar 22, 2020 - Abstract #DDG2020DDG_334;
Switching to iGlarLixi improved the blood sugar control of T2DM patients with insufficient HbA1c control, despite the maximum tolerated GLP-1-RA dose in previous therapy. The efficacy and tolerability of iGlarLixi were maintained through the study extension until week 52.

|||||||||| Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
Review, Journal: MANAGEMENT OF ENDOCRINE DISEASE: Are all GLP-1 agonist equal in the treatment of type 2 diabetes? (Pubmed Central) - Mar 18, 2020
Most GLP-1 receptor agonists (lixisenatide q.d., liraglutide q.d., exenatide q.w., dulaglutide q.w., albiglutide q.w., semaglutide q.w., all for s.c. injection, and the first oral preparation, oral semaglutide) have been examined in cardiovascular outcomes studies...Liraglutide, in addition, reduced cardiovascular and all-cause mortality. It is the purpose of the present review to describe clinically important differences, regarding pharmacokinetic behaviour, glucose-lowering potency, effectiveness of reducing body weight and controlling other cardiovascular risk factors, and of the influence of GLP-1 receptor agonist treatment on cardiovascular outcomes in patients either presenting with or without pre-existing cardiovascular disease (atherosclerotic, ischemic or congestive heart failure).

|||||||||| Soliqua 100/33 (lixisenatide + insulin glargine) / Sanofi, Lantus (insulin glargine) / Sanofi
Clinical, Journal: Fixed-Ratio Combination of Insulin and GLP-1 RA in Patients with Longstanding Type 2 Diabetes: A Subanalysis of LixiLan-L. (Pubmed Central) - Mar 14, 2020
It is the purpose of the present review to describe clinically important differences, regarding pharmacokinetic behaviour, glucose-lowering potency, effectiveness of reducing body weight and controlling other cardiovascular risk factors, and of the influence of GLP-1 receptor agonist treatment on cardiovascular outcomes in patients either presenting with or without pre-existing cardiovascular disease (atherosclerotic, ischemic or congestive heart failure). iGlarLixi lowered glycated haemoglobin more versus iGlar regardless of T2D duration, with benefit retained even among patients with the longest T2D duration.

|||||||||| Soliqua 100/33 (lixisenatide + insulin glargine) / Sanofi, Lantus (insulin glargine) / Sanofi, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Clinical, Clinical data, Journal: Impact of lixisenatide dose range on clinical outcomes with fixed-ratio combination iGlarLixi in patients with type 2 diabetes. (Pubmed Central) - Mar 12, 2020
iGlarLixi lowered glycated haemoglobin more versus iGlar regardless of T2D duration, with benefit retained even among patients with the longest T2D duration. This analysis demonstrates the clinical benefit of lixisenatide alone or in the formulation of iGlarLixi over the entire dose range of lixisenatide contained in iGlarLixi (5-20µg), supporting the selection of the lixisenatide dose range delivered by the iGlarLixi SoloSTAR pen.

||||||||||  Adlyxin (lixisenatide) / Sanofi, Trulicity (dulaglutide) / Eli Lilly
Trial completion date, Trial initiation date:  Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists (clinicaltrials.gov) -  Mar 11, 2020
P=N/A, N=10000, Completed,  Sponsor: University of Padova
This analysis demonstrates the clinical benefit of lixisenatide alone or in the formulation of iGlarLixi over the entire dose range of lixisenatide contained in iGlarLixi (5-20µg), supporting the selection of the lixisenatide dose range delivered by the iGlarLixi SoloSTAR pen. Trial completion date: Nov 2019 --> Feb 2020 | Initiation date: Mar 2015 --> Mar 2014

|||||||||| Lantus (insulin glargine) / Sanofi, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Journal: Expert Opinion on the Therapeutic Use of the Fixed-Ratio Combination of Insulin Glargine 100 U/mL and Lixisenatide: a Central/Eastern European Perspective. (Pubmed Central) - Mar 10, 2020
Topics included the positioning and initiation of iGlarLixi and the management of treatment. This paper summarizes the outcomes of the meeting.

|||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Journal: The protective effects of lixisenatide against inflammatory response in human rheumatoid arthritis fibroblast-like synoviocytes. (Pubmed Central) - Mar 8, 2020
Furthermore, lixisenatide improved oxidative stress, rescued mitochondrial membrane potential (ΔΨm), and prevented cell death in fibroblast-like synoviocytes. These findings suggest that agonism of the GLP-1 receptor using lixisenatide may serve as a novel therapeutic option for the treatment and prevention of RA.

|||||||||| Clinical, Journal, HEOR: Cost-effectiveness of once-weekly semaglutide versus dulaglutide and lixisenatide in patients with type 2 diabetes with inadequate glycemic control in Sweden. (Pubmed Central) - Feb 24, 2020
In patients inadequately controlled on basal insulin, the analyses versus lixisenatide were based on results from an NMA, as no head-to-head clinical trial has been conducted for this comparison. These CEA results show that once-weekly semaglutide is a cost-effective GLP-1 RA therapy for the treatment of T2D in patients inadequately controlled on metformin or basal insulin, addressing many current clinician, patient, and payer unmet needs in Sweden.

|||||||||| Soliqua 100/33 (lixisenatide + insulin glargine) / Sanofi, Lantus (insulin glargine) / Sanofi, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Journal: Insulin glargine/lixisenatide fixed-ratio combination improves glycaemic variability and control without increasing hypoglycaemia. (Pubmed Central) - Feb 7, 2020
By Week 30, iGlarLixi improved all GV parameters from baseline with no increased hypoglycaemia risk. Significant improvements were observed in SMPG, SD of SMPG, HBGI, AUCn, MAG, and MAGE compared with iGlar, and in SMPG, HBGI, and AUCn, compared with Lixi.

|||||||||| Byetta (exenatide) / AstraZeneca
Preclinical, Journal: Ureidopeptide GLP-1 analogues with prolonged activity in vivo via signal bias and altered receptor trafficking. (Pubmed Central) - Feb 6, 2020
Further analyses demonstrated that the improvement was due mainly to differences in signal bias and trafficking of the GLP-1 receptor. This study demonstrates the efficacy of single α-amino acid substitution with ureido residues to design long lasting peptides.

|||||||||| Lantus (insulin glargine) / Sanofi
Journal: Combined Insulin and GLP-1 Receptor Agonists: Simplifying Treatment or Adding Obstacles? (Pubmed Central) - Jan 30, 2020
With the availability of these agents, concerns with transitions of care arise due to multiple vulnerabilities in reconciling these agents throughout the inpatient admission and discharge process. Provider awareness of the availability and dosing of insulin glargine/lixisenatide and insulin degludec/liraglutide is essential to reduce errors in the medication reconciliation process.

||||||||||  Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Trial completion:  A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) -  Jan 30, 2020
P1, N=23, Completed,  Sponsor: Sanofi
Provider awareness of the availability and dosing of insulin glargine/lixisenatide and insulin degludec/liraglutide is essential to reduce errors in the medication reconciliation process. Active, not recruiting --> Completed

|||||||||| Lantus (insulin glargine) / Sanofi
Review, Journal, Combination therapy: Optimizing Fixed-Ratio Combination Therapy in Type 2 Diabetes. (Pubmed Central) - Jan 25, 2020
FRCs have demonstrated enhanced glycemic control compared with their constituent components alone, comparable risk of hypoglycemia compared with basal insulin alone, and better tolerability compared with the GLP-1RA component alone due to the slower titration. In this article, we discuss the advantages of FRCs over multiple daily injections, present case studies of typical patients who could benefit from FRC therapy, and outline practical considerations for the initiation of FRC therapy in clinical practice.Funding Sanofi.

|||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Journal: Sustained Release Strategy Designed for Lixisenatide Delivery to Synchronously Treat Diabetes and Associated Complications. (Pubmed Central) - Jan 21, 2020
Finally, an improvement in hyperlipidemia, augmentation of nerve fiber density and enhancement of motor nerve conduction velocity in the gel formulation-treated db/db mice indicated that the sustained delivery of Lixi arrested and even ameliorated diabetic complications. These findings suggested that the Lixi-loaded mixture hydrogel has great potential for the treatment of T2DM with significant improvements in the health and quality of life of patients.

|||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Clinical, Retrospective data, Journal: Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. (Pubmed Central) - Jan 21, 2020
P3
Registered 11 September 2009, NCT00866658. Registered 20 March 2009.

||||||||||  Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Enrollment closed:  A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM) (clinicaltrials.gov) -  Jan 7, 2020
P1, N=23, Active, not recruiting,  Sponsor: Sanofi
Registered 20 March 2009. Recruiting --> Active, not recruiting

|||||||||| Taltz (ixekizumab) / Eli Lilly, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
😂😂 Thank you @mmamas1973 Maybe Adlyxin or Byvalson or Taltz😉 It is fascinating how the drug names are selected https://t.co/H4PQyxIfyx via @statnews (Twitter) - Dec 30, 2019

|||||||||| SAFETY AND EFFICACY OF INSULIN GLARGINE/LIXISENATIDE AND INSULIN DEGLUDEC/INSULIN ASPART IN TYPE 2 DIABETES PATIENTS NOT CONTROLLED ON BASAL INSULIN: A NETWORK META-ANALYSIS (E-Poster Area) - Dec 29, 2019 - Abstract #ATTD2020ATTD_596;
Patients on IGlarLixi were also more likely to achieve HbA1c<7% than patients on IDegAsp (odds ratio [OR]=0.401 [95%CI -0.083;0.884], P<0.0001), with lower overall incidence of hypoglycaemia (OR=1.328 [95%CI 0.859;1.797], P<0.001). Conclusions In this trial meta-analysis, IGlarLixi seemed to be more efficient than IDegAsp in controlling HbA1c and PPG and was associated with greater weight loss and lower incidence of hypoglycaemia.

|||||||||| Rybelsus (semaglutide oral) / Novo Nordisk, metformin / Generic mfg., Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Review, Journal: Oral semaglutide (Rybelsus) for type 2 diabetes. (Pubmed Central) - Dec 22, 2019
Conclusions In this trial meta-analysis, IGlarLixi seemed to be more efficient than IDegAsp in controlling HbA1c and PPG and was associated with greater weight loss and lower incidence of hypoglycaemia. No abstract available

|||||||||| Review, Journal: Drugs for type 2 diabetes. (Pubmed Central) - Dec 22, 2019
No abstract available No abstract available

|||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
[VIRTUAL] INSULIN, LIXISENATIDE, AND RISK OF CARDIOVASCULAR EVENTS IN PATIENTS WITH TYPE 2 DIABETES AND A RECENT ACUTE CORONARY SYNDROME (eAbstract Virtual Hall) - Dec 22, 2019 - Abstract #ACC2020ACC_6958;
No abstract available While combined insulin use and lixisenatide was not associated with improved CV outcomes, the combination had favorable metabolic effects compared to insulin and placebo.

|||||||||| Clinical, Journal: Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. (Pubmed Central) - Dec 22, 2019
P3
While combined insulin use and lixisenatide was not associated with improved CV outcomes, the combination had favorable metabolic effects compared to insulin and placebo. In patients with T2D inadequately controlled on basal insulin, iGlarLixi offers an effective alternative to BB regimen for reducing HbA1c, without increased risk of hypoglycemia and weight gain.

|||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Journal: Lixisenatide reduces chylomicron triacylglycerol due to increased clearance. (Pubmed Central) - Dec 21, 2019
Lixisenatide reduced [13C]oleate concentration, derived from a single meal in CM-TAG, as well as glucose Rameal, through delayed gastric emptying. However day-long CM production, measured with repeated meal-feeding, was not reduced by lixisenatide and decreased CM-TAG concentration was due to increased CM-TAG clearance.

||||||||||  Adlyxin (lixisenatide) / Sanofi, Trulicity (dulaglutide) / Eli Lilly
New trial:  Cardiovascular Outcomes SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists (clinicaltrials.gov) -  Dec 3, 2019
P, N=10000, Completed,  Sponsor: University of Padova

|||||||||| Soliqua 100/33 (lixisenatide + insulin glargine) / Sanofi, Lantus (insulin glargine) / Sanofi
Clinical, Journal: EFFICACY AND SAFETY OF IGLARLIXI IN HISPANICS AND NON-HISPANIC WHITES WITH TYPE 2 DIABETES. (Pubmed Central) - Nov 29, 2019
P3
Nevertheless, in both trials, a greater proportion of patients taking iGlarLixi than iGlar reached the composite efficacy endpoints of target A1C without hypoglycemia, and target A1C without weight gain, regardless of ethnicity. These results indicate that iGlarLixi is a viable therapeutic option for both Hispanic and NHW patients with T2D, as it is efficacious without a significant increase in hypoglycemia, irrespective of ethnicity.

|||||||||| semaglutide SC once-daily (NN9536) / Novo Nordisk
Clinical, Journal: Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. (Pubmed Central) - Nov 28, 2019
P3, P4
Most adults with T2D in the United States would have qualified for enrollment into at least 1 of the GLP-1 RA CVOTs evaluated. EXSCEL had the most generalizable eligibility criteria of these trials and ELIXA the least.

|||||||||| Lantus (insulin glargine) / Sanofi, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Clinical, Journal: Renal tubular effects of prolonged therapy with the GLP-1 receptor agonist lixisenatide in patients with type 2 diabetes mellitus. (Pubmed Central) - Nov 28, 2019
In conclusion, lixisenatide affects postprandial urinary excretion of several electrolytes and increases urinary pH compared to insulin glulisine in T2DM patients after 8 weeks of treatment. This is most likely explained by a drug-induced rise in blood pressure, or direct inhibitory effects on NHE3 in the proximal tubule.

|||||||||| Lantus (insulin glargine) / Sanofi
Journal: Evaluating the managed care implications of longer-acting basal insulin analog therapies. (Pubmed Central) - Nov 24, 2019
This article spotlights the outcomes of the phase 3 clinical trials for these newer formulations, as well as more recent meta-analyses and real-world studies. It also highlights the implications for managed care plans as they move to add these insulins to their formularies.

|||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Journal: GLP-1 receptor agonist lixisenatide protects against high free fatty acids-induced oxidative stress and inflammatory response. (Pubmed Central) - Nov 21, 2019
This evidence indicates that lixisenatide suppresses activation of the NF-κB pathway in endothelial cells. Collectively, our findings suggest that lixisenatide might have therapeutic potential to modulate diabetes-associated vascular complications.

|||||||||| Soliqua 100/33 (lixisenatide + insulin glargine) / Sanofi, Lantus (insulin glargine) / Sanofi, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Gastrointestinal adverse events with insulin glargine/lixisenatide vs. GLP-1RAs in type 2 DM: a network meta-analysis (Poster Area) - Nov 20, 2019 - Abstract #IDF2019IDF_1184;

|||||||||| Jardiance (empagliflozin) / Eli Lilly, Boehringer Ingelheim, semaglutide SC once-daily (NN9536) / Novo Nordisk
Clinical, Review, Journal: Clinical implications of current cardiovascular outcome trials with sodium glucose cotransporter-2 (SGLT2) inhibitors. (Pubmed Central) - Oct 31, 2019
Two large-scale CV outcome trials with SGLT2 inhibitors showed significant empagliflozin proved to be superior in preventing CV and all-cause mortality, and canagliflozin proved to be superior in preventing CV mortality but not all-cause mortality...However, the risk-benefit profile for these new drugs will need further elucidation, and more studies are warranted to reveal the possible mechanisms. It will also be important to confirm these results from other ongoing trials with SGLT2 inhibitors.

|||||||||| Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
Review, Journal: Glucagon-Like Peptide-1 Receptor Analogues in Type 2 Diabetes: Their Use and Differential Features. (Pubmed Central) - Oct 29, 2019
The six subcutaneous GLP-1RA formulations (i.e. twice-daily exenatide, once-daily liraglutide and lixisenatide, and once-weekly dulaglutide, exenatide and semaglutide) currently available in the EU and USA have many similarities, but also some unique features and properties...GLP-1RAs are generally well tolerated, with gastrointestinal and injection-site reactions being the most troublesome drug-related adverse events, and are associated with a very low intrinsic risk of hypoglycaemia. Treatment with GLP-1RAs should be customized to meet the clinical needs and personal preferences of the individual.

|||||||||| Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
Review, Journal: Glucagon-Like Peptide-1 Receptor Agonists and Cardiovascular Risk Reduction in Type 2 Diabetes Mellitus: Is It a Class Effect? (Pubmed Central) - Oct 24, 2019
Once-weekly exenatide demonstrated only a non-significant (p = 0.06) favorable trend for CV superiority, possibly due to in-trial mishaps, including placebo drop-ins with other CV protective medications...Maintenance of 24-h circulating levels, by an alternative administration method, may resurrect lixisenatide as a cardioprotective agent. Before a GLP-1 RA bioequivalence "class effect" claim for composite MACE risk reduction superiority can be fully discussed, we are obliged to wait for the pending results of CVOTs with other GLP-1 RAs, particularly albiglutide and dulaglutide, where steric hindrance may potentially inhibit full mimicry of pharmacologic GLP-1.

|||||||||| Soliqua 100/33 (lixisenatide + insulin glargine) / Sanofi, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
#Suliqua launches in #UK https://t.co/Kci70bugDa @PharmaTimes @sanofi #insulin #glargine #lixisenatide #diabetes (Twitter) - Sep 30, 2019

|||||||||| Tanzeum (albiglutide) / GSK, Byetta (exenatide) / AstraZeneca
Journal: Albiglutide for the management of type 2 diabetes. (Pubmed Central) - Sep 22, 2019
A large long-term study is now underway to determine if albiglutide, with its relatively favorable GI tolerance, has a place in the treatment of patients with increased risk of cardiovascular events. At present, albiglutide is a safe agent to introduce GLP-1 RA treatment into the regimen for type 2 diabetes patients and may be the GLP-1 agent of choice in patients with renal insufficiency.

|||||||||| Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
Clinical, Journal: Assessment of Cardiovascular Risk With Glucagon-Like Peptide 1 Receptor Agonists in Patients With Type 2 Diabetes Using an Alternative Measure to the Hazard Ratio. (Pubmed Central) - Sep 20, 2019
Liraglutide and semaglutide decrease the risk of major adverse cardiovascular events compared with placebo when using the difference in RMST. The previously reported result that GLP-1 receptor agonists do not increase the risk of cardiovascular outcomes compared with placebo is also confirmed.

|||||||||| Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Journal: Lixisenatide enhances mitochondrial biogenesis and function through regulating the CREB/PGC-1α pathway. (Pubmed Central) - Sep 12, 2019
Blockage of CREB phosphorylation using its inhibitor H89 abolished the effects of lixisenatide on the activation of PGC-1α/NRF-1/TFAM as well as the increase in mtDNA/nDNA. These findings suggest that lixisenatide promoted mitochondrial biogenesis in endothelial cells through activating the PGC-1α signaling pathway, which is mediated by the transcriptional factor CREB.

|||||||||| Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
Clinical, Review, Journal: Cardiovascular Effects of Different GLP-1 Receptor Agonists in Patients with Type 2 Diabetes. (Pubmed Central) - Sep 8, 2019
The present review confirms the cardiovascular safety and efficacy vs placebo of GLP-1 RAs in patients with type 2 diabetes at moderate-to-high atherosclerotic cardiovascular risk without significant side effects. Although professional guidelines recommend metformin as the sole first-line agent, GLP-1 RAs can be used as first-line therapy in individuals with type 2 diabetes who either are intolerant to metformin or have high cardiovascular risk factors.

|||||||||| Byetta (exenatide) / AstraZeneca, semaglutide SC once-daily (NN9536) / Novo Nordisk
Review, Journal: Cardiovascular benefits of GLP-1 agonists in type 2 diabetes: a comparative review. (Pubmed Central) - Aug 28, 2019
Contrary to the assertions that (a) all GLP-1 agonists reduce CV disease in T2D but to different extents or (b) the magnitude of CV protection is predominantly related to glucose-lowering, we argue that CV benefit is specific to agents that provide longer acting agonism at the GLP-1 receptor. The mechanisms involve reduction in body weight and BP, and lowering of LDL-cholesterol and glucose, but pleiotropic effects-including suppression of low grade inflammation, vasodilation, and natriuresis-are also likely relevant.

|||||||||| Review, Journal: Cardiovascular protection in type 2 diabetes: insights from recent outcome trials. (Pubmed Central) - Aug 21, 2019
...Some studies on glucagon-like peptide-1 receptor agonists (liraglutide: LEADER trial; semaglutide: SUSTAIN-6 trial) found significant benefits for MACE, while treatment with sodium-glucose co-transporter-2 inhibitors (empagliflozin: EMPA-REG OUTCOME trial; canagliflozin: CANVAS trial) also significantly reduced MACE and reduced hospitalization for heart failure...This contrasts with the overall type 2 diabetes population receiving glucose-lowering therapies, where the majority of patients will not have had a MACE and will be regarded as primary prevention. Overall, the trials provide reassuring evidence that new glucose-lowering medications do not adversely affect CV events and some of these agents may offer CV protection.

|||||||||| Byetta (exenatide) / AstraZeneca, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
Preclinical, Journal: Lixisenatide requires a functional gut-vagus nerve-brain axis to trigger insulin secretion in controls and type 2 diabetic mice. (Pubmed Central) - Aug 17, 2019
Overall, the trials provide reassuring evidence that new glucose-lowering medications do not adversely affect CV events and some of these agents may offer CV protection. Altogether, our findings show that lixisenatide requires a functional vagus nerve and neuronal gut-brain-islets axis as well as the GLP-1 receptor to regulate glucose-induced insulin secretion in healthy and diabetic mice.



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